# Vaginal-probe EMG biofeedback × Added benefit at 24 months on top of standard PFMT — Evidence checklist 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/mixed urinary incontinence able to contract; urgency-only incontinence and inability to contract excluded - Ingredient, formulation and route: Home vaginal-probe EMG biofeedback added to supervised PFMT - Dose: Not recorded - Comparator: Supervised PFMT common to both groups; active comparison of added device benefit - Measured outcome: 24-month ICIQ-UI SF and adjusted mean difference; distinct from quality of life, episodes and cure rates - Duration: 24-month assessment; exact study training/device-exposure duration unverified - Questions outside this scope: Relabeling improvement during common PFMT as added device benefit or certification of a causal PFMT effect from this comparison alone; Extending the selected population/use to inability to contract, urgency-only incontinence, learning support or other devices; Replacing adjusted −.09 with a new difference calculated from original means 8.2/8.5; Creating a prespecified criterion, new independent trial or additional bibliographic report from the later 1.9-point MID using the same OPAL data; Calculating new attrition, totals or complementary percentages from 225/235, original 460, approximately 78% in Korean/approximately 22% in English; Inventing unverified correspondence for Burgio three-arm programs/populations or adding whole-review, outcome-subset and OPAL participants; Converting the review cure OR lower CI bound of 1.00 into a new significance, benefit or null verdict; Converting 4 unverified manufacturer-related items into absence of each relationship or independence certification; Adding the same bibliography, participants, groups, time points, sibling sheets, outcomes or later analyses as new independent trials/participants; Converting original registration wording of unverified, historical absence before the registration system or not applicable into an actual registration identifier or current confirmation of absent registration; Inheriting parent score/axes or historical cross-checking as subclaim score, current content review or external reading; New numeric calculations, invented values, effects/CIs, grades, independence certification or treatment/device-use/training instructions ## Checklist items ### N01 · How are the selected added-device effect and parent verdict distinguished? Verification status: Partly verified Reading scope: Summary read; external material unread - Current findings: The selected question is added benefit from a device on top of standard PFMT. Preserve subclaim grade D and its note about one confirmatory trial and exclusion of the 1.9-point/2.5-point thresholds. Parent D with 34 points is broader context. - Why unverified: Only the relevant stored-summary information is recorded; detailed original material is unread and review of existing content remains incomplete. The subclaim has no score/status/axis keys; parent values are not inserted. The sibling question about PFMT itself is not merged into this added-device effect. Review of the existing content remains incomplete. - Reason for missing information: The subclaim has no score/status/axis keys; parent values are not inserted. The sibling question about PFMT itself is not merged into this added-device effect. - Required materials and conditions: Separate the existing subclaim, grade D and note from parent score and axes - Materials to obtain first: Correction records for the selected claim and parent assessment - Further research: Update the existing question and parent context separately. This is a recorded proposal; no new search, calculation or experiment was performed. - Conditions for verification: Original materials and the applicable analytical scope for Separate the existing subclaim, grade D and note from parent score and axes are required, with unresolved items distinguished. This record links preserved wording; review of the existing content remains incomplete. - Why this condition is needed: Production condition for distinguishing Separate the existing subclaim, grade D and note from parent score and axes and linking required and currently available materials for the selected question. - Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material. - Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review. - Referenced methods: M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed separation rules are internally designed; M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design - Related sources: S01, S02, S03 ### N02 · Which population of women was included in OPAL? Verification status: Partly verified Reading scope: Summary read; external material unread - Current findings: Preserve the manuscript describing 600 women with stress or mixed urinary incontinence at 23 UK centers, excluding urgency-only incontinence and women unable to contract their pelvic floor muscles. - Why unverified: Only the relevant stored-summary information is recorded; detailed original material is unread and review of existing content remains incomplete. Age, baseline severity, recruitment/screening procedures and the mixed-incontinence proportion remain unverified in this summary. Review of the existing content remains incomplete. - Reason for missing information: Age, baseline severity, recruitment/screening procedures and the mixed-incontinence proportion remain unverified in this summary. - Required materials and conditions: Incontinence type, contraction ability, eligibility/exclusions and baseline conditions - Materials to obtain first: OPAL recruitment criteria and baseline characteristics table - Further research: Link inclusion and exclusion boundaries to the results. This is a recorded proposal; no new search, calculation or experiment was performed. - Conditions for verification: Original materials and the applicable analytical scope for Incontinence type, contraction ability, eligibility/exclusions and baseline conditions are required, with unresolved items distinguished. This record links preserved wording; review of the existing content remains incomplete. - Why this condition is needed: Production condition for distinguishing Incontinence type, contraction ability, eligibility/exclusions and baseline conditions and linking required and currently available materials for the selected question. - Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material. - Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review. - Referenced methods: M03 §3.2.1; detailed population conditions are Chamgap's own design - Related sources: S01 ### N03 · What are the device and PFMT common to both groups? Verification status: Partly verified Reading scope: Summary read; external material unread - Current findings: The vaginal probe displays pelvic-floor electrical activity as an aid. Both groups received supervised PFMT as an active control. - Why unverified: Only the relevant stored-summary information is recorded; detailed original material is unread and review of existing content remains incomplete. The exact device model, shared/group-specific training, support intensity and actual exposure remain unverified. This wording does not create use or training instructions. Review of the existing content remains incomplete. - Reason for missing information: The exact device model, shared/group-specific training, support intensity and actual exposure remain unverified. This wording does not create use or training instructions. - Required materials and conditions: Home vaginal-probe EMG, supervised PFMT and actual comparator composition - Materials to obtain first: Device identity and group-specific intervention plans - Further research: Separate the shared underlying intervention from the added device component. This is a recorded proposal; no new search, calculation or experiment was performed. - Conditions for verification: Original materials and the applicable analytical scope for Home vaginal-probe EMG, supervised PFMT and actual comparator composition are required, with unresolved items distinguished. This record links preserved wording; review of the existing content remains incomplete. - Why this condition is needed: Production condition for distinguishing Home vaginal-probe EMG, supervised PFMT and actual comparator composition and linking required and currently available materials for the selected question. - Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material. - Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review. - Referenced methods: M03 §3.2.2–3.2.3; Reverse-direction labels and assessment adaptation are Chamgap design; M03 §3.2.3 and M08 §8.2.2–8.2.3; Chamgap application - Related sources: S01 ### N04 · Is the comparison against no treatment, or about added device benefit? Verification status: Partly verified Reading scope: Summary read; external material unread - Current findings: The selected comparison is PFMT plus biofeedback versus PFMT. Improvement in both groups is not transferred to added device benefit. - Why unverified: Only the relevant stored-summary information is recorded; detailed original material is unread and review of existing content remains incomplete. Improvement during common PFMT is not certified as an independent causal PFMT effect from this comparison alone. Review of the existing content remains incomplete. - Reason for missing information: Improvement during common PFMT is not certified as an independent causal PFMT effect from this comparison alone. - Required materials and conditions: Effect of interest, active comparison and attribution of common treatment - Materials to obtain first: Definition of the effect of interest and comparative analysis - Further research: Keep the PFMT-itself and added-device-effect questions separate. This is a recorded proposal; no new search, calculation or experiment was performed. - Conditions for verification: Original materials and the applicable analytical scope for Effect of interest, active comparison and attribution of common treatment are required, with unresolved items distinguished. This record links preserved wording; review of the existing content remains incomplete. - Why this condition is needed: Production condition for distinguishing Effect of interest, active comparison and attribution of common treatment and linking required and currently available materials for the selected question. - Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material. - Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review. - Referenced methods: M03 §3.2.2–3.2.3; reverse-direction labels and test adaptations are Chamgap design; M08 §8.2.2, M15 §15.3.1; Chamgap adaptation - Related sources: S01 ### N05 · What is