# Pelvic floor muscle training itself × Female urinary incontinence — Common treatment and added device effects distinguished Verdict 2951 · Evidence Check Stored-material review date: Not recorded Original evidence cut-off: 2026-08-26 Review-criteria version: 1.0 Public page/material preparation date: 2026-10-11 Clinical papers were not read directly; existing review summaries were checked. No new clinical-literature search was performed. Unverified does not mean that research is absent or that there is no effect. ## Assessment scope - 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 ## Checklist items ### N01 · Is the selected subclaim preserved separately from the added device effect? Verification status: Partly verified Reading scope: Summary read; external materials not read - 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. - 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. - 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. - Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification. - Referenced methods: Benefit of PFMT itself - Related sources: R01 ### N02 · Does OPAL's comparison identify the causal effect of PFMT itself? Verification status: Partly verified Reading scope: Summary read; external materials not read - 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. - 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. - 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. - Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification. - Referenced methods: Benefit of PFMT itself - Related sources: R01 ### N03 · What are the women's incontinence types and baseline ability to contract? Verification status: Partly verified Reading scope: Summary read; external materials not read - 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. - 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. - 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. - Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification. - Referenced methods: Benefit of PFMT itself - Related sources: R01 ### N04 · Are the shared PFMT program and accompanying treatments preserved? Verification status: Partly verified Reading scope: Summary read; external materials not read - Current findings: Supervised PFMT in both groups is stated, but this summary does not specify the training schedule, actual exposure or accompanying treatments. - 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. - 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. - Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification. - Referenced methods: Benefit of PFMT itself - Related sources: R01 ### N05 · Are the home probe's characteristics distinguished from the effect of PFMT itself? Verification status: Partly verified Reading scope: Summary read; external materials not read - 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. - 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. - 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. - Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification. - Referenced methods: Benefit of PFMT itself - Related sources: R01 ### N06 · To which comparison do randomization and blinding details apply? Verification status: Partly verified Reading scope: Summary read; external materials not read - 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. - 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. - 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. - Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification. - Referenced methods: Benefit of PFMT itself - Related sources: R01 ### N07 · What does the 24-month ICIQ-UI SF result show about PFMT itself? Verification status: Partly verified Reading scope: Summary read; external materials not read - 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. - 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. - 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. - Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification. - 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? Verification status: Partly verified Reading scope: Summary read; external materials not read - 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. - 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. - 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. - Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification. - 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? Verification status: Partly verified Reading scope: Summary read; external materials not read - 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. - 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. - 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. - Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification. - Referenced methods: Benefit of PFMT itself - Related sources: R01 ### N10 · To which outcome do analytical counts, questionnaire return and missing data apply? Verification status: Partly verified Reading scope: Summary read; external materials not read - 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. - 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. - 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. - Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification. - Referenced methods: Benefit of PFMT itself - Related sources: R01 ### N11 · Are training adherence, actual exposure and departures distinguished in effect interpretation? Verification status: Unverified Reading scope: Summary read; external materials not read - 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. - 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. - 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. - Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification. - Referenced methods: Benefit of PFMT itself - Related sources: R01 ### N12 · Are the outcome, time point and analytical hierarchy specified directly for PFMT effects? Verification status: Partly verified Reading scope: Summary read; external materials not read - Current findings: OPAL's original key outcome was ICIQ-UI SF at 24 months, and the evidence record contains registration identifier ISRCTN57746448. - 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. - 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. - Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification. - Referenced methods: Benefit of PFMT itself - Related sources: R01 ### N13 · Are incontinence episodes, quality of life, cure or improvement and symptom scores distinguished? Verification status: Partly verified Reading scope: Summary read; external materials not read - Current findings: OPAL summarizes ICIQ-UI SF, Burgio summarizes reductions in incontinence episodes, and Cochrane summarizes quality of life and cure or improvement. - 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. - 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. - Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification. - Referenced methods: Benefit of PFMT itself - Related sources: R01, R02, R03 ### N14 · Did Burgio 2002 directly test the selected question? Verification status: Partly verified Reading scope: Summary read; external materials not read - 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. - 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. - 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. - Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification. - Referenced methods: Benefit of PFMT itself - Related sources: R02 ### N15 · What are the Cochrane review's overall comparison and outcome-specific denominators? Verification status: Partly verified Reading scope: Summary read; external materials not read - 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. - 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. - 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. - Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification. - Referenced methods: Benefit of PFMT itself - Related sources: R03 ### N16 · Do the review's effects and CIs concern PFMT itself? Verification status: Partly verified Reading scope: Summary read; external materials not read - 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. - 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. - 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. - Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification. - Referenced methods: Benefit of PFMT itself - Related sources: R03 ### N17 · Are the same reports and OPAL data kept