Pelvic floor muscle training itself × Female urinary incontinence — Common treatment and added device effects distinguished

Required evidence, verification status and materials actually read
Item	AVerification status	BReading scope	CReview item	DCurrent findings	EWhy unverified	FRequired materials and conditions	GFurther research
1	Partly verified	Full text not readStored summary read	N01 · Comparative efficacyIs the selected subclaim preserved separately from the added device effect?Required	The original subclaim is ‘Benefit of PFMT itself’, with grade B and the note ‘It was common to both arms and is not the target claim.’ The parent verdict concerns the added device effect and is D with 34 points. R01	Only the relevant stored-summary information is recorded; detailed original material and review of the existing content remain outstanding. The subclaim has no score, status or assessment axes, and parent values are not used to fill them. Its B grade has not been reassessed during this production.	Separate records of the original PFMT claim, verdict and boundaries	If a direct comparison evaluating PFMT itself is linked, review of the existing content can clarify its applicable scope.
2	Partly verified	Full text not readStored summary read	N02 · Comparative efficacyDoes OPAL's comparison identify the causal effect of PFMT itself?Required	Both OPAL groups received supervised PFMT; the difference was the addition of home vaginal-probe EMG biofeedback. The original text explicitly places PFMT itself outside this verdict's scope. R01	Only the relevant stored-summary information is recorded; detailed original material and review of the existing content remain outstanding. This active-control design provides no estimate separating the shared training effect from natural history, expectations and accompanying care.	Direct evidence comparing PFMT with an appropriate comparison without that training	A study with a comparator suitable for the PFMT-itself question, or preserved material containing such direct evidence, is needed.
3	Partly verified	Full text not readStored summary read	N03 · Comparative efficacyWhat are the women's incontinence types and baseline ability to contract?Required	OPAL included 600 women with stress or mixed urinary incontinence at 23 UK centers. Women with urgency-only incontinence or no ability to contract their pelvic floor muscles were excluded. R01	Only the relevant stored-summary information is recorded; detailed original material and review of the existing content remain outstanding. The stored summary does not provide denominators by baseline severity or incontinence type, or direct effects of PFMT itself within them.	Eligible populations and denominators by diagnosis, baseline severity and contraction ability	Obtain the original trial's eligibility criteria and baseline characteristics to distinguish populations appropriate to the PFMT-itself question.
4	Partly verified	Full text not readStored summary read	N04 · Comparative efficacyAre the shared PFMT program and accompanying treatments preserved?Required	Supervised PFMT in both groups is stated, but this summary does not specify the training schedule, actual exposure or accompanying treatments. R01	Only the relevant stored-summary information is recorded; detailed original material and review of the existing content remain outstanding. Research training methods are not invented or turned into instructions. Separation of the contributions of shared care remains unverified.	Research records of training, supervision, contact and accompanying treatments common to both groups	Link the original protocol's program components and actual exposure and accompanying-treatment data.
5	Partly verified	Full text not readStored summary read	N05 · Comparative efficacyAre the home probe's characteristics distinguished from the effect of PFMT itself?Required	The original text describes a vaginal probe displaying pelvic-floor electrical activity as a training aid. The warning against relabeling training benefit as device benefit is preserved. R01	Only the relevant stored-summary information is recorded; detailed original material and review of the existing content remain outstanding. The B grade for PFMT itself is not extended to every probe or every form of PFMT.	Material identifying training and the added device intervention separately	Link direct comparisons by device use and training components separately when available.
6	Partly verified	Full text not readStored summary read	N06 · Comparative efficacyTo which comparison do randomization and blinding details apply?Required	OPAL was a multicenter randomized active-control trial assigning 300 women to each group. Participants and therapists could not be blinded because of the nature of the interventions. R01	Only the relevant stored-summary information is recorded; detailed original material and review of the existing content remain outstanding. These randomized results are not transferred to a comparison of PFMT itself. Allocation concealment and detailed questionnaire measurement procedures are unread.	Records of the selected question's comparator, allocation concealment and outcome-assessment blinding	Obtain allocation and measurement procedures together with a direct comparison design for the selected question.
7	Partly verified	Full text not readStored summary read	N07 · Comparative efficacyWhat does the 24-month ICIQ-UI SF result show about PFMT itself?Required	OPAL's 24-month scores were 8.2 versus 8.5, comparing added-device treatment with the shared-training group. The original text states that both groups improved. R01	Only the relevant stored-summary information is recorded; detailed original material and review of the existing content remain outstanding. Within-group improvement is not converted into an effect size or CI for PFMT itself versus a comparator. Specific changes from baseline are not provided.	Baseline, comparator, between-group estimates and scale definitions for PFMT itself	Preserve between-group effects and CIs on the same scale from a direct comparison of PFMT itself.
8	Partly verified	Full text not readStored summary read	N08 · Comparative efficacyAre the added-device mean difference, CI and P value separated from PFMT-itself values?Required	The adjusted mean difference of −0.09 points, 95% CI −0.92 to 0.75 and P=0.84 describe the added device effect at 24 months. They are not effect estimates for PFMT itself. R01	Only the relevant stored-summary information is recorded; detailed original material and review of the existing content remain outstanding. A mean difference, CI and P value for PFMT itself were not directly established from this material.	Original effects, intervals and significance results matched to each question	Obtain original effects, intervals and analytical denominators from research directly comparing PFMT itself.
9	Partly verified	Full text not readStored summary read	N09 · Comparative efficacyTo which question do the 1.9-point and 2.5-point clinical thresholds apply?Required	The between-group threshold used for sample-size calculation was 2.5 points. A subsequent anchor analysis using the same OPAL data estimated a two-year minimal important difference of 1.9 points (95% CI 1.1 to 2.7) for conservative treatment. The original text judges that the added-device CI excludes both thresholds. R01	Only the relevant stored-summary information is recorded; detailed original material and review of the existing content remain outstanding. Exclusion of an added device benefit is not transferred into direct proof that PFMT itself is ineffective or effective. The subsequent anchor analysis is not a new independent efficacy trial.	Clinical-importance thresholds and plans appropriate to the selected comparison, population and duration	Preserve clinical importance and prespecified plans for a PFMT-itself comparison separately from the subsequent anchor analysis's applicability conditions.
10	Partly verified	Full text not readStored summary read	N10 · Comparative efficacyTo which outcome do analytical counts, questionnaire return and missing data apply?Required	OPAL randomized 600 women, with 225 and 235 in the 24-month primary analysis; the original text records 460. The Korean questionnaire-return wording of about 78% and English attrition wording of about 22% are preserved as originally written. R01	Only the relevant stored-summary information is recorded; detailed original material and review of the existing content remain outstanding. No new participant totals or percentages are calculated. Denominators, missing-data handling and reasons for missingness for a PFMT-itself comparison are unverified.	Original randomized and outcome-analysis denominators, attrition and missing-data handling	Obtain group-specific reasons and handling of missing questionnaires, sensitivity analyses and denominators for a direct PFMT comparison.
11	Unverified	Full text not readStored summary read	N11 · Comparative efficacyAre training adherence, actual exposure and departures distinguished in effect interpretation?Required	The summary states that both groups received supervised training, but this preserved material contains no data on training frequency, adherence, crossover or maintenance over time. R01	Only the relevant stored-summary information is recorded; detailed original material and review of the existing content remain outstanding. Unread material is not interpreted as no adherence or no training effect.	Links between actual training exposure, adherence, crossover, departures and outcomes	Link actual exposure, adherence and departure data from the original report and protocol.
12	Partly verified	Full text not readStored summary read	N12 · Comparative efficacyAre the outcome, time point and analytical hierarchy specified directly for PFMT effects?Required	OPAL's original key outcome was ICIQ-UI SF at 24 months, and the evidence record contains registration identifier ISRCTN57746448. R01	Only the relevant stored-summary information is recorded; detailed original material and review of the existing content remain outstanding. The source provides no registry URL, and the registry, protocol and SAP have not been newly read. The device comparison's primary-outcome hierarchy is not transferred to PFMT itself.	Primary outcome, duration and prespecified analysis plan for a PFMT-itself comparison	Link the registry, protocol, SAP and amendment history of a direct PFMT-itself comparison.
13	Partly verified	Full text not readStored summary read	N13 · Comparative efficacyAre incontinence episodes, quality of life, cure or improvement and symptom scores distinguished?Required	OPAL summarizes ICIQ-UI SF, Burgio summarizes reductions in incontinence episodes, and Cochrane summarizes quality of life and cure or improvement. R01 R02 R03	Only the relevant stored-summary information is recorded; detailed original material and review of the existing content remain outstanding. Different scales or composite responses are not combined as the same value for PFMT itself on 24-month symptoms.	Outcome-specific definitions, denominators, time points and direct-comparison scope	Link each outcome definition and report from a PFMT-itself comparison separately.
14	Partly verified	Full text not readStored summary read	N14 · Comparative efficacyDid Burgio 2002 directly test the selected question?Required	Burgio compared three different multicomponent behavioral programs in 222 women with urge or urge-predominant mixed incontinence. Episode reductions were 63.1% versus 69.4% versus 58.6%, P=0.23. R02	Only the relevant stored-summary information is recorded; detailed original material and review of the existing content remain outstanding. Those values are not the effect of PFMT itself versus no treatment. Group denominators, CIs and component-specific effects are absent from the summary.	Direct effect evidence with appropriate populations, interventions and comparisons	Obtain original components of each multicomponent program and material directly comparing PFMT.
15	Partly verified	Full text not readStored summary read	N15 · Comparative efficacyWhat are the Cochrane review's overall comparison and outcome-specific denominators?Required	The overall PFMT-plus-biofeedback versus PFMT comparison included 33 trials and 3,031 women. Quality of life included 11 trials and 1,169 women; cure or improvement included 14 trials and 1,383 women. R03	Only the relevant stored-summary information is recorded; detailed original material and review of the existing content remain outstanding. The 33 trials are not relabeled as direct trials of training versus no training or independent replications. Outcome-specific participant counts are not added together.	Eligible review comparisons, outcome-specific trial and participant counts, and overlap lists	Preserve the review's included-trial table, direct comparisons appropriate to the selected question and overlap mapping.
16	Partly verified	Full text not readStored summary read	N16 · Comparative efficacyDo the review's effects and CIs concern PFMT itself?Required	Quality-of-life SMD −0.07 (95% CI −0.18 to 0.05) and cure-or-improvement OR 1.26 (95% CI 1.00 to 1.58) concern added feedback. The original text records that the OR's lower bound of 1.00 prevents a conclusive characterization as either null or beneficial. R03	Only the relevant stored-summary information is recorded; detailed original material and review of the existing content remain outstanding. The review effects are not transferred to PFMT itself or treated as a confirmed null effect.	Original effects and CIs by outcome for comparisons appropriate to the selected question	Obtain outcome-specific effects and CIs, heterogeneity and analysis plans for PFMT-itself comparisons.
17	Partly verified	Full text not readStored summary read	N17 · Comparative efficacyAre the same reports and OPAL data kept from being counted as independent replications?Required	The OPAL summary and subsequent clinical-importance anchor analysis using the same data are preserved within one trial context. The original text did not count Burgio or Cochrane as independent replications of the same claim because their populations and comparisons differ. R01 R02 R03	Only the relevant stored-summary information is recorded; detailed original material and review of the existing content remain outstanding. Overlap between review trials and individual reports is unread externally. Final unique-trial and participant totals are not established.	Study-family links between original trials, subsequent analyses and reviews	Link identifiers for original trials, subsequent analyses and reviews containing them without newly certifying independence.
18	Partly verified	Full text not readStored summary read	N18 · Comparative efficacyAre sufficient direct sources linked for PFMT itself?Required	The subclaim's B grade is preserved as an original value, but the original text explicitly says that it is not the target of this device comparison. The three current references concern added devices or other behavioral-training contexts. R01 R02 R03	Only the relevant stored-summary information is recorded; detailed original material and review of the existing content remain outstanding. No separate direct material to newly establish the B grade for PFMT itself was searched during this production.	Separate direct sources and effect scope corresponding to the subclaim's B grade	If existing direct sources for PFMT itself are provided, link their population, comparator and outcome scope separately.
19	Partly verified	Full text not readStored summary read	N19 · Comparative efficacyIs the result applied to other incontinence types or women unable to contract?Required	OPAL's exclusions of women unable to contract and urgency-only incontinence are preserved. The original text does not rule out a role in helping women first learn to contract. R01 R02	Only the relevant stored-summary information is recorded; detailed original material and review of the existing content remain outstanding. Possible learning support is not turned into established efficacy, and studies of other types are not transferred unchanged.	Direct comparisons and denominators appropriate to population subgroups	Direct comparisons by incontinence type and baseline contraction ability are needed.
20	Partly verified	Full text not readStored summary read	N20 · Comparative efficacyIs training benefit extended to long-term clinical function or every product?Required	The selected claim concerns PFMT itself, while the parent material concerns urinary-incontinence symptoms at 24 months. Product advertising scope is separately cautioned about. R01	Only the relevant stored-summary information is recorded; detailed original material and review of the existing content remain outstanding. No new efficacy or instructions are created for other clinical functions, products, apps or devices.	Direct evidence for the selected symptoms and function- or product-specific applications	Link direct comparisons appropriate to each outcome, product and time point separately when available.
21	Partly verified	Full text not readStored summary read	N21 · Comparative efficacyAre public funding and sponsorship distinguished from the manufacturer's four roles?Required	Full funding by NIHR HTA project 11/71/03 and sponsorship by Glasgow Caledonian University are stated. The original text records manufacturer cash funding, free equipment, employed authors and outsourced analysis as unverified. R01	Only the relevant stored-summary information is recorded; detailed original material and review of the existing content remain outstanding. Unverified relationships are not converted into certification that all were absent or that independence was established. Funding structures for PFMT-itself evidence are separately unverified.	Separate records of cash funding, free equipment, employed authors and outsourced analysis	Obtain original disclosures for funding, equipment provision, affiliations and analytical roles separately.
22	Partly verified	Full text not readStored summary read	N22 · Comparative efficacyAre Burgio and review funding details kept separate from another trial's funding?Required	Burgio's evidence record lists US NIA/NIH, and the review is recorded as a Cochrane review. Both are preserved separately from OPAL's public funding. R02 R03	Only the relevant stored-summary information is recorded; detailed original material and review of the existing content remain outstanding. The review's funding wording alone does not establish manufacturer involvement or independence of its included trials.	Separate funding, investigator and comparison identities for each source	Link each report's original disclosures and funding mapping for its included trials.
23	Partly verified	Full text not readStored summary read	N23 · Supplementary harm evidenceTo which intervention do participant counts and relatedness of adverse events belong?Required	The original safety text records 48 participants reporting non-serious adverse events, with events in 23 judged related or possibly related to the intervention. Probe-associated discomfort and bleeding are recorded. R01	Only the relevant stored-summary information is recorded; detailed original material and review of the existing content remain outstanding. The 48 and 23 are not converted into event counts or harm rates for PFMT itself. Group-specific harm denominators and event tables are unread.	Group-specific harm definitions, exposure, denominators, collection procedures and original event data	Obtain original safety tables and group-specific events and relatedness, distinguishing training from the probe.
24	Partly verified	Full text not readStored summary read	N24 · Supplementary harm evidenceAre serious related complications distinguished from gaps in long-term and rare harms?Required	The original text records no serious related complications, and the parent's safety label is Caution. R01	Only the relevant stored-summary information is recorded; detailed original material and review of the existing content remain outstanding. No reported serious related complications is not extended to no serious events of any kind or established safety of PFMT itself.	Adequate observations by severity, relatedness, follow-up and rare harms	Link original group-specific serious events, long-term follow-up, rare harms and reasons for discontinuation.
25	Unverified	Full text not readStored summary read	N25 · Supplementary harm evidenceIs material available to separately replicate and verify harms of training and the probe?Required	Currently preserved harm information summarizes an active-control trial of an added device. Separate repeated harm evidence for PFMT itself is not provided. R01	Only the relevant stored-summary information is recorded; detailed original material and review of the existing content remain outstanding. Device-related discomfort and bleeding are not transferred to PFMT-itself harms. No new certification of replicated harms is performed.	Exposure, comparator and replicated harm evidence appropriate to PFMT itself	Harm data distinguishing training from probe exposure and follow-up of sufficient duration are needed.
26	Partly verified	Full text not readStored summary read	N26 · Comparative efficacyAre stored-summary reading and unread external sources distinguished?Required	The entire parent JSON, including Korean and English text, evidence, citations and subclaims, was read for production. The three bibliographic URLs were linked as originally recorded; external material was not opened. R01 R02 R03	Only the relevant stored-summary information is recorded; detailed original material and review of the existing content remain outstanding. Having a URL does not upgrade an abstract, full text, registry, protocol or SAP to having been read during this work.	Individual access records for summaries, papers, reviews, registries, protocols and SAPs	If obtained original material is provided, link actual access and evidence for the relevant question separately for each source.
27	Partly verified	Full text not readStored summary read	N27 · Comparative efficacyAre dates, corrections, Korean and English text and original-verdict history preserved?Required	The entire source copy preserves the original date 2026-08-26, an empty corrections array, Korean and English text, parent grade D with 34 points and Caution with its assessment axes, and subclaim grade B. R01 R02 R03	Only the relevant stored-summary information is recorded; detailed original material and review of the existing content remain outstanding. No new-date verification, clinical-grade change or correction-target check was performed. This production date is not a new evidence date.	Unchanged preservation of original values, language-specific wording, dates and corrections	If additional material arises, preserve the original text and link a separate update event to review of the existing content.
28	Partly verified	Full text not readStored summary read	N28 · Comparative efficacyIs current production distinguished from independence or completed content review?Supplementary	The original candidate's need for boundary review and production-eligibility values are preserved as history. Existing content review remains incomplete, and model, content and boundary review activation and completion flags are false. R01 R02 R03	Only the relevant stored-summary information is recorded; detailed original material and review of the existing content remain outstanding. Production itself is neither clinical certification of the subclaim's B grade or independence nor completed review. No structural unit was added, and the final independent count remains unrecorded.	Separate records of produced files, candidate history and existing-content review status	After content review, reflect only provided decisions and material in a separate event.