known about study exposure, duration and adherence? Verification status: Unverified Reading scope: Summary read; external material unread - Current findings: Only the preserved scope of a home vaginal probe, supervised PFMT and a 24-month assessment is linked. - Why unverified: The currently required information is unverified in the stored summary. Exact training duration/frequency/exposure, device adherence and group-specific treatment changes/rescue treatment remain unverified. Review of the existing content remains incomplete. - Reason for missing information: Exact training duration/frequency/exposure, device adherence and group-specific treatment changes/rescue treatment remain unverified. - Required materials and conditions: Intervention frequency/duration, actual device use, common treatment and rescue treatment - Materials to obtain first: Intervention, adherence, concomitant treatment and change records - Further research: Record actual exposure separately from observation duration. This is a recorded proposal; no new search, calculation or experiment was performed. - Conditions for verification: Original materials and the applicable analytical scope for Intervention frequency/duration, actual device use, common treatment and rescue treatment are required, with unresolved items distinguished. This record links preserved wording; review of the existing content remains incomplete. - Why this condition is needed: Production condition for distinguishing Intervention frequency/duration, actual device use, common treatment and rescue treatment and linking required and currently available materials for the selected question. - Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material. - Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review. - Referenced methods: M03 §3.2.3, M08 §8.2.2–8.2.3; own application; M03 §3.2.2–3.2.3; reverse-direction labels and test adaptations are our own design - Related sources: S01 ### N06 · How were randomization and baseline balance recorded? Verification status: Partly verified Reading scope: Summary read; external material unread - Current findings: The manuscript describes OPAL as a multicenter randomized active-control trial allocating 600 participants, 300 per group. - Why unverified: Only the relevant stored-summary information is recorded; detailed original material is unread and review of existing content remains incomplete. Details of allocation sequence, concealment and baseline balance between groups remain unverified. Review of the existing content remains incomplete. - Reason for missing information: Details of allocation sequence, concealment and baseline balance between groups remain unverified. - Required materials and conditions: Randomization method, concealment and group-specific baseline characteristics - Materials to obtain first: Allocation methods and baseline characteristics - Further research: Distinguish the RCT label from actual allocation information. This is a recorded proposal; no new search, calculation or experiment was performed. - Conditions for verification: Original materials and the applicable analytical scope for Randomization method, concealment and group-specific baseline characteristics are required, with unresolved items distinguished. This record links preserved wording; review of the existing content remains incomplete. - Why this condition is needed: Production condition for distinguishing Randomization method, concealment and group-specific baseline characteristics and linking required and currently available materials for the selected question. - Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material. - Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review. - Referenced methods: M08 §8.1–8.2.3; own application; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptation is our own design - Related sources: S01 ### N07 · Which measurement is affected by blinding limitations? Verification status: Partly verified Reading scope: Summary read; external material unread - Current findings: Preserve the original Korean account that participant and therapist blinding was impossible because of the intervention. - Why unverified: Only the relevant stored-summary information is recorded; detailed original material is unread and review of existing content remains incomplete. ICIQ collection, assessor/analyst blinding and differences in response collection remain unverified. Inability to blind is not automatically judged a failure. Review of the existing content remains incomplete. - Reason for missing information: ICIQ collection, assessor/analyst blinding and differences in response collection remain unverified. Inability to blind is not automatically judged a failure. - Required materials and conditions: Participant, therapist and assessor blinding and measurement procedures - Materials to obtain first: Measurement and blinding procedures - Further research: Link subjective-symptom measurement conditions to the known limitations. This is a recorded proposal; no new search, calculation or experiment was performed. - Conditions for verification: Original materials and the applicable analytical scope for Participant, therapist and assessor blinding and measurement procedures are required, with unresolved items distinguished. This record links preserved wording; review of the existing content remains incomplete. - Why this condition is needed: Production condition for distinguishing Participant, therapist and assessor blinding and measurement procedures and linking required and currently available materials for the selected question. - Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material. - Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review. - Referenced methods: M08 Table 8.2.a, M03 §3.2.4; internal application - Related sources: S01 ### N08 · What does the 24-month ICIQ-UI SF value measure? Verification status: Partly verified Reading scope: Summary read; external material unread - Current findings: The selected key result is ICIQ-UI SF at 24 months. The manuscript calls it the 24-month primary analysis. - Why unverified: Only the relevant stored-summary information is recorded; detailed original material is unread and review of existing content remains incomplete. Detailed scale collection, baseline values, change analysis and prespecified hierarchy for other time points/outcomes remain unverified. Review of the existing content remains incomplete. - Reason for missing information: Detailed scale collection, baseline values, change analysis and prespecified hierarchy for other time points/outcomes remain unverified. - Required materials and conditions: Scale, units, final value/change, time point and primary-outcome definition - Materials to obtain first: Scale description and prespecified outcome/results tables - Further research: Attribute time point, scale, final values and change values separately. This is a recorded proposal; no new search, calculation or experiment was performed. - Conditions for verification: Original materials and the applicable analytical scope for Scale, units, final value/change, time point and primary-outcome definition are required, with unresolved items distinguished. This record links preserved wording; review of the existing content remains incomplete. - Why this condition is needed: Production condition for distinguishing Scale, units, final value/change, time point and primary-outcome definition and linking required and currently available materials for the selected question. - Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material. - Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review. - Referenced methods: M03 §3.2.4, M15 §15.3.1–15.3.3; outcome adaptation to each question is internally designed; M08 Table 8.2.a, M03 §3.2.4; internal application; M08 Table 8.2.a, M04 §4.6.3; internal application - Related sources: S01 ### N09 · Are group means distinguished from the adjusted mean difference? Verification status: Partly verified Reading scope: Summary read; external material unread - Current findings: Preserve the 24-month means of 8.2 versus 8.5 and adjusted mean difference −0.09 as original values. No new difference calculated from the two means replaces the adjusted estimate. - Why unverified: Only the relevant stored-summary information is recorded; detailed original material is unread and review of existing content remains incomplete. Explicit group-specific results tables, adjustment variables/model and variance were not read. Review of the existing content remains incomplete. - Reason for missing information: Explicit group-specific results tables, adjustment variables/model and variance were not read. - Required materials and conditions: Group correspondence, original means, adjusted estimator and model - Materials to obtain first: Group-specific results tables and adjusted analysis - Further research: Keep original means and the adjusted comparative estimator as different values. This is a recorded proposal; no new search, calculation or experiment was performed. - Conditions for verification: Original materials and the applicable analytical scope for Group correspondence, original means, adjusted estimator and model are required, with unresolved items distinguished. This record links preserved wording; review of the existing content remains incomplete. - Why this condition is needed: Production condition for distinguishing Group correspondence, original means, adjusted estimator and model and linking required and currently available materials for the selected question. - Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material. - Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review. - Referenced methods: M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are our own design; M08 §8.2.2, M15 §15.3.1; our own application - Related sources: S01 ### N10 · What are the observed interval, P value and clinical importance? Verification status: Partly verified Reading scope: Summary read; external material unread - Current findings: Preserve adjusted difference −0.09, 95% CI −0.92 to 0.75 and P=0.84. Non-significance is not converted into an exact zero effect or equivalence. - Why unverified: Only the relevant stored-summary information is recorded; detailed original material is unread and review of existing content remains incomplete. Details of the original interval model, variance and denominator, and original threshold evidence, were not read. Review of the existing content remains incomplete. - Reason for missing information: Details of the original interval model, variance and denominator, and original threshold evidence, were not read. - Required materials and conditions: Original effect, CI, P value and range of important