Urinary Incontinence, Stress, Urinary Incontinence, Urge
Conditions
Keywords
urinary incontinence, midurethral sling, pelvic floor therapy
Brief summary
The overarching goal of this randomized trial is to estimate the effect of combined midurethral sling (MUS) and peri-operative behavioral/pelvic floor therapy (BPTx) compared to MUS alone on successful treatment of MUI symptoms in 472 women. Secondary objectives include estimating the effect of combined treatment compared to MUS on improving overactive bladder (OAB) and stress urinary incontinence (SUI) outcomes separately, need for additional treatment, time to failure and identifying predictors of poor outcomes in this MUI population. A supplemental study, The Human Microbiome Study of ESTEEM, will evaluate the urinary and vaginal microbiome as it relates to women with MUI, their treatment and unaffected controls.
Detailed description
ESTEEM is a multi-center randomized trial of 472 women with MUI who have elected to undergo surgical treatment for SUI. Participants will be randomized to a peri-operative BPTx program+MUS versus MUS alone. The purpose is to compare combined MUS+BPTx versus MUS alone (control) on improving MUI symptoms at 1 year. Patients will be assigned to one of the two treatment groups. Randomization will be stratified by clinical site and by UUI severity, which will be defined by the number of urgency urinary IEs on diary. The primary outcome for this study is the mean change from baseline in UDI-total score at 1 year postoperative. The UDI is a validated, disease-specific, patient-reported outcome (PRO) measure. Secondary outcomes UUI/OAB outcomes will be measured using the UDI-irritative subscale that measures symptom burden, impact, and changes related to OAB. It is highly responsive to treatment-related change and is able to discriminate among levels of change in all bladder diary variables (urinary urgency, frequency and urge incontinence) and patient ratings of treatment benefit that will characterize how MUS may affect all OAB symptoms individually and as a whole. SUI symptom outcomes will be measured using the UDI-stress subscale to compare SUI outcomes between women randomized to MUS + BPTx versus MUS alone. Other UUI/OAB outcomes that will be compared between groups include 1) the change in IE frequency and type, number of urgency episodes, urgency severity with voids, number of diurnal voids, and number of nocturnal voids using a bladder diary; 2) patient satisfaction with treatment using the OAB-SAT-q; 3) bother and heal related quality of life using the OAB-q subscale For analyzing time to failure, failure will be defined as initiation of any additional treatment for either SUI or UUI/OAB symptoms during the follow-up period. Subjects lost to follow up will be censored at the time of their last visit. Quality of life/global impression will be assessed be compared between treatment groups using the a) Incontinence Impact Questionnaire (IIQ), Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ), c) European Quality of Life-5 Dimensions (EQ-5D), d) Adaptation Index and e) Patient Global Impression of Improvement (PGI-I) and Patient Global Impression of Severity (PGI-S). Safety/additional treatments will be characterized as a) additional re-treatments for SUI or UUI within 12 months of treatment, and type of re-treatment and b) return to OR for sling revision due to worsened OAB symptoms. To evaluate the association between PFM strength and improvements in UI symptoms, we will objectively assess PFM strength changes using the Peritron Perineometer, and instrument specifically designed for pelvic floor assessment.
Interventions
PROCEDUREMiduretheral Sling
MUS can include the TVT™ (mechanical cut mesh only, Gynecare, ETHICON Women's Health & Urology, Somerville, NJ), TVT-O™ (mechanical cut mesh only, Gynecare), or Monarc™ (American Medical Systems, Minnetonka, MN).
OTHERMiduretheral Sling with behavioral/pelvic floor therapy
MUS is combined with components of behavioral therapy (designed to change behaviors to encourage continence), and pelvic floor muscle therapy (designed to strengthen the pelvic floor muscles, enhance the physiological closure of the bladder neck, and improve coordination). This is done prior to MUS (1 visit) and after MUS for 5 visits at 2, 4, 6, 8 weeks and 6 months.
Sponsors
Women and Infants Hospital of Rhode Island
The Cleveland Clinic
Duke University
University of Alabama at Birmingham
University of New Mexico
University of Pennsylvania
University of Pittsburgh
University of California, San Diego
Kaiser Permanente
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
RTI International
NICHD Pelvic Floor Disorders Network
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Caregiver)
Eligibility
Sex/Gender
FEMALE
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Presence of both SUI and UUI on bladder diary; and \> 2 IEs/3 days 1. \> 1 Stress IE/3 day diary 2. \> 1 Urge IE/3 day diary 2. Reporting at least moderate bother from UUI item on the UDI Do you usually experience urine leakage associated with a feeling of urgency, that is a strong sensation of needing to go to the bathroom? 3. Reporting at least moderate bother from SUI item on UDI Do you usually experience urine leakage related to coughing, sneezing, or laughing 4. Diagnosis of SUI defined by a positive cough stress test (CST) or urodynamic evaluation within the past 18 months 5. Desires surgical treatment for SUI symptoms 6. Urinary symptoms \>3 months 7. Subjects understand that BPTx is a treatment option for MUI outside of ESTEEM study protocol 8. Urodynamics within past 18 months
Exclusion criteria
1. Anterior or apical compartment prolapse at or beyond the hymen (\>0 on POPQ), regardless if patient is symptomatic a)Women with anterior or apical prolapse above the hymen (\<0) who do not report vaginal bulge symptoms will be eligible 2. Planned concomitant surgery for anterior vaginal wall or apical prolapse \> 0 a)Women undergoing only rectocele repair are eligible 3. Women undergoing hysterectomy for any indication will be excluded 4. Active pelvic organ malignancy 5. Age \<21 years 6. Pregnant or plans for future pregnancy in next 12 months, or within 12 months post-partum 7. Post-void residual \>150 cc on 2 occasions, or current catheter use 8. Participation in other trial that may influence results of this study 9. Unevaluated hematuria 10. Prior sling, synthetic mesh for prolapse, implanted nerve stimulator for incontinence 11. Spinal cord injury or advanced/severe neurologic conditions including Multiple Sclerosis, Parkinsons 12. Women on anti-muscarinic therapy will be eligible after 3 week wash-out period 13. Non-ambulatory 14. History of serious adverse reaction to synthetic mesh 15. Not able to complete study assessments per clinician judgment, or not available for 12 month follow-up 16. Women who only report other IE on bladder diary, and do not report at minimum 1 stress and 1 urge IE/3 days 17. Diagnosis of and/or history of bladder pain or chronic pelvic pain 18. Women who had intravesical Botox injection within the past 12 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline UDI Total Score | 3, 6, and 12 Months | The Urogenital Distress Inventory (UDI) is a standardized a measure of overactive bladder symptoms and health-related quality of life. The UDI scale has a range from 0 to 300 with higher scores indicating greater distress. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline UDI Stress Score | 3, 6, and 12 Months | The Urogenital Distress Inventory is a standardized a measure of overactive bladder symptoms and health-related quality of life. The UDI Stress subscale has a range from 0 to 100 with higher scores indicating greater distress. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline. |
| Change From Baseline UDI Irritative Score | 3, 6, and 12 Months | The Urogenital Distress Inventory is a standardized a measure of overactive bladder symptoms and health-related quality of life. The UDI Irritative subscale has a range from 0 to 100 with higher scores indicating greater distress. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline. |
| Change From Baseline UDI Obstructive Score | 3, 6, and 12 Months | The Urogenital Distress Inventory is a standardized a measure of overactive bladder symptoms and health-related quality of life. The UDI Obstructive subscale has a range from 0 to 100 with higher scores indicating greater distress. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline Number of Wet Pads Per Day | 2 weeks and 2, 6, and 12 Months | Based on data collected from participant-completed diaries at baseline, 2 weeks, and 2, 6, and 12 months, the outcome variable is computed as the difference in number of wet pads per day at 2 weeks, 2, 6, or 12 months and the number of wet pads per day at baseline. |
| Change From Baseline Number of Pads Per Day | 2 weeks and 2, 6, and 12 Months | Based on data collected from participant-completed diaries at baseline, 2 weeks, and 2, 6, and 12 months, the outcome variable is computed as the difference in total number of pads per day at 2 weeks, 2, 6, or 12 months and the total number of pads per day at baseline. |
| Change From Baseline Number of Daytime Voids | 2 weeks and 2, 6, and 12 Months | Based on data collected from participant-completed diaries at baseline, 2 weeks, and 2, 6, and 12 months, the outcome variable is computed as the difference in number of daytime voids at 2 weeks, 2, 6, or 12 months and the number of daytime voids at baseline. |
| Change From Baseline Number of Nighttime Voids | 2 weeks and 2, 6, and 12 Months | Based on data collected from participant-completed diaries at baseline, 2 weeks, and 2, 6, and 12 months, the outcome variable is computed as the difference in number of nighttime voids at 2 weeks, 2, 6, or 12 months and the number of nighttime voids at baseline. |
| Change From Baseline Number of Urgency Voids Without Incontinence | 2 weeks and 2, 6, and 12 Months | Based on data collected from participant-completed diaries at baseline, 2 weeks, and 2, 6, and 12 months, the outcome variable is computed as the difference in number of urgency voids without incontinence at 2 weeks, 2, 6, or 12 months and the number of urgency voids without incontinence at baseline. |
| Number of Participants With <8 Voids After Baseline (Normalization of Voiding Frequency) | 2 weeks and 2, 6, and 12 Months | Based on data collected from participant-completed diaries at baseline, 2 weeks, and 2, 6, and 12 months, for participants with \>8 voids at baseline, the outcome is calculated as Yes=no more than 8 voids noted at the time point, No=Otherwise |
| Number of Participants With 50% Reduction in Voids Relative to Baseline (Improved Voiding Frequency) | 2 weeks and 2, 6, and 12 Months | Based on data collected from participant-completed diaries at baseline, 2 weeks, and 2, 6, and 12 months, the outcome is calculated as Yes=at least 50% reduction in the number of voids between 2 weeks, 2, 6, and 12 months and baseline, No=Otherwise |
| Number of Participants With Greater Number of Voids Relative to Baseline or >8 Voids (Worsening Voiding Frequency) | 2 weeks and 2, 6, and 12 Months | Based on data collected from participant-completed diaries at baseline, 2 weeks, and 2, 6, and 12 months, the outcome is calculated as Yes=greater than baseline number of voids at the time point or with greater than 8 voids at the time point, No=Otherwise |