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28 itemsWhat the statuses mean

Assessment scope

Stored-material review date: Not recorded
Original evidence cut-off: 2026-08-26
Scope actually checked: Existing review summaries and stored records of methodological application. Full papers, supplements, registrations, plans and original data were not read.
What the dates mean: This is the date the stored materials were checked, not the date of a new search of the clinical literature.
Population: Women with stress or mixed urinary incontinence able to contract in OPAL; parent comparison context excluding urgency-only incontinence and inability to contract
Ingredient, formulation and route: Supervised PFMT; treatment common to both OPAL groups
Dose: Specific training schedules and actual exposure are unverified in the stored summary; no instructions are generated
Comparator: The selected question requires a direct comparison of PFMT itself; OPAL compared PFMT plus EMG biofeedback with PFMT
Measured outcome: The selected question concerns PFMT itself; the parent OPAL outcome is ICIQ-UI SF at 24 months
Duration: Parent OPAL follow-up was 24 months; duration of direct PFMT-itself comparisons is unverified
Questions outside this scope: Transferring the added device effect to PFMT itself; Automatic application to women unable to contract or with urgency-only incontinence; Establishing efficacy of devices, apps or all forms of training; Instructions for training or treatment

Evidence and sources

The links below lead to the sources. A link alone does not mean the original source was read or its latest publication status verified.