differences - Materials to obtain first: Analysis tables and importance criteria - Further research: Record the observed interval and original importance interpretation within their source scope. This is a recorded proposal; no new search, calculation or experiment was performed. - Conditions for verification: Original materials and the applicable analytical scope for Original effect, CI, P value and range of important differences are required, with unresolved items distinguished. This record links preserved wording; review of the existing content remains incomplete. - Why this condition is needed: Production condition for distinguishing Original effect, CI, P value and range of important differences and linking required and currently available materials for the selected question. - Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material. - Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review. - Referenced methods: M15 §15.3.1–15.3.3; Chamgap adaptation; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are Chamgap design - Related sources: S01 ### N11 · What prespecified criterion is the 2.5-point threshold? Verification status: Partly verified Reading scope: Summary read; external material unread - Current findings: Preserve the original account that OPAL used a clinically important between-group difference of 2.5 points for its sample-size calculation. - Why unverified: Only the relevant stored-summary information is recorded; detailed original material is unread and review of existing content remains incomplete. Sample-size assumptions, importance rationale and the original protocol were not read. No new threshold is created. Review of the existing content remains incomplete. - Reason for missing information: Sample-size assumptions, importance rationale and the original protocol were not read. No new threshold is created. - Required materials and conditions: Important between-group difference for sample-size calculation, rationale and timing - Materials to obtain first: Sample-size plan and rationale for 2.5 points - Further research: Link the original prespecified criterion separately from later analytical criteria. This is a recorded proposal; no new search, calculation or experiment was performed. - Conditions for verification: Original materials and the applicable analytical scope for Important between-group difference for sample-size calculation, rationale and timing are required, with unresolved items distinguished. This record links preserved wording; review of the existing content remains incomplete. - Why this condition is needed: Production condition for distinguishing Important between-group difference for sample-size calculation, rationale and timing and linking required and currently available materials for the selected question. - Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material. - Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review. - Referenced methods: M15 §15.3.1–15.3.3; internal application; M08 Table 8.2.a, M04 §4.6.3; internal application - Related sources: S01 ### N12 · Is the 1.9-point MID from another independent trial? Verification status: Partly verified Reading scope: Summary read; external material unread - Current findings: Preserve the original account of a later anchor analysis using OPAL data: two-year conservative-treatment MID 1.9 points, 95% CI 1.1 to 2.7. - Why unverified: Only the relevant stored-summary information is recorded; detailed original material is unread and review of existing content remains incomplete. A separate bibliography, anchor method and denominator are not recorded in this stored review summary. The 1.9-point value is not converted into a prespecified criterion or a new independent trial. Review of the existing content remains incomplete. - Reason for missing information: A separate bibliography, anchor method and denominator are not recorded in this stored review summary. The 1.9-point value is not converted into a prespecified criterion or a new independent trial. - Required materials and conditions: Data identity, timing, model and precision of the later anchor analysis - Materials to obtain first: Later anchor-analysis bibliography, methods and data linkage - Further research: Link the later analysis of the same OPAL data to the original trial. This is a recorded proposal; no new search, calculation or experiment was performed. - Conditions for verification: Original materials and the applicable analytical scope for Data identity, timing, model and precision of the later anchor analysis are required, with unresolved items distinguished. This record links preserved wording; review of the existing content remains incomplete. - Why this condition is needed: Production condition for distinguishing Data identity, timing, model and precision of the later anchor analysis and linking required and currently available materials for the selected question. - Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material. - Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review. - Referenced methods: M04 §4.6.1–4.6.2 distinction between studies and reports; cohort/outcome linking is Chamgap adaptation; M15 §15.3.1–15.3.3; Chamgap adaptation; M08 Table 8.2.a, M04 §4.6.3; Chamgap adaptation - Related sources: S01 ### N13 · How far is the original interpretation of excluding both thresholds preserved? Verification status: Partly verified Reading scope: Summary read; external material unread - Current findings: The manuscript records that the observed CI excluded the 1.9-point and 2.5-point thresholds. Preserve this as interpretation history for subclaim D and its note and parent D with 34 points. - Why unverified: Only the relevant stored-summary information is recorded; detailed original material is unread and review of existing content remains incomplete. No new interval/threshold calculation, prespecified-criterion comparison, equivalence certification or certification of no effect from all devices is performed. Review of the existing content remains incomplete. - Reason for missing information: No new interval/threshold calculation, prespecified-criterion comparison, equivalence certification or certification of no effect from all devices is performed. - Required materials and conditions: Original observed interval, 1.9/2.5 criteria and interpretation history - Materials to obtain first: Threshold evidence and original analysis/plans - Further research: Distinguish the original interpretation from decisions based on new material. This is a recorded proposal; no new search, calculation or experiment was performed. - Conditions for verification: Original materials and the applicable analytical scope for Original observed interval, 1.9/2.5 criteria and interpretation history are required, with unresolved items distinguished. This record links preserved wording; review of the existing content remains incomplete. - Why this condition is needed: Production condition for distinguishing Original observed interval, 1.9/2.5 criteria and interpretation history and linking required and currently available materials for the selected question. - Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material. - Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review. - Referenced methods: M15 §15.3.1–15.3.3; Chamgap adaptation; M04 §4.5, §4.6.3; limitations of the current material conversion follow the review scope and Chamgap design - Related sources: S01 ### N14 · How do allocation and 24-month analysis denominators differ? Verification status: Partly verified Reading scope: Summary read; external material unread - Current findings: Preserve separately 600 participants, allocation of 300 per group, 225/235 in the 24-month primary analysis and the original evidence-list total of 460. - Why unverified: Only the relevant stored-summary information is recorded; detailed original material is unread and review of existing content remains incomplete. Exact correspondence of observed, completed and model-included denominators and group-specific exclusion reasons remain unverified. No new totals or attrition counts are calculated. Review of the existing content remains incomplete. - Reason for missing information: Exact correspondence of observed, completed and model-included denominators and group-specific exclusion reasons remain unverified. No new totals or attrition counts are calculated. - Required materials and conditions: Allocation, questionnaire observations and outcome-specific analytical denominators - Materials to obtain first: Outcome-specific flow diagrams and denominator tables - Further research: Link original allocation, observation and analysis denominators separately. This is a recorded proposal; no new search, calculation or experiment was performed. - Conditions for verification: Original materials and the applicable analytical scope for Allocation, questionnaire observations and outcome-specific analytical denominators are required, with unresolved items distinguished. This record links preserved wording; review of the existing content remains incomplete. - Why this condition is needed: Production condition for distinguishing Allocation, questionnaire observations and outcome-specific analytical denominators and linking required and currently available materials for the selected question. - Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material. - Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review. - Referenced methods: M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are Chamgap design - Related sources: S01 ### N15 · What are the language-specific stored descriptions of return and attrition? Verification status: Partly verified Reading scope: Summary read; external material unread - Current findings: Preserve the original Korean wording of approximately 78% questionnaire return and original English wording of approximately 22% questionnaire attrition as their respective stored-summary descriptions. - Why unverified: Only the relevant stored-summary information is recorded; detailed original material is unread and review of existing content remains incomplete. Exact denominator, timing and definition correspondence of the two descriptions and group-specific missing-data assumptions remain unverified. No new complementary percentage or missing count is calculated. Review of the existing content remains incomplete. - Reason for missing information: Exact denominator, timing and definition correspondence of the two descriptions and group-specific missing-data assumptions remain unverified. No new complementary percentage or missing count is calculated. - Required materials and conditions: Questionnaire return, missingness/attrition definitions, group-specific reasons and handling - Materials