| Change From Baseline PISQ-IR NSAPR Score | 3, 6, and 12 Months | The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised (PISQ-IR) is a questionnaire measuring the impact of incontinence symptoms on sexual function and satisfaction. Using the Rockwood scoring, the PISQ-IR Not Partner Related subscale (NSA-PR) ranges from 0 to 100 with higher scores indicating worse function/satisfaction. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline. |
| Change From Baseline PISQ-IR NSACS Score | 3, 6, and 12 Months | The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised (PISQ-IR) is a questionnaire measuring the impact of incontinence symptoms on sexual function and satisfaction. Using the Rockwood scoring, the PISQ-IR Not Sexually Active-Condition Specific subscale (NSA-CS) ranges from 0 to 100 with worse scores indicating better function/satisfaction. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline. |
| Change From Baseline PISQ-IR NSAGQR Score | 3, 6, and 12 Months | The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised (PISQ-IR) is a questionnaire measuring the impact of incontinence symptoms on sexual function and satisfaction. Using the Rockwood scoring, the PISQ-IR Not Sexually Active-Global Quality Rating subscale (NSA-GQR) ranges from 0 to 100 with higher scores indicating worse function/satisfaction. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline. |
| Change From Baseline PISQ-IR NSACI Score | 3, 6, and 12 Months | The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised (PISQ-IR) is a questionnaire measuring the impact of incontinence symptoms on sexual function and satisfaction. Using the Rockwood scoring, the PISQ-IR Not Sexually Active-Condition Impact subscale (NSA-CI) ranges from 0 to 100 with higher scores indicating worse function/satisfaction. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline. |
| Change From Baseline PISQ-IR SAAO Score | 3, 6, and 12 Months | The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised (PISQ-IR) is a questionnaire measuring the impact of incontinence symptoms on sexual function and satisfaction. Using the Rockwood scoring, the PISQ-IR Sexually Active-Arousal, Orgasm subscale (SA-AO) ranges from 0 to 100 with higher scores indicating worse function/satisfaction. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline. |
| Change From Baseline PISQ-IR SAPR Score | 3, 6, and 12 Months | The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised (PISQ-IR) is a questionnaire measuring the impact of incontinence symptoms on sexual function and satisfaction. Using the Rockwood scoring, the PISQ-IR Sexually Active-Partner Related subscale (SA-PR) ranges from 0 to 100 with higher scores indicating better function/satisfaction. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline. |
| Change From Baseline PISQ-IR SACS Score | 3, 6, and 12 Months | The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised (PISQ-IR) is a questionnaire measuring the impact of incontinence symptoms on sexual function and satisfaction. Using the Rockwood scoring, the PISQ-IR Sexually Active-Condition Specific subscale (SA-CS) ranges from 0 to 100 with higher scores indicating better function/satisfaction. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline. |
| Change From Baseline PISQ-IR SAGQR Score | 3, 6, and 12 Months | The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised (PISQ-IR) is a questionnaire measuring the impact of incontinence symptoms on sexual function and satisfaction. Using the Rockwood scoring, the PISQ-IR Sexually Active-Global Quality Rating subscale (SA-GQR) ranges from 0 to 100 with higher scores indicating better function/satisfaction. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline. |
| Change From Baseline PISQ-IR SACI Score | 3, 6, and 12 Months | The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised (PISQ-IR) is a questionnaire measuring the impact of incontinence symptoms on sexual function and satisfaction. Using the Rockwood scoring, the PISQ-IR Sexually Active-Condition Impact subscale (SA-CI) ranges from 0 to 100 with higher scores indicating better function/satisfaction. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline. |
| Change From Baseline PISQ-IR SAD Score | 3, 6, and 12 Months | The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised (PISQ-IR) is a questionnaire measuring the impact of incontinence symptoms on sexual function and satisfaction. Using the Rockwood scoring, the PISQ-IR Sexually Active-Desire subscale (SA-D) ranges from 0 to 100 with higher scores indicating better function/satisfaction. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline. |
| Change From Baseline EQ-5D Index Score | 3, 6, and 12 Months | EQ-5D is a standardized instrument developed by the EuroQol Group as a measure of health-related quality of life. The index score ranges from 0 to 1 with higher scores indicating a better quality of life. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline. |
| Change From Baseline EQ-5D Visual Analog Scale Score | 3, 6, and 12 Months | EQ-5D is a standardized instrument developed by the EuroQol Group as a measure of health-related quality of life. The visual analog scale (VAS) score ranges from 0 to 100 with higher scores indicating a better quality of life. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline. |
| Change From Baseline OABq-LF Symptom Severity Score | 3, 6, and 12 Months | The Overactive Bladder Questionnaire-Long Form is a standardized a measure of overactive bladder symptoms and health-related quality of life. The OABq-LF Symptom Severity score ranges from 0 to 100 with higher score indicating worse quality of life. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline. |
| Change From Baseline OABq-LF Coping Score | 3, 6, and 12 Months | The Overactive Bladder Questionnaire-Long Form is a standardized a measure of overactive bladder symptoms and health-related quality of life. The OABq-LF Coping score ranges from 0 to 100 with higher score indicating better quality of life. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline. |
| Change From Baseline OABq-LF Concern Score | 3, 6, and 12 Months | The Overactive Bladder Questionnaire-Long Form is a standardized a measure of overactive bladder symptoms and health-related quality of life. The OABq-LF Concern score ranges from 0 to 100 with higher score indicating better quality of life. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline. |
| Change From Baseline OABq-LF Sleep Score | 3, 6, and 12 Months | The Overactive Bladder Questionnaire-Long Form is a standardized a measure of overactive bladder symptoms and health-related quality of life. The OABq-LF Sleep score ranges from 0 to 100 with higher score indicating better quality of life. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline. |
| Change From Baseline OABq-LF Social Score | 3, 6, and 12 Months | The Overactive Bladder Questionnaire-Long Form is a standardized a measure of overactive bladder symptoms and health-related quality of life. The OABq-LF Social score ranges from 0 to 100 with higher score indicating better quality of life. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline. |
| Change From Baseline OABq-LF HRQL Total Score | 3, 6, and 12 Months | The Overactive Bladder Questionnaire-Long Form is a standardized a measure of overactive bladder symptoms and health-related quality of life. The OABq-LF HRQL score ranges from 0 to 100 with higher score indicating better quality of life. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline. |
| OAB-SATq Satisfaction Score | 3, 6, and 12 Months | The Overactive Bladder Satisfaction with Treatment Questionnaire is a standardized a measure of satisfaction with treatment for overactive bladder symptoms. The OAB-SATq Satisfaction score ranges from 0 to 100 with higher scores indicating higher satisfaction. |
| OAB-SATq Side Effect Score | 3, 6, and 12 Months | The Overactive Bladder Satisfaction with Treatment Questionnaire is a standardized a measure of satisfaction with treatment for overactive bladder symptoms. The OAB-SATq Side Effect score ranges from 0 to 100 with higher scores indicating fewer side effects. |
| OAB-SATq Endorsement Score | 3, 6, and 12 Months | The Overactive Bladder Satisfaction with Treatment Questionnaire is a standardized a measure of satisfaction with treatment for overactive bladder symptoms. The OAB-SATq Endorsement score ranges from 0 to 100 with higher scores indicating greater endorsement. |
| OAB-SATq Convenience Score | 3, 6, and 12 Months | The Overactive Bladder Satisfaction with Treatment Questionnaire is a standardized a measure of satisfaction with treatment for overactive bladder symptoms. The OAB-SATq Convenience score ranges from 0 to 100 with higher scores indicating greater convenience. |
| OAB-SATq Preference Score | 3, 6, and 12 Months | The Overactive Bladder Satisfaction with Treatment Questionnaire is a standardized a measure of satisfaction with treatment for overactive bladder symptoms. The preference score is a binary \[yes/no\] indicator as to whether a subject indicated slight or definite preference for the treatment among women that have had previous treatment for overactive bladder. The outcome is the percentage of participants that prefer the current treatment to previous treatments. |
| Change From Baseline IIq-LF Physical Activity Score | 3, 6, and 12 Months | The Incontinence Impact Questionnaire-Long Form is a standardized a measure of health-related quality of life. The IIq-LF Physical Activity score ranges from 0 to 100 with higher scores indicating worse impact. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline. |
| Change From Baseline IIq-LF Travel Score | 3, 6, and 12 Months | The Incontinence Impact Questionnaire-Long Form is a standardized a measure of health-related quality of life. The IIq-LF Travel score ranges from 0 to 100 with higher scores indicating worse impact. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline. |
| Change From Baseline IIq-LF Social Relationship Score | 3, 6, and 12 Months | The Incontinence Impact Questionnaire-Long Form is a standardized a measure of health-related quality of life. The IIq-LF Social Relationship score ranges from 0 to 100 with higher scores indicating worse impact. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline. |
| Change From Baseline IIq-LF Emotional Health Score | 3, 6, and 12 Months | The Incontinence Impact Questionnaire-Long Form is a standardized a measure of health-related quality of life. The IIq-LF Emotional Health score ranges from 0 to 100 with higher scores indicating worse impact. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline. |
| Change From Baseline IIq-LF Total Score | 3, 6, and 12 Months | The Incontinence Impact Questionnaire-Long Form is a standardized a measure of health-related quality of life. The IIq-LF Total score ranges from 0 to 400 with higher scores indicating worse impact. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline. |
| Change From Baseline ADI Hygiene Score | 3, 6, and 12 Months | The Adaptation Index is a standardized measure of health-related quality of life. The ADI Hygiene score ranges from 0 to 100 with higher score indicating worse severity in adaptive behaviors. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline. |
| Change From Baseline ADI Avoidance Score | 3, 6, and 12 Months | The Adaptation Index is a standardized measure of health-related quality of life. The ADI Avoidance score ranges from 0 to 100 with higher score indicating worse severity in adaptive behaviors. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline. |