R01 · Hagen S, Bugge C, Dean SG, et al. BMJ. 2020;371:m3719. PMID: 33055247.

PubMed

Material type: Trial report
Materials actually read: Summary read; external materials not read
Findings recorded in the stored summary: 8.2 versus 8.5; adjusted difference −0.09 (95% CI −0.92 to 0.75), P=0.84
Record level: Preserved review summary; not a result of actually reading external papers or communications
Study overlap and independent replication: OPAL: a subsequent anchor analysis of the same trial is not counted as another trial; Burgio 2002: different population and multicomponent behavioral comparisons; Cochrane review: included-trial overlap and the list of direct PFMT comparisons are unread; reports, reviews, reanalyses and the same population are not summed as new independent trials or participants. Family identifiers link relationships and do not certify unique-trial counts.

Public availability, access and reading status by material
Material	Public availability	Access status	Actually read	Notes
Stored summary	Original source link preserved	Summary read	Summary read	Preserved parent summary
External abstract	Original source link preserved	Not read	Not read	External material unread; the presence or absence of a URL does not mean material acquisition or completed review
External full text or regulatory source	No separate URL in the original material	Not read	Not read	External material unread; the presence or absence of a URL does not mean material acquisition or completed review
Registration material	No separate URL in the original material	Not read	Not read	External material unread; the presence or absence of a URL does not mean material acquisition or completed review
Protocol and statistical analysis plan	No separate URL in the original material	Not read	Not read	External material unread; the presence or absence of a URL does not mean material acquisition or completed review

R02 · Burgio KL, et al. JAMA. 2002;288:2293-2299. PMID: 12425706.

PubMed

Material type: Trial report
Materials actually read: Summary read; external materials not read
Findings recorded in the stored summary: 63.1% versus 69.4% versus 58.6%, P=0.23
Record level: Preserved review summary; not a result of actually reading external papers or communications
Study overlap and independent replication: OPAL: a subsequent anchor analysis of the same trial is not counted as another trial; Burgio 2002: different population and multicomponent behavioral comparisons; Cochrane review: included-trial overlap and the list of direct PFMT comparisons are unread; reports, reviews, reanalyses and the same population are not summed as new independent trials or participants. Family identifiers link relationships and do not certify unique-trial counts.

Public availability, access and reading status by material
Material	Public availability	Access status	Actually read	Notes
Stored summary	Original source link preserved	Summary read	Summary read	Preserved parent summary
External abstract	Original source link preserved	Not read	Not read	External material unread; the presence or absence of a URL does not mean material acquisition or completed review
External full text or regulatory source	No separate URL in the original material	Not read	Not read	External material unread; the presence or absence of a URL does not mean material acquisition or completed review
Registration material	No separate URL in the original material	Not read	Not read	External material unread; the presence or absence of a URL does not mean material acquisition or completed review
Protocol and statistical analysis plan	No separate URL in the original material	Not read	Not read	External material unread; the presence or absence of a URL does not mean material acquisition or completed review

R03 · Fernandes ACNL, et al. Cochrane Database Syst Rev. Pelvic floor muscle training with feedback or biofeedback for urinary incontinence in women.

Official source

Material type: Systematic review
Materials actually read: Summary read; external materials not read
Findings recorded in the stored summary: Quality of life: 11 trials, 1,169 women, SMD −0.07 (95% CI −0.18 to 0.05); cure or improvement: 14 trials, 1,383 women, OR 1.26 (95% CI 1.00 to 1.58)
Record level: Preserved review summary; not a result of actually reading external papers or communications
Study overlap and independent replication: OPAL: a subsequent anchor analysis of the same trial is not counted as another trial; Burgio 2002: different population and multicomponent behavioral comparisons; Cochrane review: included-trial overlap and the list of direct PFMT comparisons are unread; reports, reviews, reanalyses and the same population are not summed as new independent trials or participants. Family identifiers link relationships and do not certify unique-trial counts.

Public availability, access and reading status by material
Material	Public availability	Access status	Actually read	Notes
Stored summary	Original source link preserved	Summary read	Summary read	Preserved parent summary
External abstract	No separate URL in the original material	Not read	Not read	External material unread; the presence or absence of a URL does not mean material acquisition or completed review
External full text or regulatory source	Original source link preserved	Not read	Not read	External material unread; the presence or absence of a URL does not mean material acquisition or completed review
Registration material	No separate URL in the original material	Not read	Not read	External material unread; the presence or absence of a URL does not mean material acquisition or completed review
Protocol and statistical analysis plan	No separate URL in the original material	Not read	Not read	External material unread; the presence or absence of a URL does not mean material acquisition or completed review

Report counts versus independent study counts

OPAL: a subsequent anchor analysis of the same trial is not counted as another trial; Burgio 2002: different population and multicomponent behavioral comparisons; Cochrane review: included-trial overlap and the list of direct PFMT comparisons are unread; reports, reviews, reanalyses and the same population are not summed as new independent trials or participants. Family identifiers link relationships and do not certify unique-trial counts.

Review criteria

Version 1.0 · Criteria record date 2026-10-06. These are Chamgap's own application conditions, informed by the referenced methods. They do not constitute official assessment-tool certification or a new efficacy score.

N01 · Is the selected subclaim preserved separately from the added device effect?

Required materials and conditions: Separate records of the original PFMT claim, verdict and boundaries
Conditions for verification: Separate records of the original PFMT claim, verdict and boundaries
Requirement and applicability: Required
Application exceptions: Unread external material or results outside the question’s scope are not substituted with satisfied, null-effect or safe labels.
Why this condition is needed: Condition for recording direct comparisons, original values and interpretation boundaries for the selected question
Referenced methods: Benefit of PFMT itself

N02 · Does OPAL's comparison identify the causal effect of PFMT itself?

Required materials and conditions: Direct evidence comparing PFMT with an appropriate comparison without that training
Conditions for verification: Direct evidence comparing PFMT with an appropriate comparison without that training
Requirement and applicability: Required
Application exceptions: Unread external material or results outside the question’s scope are not substituted with satisfied, null-effect or safe labels.
Why this condition is needed: Condition for recording direct comparisons, original values and interpretation boundaries for the selected question
Referenced methods: Benefit of PFMT itself

N03 · What are the women's incontinence types and baseline ability to contract?

Required materials and conditions: Eligible populations and denominators by diagnosis, baseline severity and contraction ability
Conditions for verification: Eligible populations and denominators by diagnosis, baseline severity and contraction ability
Requirement and applicability: Required
Application exceptions: Unread external material or results outside the question’s scope are not substituted with satisfied, null-effect or safe labels.
Why this condition is needed: Condition for recording direct comparisons, original values and interpretation boundaries for the selected question
Referenced methods: Benefit of PFMT itself

N04 · Are the shared PFMT program and accompanying treatments preserved?

Required materials and conditions: Research records of training, supervision, contact and accompanying treatments common to both groups
Conditions for verification: Research records of training, supervision, contact and accompanying treatments common to both groups
Requirement and applicability: Required
Application exceptions: Unread external material or results outside the question’s scope are not substituted with satisfied, null-effect or safe labels.
Why this condition is needed: Condition for recording direct comparisons, original values and interpretation boundaries for the selected question
Referenced methods: Benefit of PFMT itself

N05 · Are the home probe's characteristics distinguished from the effect of PFMT itself?

Required materials and conditions: Material identifying training and the added device intervention separately
Conditions for verification: Material identifying training and the added device intervention separately
Requirement and applicability: Required
Application exceptions: Unread external material or results outside the question’s scope are not substituted with satisfied, null-effect or safe labels.
Why this condition is needed: Condition for recording direct comparisons, original values and interpretation boundaries for the selected question
Referenced methods: Benefit of PFMT itself

N06 · To which comparison do randomization and blinding details apply?

Required materials and conditions: Records of the selected question's comparator, allocation concealment and outcome-assessment blinding
Conditions for verification: Records of the selected question's comparator, allocation concealment and outcome-assessment blinding
Requirement and applicability: Required
Application exceptions: Unread external material or results outside the question’s scope are not substituted with satisfied, null-effect or safe labels.
Why this condition is needed: Condition for recording direct comparisons, original values and interpretation boundaries for the selected question
Referenced methods: Benefit of PFMT itself

N07 · What does the 24-month ICIQ-UI SF result show about PFMT itself?

Required materials and conditions: Baseline, comparator, between-group estimates and scale definitions for PFMT itself
Conditions for verification: Baseline, comparator, between-group estimates and scale definitions for PFMT itself
Requirement and applicability: Required
Application exceptions: Unread external material or results outside the question’s scope are not substituted with satisfied, null-effect or safe labels.
Why this condition is needed: Condition for recording direct comparisons, original values and interpretation boundaries for the selected question
Referenced methods: Benefit of PFMT itself

N08 · Are the added-device mean difference, CI and P value separated from PFMT-itself values?