to obtain first: Group-specific questionnaire flow and missing-data handling - Further research: Distinguish historical wording by language from actual observation/analysis definitions. This is a recorded proposal; no new search, calculation or experiment was performed. - Conditions for verification: Original materials and the applicable analytical scope for Questionnaire return, missingness/attrition definitions, group-specific reasons and handling are required, with unresolved items distinguished. This record links preserved wording; review of the existing content remains incomplete. - Why this condition is needed: Production condition for distinguishing Questionnaire return, missingness/attrition definitions, group-specific reasons and handling and linking required and currently available materials for the selected question. - Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material. - Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review. - Referenced methods: M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are Chamgap design; M04 §4.5, §4.6.3; limitations of the current material conversion follow the review scope and Chamgap design; M08 §8.2.2, M15 §15.3.1; Chamgap adaptation - Related sources: S01 ### N16 · Does the actual analysis estimate assignment effects or adherence effects? Verification status: Unverified Reading scope: Summary read; external material unread - Current findings: The original account gives an adjusted mean difference and the 24-month primary-analysis denominators. - Why unverified: The currently required information is unverified in the stored summary. This summary does not specify ITT/PP definitions, missing-data models, adherence effects or sensitivity values. ITT is not inserted by assumption. Review of the existing content remains incomplete. - Reason for missing information: This summary does not specify ITT/PP definitions, missing-data models, adherence effects or sensitivity values. ITT is not inserted by assumption. - Required materials and conditions: ITT/PP, effect of interest, adjustment, missingness and sensitivity - Materials to obtain first: SAP, analysis-population definitions and sensitivity results - Further research: Link the effect answered by the analysis to the selected question. This is a recorded proposal; no new search, calculation or experiment was performed. - Conditions for verification: Original materials and the applicable analytical scope for ITT/PP, effect of interest, adjustment, missingness and sensitivity are required, with unresolved items distinguished. This record links preserved wording; review of the existing content remains incomplete. - Why this condition is needed: Production condition for distinguishing ITT/PP, effect of interest, adjustment, missingness and sensitivity and linking required and currently available materials for the selected question. - Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material. - Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review. - Referenced methods: M08 §8.2.2 and M15 §15.3.1: in-house application; M08 Table 8.2.a, M15 §15.3 and M19 §19.1.2–19.2.4: design-specific adaptation is in-house. - Related sources: S01 ### N17 · Were the registry, protocol and SAP actually compared? Verification status: Partly verified Reading scope: Summary read; external material unread - Current findings: The original registration identifier for S01 is ISRCTN57746448. Only the summary of the 24-month primary analysis and thresholds was linked. - Why unverified: Only the relevant stored-summary information is recorded; detailed original material is unread and review of existing content remains incomplete. Registration, protocol, SAP and change history were not read or accessed; agreement with plans or selective reporting is not established. Review of the existing content remains incomplete. - Reason for missing information: Registration, protocol, SAP and change history were not read or accessed; agreement with plans or selective reporting is not established. - Required materials and conditions: Original registration identifier, plans, change history and primary outcome - Materials to obtain first: Registration history, protocol, and SAP - Further research: Distinguish changes if material comparing prespecified plans with actual reporting is provided. This is a recorded proposal; no new search, calculation or experiment was performed. - Conditions for verification: Original materials and the applicable analytical scope for Original registration identifier, plans, change history and primary outcome are required, with unresolved items distinguished. This record links preserved wording; review of the existing content remains incomplete. - Why this condition is needed: Production condition for distinguishing Original registration identifier, plans, change history and primary outcome and linking required and currently available materials for the selected question. - Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material. - Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review. - Referenced methods: M08 Table 8.2.a, M04 §4.6.3; Chamgap application; M04 §4.5–4.6 principles for collecting and selecting materials; separation of access and reading and hyperlink rules are Chamgap's own design - Related sources: S01 ### N18 · What were the public funding and sponsor institution? Verification status: Partly verified Reading scope: Summary read; external material unread - Current findings: Preserve the Korean wording of full funding by NIHR HTA project 11/71/03 and sponsorship by Glasgow Caledonian University. - Why unverified: Only the relevant stored-summary information is recorded; detailed original material is unread and review of existing content remains incomplete. Original itemized spending, institutional roles, contracts and additional disclosures were not read. Full funding is not expanded into verification of every independence issue. Review of the existing content remains incomplete. - Reason for missing information: Original itemized spending, institutional roles, contracts and additional disclosures were not read. Full funding is not expanded into verification of every independence issue. - Required materials and conditions: Separate funding, project, sponsor institution and roles - Materials to obtain first: NIHR/sponsor and COI disclosures - Further research: Link funding, institutions and actual roles separately. This is a recorded proposal; no new search, calculation or experiment was performed. - Conditions for verification: Original materials and the applicable analytical scope for Separate funding, project, sponsor institution and roles are required, with unresolved items distinguished. This record links preserved wording; review of the existing content remains incomplete. - Why this condition is needed: Production condition for distinguishing Separate funding, project, sponsor institution and roles and linking required and currently available materials for the selected question. - Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material. - Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review. - Referenced methods: Chamgap's own conditions for independence and attribution. The official methodological sections used in this example do not validate every detail of these items. - Related sources: S01 ### N19 · Are the four manufacturer-related items actually absent? Verification status: Unverified Reading scope: Summary read; external material unread - Current findings: The existing product information records that manufacturer cash funding, free supply, employed authors and outsourced analysis were not verified. - Why unverified: The currently required information is unverified in the stored summary. Unverified items are not converted into absence of each relationship or independence certification. Original disclosures and actual roles were not read. Review of the existing content remains incomplete. - Reason for missing information: Unverified items are not converted into absence of each relationship or independence certification. Original disclosures and actual roles were not read. - Required materials and conditions: Cash funding, free equipment, employed authors and outsourced analysis - Materials to obtain first: Manufacturer provision, author affiliations and analysis contracts - Further research: Update each unverified item separately. This is a recorded proposal; no new search, calculation or experiment was performed. - Conditions for verification: Original materials and the applicable analytical scope for Cash funding, free equipment, employed authors and outsourced analysis are required, with unresolved items distinguished. This record links preserved wording; review of the existing content remains incomplete. - Why this condition is needed: Production condition for distinguishing Cash funding, free equipment, employed authors and outsourced analysis and linking required and currently available materials for the selected question. - Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material. - Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review. - Referenced methods: Chamgap's own conditions for independence and attribution. The official methodological sections used in this example do not validate every detail of these items. - Related sources: S01 ### N20 · Are other COI, patents and writing/publication support known? Verification status: Unverified Reading scope: Summary read; external material unread - Current findings: A stored summary describes full NIHR funding and four unverified manufacturer-related items. - Why unverified: The currently required information is unverified in the stored summary. Other individual COI, patents, writing/publication support and actual non-involvement remain unverified. Review of the existing content remains incomplete. - Reason for missing information: Other individual COI, patents, writing/publication support and actual non-involvement remain unverified. - Required materials and conditions: Individual disclosures, patents, manuscript/publication costs and roles - Materials to obtain first: Individual COI and writing/publication-support disclosures - Further research: Link disclosed roles to their funding scope. This is a recorded proposal; no new search, calculation or experiment was performed. - Conditions for verification: Original materials and the applicable analytical scope for Individual disclosures, patents, manuscript/publication costs and roles are required, with unresolved items distinguished. This record links preserved wording; review of the existing content remains incomplete. - Why this condition is needed: Production condition for distinguishing Individual disclosures, patents, manuscript/publication