| Change From Baseline Brink Score | 2 weeks and 2 and 12 Months | The Brink scale considers three pelvic floor muscle contraction variables: vaginal pressure or muscle force, elevation or vertical displacement of the examiner fingers, and duration of contraction. The score ranges from 3 to 12 with higher scores indicating greater PFM function. The change from baseline outcome is calculated as the difference in score at 3 or 12 months and the score at baseline. |
| Change From Baseline Number of Stress Incontinence Episodes | 2 weeks and 2, 6, and 12 Months | Based on data collected from participant-completed diaries at baseline, 2 weeks, and 2, 6, and 12 months, the outcome variable is computed as the difference in number of stress incontinence episodes at 2 weeks, 2, 6, or 12 months and the number of stress incontinence episodes at baseline. |
| PGI-I | 3, 6, and 12 Months | The Patient Global Impression of Improvement (PGI-I) is a patient-reported measure of perceived improvement with treatment, as assessed on a scale of 1 (very much better) to 7 (very much worse). Included here are participants who had improvement as indicated by a rating of 1 (very much better), 2 (much better). |
| PGI-S | Baseline 3, 6, and 12 Months | The Patient Global Impression of Severity (PGI-S) is a patient-reported measure of perceived severity of condition, as assessed on a scale of 1 (Normal) to 4 (Severe). Included here are participants who reported Normal or Mild severity as indicated by a rating of 1 or 2. |
| Change From Average Peak Muscle Contraction Pressure (cm H2O) | 2 weeks and 2 and 12 Months | The average peak muscle contraction is measured during a physical exam. The outcome is calculated as the difference in measured value at 3 or 12 months and the score at baseline. |
| Change From Baseline Number of Urge Incontinence Episodes | 2 weeks and 2, 6, and 12 Months | Based on data collected from participant-completed diaries at baseline, 2 weeks, and 2, 6, and 12 months, the outcome variable is computed as the difference in number of urge incontinence episodes at 2 weeks, 2, 6, or 12 months and the number of urge incontinence episodes at baseline. |
| Change From Baseline Number of Unknown Incontinence Episodes | 2 weeks and 2, 6, and 12 Months | Based on data collected from participant-completed diaries at baseline, 2 weeks, and 2, 6, and 12 months, the outcome variable is computed as the difference in number of unknown incontinence episodes at 2 weeks, 2, 6, or 12 months and the number of unknown incontinence episodes at baseline. |
| Change From Baseline Total Number of Incontinence Episodes | 2 weeks and 2, 6, and 12 Months | Based on data collected from participant-completed diaries at baseline, 2 weeks, and 2, 6, and 12 months, the outcome variable is computed as the difference in total number of incontinence episodes at 2 weeks, 2, 6, or 12 months and the total number of incontinence episodes at baseline. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| MUS Only Midurethral sling alone | 229 |
| MUS+BPTx Midurethral sling and behavioral/pelvic floor therapy | 235 |
| Total | 464 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Protocol Violation | 9 | 7 |
Baseline characteristics
| Characteristic | MUS Only | MUS+BPTx | Total |
|---|---|---|---|
| Age, Continuous | 53.6 years STANDARD_DEVIATION 10.4 | 54.3 years STANDARD_DEVIATION 11 | 54 years STANDARD_DEVIATION 10.7 |
| Body Mass Index | 32.3 kg/m^2 STANDARD_DEVIATION 7 | 31.7 kg/m^2 STANDARD_DEVIATION 7 | 32 kg/m^2 STANDARD_DEVIATION 7 |
| Current Smoker No | 200 Participants | 203 Participants | 403 Participants |
| Current Smoker Unknown or Not Reported | 1 Participants | 0 Participants | 1 Participants |
| Current Smoker Yes | 28 Participants | 32 Participants | 60 Participants |
| Ever Pregnant No | 10 Participants | 15 Participants | 25 Participants |
| Ever Pregnant Unknown or Not Reported | 1 Participants | 0 Participants | 1 Participants |
| Ever Pregnant Yes | 218 Participants | 220 Participants | 438 Participants |
| Menstrual Status not sure | 28 Participants | 32 Participants | 60 Participants |
| Menstrual Status post-menopausal | 124 Participants | 138 Participants | 262 Participants |
| Menstrual Status pre-menopausal | 76 Participants | 65 Participants | 141 Participants |
| Menstrual Status Unknown or Not Reported | 1 Participants | 0 Participants | 1 Participants |
| Number of Cesarean Deliveries | 0 Number of deliveries | 0 Number of deliveries | 0 Number of deliveries |
| Number of Vaginal Deliveries | 2 Number of deliveries | 2 Number of deliveries | 2 Number of deliveries |
| Race/Ethnicity, Customized American Indian/Alaskan Native | 3 Participants | 7 Participants | 10 Participants |
| Race/Ethnicity, Customized Asian | 1 Participants | 2 Participants | 3 Participants |
| Race/Ethnicity, Customized Black/African American | 19 Participants | 22 Participants | 41 Participants |
| Race/Ethnicity, Customized Hispanic/Latina | 56 Participants | 49 Participants | 105 Participants |
| Race/Ethnicity, Customized More than one race | 1 Participants | 2 Participants | 3 Participants |
| Race/Ethnicity, Customized Not Hispanic/Not Latina | 169 Participants | 184 Participants | 353 Participants |
| Race/Ethnicity, Customized Other | 23 Participants | 19 Participants | 42 Participants |
| Race/Ethnicity, Customized Unknown/Not Reported | 4 Participants | 2 Participants | 3 Participants |
| Race/Ethnicity, Customized White | 181 Participants | 181 Participants | 362 Participants |
| Sex/Gender, Customized Female | 229 Participants | 235 Participants | 464 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 238 | 0 / 242 |
| other Total, other adverse events | 163 / 238 | 172 / 242 |
| serious Total, serious adverse events | 28 / 238 | 21 / 242 |
Outcome results
Primary
Change From Baseline UDI Total Score
The Urogenital Distress Inventory (UDI) is a standardized a measure of overactive bladder symptoms and health-related quality of life. The UDI scale has a range from 0 to 300 with higher scores indicating greater distress. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline.
Time frame: 3, 6, and 12 Months
Population: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. Data that was collected after a participant was retreated for urinary incontinence was excluded from the analysis.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| MUS Only | Change From Baseline UDI Total Score | 3 Months | -138.8 units on a scale |
| MUS Only | Change From Baseline UDI Total Score | 6 Months | -137 units on a scale |
| MUS Only | Change From Baseline UDI Total Score | 12 Months | -137.9 units on a scale |
| MUS+BPTx | Change From Baseline UDI Total Score | 3 Months | -142.7 units on a scale |
| MUS+BPTx | Change From Baseline UDI Total Score | 6 Months | -147.4 units on a scale |
| MUS+BPTx | Change From Baseline UDI Total Score | 12 Months | -147.7 units on a scale |
Secondary
Change From Baseline UDI Irritative Score
The Urogenital Distress Inventory is a standardized a measure of overactive bladder symptoms and health-related quality of life. The UDI Irritative subscale has a range from 0 to 100 with higher scores indicating greater distress. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline.
Time frame: 3, 6, and 12 Months
Population: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. Data that was collected after a participant was retreated for urinary incontinence was excluded from the analysis.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| MUS Only | Change From Baseline UDI Irritative Score | 3 Months | -49.7 units on a scale |
| MUS Only | Change From Baseline UDI Irritative Score | 6 Months | -49.5 units on a scale |
| MUS Only | Change From Baseline UDI Irritative Score | 12 Months | -50 units on a scale |
| MUS+BPTx | Change From Baseline UDI Irritative Score | 3 Months | -50.1 units on a scale |
| MUS+BPTx | Change From Baseline UDI Irritative Score | 6 Months | -53.5 units on a scale |
| MUS+BPTx | Change From Baseline UDI Irritative Score | 12 Months | -53.5 units on a scale |
Secondary
Change From Baseline UDI Obstructive Score
The Urogenital Distress Inventory is a standardized a measure of overactive bladder symptoms and health-related quality of life. The UDI Obstructive subscale has a range from 0 to 100 with higher scores indicating greater distress. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline.
Time frame: 3, 6, and 12 Months
Population: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. Data that was collected after a participant was retreated for urinary incontinence was excluded from the analysis.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| MUS Only | Change From Baseline UDI Obstructive Score | 3 Months | -18.5 units on a scale |
| MUS Only | Change From Baseline UDI Obstructive Score | 6 Months | -18 units on a scale |
| MUS Only | Change From Baseline UDI Obstructive Score | 12 Months | -18.5 units on a scale |
| MUS+BPTx | Change From Baseline UDI Obstructive Score | 3 Months | -20.2 units on a scale |
| MUS+BPTx | Change From Baseline UDI Obstructive Score | 6 Months | -21.1 units on a scale |
| MUS+BPTx | Change From Baseline UDI Obstructive Score | 12 Months | -20.3 units on a scale |
Secondary
Change From Baseline UDI Stress Score
The Urogenital Distress Inventory is a standardized a measure of overactive bladder symptoms and health-related quality of life. The UDI Stress subscale has a range from 0 to 100 with higher scores indicating greater distress. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline.
Time frame: 3, 6, and 12 Months
Population: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. Data that was collected after a participant was retreated for urinary incontinence was excluded from the analysis.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| MUS Only | Change From Baseline UDI Stress Score | 3 Months | -70.6 units on a scale |
| MUS Only | Change From Baseline UDI Stress Score | 6 Months | -69.5 units on a scale |
| MUS Only | Change From Baseline UDI Stress Score | 12 Months | -69.3 units on a scale |
| MUS+BPTx | Change From Baseline UDI Stress Score | 3 Months | -72.5 units on a scale |
| MUS+BPTx | Change From Baseline UDI Stress Score | 6 Months | -72.8 units on a scale |
| MUS+BPTx | Change From Baseline UDI Stress Score | 12 Months | -73.8 units on a scale |
Other Pre-specified
Change From Average Peak Muscle Contraction Pressure (cm H2O)
The average peak muscle contraction is measured during a physical exam. The outcome is calculated as the difference in measured value at 3 or 12 months and the score at baseline.
Time frame: 2 weeks and 2 and 12 Months
Population: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. Data that was collected after a participant was retreated for urinary incontinence was excluded from the analysis.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| MUS Only | Change From Average Peak Muscle Contraction Pressure (cm H2O) | 0.5 Months | 3.7 cm H2O |
| MUS Only | Change From Average Peak Muscle Contraction Pressure (cm H2O) | 2 Months | 5 cm H2O |
| MUS Only | Change From Average Peak Muscle Contraction Pressure (cm H2O) | 12 Months | 4 cm H2O |
| MUS+BPTx | Change From Average Peak Muscle Contraction Pressure (cm H2O) | 0.5 Months | 0.7 cm H2O |
| MUS+BPTx | Change From Average Peak Muscle Contraction Pressure (cm H2O) | 2 Months | 4.6 cm H2O |
| MUS+BPTx | Change From Average Peak Muscle Contraction Pressure (cm H2O) | 12 Months | 4.4 cm H2O |
Other Pre-specified
Change From Baseline ADI Avoidance Score
The Adaptation Index is a standardized measure of health-related quality of life. The ADI Avoidance score ranges from 0 to 100 with higher score indicating worse severity in adaptive behaviors. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline.