Required materials and conditions: Original effects, intervals and significance results matched to each question
Conditions for verification: Original effects, intervals and significance results matched to each question
Requirement and applicability: Required
Application exceptions: Unread external material or results outside the question’s scope are not substituted with satisfied, null-effect or safe labels.
Why this condition is needed: Condition for recording direct comparisons, original values and interpretation boundaries for the selected question
Referenced methods: Benefit of PFMT itself

N09 · To which question do the 1.9-point and 2.5-point clinical thresholds apply?

Required materials and conditions: Clinical-importance thresholds and plans appropriate to the selected comparison, population and duration
Conditions for verification: Clinical-importance thresholds and plans appropriate to the selected comparison, population and duration
Requirement and applicability: Required
Application exceptions: Unread external material or results outside the question’s scope are not substituted with satisfied, null-effect or safe labels.
Why this condition is needed: Condition for recording direct comparisons, original values and interpretation boundaries for the selected question
Referenced methods: Benefit of PFMT itself

N10 · To which outcome do analytical counts, questionnaire return and missing data apply?

Required materials and conditions: Original randomized and outcome-analysis denominators, attrition and missing-data handling
Conditions for verification: Original randomized and outcome-analysis denominators, attrition and missing-data handling
Requirement and applicability: Required
Application exceptions: Unread external material or results outside the question’s scope are not substituted with satisfied, null-effect or safe labels.
Why this condition is needed: Condition for recording direct comparisons, original values and interpretation boundaries for the selected question
Referenced methods: Benefit of PFMT itself

N11 · Are training adherence, actual exposure and departures distinguished in effect interpretation?

Required materials and conditions: Links between actual training exposure, adherence, crossover, departures and outcomes
Conditions for verification: Links between actual training exposure, adherence, crossover, departures and outcomes
Requirement and applicability: Required
Application exceptions: Unread external material or results outside the question’s scope are not substituted with satisfied, null-effect or safe labels.
Why this condition is needed: Condition for recording direct comparisons, original values and interpretation boundaries for the selected question
Referenced methods: Benefit of PFMT itself

N12 · Are the outcome, time point and analytical hierarchy specified directly for PFMT effects?

Required materials and conditions: Primary outcome, duration and prespecified analysis plan for a PFMT-itself comparison
Conditions for verification: Primary outcome, duration and prespecified analysis plan for a PFMT-itself comparison
Requirement and applicability: Required
Application exceptions: Unread external material or results outside the question’s scope are not substituted with satisfied, null-effect or safe labels.
Why this condition is needed: Condition for recording direct comparisons, original values and interpretation boundaries for the selected question
Referenced methods: Benefit of PFMT itself

N13 · Are incontinence episodes, quality of life, cure or improvement and symptom scores distinguished?

Required materials and conditions: Outcome-specific definitions, denominators, time points and direct-comparison scope
Conditions for verification: Outcome-specific definitions, denominators, time points and direct-comparison scope
Requirement and applicability: Required
Application exceptions: Unread external material or results outside the question’s scope are not substituted with satisfied, null-effect or safe labels.
Why this condition is needed: Condition for recording direct comparisons, original values and interpretation boundaries for the selected question
Referenced methods: Benefit of PFMT itself

N14 · Did Burgio 2002 directly test the selected question?

Required materials and conditions: Direct effect evidence with appropriate populations, interventions and comparisons
Conditions for verification: Direct effect evidence with appropriate populations, interventions and comparisons
Requirement and applicability: Required
Application exceptions: Unread external material or results outside the question’s scope are not substituted with satisfied, null-effect or safe labels.
Why this condition is needed: Condition for recording direct comparisons, original values and interpretation boundaries for the selected question
Referenced methods: Benefit of PFMT itself

N15 · What are the Cochrane review's overall comparison and outcome-specific denominators?

Required materials and conditions: Eligible review comparisons, outcome-specific trial and participant counts, and overlap lists
Conditions for verification: Eligible review comparisons, outcome-specific trial and participant counts, and overlap lists
Requirement and applicability: Required
Application exceptions: Unread external material or results outside the question’s scope are not substituted with satisfied, null-effect or safe labels.
Why this condition is needed: Condition for recording direct comparisons, original values and interpretation boundaries for the selected question
Referenced methods: Benefit of PFMT itself

N16 · Do the review's effects and CIs concern PFMT itself?

Required materials and conditions: Original effects and CIs by outcome for comparisons appropriate to the selected question
Conditions for verification: Original effects and CIs by outcome for comparisons appropriate to the selected question
Requirement and applicability: Required
Application exceptions: Unread external material or results outside the question’s scope are not substituted with satisfied, null-effect or safe labels.
Why this condition is needed: Condition for recording direct comparisons, original values and interpretation boundaries for the selected question
Referenced methods: Benefit of PFMT itself

N17 · Are the same reports and OPAL data kept from being counted as independent replications?

Required materials and conditions: Study-family links between original trials, subsequent analyses and reviews
Conditions for verification: Study-family links between original trials, subsequent analyses and reviews
Requirement and applicability: Required
Application exceptions: Unread external material or results outside the question’s scope are not substituted with satisfied, null-effect or safe labels.
Why this condition is needed: Condition for recording direct comparisons, original values and interpretation boundaries for the selected question
Referenced methods: Benefit of PFMT itself

N18 · Are sufficient direct sources linked for PFMT itself?

Required materials and conditions: Separate direct sources and effect scope corresponding to the subclaim's B grade
Conditions for verification: Separate direct sources and effect scope corresponding to the subclaim's B grade
Requirement and applicability: Required
Application exceptions: Unread external material or results outside the question’s scope are not substituted with satisfied, null-effect or safe labels.
Why this condition is needed: Condition for recording direct comparisons, original values and interpretation boundaries for the selected question
Referenced methods: Benefit of PFMT itself

N19 · Is the result applied to other incontinence types or women unable to contract?

Required materials and conditions: Direct comparisons and denominators appropriate to population subgroups
Conditions for verification: Direct comparisons and denominators appropriate to population subgroups
Requirement and applicability: Required
Application exceptions: Unread external material or results outside the question’s scope are not substituted with satisfied, null-effect or safe labels.
Why this condition is needed: Condition for recording direct comparisons, original values and interpretation boundaries for the selected question
Referenced methods: Benefit of PFMT itself

N20 · Is training benefit extended to long-term clinical function or every product?

Required materials and conditions: Direct evidence for the selected symptoms and function- or product-specific applications
Conditions for verification: Direct evidence for the selected symptoms and function- or product-specific applications
Requirement and applicability: Required
Application exceptions: Unread external material or results outside the question’s scope are not substituted with satisfied, null-effect or safe labels.
Why this condition is needed: Condition for recording direct comparisons, original values and interpretation boundaries for the selected question
Referenced methods: Benefit of PFMT itself

N21 · Are public funding and sponsorship distinguished from the manufacturer's four roles?

Required materials and conditions: Separate records of cash funding, free equipment, employed authors and outsourced analysis
Conditions for verification: Separate records of cash funding, free equipment, employed authors and outsourced analysis
Requirement and applicability: Required
Application exceptions: Unread external material or results outside the question’s scope are not substituted with satisfied, null-effect or safe labels.
Why this condition is needed: Condition for recording direct comparisons, original values and interpretation boundaries for the selected question
Referenced methods: Benefit of PFMT itself

N22 · Are Burgio and review funding details kept separate from another trial's funding?

Required materials and conditions: Separate funding, investigator and comparison identities for each source
Conditions for verification: Separate funding, investigator and comparison identities for each source
Requirement and applicability: Required
Application exceptions: Unread external material or results outside the question’s scope are not substituted with satisfied, null-effect or safe labels.
Why this condition is needed: Condition for recording direct comparisons, original values and interpretation boundaries for the selected question
Referenced methods: Benefit of PFMT itself

N23 · To which intervention do participant counts and relatedness of adverse events belong?

Required materials and conditions: Group-specific harm definitions, exposure, denominators, collection procedures and original event data
Conditions for verification: Group-specific harm definitions, exposure, denominators, collection procedures and original event data
Requirement and applicability: Required
Application exceptions: Unread external material or results outside the question’s scope are not substituted with satisfied, null-effect or safe labels.
Why this condition is needed: Condition for recording direct comparisons, original values and interpretation boundaries for the selected question
Referenced methods: Benefit of PFMT itself

N24 · Are serious related complications distinguished from gaps in long-term and rare harms?

Required materials and conditions: Adequate observations by severity, relatedness, follow-up and rare harms
Conditions for verification: Adequate observations by severity, relatedness, follow-up and rare harms
Requirement and applicability: Required
Application exceptions: Unread external material or results outside the question’s scope are not substituted with satisfied, null-effect or safe labels.
Why this condition is needed: Condition for recording direct comparisons, original values and interpretation boundaries for the selected question
Referenced methods: Benefit of PFMT itself

N25 · Is material available to separately replicate and verify harms of training and the probe?

Required materials and conditions: Exposure, comparator and replicated harm evidence appropriate to PFMT itself
Conditions for verification: Exposure, comparator and replicated harm evidence appropriate to PFMT itself
Requirement and applicability: Required
Application exceptions: Unread external material or results outside the question’s scope are not substituted with satisfied, null-effect or safe labels.
Why this condition is needed: Condition for recording direct comparisons, original values and interpretation boundaries for the selected question
Referenced methods: Benefit of PFMT itself

N26 · Are stored-summary reading and unread external sources distinguished?