from being counted as independent replications? Verification status: Partly verified Reading scope: Summary read; external materials not read - 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. - 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. - 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. - Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification. - Referenced methods: Benefit of PFMT itself - Related sources: R01, R02, R03 ### N18 · Are sufficient direct sources linked for PFMT itself? Verification status: Partly verified Reading scope: Summary read; external materials not read - 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. - 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. - 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. - Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification. - 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? Verification status: Partly verified Reading scope: Summary read; external materials not read - 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. - 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. - 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. - Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification. - Referenced methods: Benefit of PFMT itself - Related sources: R01, R02 ### N20 · Is training benefit extended to long-term clinical function or every product? Verification status: Partly verified Reading scope: Summary read; external materials not read - 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. - 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. - 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. - Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification. - Referenced methods: Benefit of PFMT itself - Related sources: R01 ### N21 · Are public funding and sponsorship distinguished from the manufacturer's four roles? Verification status: Partly verified Reading scope: Summary read; external materials not read - 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. - 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. - 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. - Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification. - Referenced methods: Benefit of PFMT itself - Related sources: R01 ### N22 · Are Burgio and review funding details kept separate from another trial's funding? Verification status: Partly verified Reading scope: Summary read; external materials not read - 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. - 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. - 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. - Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification. - Referenced methods: Benefit of PFMT itself - Related sources: R02, R03 ### N23 · To which intervention do participant counts and relatedness of adverse events belong? Verification status: Partly verified Reading scope: Summary read; external materials not read - 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. - 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. - 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. - Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification. - Referenced methods: Benefit of PFMT itself - Related sources: R01 ### N24 · Are serious related complications distinguished from gaps in long-term and rare harms? Verification status: Partly verified Reading scope: Summary read; external materials not read - Current findings: The original text records no serious related complications, and the parent's safety label is Caution. - 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. - 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. - Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification. - Referenced methods: Benefit of PFMT itself - Related sources: R01 ### N25 · Is material available to separately replicate and verify harms of training and the probe? Verification status: Unverified Reading scope: Summary read; external materials not read - 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. - 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. - 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. - Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification. - Referenced methods: Benefit of PFMT itself - Related sources: R01 ### N26 · Are stored-summary reading and unread external sources distinguished? Verification status: Partly verified Reading scope: Summary read; external materials not read - 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. - 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. - 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. - Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification. - Referenced methods: Benefit of PFMT itself - Related sources: R01, R02, R03 ### N27 · Are dates, corrections, Korean and English text and original-verdict history preserved? Verification status: Partly verified Reading scope: Summary read; external materials not read - 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. - 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. - 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. - Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification. - Referenced methods: Benefit of PFMT itself - Related sources: R01, R02, R03 ### N28 · Is current production distinguished from independence or completed content review? Verification status: Partly verified Reading scope: Summary read; external materials not read - 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. - 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. - 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. - Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification. - Referenced methods: Benefit of PFMT itself - Related sources: R01, R02, R03 ## Evidence and sources ### R01 Hagen S, Bugge C, Dean SG, et al. BMJ. 2020;371:m3719. PMID: 33055247. [PubMed](https://pubmed.ncbi.nlm.nih.gov/33055247/) Materials actually read: Summary read; external materials not read Findings recorded in the 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 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. | 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](https://pubmed.ncbi.nlm.nih.gov/12425706/) Materials actually read: Summary read; external materials not read Findings recorded in the 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 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. | 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](https://www.cochrane.org/evidence/CD009252_exercise-pelvic-floor-muscles-more-effective-treating-unintentional-passing-urine-incontinence-women) Materials actually read: Summary read; external materials not read Findings recorded in the 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 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. | 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 | ## Review criteria and methods These are Chamgap's own application conditions, informed by the relevant sections of official methodological guidance. They do not constitute official assessment-tool certification or a new efficacy score. - M03 [Cochrane Handbook 6.5 (2024), chapter updated 2023-08](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-03) · §3.1, §3.2.1–3.2.3, MECIR C5/C7/C13 · Clearly record the question, eligibility conditions and reasons for changes, and distinguish variations in interventions. · 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](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-04) · §4.5, §4.6.1–4.6.3, MECIR C42 · Distinguish studies from reports and link them; do not omit a study solely because results are unreported. · 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](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-08) · §8.1–8.2.3, Table 8.2.a · Define the outcome and effect of interest, then examine randomization, deviations, missing data, measurement and selective reporting. · 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](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-15) · §15.2.4, §15.3.1–15.3.3 · Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision. · 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](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-19) · §19.1.2, §19.2.1–19.2.4 · Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence rates. · 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/materials 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.