costs and roles and linking required and currently available materials for the selected question. - Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material. - Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review. - Referenced methods: Chamgap's own conditions for independence and attribution. The official methodological sections used in this example do not validate every detail of these items. - Related sources: S01 ### N21 · Did Burgio 2002 test the same device added to PFMT? Verification status: Partly verified Reading scope: Summary read; external material unread - Current findings: A three-arm RCT compared three different multicomponent behavioral programs in 222 women with urge or urge-predominant mixed urinary incontinence. - Why unverified: Only the relevant stored-summary information is recorded; detailed original material is unread and review of existing content remains incomplete. Exact programs, group-specific denominators and duration remain unverified. This is not converted into direct replication of OPAL adding only a device to the same PFMT. Review of the existing content remains incomplete. - Reason for missing information: Exact programs, group-specific denominators and duration remain unverified. This is not converted into direct replication of OPAL adding only a device to the same PFMT. - Required materials and conditions: Differences in population, three multicomponent behavioral programs, comparison and outcome - Materials to obtain first: Burgio intervention/comparator, population and methods tables - Further research: Link this as context with different populations and comparison definitions. This is a recorded proposal; no new search, calculation or experiment was performed. - Conditions for verification: Original materials and the applicable analytical scope for Differences in population, three multicomponent behavioral programs, comparison and outcome are required, with unresolved items distinguished. This record links preserved wording; review of the existing content remains incomplete. - Why this condition is needed: Production condition for distinguishing Differences in population, three multicomponent behavioral programs, comparison and outcome and linking required and currently available materials for the selected question. - Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material. - Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review. - Referenced methods: M04 §4.6.1–4.6.2 and M15 §15.3.1: in-house application; M03 §3.2.1: detailed population conditions are in-house; M03 §3.2.2–3.2.3: reverse-direction labeling and test adaptation are in-house. - Related sources: S02 ### N22 · What are the values from Burgio's three arms? Verification status: Partly verified Reading scope: Summary read; external material unread - Current findings: Preserve original incontinence-episode reductions of 63.1% versus 69.4% versus 58.6%, P=0.23. - Why unverified: Only the relevant stored-summary information is recorded; detailed original material is unread and review of existing content remains incomplete. Group/program correspondence, person/episode denominators, definitions, CI and timing remain unverified. No new difference, ratio or OPAL device effect is calculated. Review of the existing content remains incomplete. - Reason for missing information: Group/program correspondence, person/episode denominators, definitions, CI and timing remain unverified. No new difference, ratio or OPAL device effect is calculated. - Required materials and conditions: Episode reduction, group correspondence, original percentages, P value and denominators - Materials to obtain first: Three-arm results tables, definitions and denominators - Further research: Distinguish episode reduction from ICIQ, quality of life and cure rates. This is a recorded proposal; no new search, calculation or experiment was performed. - Conditions for verification: Original materials and the applicable analytical scope for Episode reduction, group correspondence, original percentages, P value and denominators are required, with unresolved items distinguished. This record links preserved wording; review of the existing content remains incomplete. - Why this condition is needed: Production condition for distinguishing Episode reduction, group correspondence, original percentages, P value and denominators and linking required and currently available materials for the selected question. - Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material. - Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review. - Referenced methods: M03 §3.2.4, M15 §15.3.1–15.3.3; outcome adaptations by question are our own design; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; adaptations by study design are our own design; M08 §8.2.2, M15 §15.3.1; our own application; M04 §4.6.1–4.6.2, M15 §15.3.1; our own application - Related sources: S02 ### N23 · What history do Burgio's registration and funding descriptions record? Verification status: Partly verified Reading scope: Summary read; external material unread - Current findings: Preserve US NIA/NIH support and the original registration wording that it did not exist because the study preceded the registration system. - Why unverified: Only the relevant stored-summary information is recorded; detailed original material is unread and review of existing content remains incomplete. This is not a current confirmation of absent registration or a detailed funding/product/author-COI comparison. The wording is not used as an identifier. Review of the existing content remains incomplete. - Reason for missing information: This is not a current confirmation of absent registration or a detailed funding/product/author-COI comparison. The wording is not used as an identifier. - Required materials and conditions: Registration wording, actual identifier and funding/COI - Materials to obtain first: Original trial plans, funding and COI - Further research: Record historical wording separately from actual identity material provided. This is a recorded proposal; no new search, calculation or experiment was performed. - Conditions for verification: Original materials and the applicable analytical scope for Registration wording, actual identifier and funding/COI are required, with unresolved items distinguished. This record links preserved wording; review of the existing content remains incomplete. - Why this condition is needed: Production condition for distinguishing Registration wording, actual identifier and funding/COI and linking required and currently available materials for the selected question. - Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material. - Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review. - Referenced methods: Chamgap’s own independence/attribution conditions. The official methodological sections in this pilot do not warrant all these detailed items; M08 Table 8.2.a, M04 §4.6.3; Chamgap adaptation; M04 §4.5, §4.6.3; limitations of the current material conversion follow the review scope and Chamgap design - Related sources: S02 ### N24 · What are Cochrane's overall comparison and outcome-specific denominators? Verification status: Partly verified Reading scope: Summary read; external material unread - Current findings: The original 2024 update gives 33 trials and 3,031 participants for PFMT plus biofeedback versus PFMT overall. Quality of life and cure/improvement are different subsets. - Why unverified: Only the relevant stored-summary information is recorded; detailed original material is unread and review of existing content remains incomplete. Included-trial tables, OPAL inclusion, subset overlap and denominator correspondence remain unverified. Overall/subset counts or OPAL participants are not newly added together. Review of the existing content remains incomplete. - Reason for missing information: Included-trial tables, OPAL inclusion, subset overlap and denominator correspondence remain unverified. Overall/subset counts or OPAL participants are not newly added together. - Required materials and conditions: Whole review, analytical subsets and trial/participant overlap - Materials to obtain first: Review included-trial tables and outcome-specific linkage tables - Further research: Link the review to original trials and outcome analyses. This is a recorded proposal; no new search, calculation or experiment was performed. - Conditions for verification: Original materials and the applicable analytical scope for Whole review, analytical subsets and trial/participant overlap are required, with unresolved items distinguished. This record links preserved wording; review of the existing content remains incomplete. - Why this condition is needed: Production condition for distinguishing Whole review, analytical subsets and trial/participant overlap and linking required and currently available materials for the selected question. - Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material. - Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review. - Referenced methods: Distinction between studies and reports in M04 §4.6.1–4.6.2; cohort/outcome linking is Chamgap adaptation; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are Chamgap design; M04 §4.6.1–4.6.2, M15 §15.3.1; Chamgap adaptation - Related sources: S03 ### N25 · Is the review quality-of-life value the same as the added ICIQ effect? Verification status: Partly verified Reading scope: Summary read; external material unread - Current findings: The original quality-of-life result is 11 trials, 1,169 participants, SMD −0.07, 95% CI −0.18 to 0.05. - Why unverified: Only the relevant stored-summary information is recorded; detailed original material is unread and review of existing content remains incomplete. Scale composition, group-specific analyses, heterogeneity and exact population comparisons were not read. This SMD is not converted into an OPAL ICIQ point difference. Review of the existing content remains incomplete. - Reason for missing information: Scale composition, group-specific analyses, heterogeneity and exact population comparisons were not read. This SMD is not converted into an OPAL ICIQ point difference. - Required materials and conditions: Quality-of-life outcome, standardized estimator and subset denominator - Materials to obtain first: Outcome-specific forest plots and scale/denominator material - Further research: Keep quality of life separate from 24-month ICIQ scores. This is a recorded proposal; no new search, calculation or experiment was performed. - Conditions for verification: Original materials and the applicable analytical scope for Quality-of-life outcome, standardized estimator and subset denominator are required, with unresolved items distinguished. This