Required materials and conditions: Individual access records for summaries, papers, reviews, registries, protocols and SAPs
Conditions for verification: Individual access records for summaries, papers, reviews, registries, protocols and SAPs
Requirement and applicability: Required
Application exceptions: Unread external material or results outside the question’s scope are not substituted with satisfied, null-effect or safe labels.
Why this condition is needed: Condition for recording direct comparisons, original values and interpretation boundaries for the selected question
Referenced methods: Benefit of PFMT itself

N27 · Are dates, corrections, Korean and English text and original-verdict history preserved?

Required materials and conditions: Unchanged preservation of original values, language-specific wording, dates and corrections
Conditions for verification: Unchanged preservation of original values, language-specific wording, dates and corrections
Requirement and applicability: Required
Application exceptions: Unread external material or results outside the question’s scope are not substituted with satisfied, null-effect or safe labels.
Why this condition is needed: Condition for recording direct comparisons, original values and interpretation boundaries for the selected question
Referenced methods: Benefit of PFMT itself

N28 · Is current production distinguished from independence or completed content review?

Required materials and conditions: Separate records of produced files, candidate history and existing-content review status
Conditions for verification: Separate records of produced files, candidate history and existing-content review status
Requirement and applicability: Supplementary
Application exceptions: Unread external material or results outside the question’s scope are not substituted with satisfied, null-effect or safe labels.
Why this condition is needed: Supplementary condition separating production status and scope of application
Referenced methods: Benefit of PFMT itself

Referenced methods and the sections actually reviewed

M03 · Cochrane Handbook 6.5 (2024), chapter updated 2023-08

Official methodology · §3.1, §3.2.1–3.2.3, MECIR C5/C7/C13

Referenced principle: Clearly record the question, eligibility conditions and reasons for changes, and distinguish variations in interventions.
Extent of review: Preserved methodology connections were reused for preparation. No new review of methodological content, reassessment or external-link checks were performed.

M04 · Cochrane Handbook 6.5.1 (2025), chapter updated 2025-03

Official methodology · §4.5, §4.6.1–4.6.3, MECIR C42

Referenced principle: Distinguish studies from reports and link them; do not omit a study solely because results are unreported.
Extent of review: Preserved methodology connections were reused for preparation. No new review of methodological content, reassessment or external-link checks were performed.

M08 · Cochrane Handbook 6.5 (2024), chapter updated 2019-10

Official methodology · §8.1–8.2.3, Table 8.2.a

Referenced principle: Define the outcome and effect of interest, then examine randomization, deviations, missing data, measurement and selective reporting.
Extent of review: Preserved methodology connections were reused for preparation. No new review of methodological content, reassessment or external-link checks were performed.

M15 · Cochrane Handbook 6.5 (2024), chapter updated 2023-08

Official methodology · §15.2.4, §15.3.1–15.3.3

Referenced principle: Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision.
Extent of review: Preserved methodology connections were reused for preparation. No new review of methodological content, reassessment or external-link checks were performed.

M19 · Cochrane Handbook 6.5 (2024), chapter updated 2019-10

Official methodology · §19.1.2, §19.2.1–19.2.4

Referenced principle: Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence rates.
Extent of review: Preserved methodology connections were reused for preparation. No new review of methodological content, reassessment or external-link checks were performed.

What the statuses mean

Partly verified: Some information exists in the preserved review summary; detailed original materials remain unverified. This does not certify a passed review or clinical efficacy.
Unverified: Detailed materials for the selected condition could not be established within the stored scope; this does not mean zero effect, zero studies or safety
Review incomplete: Review of existing content incomplete
Met: Use only within the relevant conditions after existing content review; no automatic designation in this preparation
Not reported: Distinguish only within materials actually read; do not turn unread external materials into unreported findings
Inaccessible: Not applied during this preparation because actual access was not tested
Not applicable: Use with a reason for non-applicability based on an explicit question boundary
Conflicting data: Judge after actual material comparison; review was not performed during this preparation
Insufficient evidence for the conditions: Do not use as a clinical grade encompassing currently unread materials

Change history

2026-10-11 · Public page/material version 1.0

Public reader pages and material were prepared from the existing 28 items. No new clinical searches, verification-state changes or scoring were performed.

The stored-material review date (Not recorded) and original evidence cut-off (2026-08-26) were retained unchanged.

Researcher downloads

These materials provide the same evidence, scope and verification status as this page.

View all item details

N01 · Is the selected subclaim preserved separately from the added device effect?

Current findings: The original subclaim is ‘Benefit of PFMT itself’, with grade B and the note ‘It was common to both arms and is not the target claim.’ The parent verdict concerns the added device effect and is D with 34 points.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Only the relevant stored-summary information is recorded; detailed original material and review of the existing content remain outstanding. The subclaim has no score, status or assessment axes, and parent values are not used to fill them. Its B grade has not been reassessed during this production.
Reason for missing information: The subclaim has no score, status or assessment axes, and parent values are not used to fill them. Its B grade has not been reassessed during this production.
Required materials and conditions: Separate records of the original PFMT claim, verdict and boundaries
Materials to obtain first: The subclaim has no score, status or assessment axes, and parent values are not used to fill them. Its B grade has not been reassessed during this production.
Further research: If a direct comparison evaluating PFMT itself is linked, review of the existing content can clarify its applicable scope.
Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification: Separate records of the original PFMT claim, verdict and boundaries
Why this condition is needed: Condition for recording direct comparisons, original values and interpretation boundaries for the selected question
Application exceptions: Unread external material or results outside the question’s scope are not substituted with satisfied, null-effect or safe labels.
Referenced methods: Benefit of PFMT itself

Related sources R01

N02 · Does OPAL's comparison identify the causal effect of PFMT itself?

Current findings: Both OPAL groups received supervised PFMT; the difference was the addition of home vaginal-probe EMG biofeedback. The original text explicitly places PFMT itself outside this verdict's scope.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Only the relevant stored-summary information is recorded; detailed original material and review of the existing content remain outstanding. This active-control design provides no estimate separating the shared training effect from natural history, expectations and accompanying care.
Reason for missing information: This active-control design provides no estimate separating the shared training effect from natural history, expectations and accompanying care.
Required materials and conditions: Direct evidence comparing PFMT with an appropriate comparison without that training
Materials to obtain first: This active-control design provides no estimate separating the shared training effect from natural history, expectations and accompanying care.
Further research: A study with a comparator suitable for the PFMT-itself question, or preserved material containing such direct evidence, is needed.
Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification: Direct evidence comparing PFMT with an appropriate comparison without that training
Why this condition is needed: Condition for recording direct comparisons, original values and interpretation boundaries for the selected question
Application exceptions: Unread external material or results outside the question’s scope are not substituted with satisfied, null-effect or safe labels.
Referenced methods: Benefit of PFMT itself

Related sources R01

N03 · What are the women's incontinence types and baseline ability to contract?

Current findings: OPAL included 600 women with stress or mixed urinary incontinence at 23 UK centers. Women with urgency-only incontinence or no ability to contract their pelvic floor muscles were excluded.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Only the relevant stored-summary information is recorded; detailed original material and review of the existing content remain outstanding. The stored summary does not provide denominators by baseline severity or incontinence type, or direct effects of PFMT itself within them.
Reason for missing information: The stored summary does not provide denominators by baseline severity or incontinence type, or direct effects of PFMT itself within them.
Required materials and conditions: Eligible populations and denominators by diagnosis, baseline severity and contraction ability
Materials to obtain first: The stored summary does not provide denominators by baseline severity or incontinence type, or direct effects of PFMT itself within them.
Further research: Obtain the original trial's eligibility criteria and baseline characteristics to distinguish populations appropriate to the PFMT-itself question.
Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification: Eligible populations and denominators by diagnosis, baseline severity and contraction ability
Why this condition is needed: Condition for recording direct comparisons, original values and interpretation boundaries for the selected question
Application exceptions: Unread external material or results outside the question’s scope are not substituted with satisfied, null-effect or safe labels.
Referenced methods: Benefit of PFMT itself

Related sources R01

N04 · Are the shared PFMT program and accompanying treatments preserved?

Current findings: Supervised PFMT in both groups is stated, but this summary does not specify the training schedule, actual exposure or accompanying treatments.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Only the relevant stored-summary information is recorded; detailed original material and review of the existing content remain outstanding. Research training methods are not invented or turned into instructions. Separation of the contributions of shared care remains unverified.
Reason for missing information: Research training methods are not invented or turned into instructions. Separation of the contributions of shared care remains unverified.
Required materials and conditions: Research records of training, supervision, contact and accompanying treatments common to both groups
Materials to obtain first: Research training methods are not invented or turned into instructions. Separation of the contributions of shared care remains unverified.
Further research: Link the original protocol's program components and actual exposure and accompanying-treatment data.
Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification: Research records of training, supervision, contact and accompanying treatments common to both groups
Why this condition is needed: Condition for recording direct comparisons, original values and interpretation boundaries for the selected question
Application exceptions: Unread external material or results outside the question’s scope are not substituted with satisfied, null-effect or safe labels.
Referenced methods: Benefit of PFMT itself

Related sources R01

N05 · Are the home probe's characteristics distinguished from the effect of PFMT itself?