Time frame: 3, 6, and 12 Months
Population: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. Data that was collected after a participant was retreated for urinary incontinence was excluded from the analysis.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| MUS Only | Change From Baseline ADI Avoidance Score | 3 Months | -31.3 units on a scale |
| MUS Only | Change From Baseline ADI Avoidance Score | 6 Months | -32.5 units on a scale |
| MUS Only | Change From Baseline ADI Avoidance Score | 12 Months | -33 units on a scale |
| MUS+BPTx | Change From Baseline ADI Avoidance Score | 3 Months | -33.8 units on a scale |
| MUS+BPTx | Change From Baseline ADI Avoidance Score | 6 Months | -34.5 units on a scale |
| MUS+BPTx | Change From Baseline ADI Avoidance Score | 12 Months | -35.7 units on a scale |
Other Pre-specified
Change From Baseline ADI Hygiene Score
The Adaptation Index is a standardized measure of health-related quality of life. The ADI Hygiene score ranges from 0 to 100 with higher score indicating worse severity in adaptive behaviors. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline.
Time frame: 3, 6, and 12 Months
Population: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. Data that was collected after a participant was retreated for urinary incontinence was excluded from the analysis.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| MUS Only | Change From Baseline ADI Hygiene Score | 3 Months | -32.1 units on a scale |
| MUS Only | Change From Baseline ADI Hygiene Score | 6 Months | -34.6 units on a scale |
| MUS Only | Change From Baseline ADI Hygiene Score | 12 Months | -35.5 units on a scale |
| MUS+BPTx | Change From Baseline ADI Hygiene Score | 6 Months | -37.6 units on a scale |
| MUS+BPTx | Change From Baseline ADI Hygiene Score | 3 Months | -36.7 units on a scale |
| MUS+BPTx | Change From Baseline ADI Hygiene Score | 12 Months | -38.8 units on a scale |
Other Pre-specified
Change From Baseline Brink Score
The Brink scale considers three pelvic floor muscle contraction variables: vaginal pressure or muscle force, elevation or vertical displacement of the examiner fingers, and duration of contraction. The score ranges from 3 to 12 with higher scores indicating greater PFM function. The change from baseline outcome is calculated as the difference in score at 3 or 12 months and the score at baseline.
Time frame: 2 weeks and 2 and 12 Months
Population: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. Data that was collected after a participant was retreated for urinary incontinence was excluded from the analysis.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| MUS Only | Change From Baseline Brink Score | 0.5 Months | 0.5 units on a scale |
| MUS Only | Change From Baseline Brink Score | 2 Months | 0.5 units on a scale |
| MUS Only | Change From Baseline Brink Score | 12 Months | 0.6 units on a scale |
| MUS+BPTx | Change From Baseline Brink Score | 0.5 Months | 0.2 units on a scale |
| MUS+BPTx | Change From Baseline Brink Score | 2 Months | 0.6 units on a scale |
| MUS+BPTx | Change From Baseline Brink Score | 12 Months | 0.6 units on a scale |
Other Pre-specified
Change From Baseline EQ-5D Index Score
EQ-5D is a standardized instrument developed by the EuroQol Group as a measure of health-related quality of life. The index score ranges from 0 to 1 with higher scores indicating a better quality of life. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline.
Time frame: 3, 6, and 12 Months
Population: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. Data that was collected after a participant was retreated for urinary incontinence was excluded from the analysis.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| MUS Only | Change From Baseline EQ-5D Index Score | 3 Months | 0 units on a scale |
| MUS Only | Change From Baseline EQ-5D Index Score | 6 Months | 0 units on a scale |
| MUS Only | Change From Baseline EQ-5D Index Score | 12 Months | 0 units on a scale |
| MUS+BPTx | Change From Baseline EQ-5D Index Score | 3 Months | 0 units on a scale |
| MUS+BPTx | Change From Baseline EQ-5D Index Score | 6 Months | 0 units on a scale |
| MUS+BPTx | Change From Baseline EQ-5D Index Score | 12 Months | 0 units on a scale |
Other Pre-specified
Change From Baseline EQ-5D Visual Analog Scale Score
EQ-5D is a standardized instrument developed by the EuroQol Group as a measure of health-related quality of life. The visual analog scale (VAS) score ranges from 0 to 100 with higher scores indicating a better quality of life. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline.
Time frame: 3, 6, and 12 Months
Population: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. Data that was collected after a participant was retreated for urinary incontinence was excluded from the analysis.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| MUS Only | Change From Baseline EQ-5D Visual Analog Scale Score | 3 Months | 0.3 units on a scale |
| MUS Only | Change From Baseline EQ-5D Visual Analog Scale Score | 6 Months | 2.5 units on a scale |
| MUS Only | Change From Baseline EQ-5D Visual Analog Scale Score | 12 Months | 1.2 units on a scale |
| MUS+BPTx | Change From Baseline EQ-5D Visual Analog Scale Score | 3 Months | 4 units on a scale |
| MUS+BPTx | Change From Baseline EQ-5D Visual Analog Scale Score | 6 Months | 3.1 units on a scale |
| MUS+BPTx | Change From Baseline EQ-5D Visual Analog Scale Score | 12 Months | 4.8 units on a scale |
Other Pre-specified
Change From Baseline IIq-LF Emotional Health Score
The Incontinence Impact Questionnaire-Long Form is a standardized a measure of health-related quality of life. The IIq-LF Emotional Health score ranges from 0 to 100 with higher scores indicating worse impact. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline.
Time frame: 3, 6, and 12 Months
Population: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. Data that was collected after a participant was retreated for urinary incontinence was excluded from the analysis.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| MUS Only | Change From Baseline IIq-LF Emotional Health Score | 3 Months | -38.4 units on a scale |
| MUS Only | Change From Baseline IIq-LF Emotional Health Score | 6 Months | -38.6 units on a scale |
| MUS Only | Change From Baseline IIq-LF Emotional Health Score | 12 Months | -38.3 units on a scale |
| MUS+BPTx | Change From Baseline IIq-LF Emotional Health Score | 3 Months | -40.7 units on a scale |
| MUS+BPTx | Change From Baseline IIq-LF Emotional Health Score | 6 Months | -41.5 units on a scale |
| MUS+BPTx | Change From Baseline IIq-LF Emotional Health Score | 12 Months | -42.8 units on a scale |
Other Pre-specified
Change From Baseline IIq-LF Physical Activity Score
The Incontinence Impact Questionnaire-Long Form is a standardized a measure of health-related quality of life. The IIq-LF Physical Activity score ranges from 0 to 100 with higher scores indicating worse impact. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline.
Time frame: 3, 6, and 12 Months
Population: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. Data that was collected after a participant was retreated for urinary incontinence was excluded from the analysis.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| MUS Only | Change From Baseline IIq-LF Physical Activity Score | 3 Months | -39.2 units on a scale |
| MUS Only | Change From Baseline IIq-LF Physical Activity Score | 6 Months | -39.1 units on a scale |
| MUS Only | Change From Baseline IIq-LF Physical Activity Score | 12 Months | -42.3 units on a scale |
| MUS+BPTx | Change From Baseline IIq-LF Physical Activity Score | 3 Months | -40.9 units on a scale |
| MUS+BPTx | Change From Baseline IIq-LF Physical Activity Score | 6 Months | -42.1 units on a scale |
| MUS+BPTx | Change From Baseline IIq-LF Physical Activity Score | 12 Months | -42.5 units on a scale |
Other Pre-specified
Change From Baseline IIq-LF Social Relationship Score
The Incontinence Impact Questionnaire-Long Form is a standardized a measure of health-related quality of life. The IIq-LF Social Relationship score ranges from 0 to 100 with higher scores indicating worse impact. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline.
Time frame: 3, 6, and 12 Months
Population: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. Data that was collected after a participant was retreated for urinary incontinence was excluded from the analysis.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| MUS Only | Change From Baseline IIq-LF Social Relationship Score | 3 Months | -28.9 units on a scale |
| MUS Only | Change From Baseline IIq-LF Social Relationship Score | 6 Months | -28.6 units on a scale |
| MUS Only | Change From Baseline IIq-LF Social Relationship Score | 12 Months | -30 units on a scale |
| MUS+BPTx | Change From Baseline IIq-LF Social Relationship Score | 3 Months | -32.8 units on a scale |
| MUS+BPTx | Change From Baseline IIq-LF Social Relationship Score | 6 Months | -33.7 units on a scale |
| MUS+BPTx | Change From Baseline IIq-LF Social Relationship Score | 12 Months | -34.1 units on a scale |
Other Pre-specified
Change From Baseline IIq-LF Total Score
The Incontinence Impact Questionnaire-Long Form is a standardized a measure of health-related quality of life. The IIq-LF Total score ranges from 0 to 400 with higher scores indicating worse impact. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline.
Time frame: 3, 6, and 12 Months
Population: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. Data that was collected after a participant was retreated for urinary incontinence was excluded from the analysis.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| MUS Only | Change From Baseline IIq-LF Total Score | 3 Months | -140.4 units on a scale |
| MUS Only | Change From Baseline IIq-LF Total Score | 6 Months | -139.8 units on a scale |
| MUS Only | Change From Baseline IIq-LF Total Score | 12 Months | -146 units on a scale |
| MUS+BPTx | Change From Baseline IIq-LF Total Score | 3 Months | -153.3 units on a scale |
| MUS+BPTx | Change From Baseline IIq-LF Total Score | 6 Months | -158.2 units on a scale |
| MUS+BPTx | Change From Baseline IIq-LF Total Score | 12 Months | -160.1 units on a scale |
Other Pre-specified
Change From Baseline IIq-LF Travel Score
The Incontinence Impact Questionnaire-Long Form is a standardized a measure of health-related quality of life. The IIq-LF Travel score ranges from 0 to 100 with higher scores indicating worse impact. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline.