record links preserved wording; review of the existing content remains incomplete. - Why this condition is needed: Production condition for distinguishing Quality-of-life outcome, standardized estimator and subset denominator and linking required and currently available materials for the selected question. - Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material. - Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review. - Referenced methods: M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are Chamgap design; M15 §15.3.1–15.3.3; Chamgap adaptation; M04 §4.6.1–4.6.2, M15 §15.3.1; Chamgap adaptation - Related sources: S03 ### N26 · How are review cure/improvement and its lower CI bound preserved? Verification status: Partly verified Reading scope: Summary read; external material unread - Current findings: The result is 14 trials, 1,383 participants, OR 1.26, 95% CI 1.00 to 1.58. The manuscript records that a lower bound of 1.00 does not establish either a null result or benefit conclusively. - Why unverified: Only the relevant stored-summary information is recorded; detailed original material is unread and review of existing content remains incomplete. Definitions, estimation models, individual-trial denominators/events, unrounded intervals and multiplicity remain unverified. No new significance/benefit/null verdict or CI calculation is made. Review of the existing content remains incomplete. - Reason for missing information: Definitions, estimation models, individual-trial denominators/events, unrounded intervals and multiplicity remain unverified. No new significance/benefit/null verdict or CI calculation is made. - Required materials and conditions: Cure/improvement definitions, OR, interval and subset denominator - Materials to obtain first: Cure/improvement definitions and review analysis tables - Further research: Preserve original interval-boundary wording and separate outcome status. This is a recorded proposal; no new search, calculation or experiment was performed. - Conditions for verification: Original materials and the applicable analytical scope for Cure/improvement definitions, OR, interval and subset denominator are required, with unresolved items distinguished. This record links preserved wording; review of the existing content remains incomplete. - Why this condition is needed: Production condition for distinguishing Cure/improvement definitions, OR, interval and subset denominator and linking required and currently available materials for the selected question. - Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material. - Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review. - Referenced methods: M15 §15.3.1–15.3.3; Chamgap adaptation; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are Chamgap design; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are Chamgap design; M04 §4.6.3, M15 §15.3.1–15.3.3; separation of statuses is Chamgap design - Related sources: S03 ### N27 · Do the review funding and registration fields represent actual disclosures? Verification status: Unverified Reading scope: Summary read; external material unread - Current findings: The funding description is 'Cochrane review' and the registration field says 'not applicable'. The former describes material type and is not used as identification of an actual funder. - Why unverified: The currently required information is unverified in the stored summary. Actual review funding, COI and plans/registration remain unverified; external material is unread. 'Not applicable' does not certify that plans are absent. Review of the existing content remains incomplete. - Reason for missing information: Actual review funding, COI and plans/registration remain unverified; external material is unread. 'Not applicable' does not certify that plans are absent. - Required materials and conditions: Review funding/COI, protocol and registration identity - Materials to obtain first: Review funding/COI and protocol material - Further research: Distinguish material type from funding and identity fields. This is a recorded proposal; no new search, calculation or experiment was performed. - Conditions for verification: Original materials and the applicable analytical scope for Review funding/COI, protocol and registration identity are required, with unresolved items distinguished. This record links preserved wording; review of the existing content remains incomplete. - Why this condition is needed: Production condition for distinguishing Review funding/COI, protocol and registration identity and linking required and currently available materials for the selected question. - Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material. - Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review. - Referenced methods: Chamgap’s own independence/attribution conditions. The official methodological sections in this pilot do not warrant all these detailed items; M08 Table 8.2.a, M04 §4.6.3; Chamgap adaptation; material-collection/selection principles in M04 §4.5–4.6; separation of access/reading and the hyperlink contract are Chamgap design - Related sources: S03 ### N28 · Are independent replication and later analysis of the same data distinguished? Verification status: Partly verified Reading scope: Summary read; external material unread - Current findings: The manuscript records OPAL as the only direct confirmatory trial. Burgio and Cochrane provide context under different conditions, while the later MID uses the same OPAL data. - Why unverified: Only the relevant stored-summary information is recorded; detailed original material is unread and review of existing content remains incomplete. Identity of included trials and related reports remains externally unverified. Three reports, review trial counts and the MID analysis are not newly counted as independent replications. Review of the existing content remains incomplete. - Reason for missing information: Identity of included trials and related reports remains externally unverified. Three reports, review trial counts and the MID analysis are not newly counted as independent replications. - Required materials and conditions: Report-to-trial-family-to-result linkage and direct/context relationships - Materials to obtain first: Related reports, registrations and review included-trial linkage - Further research: Separate report-item counts from unique clinical-trial/participant counts. This is a recorded proposal; no new search, calculation or experiment was performed. - Conditions for verification: Original materials and the applicable analytical scope for Report-to-trial-family-to-result linkage and direct/context relationships are required, with unresolved items distinguished. This record links preserved wording; review of the existing content remains incomplete. - Why this condition is needed: Production condition for distinguishing Report-to-trial-family-to-result linkage and direct/context relationships and linking required and currently available materials for the selected question. - Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material. - Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review. - Referenced methods: M04 §4.6.1–4.6.2 distinction between studies and reports; cohort/outcome linking is Chamgap adaptation; M04 §4.6.1–4.6.2, M15 §15.3.1; Chamgap adaptation; M04 §4.6.3, M15 §15.3.1–15.3.3; separation of statuses is Chamgap design - Related sources: S01, S02, S03 ### N29 · What is the reporting scope of non-serious adverse events? Verification status: Partly verified Reading scope: Summary read; external material unread - Current findings: Preserve the original account that 48 participants reported non-serious adverse events and events in 23 participants were judged related or possibly related. - Why unverified: Only the relevant stored-summary information is recorded; detailed original material is unread and review of existing content remains incomplete. Group-specific person/event counts, exact collection periods, denominators and assessment methods remain unverified. No new frequency or risk difference uses 600 as a denominator. Review of the existing content remains incomplete. - Reason for missing information: Group-specific person/event counts, exact collection periods, denominators and assessment methods remain unverified. No new frequency or risk difference uses 600 as a denominator. - Required materials and conditions: Person/event counts, group-specific denominators, duration and collection - Materials to obtain first: Group-specific adverse-event tables and collection/assessment plans - Further research: Separate efficacy-analysis denominators from harm-observation denominators. This is a recorded proposal; no new search, calculation or experiment was performed. - Conditions for verification: Original materials and the applicable analytical scope for Person/event counts, group-specific denominators, duration and collection are required, with unresolved items distinguished. This record links preserved wording; review of the existing content remains incomplete. - Why this condition is needed: Production condition for distinguishing Person/event counts, group-specific denominators, duration and collection and linking required and currently available materials for the selected question. - Application exceptions: Supplement safety-information gaps for the selected subclaim. Incontinence-symptom results or parent safety wording do not establish safety, harm incidence or new device-use instructions. - Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review. - Referenced methods: M19 §19.1.2–19.2.4; Chamgap adaptation; M19 §19.1.2–19.2.4; detailed distinctions are Chamgap design; M19 §19.1.2–19.2.4; Chamgap adaptation; M19 §19.1.2–19.2.4, M04 §4.6.3; Chamgap adaptation - Related sources: S01 ### N30 · How far do probe-related event and seriousness descriptions extend? Verification status: Partly verified Reading scope: Summary read; external material unread - Current findings: Preserve the original account of vaginal-probe discomfort, bleeding and similar events, with no serious related complication reported. - Why unverified: Only the relevant stored-summary information is recorded; detailed original material is unread and review of existing content remains incomplete. Event-specific definitions, timing, concomitant/baseline risks and reporting scope remain unverified. This is not expanded into certification that all serious events or long-term harms are absent. Review of the existing content remains incomplete. - Reason for missing information: Event-specific definitions, timing, concomitant/baseline risks and reporting scope remain unverified. This is not expanded into certification that all serious events or long-term