Current findings: The original text describes a vaginal probe displaying pelvic-floor electrical activity as a training aid. The warning against relabeling training benefit as device benefit is preserved.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Only the relevant stored-summary information is recorded; detailed original material and review of the existing content remain outstanding. The B grade for PFMT itself is not extended to every probe or every form of PFMT.
Reason for missing information: The B grade for PFMT itself is not extended to every probe or every form of PFMT.
Required materials and conditions: Material identifying training and the added device intervention separately
Materials to obtain first: The B grade for PFMT itself is not extended to every probe or every form of PFMT.
Further research: Link direct comparisons by device use and training components separately when available.
Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification: Material identifying training and the added device intervention separately
Why this condition is needed: Condition for recording direct comparisons, original values and interpretation boundaries for the selected question
Application exceptions: Unread external material or results outside the question’s scope are not substituted with satisfied, null-effect or safe labels.
Referenced methods: Benefit of PFMT itself

Related sources R01

N06 · To which comparison do randomization and blinding details apply?

Current findings: OPAL was a multicenter randomized active-control trial assigning 300 women to each group. Participants and therapists could not be blinded because of the nature of the interventions.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Only the relevant stored-summary information is recorded; detailed original material and review of the existing content remain outstanding. These randomized results are not transferred to a comparison of PFMT itself. Allocation concealment and detailed questionnaire measurement procedures are unread.
Reason for missing information: These randomized results are not transferred to a comparison of PFMT itself. Allocation concealment and detailed questionnaire measurement procedures are unread.
Required materials and conditions: Records of the selected question's comparator, allocation concealment and outcome-assessment blinding
Materials to obtain first: These randomized results are not transferred to a comparison of PFMT itself. Allocation concealment and detailed questionnaire measurement procedures are unread.
Further research: Obtain allocation and measurement procedures together with a direct comparison design for the selected question.
Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification: Records of the selected question's comparator, allocation concealment and outcome-assessment blinding
Why this condition is needed: Condition for recording direct comparisons, original values and interpretation boundaries for the selected question
Application exceptions: Unread external material or results outside the question’s scope are not substituted with satisfied, null-effect or safe labels.
Referenced methods: Benefit of PFMT itself

Related sources R01

N07 · What does the 24-month ICIQ-UI SF result show about PFMT itself?

Current findings: OPAL's 24-month scores were 8.2 versus 8.5, comparing added-device treatment with the shared-training group. The original text states that both groups improved.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Only the relevant stored-summary information is recorded; detailed original material and review of the existing content remain outstanding. Within-group improvement is not converted into an effect size or CI for PFMT itself versus a comparator. Specific changes from baseline are not provided.
Reason for missing information: Within-group improvement is not converted into an effect size or CI for PFMT itself versus a comparator. Specific changes from baseline are not provided.
Required materials and conditions: Baseline, comparator, between-group estimates and scale definitions for PFMT itself
Materials to obtain first: Within-group improvement is not converted into an effect size or CI for PFMT itself versus a comparator. Specific changes from baseline are not provided.
Further research: Preserve between-group effects and CIs on the same scale from a direct comparison of PFMT itself.
Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification: Baseline, comparator, between-group estimates and scale definitions for PFMT itself
Why this condition is needed: Condition for recording direct comparisons, original values and interpretation boundaries for the selected question
Application exceptions: Unread external material or results outside the question’s scope are not substituted with satisfied, null-effect or safe labels.
Referenced methods: Benefit of PFMT itself

Related sources R01

N08 · Are the added-device mean difference, CI and P value separated from PFMT-itself values?

Current findings: The adjusted mean difference of −0.09 points, 95% CI −0.92 to 0.75 and P=0.84 describe the added device effect at 24 months. They are not effect estimates for PFMT itself.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Only the relevant stored-summary information is recorded; detailed original material and review of the existing content remain outstanding. A mean difference, CI and P value for PFMT itself were not directly established from this material.
Reason for missing information: A mean difference, CI and P value for PFMT itself were not directly established from this material.
Required materials and conditions: Original effects, intervals and significance results matched to each question
Materials to obtain first: A mean difference, CI and P value for PFMT itself were not directly established from this material.
Further research: Obtain original effects, intervals and analytical denominators from research directly comparing PFMT itself.
Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification: Original effects, intervals and significance results matched to each question
Why this condition is needed: Condition for recording direct comparisons, original values and interpretation boundaries for the selected question
Application exceptions: Unread external material or results outside the question’s scope are not substituted with satisfied, null-effect or safe labels.
Referenced methods: Benefit of PFMT itself

Related sources R01

N09 · To which question do the 1.9-point and 2.5-point clinical thresholds apply?

Current findings: The between-group threshold used for sample-size calculation was 2.5 points. A subsequent anchor analysis using the same OPAL data estimated a two-year minimal important difference of 1.9 points (95% CI 1.1 to 2.7) for conservative treatment. The original text judges that the added-device CI excludes both thresholds.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Only the relevant stored-summary information is recorded; detailed original material and review of the existing content remain outstanding. Exclusion of an added device benefit is not transferred into direct proof that PFMT itself is ineffective or effective. The subsequent anchor analysis is not a new independent efficacy trial.
Reason for missing information: Exclusion of an added device benefit is not transferred into direct proof that PFMT itself is ineffective or effective. The subsequent anchor analysis is not a new independent efficacy trial.
Required materials and conditions: Clinical-importance thresholds and plans appropriate to the selected comparison, population and duration
Materials to obtain first: Exclusion of an added device benefit is not transferred into direct proof that PFMT itself is ineffective or effective. The subsequent anchor analysis is not a new independent efficacy trial.
Further research: Preserve clinical importance and prespecified plans for a PFMT-itself comparison separately from the subsequent anchor analysis's applicability conditions.
Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification: Clinical-importance thresholds and plans appropriate to the selected comparison, population and duration
Why this condition is needed: Condition for recording direct comparisons, original values and interpretation boundaries for the selected question
Application exceptions: Unread external material or results outside the question’s scope are not substituted with satisfied, null-effect or safe labels.
Referenced methods: Benefit of PFMT itself

Related sources R01

N10 · To which outcome do analytical counts, questionnaire return and missing data apply?

Current findings: OPAL randomized 600 women, with 225 and 235 in the 24-month primary analysis; the original text records 460. The Korean questionnaire-return wording of about 78% and English attrition wording of about 22% are preserved as originally written.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Only the relevant stored-summary information is recorded; detailed original material and review of the existing content remain outstanding. No new participant totals or percentages are calculated. Denominators, missing-data handling and reasons for missingness for a PFMT-itself comparison are unverified.
Reason for missing information: No new participant totals or percentages are calculated. Denominators, missing-data handling and reasons for missingness for a PFMT-itself comparison are unverified.
Required materials and conditions: Original randomized and outcome-analysis denominators, attrition and missing-data handling
Materials to obtain first: No new participant totals or percentages are calculated. Denominators, missing-data handling and reasons for missingness for a PFMT-itself comparison are unverified.
Further research: Obtain group-specific reasons and handling of missing questionnaires, sensitivity analyses and denominators for a direct PFMT comparison.
Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification: Original randomized and outcome-analysis denominators, attrition and missing-data handling
Why this condition is needed: Condition for recording direct comparisons, original values and interpretation boundaries for the selected question
Application exceptions: Unread external material or results outside the question’s scope are not substituted with satisfied, null-effect or safe labels.
Referenced methods: Benefit of PFMT itself

Related sources R01

N11 · Are training adherence, actual exposure and departures distinguished in effect interpretation?

Current findings: The summary states that both groups received supervised training, but this preserved material contains no data on training frequency, adherence, crossover or maintenance over time.
Verification status: Unverified
Materials actually read: Summary read; external materials not read
Why unverified: Only the relevant stored-summary information is recorded; detailed original material and review of the existing content remain outstanding. Unread material is not interpreted as no adherence or no training effect.
Reason for missing information: Unread material is not interpreted as no adherence or no training effect.
Required materials and conditions: Links between actual training exposure, adherence, crossover, departures and outcomes
Materials to obtain first: Unread material is not interpreted as no adherence or no training effect.
Further research: Link actual exposure, adherence and departure data from the original report and protocol.
Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification: Links between actual training exposure, adherence, crossover, departures and outcomes
Why this condition is needed: Condition for recording direct comparisons, original values and interpretation boundaries for the selected question
Application exceptions: Unread external material or results outside the question’s scope are not substituted with satisfied, null-effect or safe labels.
Referenced methods: Benefit of PFMT itself

Related sources R01

N12 · Are the outcome, time point and analytical hierarchy specified directly for PFMT effects?

Current findings: OPAL's original key outcome was ICIQ-UI SF at 24 months, and the evidence record contains registration identifier ISRCTN57746448.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Only the relevant stored-summary information is recorded; detailed original material and review of the existing content remain outstanding. The source provides no registry URL, and the registry, protocol and SAP have not been newly read. The device comparison's primary-outcome hierarchy is not transferred to PFMT itself.
Reason for missing information: The source provides no registry URL, and the registry, protocol and SAP have not been newly read. The device comparison's primary-outcome hierarchy is not transferred to PFMT itself.
Required materials and conditions: Primary outcome, duration and prespecified analysis plan for a PFMT-itself comparison
Materials to obtain first: The source provides no registry URL, and the registry, protocol and SAP have not been newly read. The device comparison's primary-outcome hierarchy is not transferred to PFMT itself.
Further research: Link the registry, protocol, SAP and amendment history of a direct PFMT-itself comparison.
Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification: Primary outcome, duration and prespecified analysis plan for a PFMT-itself comparison
Why this condition is needed: Condition for recording direct comparisons, original values and interpretation boundaries for the selected question
Application exceptions: Unread external material or results outside the question’s scope are not substituted with satisfied, null-effect or safe labels.
Referenced methods: Benefit of PFMT itself

Related sources R01

N13 · Are incontinence episodes, quality of life, cure or improvement and symptom scores distinguished?