Time frame: 3, 6, and 12 Months
Population: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. Data that was collected after a participant was retreated for urinary incontinence was excluded from the analysis.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| MUS Only | Change From Baseline IIq-LF Travel Score | 3 Months | -33.9 units on a scale |
| MUS Only | Change From Baseline IIq-LF Travel Score | 6 Months | -33.4 units on a scale |
| MUS Only | Change From Baseline IIq-LF Travel Score | 12 Months | -35.4 units on a scale |
| MUS+BPTx | Change From Baseline IIq-LF Travel Score | 3 Months | -38.9 units on a scale |
| MUS+BPTx | Change From Baseline IIq-LF Travel Score | 6 Months | -40.9 units on a scale |
| MUS+BPTx | Change From Baseline IIq-LF Travel Score | 12 Months | -40.8 units on a scale |
Other Pre-specified
Change From Baseline Number of Daytime Voids
Based on data collected from participant-completed diaries at baseline, 2 weeks, and 2, 6, and 12 months, the outcome variable is computed as the difference in number of daytime voids at 2 weeks, 2, 6, or 12 months and the number of daytime voids at baseline.
Time frame: 2 weeks and 2, 6, and 12 Months
Population: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. Data that was collected after a participant was retreated for urinary incontinence was excluded from the analysis.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| MUS Only | Change From Baseline Number of Daytime Voids | 0.5 Months | -0.6 number of voids |
| MUS Only | Change From Baseline Number of Daytime Voids | 2 Months | -0.7 number of voids |
| MUS Only | Change From Baseline Number of Daytime Voids | 6 Months | -1.1 number of voids |
| MUS Only | Change From Baseline Number of Daytime Voids | 12 Months | -1.2 number of voids |
| MUS+BPTx | Change From Baseline Number of Daytime Voids | 12 Months | -2 number of voids |
| MUS+BPTx | Change From Baseline Number of Daytime Voids | 0.5 Months | -0.8 number of voids |
| MUS+BPTx | Change From Baseline Number of Daytime Voids | 6 Months | -2.2 number of voids |
| MUS+BPTx | Change From Baseline Number of Daytime Voids | 2 Months | -1.6 number of voids |
Other Pre-specified
Change From Baseline Number of Nighttime Voids
Based on data collected from participant-completed diaries at baseline, 2 weeks, and 2, 6, and 12 months, the outcome variable is computed as the difference in number of nighttime voids at 2 weeks, 2, 6, or 12 months and the number of nighttime voids at baseline.
Time frame: 2 weeks and 2, 6, and 12 Months
Population: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. Data that was collected after a participant was retreated for urinary incontinence was excluded from the analysis.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| MUS Only | Change From Baseline Number of Nighttime Voids | 0.5 Months | -0.2 number of voids |
| MUS Only | Change From Baseline Number of Nighttime Voids | 2 Months | -0.4 number of voids |
| MUS Only | Change From Baseline Number of Nighttime Voids | 6 Months | -0.5 number of voids |
| MUS Only | Change From Baseline Number of Nighttime Voids | 12 Months | -0.4 number of voids |
| MUS+BPTx | Change From Baseline Number of Nighttime Voids | 12 Months | -0.8 number of voids |
| MUS+BPTx | Change From Baseline Number of Nighttime Voids | 0.5 Months | -0.4 number of voids |
| MUS+BPTx | Change From Baseline Number of Nighttime Voids | 6 Months | -0.8 number of voids |
| MUS+BPTx | Change From Baseline Number of Nighttime Voids | 2 Months | -0.7 number of voids |
Other Pre-specified
Change From Baseline Number of Pads Per Day
Based on data collected from participant-completed diaries at baseline, 2 weeks, and 2, 6, and 12 months, the outcome variable is computed as the difference in total number of pads per day at 2 weeks, 2, 6, or 12 months and the total number of pads per day at baseline.
Time frame: 2 weeks and 2, 6, and 12 Months
Population: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. Data that was collected after a participant was retreated for urinary incontinence was excluded from the analysis.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| MUS Only | Change From Baseline Number of Pads Per Day | 0.5 Months | -1.6 number of pads |
| MUS Only | Change From Baseline Number of Pads Per Day | 2 Months | -2.2 number of pads |
| MUS Only | Change From Baseline Number of Pads Per Day | 6 Months | -2.2 number of pads |
| MUS Only | Change From Baseline Number of Pads Per Day | 12 Months | -2.3 number of pads |
| MUS+BPTx | Change From Baseline Number of Pads Per Day | 12 Months | -2.7 number of pads |
| MUS+BPTx | Change From Baseline Number of Pads Per Day | 0.5 Months | -1.9 number of pads |
| MUS+BPTx | Change From Baseline Number of Pads Per Day | 6 Months | -2.8 number of pads |
| MUS+BPTx | Change From Baseline Number of Pads Per Day | 2 Months | -2.7 number of pads |
Other Pre-specified
Change From Baseline Number of Stress Incontinence Episodes
Based on data collected from participant-completed diaries at baseline, 2 weeks, and 2, 6, and 12 months, the outcome variable is computed as the difference in number of stress incontinence episodes at 2 weeks, 2, 6, or 12 months and the number of stress incontinence episodes at baseline.
Time frame: 2 weeks and 2, 6, and 12 Months
Population: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. Data that was collected after a participant was retreated for urinary incontinence was excluded from the analysis.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| MUS Only | Change From Baseline Number of Stress Incontinence Episodes | 0.5 Months | -2.2 number of episodes |
| MUS Only | Change From Baseline Number of Stress Incontinence Episodes | 2 Months | -2.3 number of episodes |
| MUS Only | Change From Baseline Number of Stress Incontinence Episodes | 6 Months | -2.3 number of episodes |
| MUS Only | Change From Baseline Number of Stress Incontinence Episodes | 12 Months | -2.2 number of episodes |
| MUS+BPTx | Change From Baseline Number of Stress Incontinence Episodes | 12 Months | -2.2 number of episodes |
| MUS+BPTx | Change From Baseline Number of Stress Incontinence Episodes | 0.5 Months | -2.2 number of episodes |
| MUS+BPTx | Change From Baseline Number of Stress Incontinence Episodes | 6 Months | -2.3 number of episodes |
| MUS+BPTx | Change From Baseline Number of Stress Incontinence Episodes | 2 Months | -2.4 number of episodes |
Other Pre-specified
Change From Baseline Number of Unknown Incontinence Episodes
Based on data collected from participant-completed diaries at baseline, 2 weeks, and 2, 6, and 12 months, the outcome variable is computed as the difference in number of unknown incontinence episodes at 2 weeks, 2, 6, or 12 months and the number of unknown incontinence episodes at baseline.
Time frame: 2 weeks and 2, 6, and 12 Months
Population: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. Data that was collected after a participant was retreated for urinary incontinence was excluded from the analysis.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| MUS Only | Change From Baseline Number of Unknown Incontinence Episodes | 0.5 Months | -0.2 number of episodes |
| MUS Only | Change From Baseline Number of Unknown Incontinence Episodes | 2 Months | -0.3 number of episodes |
| MUS Only | Change From Baseline Number of Unknown Incontinence Episodes | 6 Months | -0.3 number of episodes |
| MUS Only | Change From Baseline Number of Unknown Incontinence Episodes | 12 Months | -0.3 number of episodes |
| MUS+BPTx | Change From Baseline Number of Unknown Incontinence Episodes | 12 Months | -0.4 number of episodes |
| MUS+BPTx | Change From Baseline Number of Unknown Incontinence Episodes | 0.5 Months | -0.4 number of episodes |
| MUS+BPTx | Change From Baseline Number of Unknown Incontinence Episodes | 6 Months | -0.4 number of episodes |
| MUS+BPTx | Change From Baseline Number of Unknown Incontinence Episodes | 2 Months | -0.4 number of episodes |
Other Pre-specified
Change From Baseline Number of Urge Incontinence Episodes
Based on data collected from participant-completed diaries at baseline, 2 weeks, and 2, 6, and 12 months, the outcome variable is computed as the difference in number of urge incontinence episodes at 2 weeks, 2, 6, or 12 months and the number of urge incontinence episodes at baseline.
Time frame: 2 weeks and 2, 6, and 12 Months
Population: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. Data that was collected after a participant was retreated for urinary incontinence was excluded from the analysis.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| MUS Only | Change From Baseline Number of Urge Incontinence Episodes | 6 Months | -2 number of episodes |
| MUS Only | Change From Baseline Number of Urge Incontinence Episodes | 2 Months | -2 number of episodes |
| MUS Only | Change From Baseline Number of Urge Incontinence Episodes | 12 Months | -1.9 number of episodes |
| MUS Only | Change From Baseline Number of Urge Incontinence Episodes | 0.5 Months | -1.8 number of episodes |
| MUS+BPTx | Change From Baseline Number of Urge Incontinence Episodes | 12 Months | -2.2 number of episodes |
| MUS+BPTx | Change From Baseline Number of Urge Incontinence Episodes | 2 Months | -2 number of episodes |
| MUS+BPTx | Change From Baseline Number of Urge Incontinence Episodes | 6 Months | -2 number of episodes |
| MUS+BPTx | Change From Baseline Number of Urge Incontinence Episodes | 0.5 Months | -1.7 number of episodes |
Other Pre-specified
Change From Baseline Number of Urgency Voids Without Incontinence
Based on data collected from participant-completed diaries at baseline, 2 weeks, and 2, 6, and 12 months, the outcome variable is computed as the difference in number of urgency voids without incontinence at 2 weeks, 2, 6, or 12 months and the number of urgency voids without incontinence at baseline.
Time frame: 2 weeks and 2, 6, and 12 Months
Population: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. Data that was collected after a participant was retreated for urinary incontinence was excluded from the analysis.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| MUS Only | Change From Baseline Number of Urgency Voids Without Incontinence | 0.5 Months | -1.1 number of voids |
| MUS Only | Change From Baseline Number of Urgency Voids Without Incontinence | 2 Months | -1.6 number of voids |
| MUS Only | Change From Baseline Number of Urgency Voids Without Incontinence | 6 Months | -3.5 number of voids |
| MUS Only | Change From Baseline Number of Urgency Voids Without Incontinence | 12 Months | -3.9 number of voids |
| MUS+BPTx | Change From Baseline Number of Urgency Voids Without Incontinence | 12 Months | -5.1 number of voids |
| MUS+BPTx | Change From Baseline Number of Urgency Voids Without Incontinence | 0.5 Months | -0.8 number of voids |
| MUS+BPTx | Change From Baseline Number of Urgency Voids Without Incontinence | 6 Months | -4.8 number of voids |
| MUS+BPTx | Change From Baseline Number of Urgency Voids Without Incontinence | 2 Months | -4.3 number of voids |
Other Pre-specified
Change From Baseline Number of Wet Pads Per Day
Based on data collected from participant-completed diaries at baseline, 2 weeks, and 2, 6, and 12 months, the outcome variable is computed as the difference in number of wet pads per day at 2 weeks, 2, 6, or 12 months and the number of wet pads per day at baseline.