harms are absent. - Required materials and conditions: Discomfort, bleeding, serious events, timing and relatedness assessment - Materials to obtain first: Event details and relatedness-assessment material - Further research: Record relatedness, seriousness and reporting-scope limitations separately. This is a recorded proposal; no new search, calculation or experiment was performed. - Conditions for verification: Original materials and the applicable analytical scope for Discomfort, bleeding, serious events, timing and relatedness assessment are required, with unresolved items distinguished. This record links preserved wording; review of the existing content remains incomplete. - Why this condition is needed: Production condition for distinguishing Discomfort, bleeding, serious events, timing and relatedness assessment and linking required and currently available materials for the selected question. - Application exceptions: Supplement safety-information gaps for the selected subclaim. Incontinence-symptom results or parent safety wording do not establish safety, harm incidence or new device-use instructions. - Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review. - Referenced methods: M19 §19.1.2–19.2.4; Chamgap adaptation; M19 §19.2 design-specific harm questions; temporal-relationship details are Chamgap design; M19 §19.2.2–19.2.4 design considerations; detailed confounding records are Chamgap design; Chamgap’s own interpretation boundary, informed by M19 principles, without running an official causality tool - Related sources: S01 ### N31 · Is the result extended to excluded groups, learning support, PFMT itself or long-term harm? Verification status: Partly verified Reading scope: Summary read; external material unread - Current findings: The manuscript places initial learning support for women unable to contract and PFMT itself outside this verdict. The observation concerns added ICIQ benefit at 24 months. - Why unverified: Only the relevant stored-summary information is recorded; detailed original material is unread and review of existing content remains incomplete. Excluded groups, other devices, separate learning purposes, effects beyond 24 months and rare harms remain unverified. No new use, training or treatment instructions are created. Review of the existing content remains incomplete. - Reason for missing information: Excluded groups, other devices, separate learning purposes, effects beyond 24 months and rare harms remain unverified. No new use, training or treatment instructions are created. - Required materials and conditions: Selected scope and direct material for separate populations, uses and durations - Materials to obtain first: Separate population/purpose trials and long-term follow-up - Further research: Separate the current added-device effect from extended questions. This is a recorded proposal; no new search, calculation or experiment was performed. - Conditions for verification: Original materials and the applicable analytical scope for Selected scope and direct material for separate populations, uses and durations are required, with unresolved items distinguished. This record links preserved wording; review of the existing content remains incomplete. - Why this condition is needed: Production condition for distinguishing Selected scope and direct material for separate populations, uses and durations and linking required and currently available materials for the selected question. - Application exceptions: Supplement safety-information gaps for the selected subclaim. Incontinence-symptom results or parent safety wording do not establish safety, harm incidence or new device-use instructions. - Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review. - Referenced methods: M03 §3.2.1–3.2.4; dose, duration and effect-modification details are Chamgap design; M03 §3.2.4; Chamgap extrapolation boundary; M19 §19.1.2–19.2.4; Chamgap adaptation; M19 §19.1.2–19.2.4; Chamgap adaptation - Related sources: S01, S02, S03 ### N32 · What is the scope of dates, language-specific wording, original axes and correction history? Verification status: Partly verified Reading scope: Summary read; external material unread - Current findings: Preserve parent D with 34 points, axes, 2026-08-26, Korean/English manuscripts, empty corrections/deliberation and historical cross-check wording in the whole review summary. The 2024 review update is historical source information. - Why unverified: Only the relevant stored-summary information is recorded; detailed original material is unread and review of existing content remains incomplete. This does not indicate a current review, registration/correction/retraction check or completion of review now. Differences in information by language are not filled with new translated facts. Review of the existing content remains incomplete. - Reason for missing information: This does not indicate a current review, registration/correction/retraction check or completion of review now. Differences in information by language are not filled with new translated facts. - Required materials and conditions: Original verdict date, Korean/English manuscripts, cross-checking and correction/retraction verification level - Materials to obtain first: New correction records, user comments and originals provided - Further research: Distinguish historical values from production/change events. This is a recorded proposal; no new search, calculation or experiment was performed. - Conditions for verification: Original materials and the applicable analytical scope for Original verdict date, Korean/English manuscripts, cross-checking and correction/retraction verification level are required, with unresolved items distinguished. This record links preserved wording; review of the existing content remains incomplete. - Why this condition is needed: Production condition for distinguishing Original verdict date, Korean/English manuscripts, cross-checking and correction/retraction verification level and linking required and currently available materials for the selected question. - Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material. - Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review. - Referenced methods: M04 §4.5, §4.6.3; current material-conversion limits reflect review scope and our own design; M04 §4.6.3, M15 §15.3.1–15.3.3; status distinctions are our own design - Related sources: S01, S02, S03 ### N33 · What was actually read in the summary and external originals? Verification status: Partly verified Reading scope: Summary read; external material unread - Current findings: The whole stored summary and three evidence/citation summaries were read for production, and original source links were retained. The summary is labeled 'summary read'; external material is 'unread'. - Why unverified: Only the relevant stored-summary information is recorded; detailed original material is unread and review of existing content remains incomplete. External originals, registry, protocol, SAP and disclosures were not accessed or link-tested. URLs and registration identifiers are not converted into full-text reading or successful access. Review of the existing content remains incomplete. - Reason for missing information: External originals, registry, protocol, SAP and disclosures were not accessed or link-tested. URLs and registration identifiers are not converted into full-text reading or successful access. - Required materials and conditions: Access status of the stored summary, papers, registry, protocol, SAP and disclosures - Materials to obtain first: Original material and actual reading history for each report - Further research: Link existence, acquisition and actual-reading levels separately for each material. This is a recorded proposal; no new search, calculation or experiment was performed. - Conditions for verification: Original materials and the applicable analytical scope for Access status of the stored summary, papers, registry, protocol, SAP and disclosures are required, with unresolved items distinguished. This record links preserved wording; review of the existing content remains incomplete. - Why this condition is needed: Production condition for distinguishing Access status of the stored summary, papers, registry, protocol, SAP and disclosures and linking required and currently available materials for the selected question. - Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material. - Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review. - Referenced methods: M04 §4.5–4.6 material collection/selection principles; acquisition/reading separation and hyperlink specifications are internally designed; M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design - Related sources: S01, S02, S03 ## Evidence and sources ### S01 Hagen S et al. 2020 OPAL [PubMed](https://pubmed.ncbi.nlm.nih.gov/33055247/) Materials actually read: Summary read; external material unread Findings recorded in the summary: 8.2 versus 8.5; adjusted difference −0.09 (95% CI −0.92 to 0.75), P=0.84. Original means and the adjusted difference remain different estimators. The sample-size threshold of 2.5 points, later MID of 1.9 points (95% CI 1.1 to 2.7) using the same OPAL data and original threshold-exclusion interpretation are historical; no new calculation, grade or equivalence certification is made. Record level: Outcome wording in the stored summary Independent replication: S01 OPAL/ISRCTN57746448 reports a 24-month comparison adding vaginal-probe EMG to supervised PFMT in 600 women with stress/mixed urinary incontinence able to contract, allocated 300 per group. The 225/235, original 460 analysis count and approximately 78% Korean return/approximately 22% English attrition wording remain distinct. The later 1.9-point MID analyzes the same OPAL data; no separate bibliography appears in this stored summary, so no new report/independent trial is created. Report/material-item counts are not totals of unique clinical trials, participants or independent replications; unique clinical totals remain unrecorded. S02 Burgio 2002 compares three different multicomponent behavioral programs in 222 women with urge or urge-predominant mixed incontinence. Exact group/program correspondence is absent from this summary, and population/comparison differ from OPAL. The original wording of absent registration before the registration system is historical, and the actual registration identifier remains null. Report/material-item counts are not unique clinical-trial/participant/independent-replication totals, which remain unrecorded. S03 is the original 2024 Cochrane update synthesis. The different analyses of 33 trials/3031 participants overall, 11 trials/1169 for quality of life and 14 trials/1383 