Current findings: OPAL summarizes ICIQ-UI SF, Burgio summarizes reductions in incontinence episodes, and Cochrane summarizes quality of life and cure or improvement.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Only the relevant stored-summary information is recorded; detailed original material and review of the existing content remain outstanding. Different scales or composite responses are not combined as the same value for PFMT itself on 24-month symptoms.
Reason for missing information: Different scales or composite responses are not combined as the same value for PFMT itself on 24-month symptoms.
Required materials and conditions: Outcome-specific definitions, denominators, time points and direct-comparison scope
Materials to obtain first: Different scales or composite responses are not combined as the same value for PFMT itself on 24-month symptoms.
Further research: Link each outcome definition and report from a PFMT-itself comparison separately.
Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification: Outcome-specific definitions, denominators, time points and direct-comparison scope
Why this condition is needed: Condition for recording direct comparisons, original values and interpretation boundaries for the selected question
Application exceptions: Unread external material or results outside the question’s scope are not substituted with satisfied, null-effect or safe labels.
Referenced methods: Benefit of PFMT itself

Related sources R01 R02 R03

N14 · Did Burgio 2002 directly test the selected question?

Current findings: Burgio compared three different multicomponent behavioral programs in 222 women with urge or urge-predominant mixed incontinence. Episode reductions were 63.1% versus 69.4% versus 58.6%, P=0.23.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Only the relevant stored-summary information is recorded; detailed original material and review of the existing content remain outstanding. Those values are not the effect of PFMT itself versus no treatment. Group denominators, CIs and component-specific effects are absent from the summary.
Reason for missing information: Those values are not the effect of PFMT itself versus no treatment. Group denominators, CIs and component-specific effects are absent from the summary.
Required materials and conditions: Direct effect evidence with appropriate populations, interventions and comparisons
Materials to obtain first: Those values are not the effect of PFMT itself versus no treatment. Group denominators, CIs and component-specific effects are absent from the summary.
Further research: Obtain original components of each multicomponent program and material directly comparing PFMT.
Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification: Direct effect evidence with appropriate populations, interventions and comparisons
Why this condition is needed: Condition for recording direct comparisons, original values and interpretation boundaries for the selected question
Application exceptions: Unread external material or results outside the question’s scope are not substituted with satisfied, null-effect or safe labels.
Referenced methods: Benefit of PFMT itself

Related sources R02

N15 · What are the Cochrane review's overall comparison and outcome-specific denominators?

Current findings: The overall PFMT-plus-biofeedback versus PFMT comparison included 33 trials and 3,031 women. Quality of life included 11 trials and 1,169 women; cure or improvement included 14 trials and 1,383 women.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Only the relevant stored-summary information is recorded; detailed original material and review of the existing content remain outstanding. The 33 trials are not relabeled as direct trials of training versus no training or independent replications. Outcome-specific participant counts are not added together.
Reason for missing information: The 33 trials are not relabeled as direct trials of training versus no training or independent replications. Outcome-specific participant counts are not added together.
Required materials and conditions: Eligible review comparisons, outcome-specific trial and participant counts, and overlap lists
Materials to obtain first: The 33 trials are not relabeled as direct trials of training versus no training or independent replications. Outcome-specific participant counts are not added together.
Further research: Preserve the review's included-trial table, direct comparisons appropriate to the selected question and overlap mapping.
Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification: Eligible review comparisons, outcome-specific trial and participant counts, and overlap lists
Why this condition is needed: Condition for recording direct comparisons, original values and interpretation boundaries for the selected question
Application exceptions: Unread external material or results outside the question’s scope are not substituted with satisfied, null-effect or safe labels.
Referenced methods: Benefit of PFMT itself

Related sources R03

N16 · Do the review's effects and CIs concern PFMT itself?

Current findings: Quality-of-life SMD −0.07 (95% CI −0.18 to 0.05) and cure-or-improvement OR 1.26 (95% CI 1.00 to 1.58) concern added feedback. The original text records that the OR's lower bound of 1.00 prevents a conclusive characterization as either null or beneficial.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Only the relevant stored-summary information is recorded; detailed original material and review of the existing content remain outstanding. The review effects are not transferred to PFMT itself or treated as a confirmed null effect.
Reason for missing information: The review effects are not transferred to PFMT itself or treated as a confirmed null effect.
Required materials and conditions: Original effects and CIs by outcome for comparisons appropriate to the selected question
Materials to obtain first: The review effects are not transferred to PFMT itself or treated as a confirmed null effect.
Further research: Obtain outcome-specific effects and CIs, heterogeneity and analysis plans for PFMT-itself comparisons.
Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification: Original effects and CIs by outcome for comparisons appropriate to the selected question
Why this condition is needed: Condition for recording direct comparisons, original values and interpretation boundaries for the selected question
Application exceptions: Unread external material or results outside the question’s scope are not substituted with satisfied, null-effect or safe labels.
Referenced methods: Benefit of PFMT itself

Related sources R03

N17 · Are the same reports and OPAL data kept from being counted as independent replications?

Current findings: The OPAL summary and subsequent clinical-importance anchor analysis using the same data are preserved within one trial context. The original text did not count Burgio or Cochrane as independent replications of the same claim because their populations and comparisons differ.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Only the relevant stored-summary information is recorded; detailed original material and review of the existing content remain outstanding. Overlap between review trials and individual reports is unread externally. Final unique-trial and participant totals are not established.
Reason for missing information: Overlap between review trials and individual reports is unread externally. Final unique-trial and participant totals are not established.
Required materials and conditions: Study-family links between original trials, subsequent analyses and reviews
Materials to obtain first: Overlap between review trials and individual reports is unread externally. Final unique-trial and participant totals are not established.
Further research: Link identifiers for original trials, subsequent analyses and reviews containing them without newly certifying independence.
Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification: Study-family links between original trials, subsequent analyses and reviews
Why this condition is needed: Condition for recording direct comparisons, original values and interpretation boundaries for the selected question
Application exceptions: Unread external material or results outside the question’s scope are not substituted with satisfied, null-effect or safe labels.
Referenced methods: Benefit of PFMT itself

Related sources R01 R02 R03

N18 · Are sufficient direct sources linked for PFMT itself?

Current findings: The subclaim's B grade is preserved as an original value, but the original text explicitly says that it is not the target of this device comparison. The three current references concern added devices or other behavioral-training contexts.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Only the relevant stored-summary information is recorded; detailed original material and review of the existing content remain outstanding. No separate direct material to newly establish the B grade for PFMT itself was searched during this production.
Reason for missing information: No separate direct material to newly establish the B grade for PFMT itself was searched during this production.
Required materials and conditions: Separate direct sources and effect scope corresponding to the subclaim's B grade
Materials to obtain first: No separate direct material to newly establish the B grade for PFMT itself was searched during this production.
Further research: If existing direct sources for PFMT itself are provided, link their population, comparator and outcome scope separately.
Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification: Separate direct sources and effect scope corresponding to the subclaim's B grade
Why this condition is needed: Condition for recording direct comparisons, original values and interpretation boundaries for the selected question
Application exceptions: Unread external material or results outside the question’s scope are not substituted with satisfied, null-effect or safe labels.
Referenced methods: Benefit of PFMT itself

Related sources R01 R02 R03

N19 · Is the result applied to other incontinence types or women unable to contract?

Current findings: OPAL's exclusions of women unable to contract and urgency-only incontinence are preserved. The original text does not rule out a role in helping women first learn to contract.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Only the relevant stored-summary information is recorded; detailed original material and review of the existing content remain outstanding. Possible learning support is not turned into established efficacy, and studies of other types are not transferred unchanged.
Reason for missing information: Possible learning support is not turned into established efficacy, and studies of other types are not transferred unchanged.
Required materials and conditions: Direct comparisons and denominators appropriate to population subgroups
Materials to obtain first: Possible learning support is not turned into established efficacy, and studies of other types are not transferred unchanged.
Further research: Direct comparisons by incontinence type and baseline contraction ability are needed.
Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification: Direct comparisons and denominators appropriate to population subgroups
Why this condition is needed: Condition for recording direct comparisons, original values and interpretation boundaries for the selected question
Application exceptions: Unread external material or results outside the question’s scope are not substituted with satisfied, null-effect or safe labels.
Referenced methods: Benefit of PFMT itself

Related sources R01 R02

N20 · Is training benefit extended to long-term clinical function or every product?

Current findings: The selected claim concerns PFMT itself, while the parent material concerns urinary-incontinence symptoms at 24 months. Product advertising scope is separately cautioned about.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Only the relevant stored-summary information is recorded; detailed original material and review of the existing content remain outstanding. No new efficacy or instructions are created for other clinical functions, products, apps or devices.
Reason for missing information: No new efficacy or instructions are created for other clinical functions, products, apps or devices.
Required materials and conditions: Direct evidence for the selected symptoms and function- or product-specific applications
Materials to obtain first: No new efficacy or instructions are created for other clinical functions, products, apps or devices.
Further research: Link direct comparisons appropriate to each outcome, product and time point separately when available.
Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification: Direct evidence for the selected symptoms and function- or product-specific applications
Why this condition is needed: Condition for recording direct comparisons, original values and interpretation boundaries for the selected question
Application exceptions: Unread external material or results outside the question’s scope are not substituted with satisfied, null-effect or safe labels.
Referenced methods: Benefit of PFMT itself

Related sources R01

N21 · Are public funding and sponsorship distinguished from the manufacturer's four roles?