Time frame: 2 weeks and 2, 6, and 12 Months
Population: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. Data that was collected after a participant was retreated for urinary incontinence was excluded from the analysis.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| MUS Only | Change From Baseline Number of Wet Pads Per Day | 0.5 Months | -2 number of pads |
| MUS Only | Change From Baseline Number of Wet Pads Per Day | 2 Months | -2.4 number of pads |
| MUS Only | Change From Baseline Number of Wet Pads Per Day | 6 Months | -2.2 number of pads |
| MUS Only | Change From Baseline Number of Wet Pads Per Day | 12 Months | -2.2 number of pads |
| MUS+BPTx | Change From Baseline Number of Wet Pads Per Day | 12 Months | -2.7 number of pads |
| MUS+BPTx | Change From Baseline Number of Wet Pads Per Day | 0.5 Months | -2.2 number of pads |
| MUS+BPTx | Change From Baseline Number of Wet Pads Per Day | 6 Months | -2.7 number of pads |
| MUS+BPTx | Change From Baseline Number of Wet Pads Per Day | 2 Months | -2.7 number of pads |
Other Pre-specified
Change From Baseline OABq-LF Concern Score
The Overactive Bladder Questionnaire-Long Form is a standardized a measure of overactive bladder symptoms and health-related quality of life. The OABq-LF Concern score ranges from 0 to 100 with higher score indicating better quality of life. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline.
Time frame: 3, 6, and 12 Months
Population: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. Data that was collected after a participant was retreated for urinary incontinence was excluded from the analysis.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| MUS Only | Change From Baseline OABq-LF Concern Score | 3 Months | 47.6 units on a scale |
| MUS Only | Change From Baseline OABq-LF Concern Score | 6 Months | 47 units on a scale |
| MUS Only | Change From Baseline OABq-LF Concern Score | 12 Months | 46.9 units on a scale |
| MUS+BPTx | Change From Baseline OABq-LF Concern Score | 3 Months | 51.2 units on a scale |
| MUS+BPTx | Change From Baseline OABq-LF Concern Score | 6 Months | 51.1 units on a scale |
| MUS+BPTx | Change From Baseline OABq-LF Concern Score | 12 Months | 50.4 units on a scale |
Other Pre-specified
Change From Baseline OABq-LF Coping Score
The Overactive Bladder Questionnaire-Long Form is a standardized a measure of overactive bladder symptoms and health-related quality of life. The OABq-LF Coping score ranges from 0 to 100 with higher score indicating better quality of life. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline.
Time frame: 3, 6, and 12 Months
Population: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. Data that was collected after a participant was retreated for urinary incontinence was excluded from the analysis.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| MUS Only | Change From Baseline OABq-LF Coping Score | 3 Months | 43.1 units on a scale |
| MUS Only | Change From Baseline OABq-LF Coping Score | 6 Months | 43.3 units on a scale |
| MUS Only | Change From Baseline OABq-LF Coping Score | 12 Months | 43.9 units on a scale |
| MUS+BPTx | Change From Baseline OABq-LF Coping Score | 3 Months | 48.2 units on a scale |
| MUS+BPTx | Change From Baseline OABq-LF Coping Score | 6 Months | 48.4 units on a scale |
| MUS+BPTx | Change From Baseline OABq-LF Coping Score | 12 Months | 47.9 units on a scale |
Other Pre-specified
Change From Baseline OABq-LF HRQL Total Score
The Overactive Bladder Questionnaire-Long Form is a standardized a measure of overactive bladder symptoms and health-related quality of life. The OABq-LF HRQL score ranges from 0 to 100 with higher score indicating better quality of life. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline.
Time frame: 3, 6, and 12 Months
Population: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. Data that was collected after a participant was retreated for urinary incontinence was excluded from the analysis.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| MUS Only | Change From Baseline OABq-LF HRQL Total Score | 3 Months | 38.6 units on a scale |
| MUS Only | Change From Baseline OABq-LF HRQL Total Score | 6 Months | 38 units on a scale |
| MUS Only | Change From Baseline OABq-LF HRQL Total Score | 12 Months | 38.6 units on a scale |
| MUS+BPTx | Change From Baseline OABq-LF HRQL Total Score | 3 Months | 41.4 units on a scale |
| MUS+BPTx | Change From Baseline OABq-LF HRQL Total Score | 6 Months | 41.4 units on a scale |
| MUS+BPTx | Change From Baseline OABq-LF HRQL Total Score | 12 Months | 41.1 units on a scale |
Other Pre-specified
Change From Baseline OABq-LF Sleep Score
The Overactive Bladder Questionnaire-Long Form is a standardized a measure of overactive bladder symptoms and health-related quality of life. The OABq-LF Sleep score ranges from 0 to 100 with higher score indicating better quality of life. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline.
Time frame: 3, 6, and 12 Months
Population: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. Data that was collected after a participant was retreated for urinary incontinence was excluded from the analysis.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| MUS Only | Change From Baseline OABq-LF Sleep Score | 3 Months | 31.7 units on a scale |
| MUS Only | Change From Baseline OABq-LF Sleep Score | 6 Months | 31.3 units on a scale |
| MUS Only | Change From Baseline OABq-LF Sleep Score | 12 Months | 31.8 units on a scale |
| MUS+BPTx | Change From Baseline OABq-LF Sleep Score | 3 Months | 31.6 units on a scale |
| MUS+BPTx | Change From Baseline OABq-LF Sleep Score | 6 Months | 31.9 units on a scale |
| MUS+BPTx | Change From Baseline OABq-LF Sleep Score | 12 Months | 32.7 units on a scale |
Other Pre-specified
Change From Baseline OABq-LF Social Score
The Overactive Bladder Questionnaire-Long Form is a standardized a measure of overactive bladder symptoms and health-related quality of life. The OABq-LF Social score ranges from 0 to 100 with higher score indicating better quality of life. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline.
Time frame: 3, 6, and 12 Months
Population: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. Data that was collected after a participant was retreated for urinary incontinence was excluded from the analysis.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| MUS Only | Change From Baseline OABq-LF Social Score | 3 Months | 25.6 units on a scale |
| MUS Only | Change From Baseline OABq-LF Social Score | 6 Months | 23.5 units on a scale |
| MUS Only | Change From Baseline OABq-LF Social Score | 12 Months | 24.1 units on a scale |
| MUS+BPTx | Change From Baseline OABq-LF Social Score | 3 Months | 26.5 units on a scale |
| MUS+BPTx | Change From Baseline OABq-LF Social Score | 6 Months | 26.1 units on a scale |
| MUS+BPTx | Change From Baseline OABq-LF Social Score | 12 Months | 25.8 units on a scale |
Other Pre-specified
Change From Baseline OABq-LF Symptom Severity Score
The Overactive Bladder Questionnaire-Long Form is a standardized a measure of overactive bladder symptoms and health-related quality of life. The OABq-LF Symptom Severity score ranges from 0 to 100 with higher score indicating worse quality of life. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline.
Time frame: 3, 6, and 12 Months
Population: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. Data that was collected after a participant was retreated for urinary incontinence was excluded from the analysis.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| MUS Only | Change From Baseline OABq-LF Symptom Severity Score | 3 Months | -45.3 units on a scale |
| MUS Only | Change From Baseline OABq-LF Symptom Severity Score | 6 Months | -45.4 units on a scale |
| MUS Only | Change From Baseline OABq-LF Symptom Severity Score | 12 Months | -45.7 units on a scale |
| MUS+BPTx | Change From Baseline OABq-LF Symptom Severity Score | 3 Months | -46.9 units on a scale |
| MUS+BPTx | Change From Baseline OABq-LF Symptom Severity Score | 6 Months | -47.2 units on a scale |
| MUS+BPTx | Change From Baseline OABq-LF Symptom Severity Score | 12 Months | -48.5 units on a scale |
Other Pre-specified
Change From Baseline PISQ-IR NSACI Score
The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised (PISQ-IR) is a questionnaire measuring the impact of incontinence symptoms on sexual function and satisfaction. Using the Rockwood scoring, the PISQ-IR Not Sexually Active-Condition Impact subscale (NSA-CI) ranges from 0 to 100 with higher scores indicating worse function/satisfaction. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline.
Time frame: 3, 6, and 12 Months
Population: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. Data that was collected after a participant was retreated for urinary incontinence was excluded from the analysis.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| MUS Only | Change From Baseline PISQ-IR NSACI Score | 3 Months | -25.2 units on a scale |
| MUS Only | Change From Baseline PISQ-IR NSACI Score | 6 Months | -32.1 units on a scale |
| MUS Only | Change From Baseline PISQ-IR NSACI Score | 12 Months | -28.8 units on a scale |
| MUS+BPTx | Change From Baseline PISQ-IR NSACI Score | 3 Months | -27.9 units on a scale |
| MUS+BPTx | Change From Baseline PISQ-IR NSACI Score | 6 Months | -23.8 units on a scale |
| MUS+BPTx | Change From Baseline PISQ-IR NSACI Score | 12 Months | -33 units on a scale |
Other Pre-specified
Change From Baseline PISQ-IR NSACS Score
The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised (PISQ-IR) is a questionnaire measuring the impact of incontinence symptoms on sexual function and satisfaction. Using the Rockwood scoring, the PISQ-IR Not Sexually Active-Condition Specific subscale (NSA-CS) ranges from 0 to 100 with worse scores indicating better function/satisfaction. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline.
Time frame: 3, 6, and 12 Months
Population: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. Data that was collected after a participant was retreated for urinary incontinence was excluded from the analysis.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| MUS Only | Change From Baseline PISQ-IR NSACS Score | 3 Months | -16.8 units on a scale |
| MUS Only | Change From Baseline PISQ-IR NSACS Score | 6 Months | -18.9 units on a scale |
| MUS Only | Change From Baseline PISQ-IR NSACS Score | 12 Months | -13.5 units on a scale |
| MUS+BPTx | Change From Baseline PISQ-IR NSACS Score | 3 Months | -20.3 units on a scale |
| MUS+BPTx | Change From Baseline PISQ-IR NSACS Score | 6 Months | -16.4 units on a scale |
| MUS+BPTx | Change From Baseline PISQ-IR NSACS Score | 12 Months | -9.9 units on a scale |
Other Pre-specified
Change From Baseline PISQ-IR NSAGQR Score
The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised (PISQ-IR) is a questionnaire measuring the impact of incontinence symptoms on sexual function and satisfaction. Using the Rockwood scoring, the PISQ-IR Not Sexually Active-Global Quality Rating subscale (NSA-GQR) ranges from 0 to 100 with higher scores indicating worse function/satisfaction. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline.