for cure/improvement remain distinct. OPAL inclusion and trial overlap remain unverified; the review is not counted as a new independent RCT or replication. The funding phrase Cochrane review describes material type; actual funding remains unverified. Report/material-item counts are not unique clinical-trial/participant/independent-replication totals, which remain unrecorded. | Material | Public availability | Access status | Actually read | Notes | |---|---|---|---|---| | Stored summary | Stored file | Stored summary | Summary read | Only stored-summary and bibliographic content was used for production. External material verification/review is not complete. | | External paper | Public availability unverified; only bibliography links preserved | Unread; access not attempted | Not read | No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status. | | Registration material | Public availability unverified; only bibliography links preserved | Unread; access not attempted | Not read | No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status. | | Protocol | Public availability unverified; only bibliography links preserved | Unread; access not attempted | Not read | No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status. | | Statistical analysis plan | Public availability unverified; only bibliography links preserved | Unread; access not attempted | Not read | No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status. | | Funding, product-support and COI material | Public availability unverified; only bibliography links preserved | Unread; access not attempted | Not read | No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status. | ### S02 Burgio KL et al. 2002 [PubMed](https://pubmed.ncbi.nlm.nih.gov/12425706/) Materials actually read: Summary read; external material unread Findings recorded in the summary: 63.1% versus 69.4% versus 58.6%, P=0.23. Original episode-reduction values are preserved; program correspondence, CIs and denominators remain unverified. They are not converted into ICIQ point differences, added device benefit or equivalence. Record level: Outcome wording in the stored summary Independent replication: S01 OPAL/ISRCTN57746448 reports a 24-month comparison adding vaginal-probe EMG to supervised PFMT in 600 women with stress/mixed urinary incontinence able to contract, allocated 300 per group. The 225/235, original 460 analysis count and approximately 78% Korean return/approximately 22% English attrition wording remain distinct. The later 1.9-point MID analyzes the same OPAL data; no separate bibliography appears in this stored summary, so no new report/independent trial is created. Report/material-item counts are not totals of unique clinical trials, participants or independent replications; unique clinical totals remain unrecorded. S02 Burgio 2002 compares three different multicomponent behavioral programs in 222 women with urge or urge-predominant mixed incontinence. Exact group/program correspondence is absent from this summary, and population/comparison differ from OPAL. The original wording of absent registration before the registration system is historical, and the actual registration identifier remains null. Report/material-item counts are not unique clinical-trial/participant/independent-replication totals, which remain unrecorded. S03 is the original 2024 Cochrane update synthesis. The different analyses of 33 trials/3031 participants overall, 11 trials/1169 for quality of life and 14 trials/1383 for cure/improvement remain distinct. OPAL inclusion and trial overlap remain unverified; the review is not counted as a new independent RCT or replication. The funding phrase Cochrane review describes material type; actual funding remains unverified. Report/material-item counts are not unique clinical-trial/participant/independent-replication totals, which remain unrecorded. | Material | Public availability | Access status | Actually read | Notes | |---|---|---|---|---| | Stored summary | Stored file | Stored summary | Summary read | Only stored-summary and bibliographic content was used for production. External material verification/review is not complete. | | External paper | Public availability unverified; only bibliography links preserved | Unread; access not attempted | Not read | No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status. | | Registration material | Public availability unverified; only bibliography links preserved | Unread; access not attempted | Not read | No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status. | | Protocol | Public availability unverified; only bibliography links preserved | Unread; access not attempted | Not read | No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status. | | Statistical analysis plan | Public availability unverified; only bibliography links preserved | Unread; access not attempted | Not read | No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status. | | Funding, product-support and COI material | Public availability unverified; only bibliography links preserved | Unread; access not attempted | Not read | No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status. | ### S03 Fernandes et al. 2024 Cochrane update [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 material unread Findings recorded in the summary: Quality of life: 11 trials, 1,169 participants, SMD −0.07 (95% CI −0.18 to 0.05); cure/improvement: 14 trials, 1,383 participants, OR 1.26 (95% CI 1.00 to 1.58). The manuscript states that a lower cure/improvement CI bound of 1.00 does not conclusively establish either a null result or benefit. No new significance or pooled effect is calculated, and subset/OPAL participants are not added together. Record level: Outcome wording in the stored summary Independent replication: S01 OPAL/ISRCTN57746448 reports a 24-month comparison adding vaginal-probe EMG to supervised PFMT in 600 women with stress/mixed urinary incontinence able to contract, allocated 300 per group. The 225/235, original 460 analysis count and approximately 78% Korean return/approximately 22% English attrition wording remain distinct. The later 1.9-point MID analyzes the same OPAL data; no separate bibliography appears in this stored summary, so no new report/independent trial is created. Report/material-item counts are not totals of unique clinical trials, participants or independent replications; unique clinical totals remain unrecorded. S02 Burgio 2002 compares three different multicomponent behavioral programs in 222 women with urge or urge-predominant mixed incontinence. Exact group/program correspondence is absent from this summary, and population/comparison differ from OPAL. The original wording of absent registration before the registration system is historical, and the actual registration identifier remains null. Report/material-item counts are not unique clinical-trial/participant/independent-replication totals, which remain unrecorded. S03 is the original 2024 Cochrane update synthesis. The different analyses of 33 trials/3031 participants overall, 11 trials/1169 for quality of life and 14 trials/1383 for cure/improvement remain distinct. OPAL inclusion and trial overlap remain unverified; the review is not counted as a new independent RCT or replication. The funding phrase Cochrane review describes material type; actual funding remains unverified. Report/material-item counts are not unique clinical-trial/participant/independent-replication totals, which remain unrecorded. | Material | Public availability | Access status | Actually read | Notes | |---|---|---|---|---| | Stored summary | Stored file | Stored summary | Summary read | Only stored-summary and bibliographic content was used for production. External material verification/review is not complete. | | External paper | Public availability unverified; only bibliography links preserved | Unread; access not attempted | Not read | No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status. | | Registration material | Public availability unverified; only bibliography links preserved | Unread; access not attempted | Not read | No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status. | | Protocol | Public availability unverified; only bibliography links preserved | Unread; access not attempted | Not read | No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status. | | Statistical analysis plan | Public availability unverified; only bibliography links preserved | Unread; access not attempted | Not read | No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status. | | Funding, product-support and COI material | Public availability unverified; only bibliography links preserved | Unread; access not attempted | Not read | No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status. | ## 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 method HTML copies; no current method-content re-review or official tool execution - 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 method HTML copies; no current method-content re-review or official tool execution - 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 method HTML copies; no current method-content re-review or official tool execution - 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 method HTML copies; no current method-content re-review or official tool execution - 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 method HTML copies; no current method-content re-review or official tool execution ## What the statuses mean - Met: Status for necessary evidence confirmed after existing content review. No completion is declared in the current presentation. - Partly verified: Some information in the stored summary is linked into the table. External comparison/content review is not complete. - Unverified: The article leaves this unverified, or required material is absent from the current stored summary. This is distinct from zero, absence or safety. - Review incomplete: Existing content review remains incomplete. - Not reported: Not reported within the stored material actually read; not extended to the entire primary paper. - Inaccessible: Means an actual access failure. Access not attempted here is not assigned this state. - Not applicable: Not used as a substitute for an evidence gap. - Conflicting data: Requires an observed disagreement under the same comparison criteria; not automatically judged in this production. - Insufficient evidence for the conditions: Marks a gap in additional material required by the selected conditions; not a new efficacy grade. ## Change history 2026-10-11 · Public page/materials 1.0. Public reader views and materials were prepared from the existing 33 items. No new clinical search, verification-status change or scoring was performed.