Current findings: Full funding by NIHR HTA project 11/71/03 and sponsorship by Glasgow Caledonian University are stated. The original text records manufacturer cash funding, free equipment, employed authors and outsourced analysis as unverified.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Only the relevant stored-summary information is recorded; detailed original material and review of the existing content remain outstanding. Unverified relationships are not converted into certification that all were absent or that independence was established. Funding structures for PFMT-itself evidence are separately unverified.
Reason for missing information: Unverified relationships are not converted into certification that all were absent or that independence was established. Funding structures for PFMT-itself evidence are separately unverified.
Required materials and conditions: Separate records of cash funding, free equipment, employed authors and outsourced analysis
Materials to obtain first: Unverified relationships are not converted into certification that all were absent or that independence was established. Funding structures for PFMT-itself evidence are separately unverified.
Further research: Obtain original disclosures for funding, equipment provision, affiliations and analytical roles separately.
Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification: Separate records of cash funding, free equipment, employed authors and outsourced analysis
Why this condition is needed: Condition for recording direct comparisons, original values and interpretation boundaries for the selected question
Application exceptions: Unread external material or results outside the question’s scope are not substituted with satisfied, null-effect or safe labels.
Referenced methods: Benefit of PFMT itself

Related sources R01

N22 · Are Burgio and review funding details kept separate from another trial's funding?

Current findings: Burgio's evidence record lists US NIA/NIH, and the review is recorded as a Cochrane review. Both are preserved separately from OPAL's public funding.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Only the relevant stored-summary information is recorded; detailed original material and review of the existing content remain outstanding. The review's funding wording alone does not establish manufacturer involvement or independence of its included trials.
Reason for missing information: The review's funding wording alone does not establish manufacturer involvement or independence of its included trials.
Required materials and conditions: Separate funding, investigator and comparison identities for each source
Materials to obtain first: The review's funding wording alone does not establish manufacturer involvement or independence of its included trials.
Further research: Link each report's original disclosures and funding mapping for its included trials.
Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification: Separate funding, investigator and comparison identities for each source
Why this condition is needed: Condition for recording direct comparisons, original values and interpretation boundaries for the selected question
Application exceptions: Unread external material or results outside the question’s scope are not substituted with satisfied, null-effect or safe labels.
Referenced methods: Benefit of PFMT itself

Related sources R02 R03

N23 · To which intervention do participant counts and relatedness of adverse events belong?

Current findings: The original safety text records 48 participants reporting non-serious adverse events, with events in 23 judged related or possibly related to the intervention. Probe-associated discomfort and bleeding are recorded.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Only the relevant stored-summary information is recorded; detailed original material and review of the existing content remain outstanding. The 48 and 23 are not converted into event counts or harm rates for PFMT itself. Group-specific harm denominators and event tables are unread.
Reason for missing information: The 48 and 23 are not converted into event counts or harm rates for PFMT itself. Group-specific harm denominators and event tables are unread.
Required materials and conditions: Group-specific harm definitions, exposure, denominators, collection procedures and original event data
Materials to obtain first: The 48 and 23 are not converted into event counts or harm rates for PFMT itself. Group-specific harm denominators and event tables are unread.
Further research: Obtain original safety tables and group-specific events and relatedness, distinguishing training from the probe.
Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification: Group-specific harm definitions, exposure, denominators, collection procedures and original event data
Why this condition is needed: Condition for recording direct comparisons, original values and interpretation boundaries for the selected question
Application exceptions: Unread external material or results outside the question’s scope are not substituted with satisfied, null-effect or safe labels.
Referenced methods: Benefit of PFMT itself

Related sources R01

N24 · Are serious related complications distinguished from gaps in long-term and rare harms?

Current findings: The original text records no serious related complications, and the parent's safety label is Caution.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Only the relevant stored-summary information is recorded; detailed original material and review of the existing content remain outstanding. No reported serious related complications is not extended to no serious events of any kind or established safety of PFMT itself.
Reason for missing information: No reported serious related complications is not extended to no serious events of any kind or established safety of PFMT itself.
Required materials and conditions: Adequate observations by severity, relatedness, follow-up and rare harms
Materials to obtain first: No reported serious related complications is not extended to no serious events of any kind or established safety of PFMT itself.
Further research: Link original group-specific serious events, long-term follow-up, rare harms and reasons for discontinuation.
Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification: Adequate observations by severity, relatedness, follow-up and rare harms
Why this condition is needed: Condition for recording direct comparisons, original values and interpretation boundaries for the selected question
Application exceptions: Unread external material or results outside the question’s scope are not substituted with satisfied, null-effect or safe labels.
Referenced methods: Benefit of PFMT itself

Related sources R01

N25 · Is material available to separately replicate and verify harms of training and the probe?

Current findings: Currently preserved harm information summarizes an active-control trial of an added device. Separate repeated harm evidence for PFMT itself is not provided.
Verification status: Unverified
Materials actually read: Summary read; external materials not read
Why unverified: Only the relevant stored-summary information is recorded; detailed original material and review of the existing content remain outstanding. Device-related discomfort and bleeding are not transferred to PFMT-itself harms. No new certification of replicated harms is performed.
Reason for missing information: Device-related discomfort and bleeding are not transferred to PFMT-itself harms. No new certification of replicated harms is performed.
Required materials and conditions: Exposure, comparator and replicated harm evidence appropriate to PFMT itself
Materials to obtain first: Device-related discomfort and bleeding are not transferred to PFMT-itself harms. No new certification of replicated harms is performed.
Further research: Harm data distinguishing training from probe exposure and follow-up of sufficient duration are needed.
Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification: Exposure, comparator and replicated harm evidence appropriate to PFMT itself
Why this condition is needed: Condition for recording direct comparisons, original values and interpretation boundaries for the selected question
Application exceptions: Unread external material or results outside the question’s scope are not substituted with satisfied, null-effect or safe labels.
Referenced methods: Benefit of PFMT itself

Related sources R01

N26 · Are stored-summary reading and unread external sources distinguished?

Current findings: The entire parent JSON, including Korean and English text, evidence, citations and subclaims, was read for production. The three bibliographic URLs were linked as originally recorded; external material was not opened.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Only the relevant stored-summary information is recorded; detailed original material and review of the existing content remain outstanding. Having a URL does not upgrade an abstract, full text, registry, protocol or SAP to having been read during this work.
Reason for missing information: Having a URL does not upgrade an abstract, full text, registry, protocol or SAP to having been read during this work.
Required materials and conditions: Individual access records for summaries, papers, reviews, registries, protocols and SAPs
Materials to obtain first: Having a URL does not upgrade an abstract, full text, registry, protocol or SAP to having been read during this work.
Further research: If obtained original material is provided, link actual access and evidence for the relevant question separately for each source.
Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification: Individual access records for summaries, papers, reviews, registries, protocols and SAPs
Why this condition is needed: Condition for recording direct comparisons, original values and interpretation boundaries for the selected question
Application exceptions: Unread external material or results outside the question’s scope are not substituted with satisfied, null-effect or safe labels.
Referenced methods: Benefit of PFMT itself

Related sources R01 R02 R03

N27 · Are dates, corrections, Korean and English text and original-verdict history preserved?

Current findings: The entire source copy preserves the original date 2026-08-26, an empty corrections array, Korean and English text, parent grade D with 34 points and Caution with its assessment axes, and subclaim grade B.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Only the relevant stored-summary information is recorded; detailed original material and review of the existing content remain outstanding. No new-date verification, clinical-grade change or correction-target check was performed. This production date is not a new evidence date.
Reason for missing information: No new-date verification, clinical-grade change or correction-target check was performed. This production date is not a new evidence date.
Required materials and conditions: Unchanged preservation of original values, language-specific wording, dates and corrections
Materials to obtain first: No new-date verification, clinical-grade change or correction-target check was performed. This production date is not a new evidence date.
Further research: If additional material arises, preserve the original text and link a separate update event to review of the existing content.
Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification: Unchanged preservation of original values, language-specific wording, dates and corrections
Why this condition is needed: Condition for recording direct comparisons, original values and interpretation boundaries for the selected question
Application exceptions: Unread external material or results outside the question’s scope are not substituted with satisfied, null-effect or safe labels.
Referenced methods: Benefit of PFMT itself

Related sources R01 R02 R03

N28 · Is current production distinguished from independence or completed content review?

Current findings: The original candidate's need for boundary review and production-eligibility values are preserved as history. Existing content review remains incomplete, and model, content and boundary review activation and completion flags are false.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Only the relevant stored-summary information is recorded; detailed original material and review of the existing content remain outstanding. Production itself is neither clinical certification of the subclaim's B grade or independence nor completed review. No structural unit was added, and the final independent count remains unrecorded.
Reason for missing information: Production itself is neither clinical certification of the subclaim's B grade or independence nor completed review. No structural unit was added, and the final independent count remains unrecorded.
Required materials and conditions: Separate records of produced files, candidate history and existing-content review status
Materials to obtain first: Production itself is neither clinical certification of the subclaim's B grade or independence nor completed review. No structural unit was added, and the final independent count remains unrecorded.
Further research: After content review, reflect only provided decisions and material in a separate event.
Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification: Separate records of produced files, candidate history and existing-content review status
Why this condition is needed: Supplementary condition separating production status and scope of application
Application exceptions: Unread external material or results outside the question’s scope are not substituted with satisfied, null-effect or safe labels.
Referenced methods: Benefit of PFMT itself

Related sources R01 R02 R03