Time frame: 3, 6, and 12 Months
Population: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. Data that was collected after a participant was retreated for urinary incontinence was excluded from the analysis.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| MUS Only | Change From Baseline PISQ-IR NSAGQR Score | 3 Months | -10 units on a scale |
| MUS Only | Change From Baseline PISQ-IR NSAGQR Score | 6 Months | -9.8 units on a scale |
| MUS Only | Change From Baseline PISQ-IR NSAGQR Score | 12 Months | -9.1 units on a scale |
| MUS+BPTx | Change From Baseline PISQ-IR NSAGQR Score | 3 Months | -14.8 units on a scale |
| MUS+BPTx | Change From Baseline PISQ-IR NSAGQR Score | 6 Months | -15.3 units on a scale |
| MUS+BPTx | Change From Baseline PISQ-IR NSAGQR Score | 12 Months | -16.5 units on a scale |
Other Pre-specified
Change From Baseline PISQ-IR NSAPR Score
The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised (PISQ-IR) is a questionnaire measuring the impact of incontinence symptoms on sexual function and satisfaction. Using the Rockwood scoring, the PISQ-IR Not Partner Related subscale (NSA-PR) ranges from 0 to 100 with higher scores indicating worse function/satisfaction. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline.
Time frame: 3, 6, and 12 Months
Population: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. Data that was collected after a participant was retreated for urinary incontinence was excluded from the analysis.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| MUS Only | Change From Baseline PISQ-IR NSAPR Score | 3 Months | 7.1 units on a scale |
| MUS Only | Change From Baseline PISQ-IR NSAPR Score | 6 Months | 5.5 units on a scale |
| MUS Only | Change From Baseline PISQ-IR NSAPR Score | 12 Months | 3.3 units on a scale |
| MUS+BPTx | Change From Baseline PISQ-IR NSAPR Score | 3 Months | -8.8 units on a scale |
| MUS+BPTx | Change From Baseline PISQ-IR NSAPR Score | 6 Months | 2.5 units on a scale |
| MUS+BPTx | Change From Baseline PISQ-IR NSAPR Score | 12 Months | 2.3 units on a scale |
Other Pre-specified
Change From Baseline PISQ-IR SAAO Score
The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised (PISQ-IR) is a questionnaire measuring the impact of incontinence symptoms on sexual function and satisfaction. Using the Rockwood scoring, the PISQ-IR Sexually Active-Arousal, Orgasm subscale (SA-AO) ranges from 0 to 100 with higher scores indicating worse function/satisfaction. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline.
Time frame: 3, 6, and 12 Months
Population: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. Data that was collected after a participant was retreated for urinary incontinence was excluded from the analysis.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| MUS Only | Change From Baseline PISQ-IR SAAO Score | 3 Months | 6.8 units on a scale |
| MUS Only | Change From Baseline PISQ-IR SAAO Score | 6 Months | 6.5 units on a scale |
| MUS Only | Change From Baseline PISQ-IR SAAO Score | 12 Months | 9.2 units on a scale |
| MUS+BPTx | Change From Baseline PISQ-IR SAAO Score | 3 Months | 10.8 units on a scale |
| MUS+BPTx | Change From Baseline PISQ-IR SAAO Score | 6 Months | 12.1 units on a scale |
| MUS+BPTx | Change From Baseline PISQ-IR SAAO Score | 12 Months | 9.6 units on a scale |
Other Pre-specified
Change From Baseline PISQ-IR SACI Score
The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised (PISQ-IR) is a questionnaire measuring the impact of incontinence symptoms on sexual function and satisfaction. Using the Rockwood scoring, the PISQ-IR Sexually Active-Condition Impact subscale (SA-CI) ranges from 0 to 100 with higher scores indicating better function/satisfaction. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline.
Time frame: 3, 6, and 12 Months
Population: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. Data that was collected after a participant was retreated for urinary incontinence was excluded from the analysis.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| MUS Only | Change From Baseline PISQ-IR SACI Score | 3 Months | 28.4 units on a scale |
| MUS Only | Change From Baseline PISQ-IR SACI Score | 6 Months | 28.9 units on a scale |
| MUS Only | Change From Baseline PISQ-IR SACI Score | 12 Months | 31.7 units on a scale |
| MUS+BPTx | Change From Baseline PISQ-IR SACI Score | 3 Months | 33.6 units on a scale |
| MUS+BPTx | Change From Baseline PISQ-IR SACI Score | 6 Months | 35.3 units on a scale |
| MUS+BPTx | Change From Baseline PISQ-IR SACI Score | 12 Months | 35.5 units on a scale |
Other Pre-specified
Change From Baseline PISQ-IR SACS Score
The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised (PISQ-IR) is a questionnaire measuring the impact of incontinence symptoms on sexual function and satisfaction. Using the Rockwood scoring, the PISQ-IR Sexually Active-Condition Specific subscale (SA-CS) ranges from 0 to 100 with higher scores indicating better function/satisfaction. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline.
Time frame: 3, 6, and 12 Months
Population: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. Data that was collected after a participant was retreated for urinary incontinence was excluded from the analysis.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| MUS Only | Change From Baseline PISQ-IR SACS Score | 3 Months | 21.1 units on a scale |
| MUS Only | Change From Baseline PISQ-IR SACS Score | 6 Months | 20 units on a scale |
| MUS Only | Change From Baseline PISQ-IR SACS Score | 12 Months | 24.2 units on a scale |
| MUS+BPTx | Change From Baseline PISQ-IR SACS Score | 3 Months | 28.2 units on a scale |
| MUS+BPTx | Change From Baseline PISQ-IR SACS Score | 6 Months | 28.9 units on a scale |
| MUS+BPTx | Change From Baseline PISQ-IR SACS Score | 12 Months | 26.3 units on a scale |
Other Pre-specified
Change From Baseline PISQ-IR SAD Score
The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised (PISQ-IR) is a questionnaire measuring the impact of incontinence symptoms on sexual function and satisfaction. Using the Rockwood scoring, the PISQ-IR Sexually Active-Desire subscale (SA-D) ranges from 0 to 100 with higher scores indicating better function/satisfaction. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline.
Time frame: 3, 6, and 12 Months
Population: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. Data that was collected after a participant was retreated for urinary incontinence was excluded from the analysis.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| MUS Only | Change From Baseline PISQ-IR SAD Score | 3 Months | 3.8 units on a scale |
| MUS Only | Change From Baseline PISQ-IR SAD Score | 6 Months | 0.4 units on a scale |
| MUS Only | Change From Baseline PISQ-IR SAD Score | 12 Months | 2.7 units on a scale |
| MUS+BPTx | Change From Baseline PISQ-IR SAD Score | 3 Months | 7.1 units on a scale |
| MUS+BPTx | Change From Baseline PISQ-IR SAD Score | 6 Months | 5.4 units on a scale |
| MUS+BPTx | Change From Baseline PISQ-IR SAD Score | 12 Months | 2.5 units on a scale |
Other Pre-specified
Change From Baseline PISQ-IR SAGQR Score
The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised (PISQ-IR) is a questionnaire measuring the impact of incontinence symptoms on sexual function and satisfaction. Using the Rockwood scoring, the PISQ-IR Sexually Active-Global Quality Rating subscale (SA-GQR) ranges from 0 to 100 with higher scores indicating better function/satisfaction. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline.
Time frame: 3, 6, and 12 Months
Population: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. Data that was collected after a participant was retreated for urinary incontinence was excluded from the analysis.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| MUS Only | Change From Baseline PISQ-IR SAGQR Score | 3 Months | 13.5 units on a scale |
| MUS Only | Change From Baseline PISQ-IR SAGQR Score | 6 Months | 12.1 units on a scale |
| MUS Only | Change From Baseline PISQ-IR SAGQR Score | 12 Months | 19 units on a scale |
| MUS+BPTx | Change From Baseline PISQ-IR SAGQR Score | 3 Months | 18.3 units on a scale |
| MUS+BPTx | Change From Baseline PISQ-IR SAGQR Score | 6 Months | 19 units on a scale |
| MUS+BPTx | Change From Baseline PISQ-IR SAGQR Score | 12 Months | 13.5 units on a scale |
Other Pre-specified
Change From Baseline PISQ-IR SAPR Score
The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised (PISQ-IR) is a questionnaire measuring the impact of incontinence symptoms on sexual function and satisfaction. Using the Rockwood scoring, the PISQ-IR Sexually Active-Partner Related subscale (SA-PR) ranges from 0 to 100 with higher scores indicating better function/satisfaction. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline.
Time frame: 3, 6, and 12 Months
Population: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. Data that was collected after a participant was retreated for urinary incontinence was excluded from the analysis.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| MUS Only | Change From Baseline PISQ-IR SAPR Score | 3 Months | 5.2 units on a scale |
| MUS Only | Change From Baseline PISQ-IR SAPR Score | 6 Months | 4.9 units on a scale |
| MUS Only | Change From Baseline PISQ-IR SAPR Score | 12 Months | 2.3 units on a scale |
| MUS+BPTx | Change From Baseline PISQ-IR SAPR Score | 3 Months | 7 units on a scale |
| MUS+BPTx | Change From Baseline PISQ-IR SAPR Score | 6 Months | 6.3 units on a scale |
| MUS+BPTx | Change From Baseline PISQ-IR SAPR Score | 12 Months | 4.6 units on a scale |
Other Pre-specified
Change From Baseline Total Number of Incontinence Episodes
Based on data collected from participant-completed diaries at baseline, 2 weeks, and 2, 6, and 12 months, the outcome variable is computed as the difference in total number of incontinence episodes at 2 weeks, 2, 6, or 12 months and the total number of incontinence episodes at baseline.
Time frame: 2 weeks and 2, 6, and 12 Months
Population: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. Data that was collected after a participant was retreated for urinary incontinence was excluded from the analysis.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| MUS Only | Change From Baseline Total Number of Incontinence Episodes | 0.5 Months | -4.2 number of episodes |
| MUS Only | Change From Baseline Total Number of Incontinence Episodes | 2 Months | -4.7 number of episodes |
| MUS Only | Change From Baseline Total Number of Incontinence Episodes | 6 Months | -4.6 number of episodes |
| MUS Only | Change From Baseline Total Number of Incontinence Episodes | 12 Months | -4.4 number of episodes |
| MUS+BPTx | Change From Baseline Total Number of Incontinence Episodes | 12 Months | -4.8 number of episodes |
| MUS+BPTx | Change From Baseline Total Number of Incontinence Episodes | 0.5 Months | -4.3 number of episodes |
| MUS+BPTx | Change From Baseline Total Number of Incontinence Episodes | 6 Months | -4.7 number of episodes |
| MUS+BPTx | Change From Baseline Total Number of Incontinence Episodes | 2 Months | -4.8 number of episodes |
Other Pre-specified
Number of Participants With 50% Reduction in Voids Relative to Baseline (Improved Voiding Frequency)
Based on data collected from participant-completed diaries at baseline, 2 weeks, and 2, 6, and 12 months, the outcome is calculated as Yes=at least 50% reduction in the number of voids between 2 weeks, 2, 6, and 12 months and baseline, No=Otherwise
Time frame: 2 weeks and 2, 6, and 12 Months
Population: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. Data that was collected after a participant was retreated for urinary incontinence was excluded from the analysis.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| MUS Only | Number of Participants With 50% Reduction in Voids Relative to Baseline (Improved Voiding Frequency) | 0.5 Months | Yes | 1 Participants |
| MUS Only | Number of Participants With 50% Reduction in Voids Relative to Baseline (Improved Voiding Frequency) | 0.5 Months | No | 198 Participants |
| MUS Only | Number of Participants With 50% Reduction in Voids Relative to Baseline (Improved Voiding Frequency) | 2 Months | Yes | 2 Participants |
| MUS Only | Number of Participants With 50% Reduction in Voids Relative to Baseline (Improved Voiding Frequency) | 2 Months | No | 189 Participants |
| MUS Only | Number of Participants With 50% Reduction in Voids Relative to Baseline (Improved Voiding Frequency) | 6 Months | Yes | 6 Participants |
| MUS Only | Number of Participants With 50% Reduction in Voids Relative to Baseline (Improved Voiding Frequency) | 6 Months | No | 152 Participants |
| MUS Only | Number of Participants With 50% Reduction in Voids Relative to Baseline (Improved Voiding Frequency) | 12 Months | Yes | 8 Participants |
| MUS Only | Number of Participants With 50% Reduction in Voids Relative to Baseline (Improved Voiding Frequency) | 12 Months | No | 153 Participants |
| MUS+BPTx | Number of Participants With 50% Reduction in Voids Relative to Baseline (Improved Voiding Frequency) | 12 Months | No | 150 Participants |
| MUS+BPTx | Number of Participants With 50% Reduction in Voids Relative to Baseline (Improved Voiding Frequency) | 0.5 Months | Yes | 8 Participants |
| MUS+BPTx | Number of Participants With 50% Reduction in Voids Relative to Baseline (Improved Voiding Frequency) | 6 Months | Yes | 15 Participants |
| MUS+BPTx | Number of Participants With 50% Reduction in Voids Relative to Baseline (Improved Voiding Frequency) | 0.5 Months | No | 190 Participants |
| MUS+BPTx | Number of Participants With 50% Reduction in Voids Relative to Baseline (Improved Voiding Frequency) | 12 Months | Yes | 15 Participants |
| MUS+BPTx | Number of Participants With 50% Reduction in Voids Relative to Baseline (Improved Voiding Frequency) | 2 Months | Yes | 13 Participants |
| MUS+BPTx | Number of Participants With 50% Reduction in Voids Relative to Baseline (Improved Voiding Frequency) | 6 Months | No | 155 Participants |
| MUS+BPTx | Number of Participants With 50% Reduction in Voids Relative to Baseline (Improved Voiding Frequency) | 2 Months | No | 177 Participants |
Other Pre-specified
Number of Participants With <8 Voids After Baseline (Normalization of Voiding Frequency)
Based on data collected from participant-completed diaries at baseline, 2 weeks, and 2, 6, and 12 months, for participants with \>8 voids at baseline, the outcome is calculated as Yes=no more than 8 voids noted at the time point, No=Otherwise
Time frame: 2 weeks and 2, 6, and 12 Months
Population: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. Data that was collected after a participant was retreated for urinary incontinence was excluded from the analysis.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| MUS Only | Number of Participants With <8 Voids After Baseline (Normalization of Voiding Frequency) | 0.5 Months | Yes | 48 Participants |
| MUS Only | Number of Participants With <8 Voids After Baseline (Normalization of Voiding Frequency) | 0.5 Months | No | 82 Participants |
| MUS Only | Number of Participants With <8 Voids After Baseline (Normalization of Voiding Frequency) | 2 Months | Yes | 49 Participants |
| MUS Only | Number of Participants With <8 Voids After Baseline (Normalization of Voiding Frequency) | 2 Months | No | 76 Participants |
| MUS Only | Number of Participants With <8 Voids After Baseline (Normalization of Voiding Frequency) | 6 Months | Yes | 46 Participants |
| MUS Only | Number of Participants With <8 Voids After Baseline (Normalization of Voiding Frequency) | 6 Months | No | 56 Participants |
| MUS Only | Number of Participants With <8 Voids After Baseline (Normalization of Voiding Frequency) | 12 Months | Yes | 48 Participants |
| MUS Only | Number of Participants With <8 Voids After Baseline (Normalization of Voiding Frequency) | 12 Months | No | 57 Participants |
| MUS+BPTx | Number of Participants With <8 Voids After Baseline (Normalization of Voiding Frequency) | 12 Months | No | 29 Participants |
| MUS+BPTx | Number of Participants With <8 Voids After Baseline (Normalization of Voiding Frequency) | 0.5 Months | Yes | 59 Participants |
| MUS+BPTx | Number of Participants With <8 Voids After Baseline (Normalization of Voiding Frequency) | 6 Months | Yes | 79 Participants |
| MUS+BPTx | Number of Participants With <8 Voids After Baseline (Normalization of Voiding Frequency) | 0.5 Months | No | 68 Participants |
| MUS+BPTx | Number of Participants With <8 Voids After Baseline (Normalization of Voiding Frequency) | 12 Months | Yes | 80 Participants |
| MUS+BPTx | Number of Participants With <8 Voids After Baseline (Normalization of Voiding Frequency) | 2 Months | Yes | 81 Participants |
| MUS+BPTx | Number of Participants With <8 Voids After Baseline (Normalization of Voiding Frequency) | 6 Months | No | 33 Participants |
| MUS+BPTx | Number of Participants With <8 Voids After Baseline (Normalization of Voiding Frequency) | 2 Months | No | 43 Participants |
Other Pre-specified
Number of Participants With Greater Number of Voids Relative to Baseline or >8 Voids (Worsening Voiding Frequency)
Based on data collected from participant-completed diaries at baseline, 2 weeks, and 2, 6, and 12 months, the outcome is calculated as Yes=greater than baseline number of voids at the time point or with greater than 8 voids at the time point, No=Otherwise
Time frame: 2 weeks and 2, 6, and 12 Months
Population: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. Data that was collected after a participant was retreated for urinary incontinence was excluded from the analysis.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| MUS Only | Number of Participants With Greater Number of Voids Relative to Baseline or >8 Voids (Worsening Voiding Frequency) | 2 Months | No | 80 Participants |
| MUS Only | Number of Participants With Greater Number of Voids Relative to Baseline or >8 Voids (Worsening Voiding Frequency) | 0.5 Months | Yes | 124 Participants |
| MUS Only | Number of Participants With Greater Number of Voids Relative to Baseline or >8 Voids (Worsening Voiding Frequency) | 0.5 Months | No | 75 Participants |
| MUS Only | Number of Participants With Greater Number of Voids Relative to Baseline or >8 Voids (Worsening Voiding Frequency) | 2 Months | Yes | 111 Participants |
| MUS Only | Number of Participants With Greater Number of Voids Relative to Baseline or >8 Voids (Worsening Voiding Frequency) | 6 Months | Yes | 81 Participants |
| MUS Only | Number of Participants With Greater Number of Voids Relative to Baseline or >8 Voids (Worsening Voiding Frequency) | 6 Months | No | 77 Participants |
| MUS Only | Number of Participants With Greater Number of Voids Relative to Baseline or >8 Voids (Worsening Voiding Frequency) | 12 Months | Yes | 79 Participants |
| MUS Only | Number of Participants With Greater Number of Voids Relative to Baseline or >8 Voids (Worsening Voiding Frequency) | 12 Months | No | 82 Participants |
| MUS+BPTx | Number of Participants With Greater Number of Voids Relative to Baseline or >8 Voids (Worsening Voiding Frequency) | 12 Months | No | 122 Participants |
| MUS+BPTx | Number of Participants With Greater Number of Voids Relative to Baseline or >8 Voids (Worsening Voiding Frequency) | 6 Months | Yes | 43 Participants |
| MUS+BPTx | Number of Participants With Greater Number of Voids Relative to Baseline or >8 Voids (Worsening Voiding Frequency) | 0.5 Months | Yes | 104 Participants |
| MUS+BPTx | Number of Participants With Greater Number of Voids Relative to Baseline or >8 Voids (Worsening Voiding Frequency) | 12 Months | Yes | 43 Participants |
| MUS+BPTx | Number of Participants With Greater Number of Voids Relative to Baseline or >8 Voids (Worsening Voiding Frequency) | 0.5 Months | No | 94 Participants |
| MUS+BPTx | Number of Participants With Greater Number of Voids Relative to Baseline or >8 Voids (Worsening Voiding Frequency) | 6 Months | No | 127 Participants |
| MUS+BPTx | Number of Participants With Greater Number of Voids Relative to Baseline or >8 Voids (Worsening Voiding Frequency) | 2 Months | Yes | 68 Participants |
| MUS+BPTx | Number of Participants With Greater Number of Voids Relative to Baseline or >8 Voids (Worsening Voiding Frequency) | 2 Months | No | 122 Participants |
Other Pre-specified
OAB-SATq Convenience Score
The Overactive Bladder Satisfaction with Treatment Questionnaire is a standardized a measure of satisfaction with treatment for overactive bladder symptoms. The OAB-SATq Convenience score ranges from 0 to 100 with higher scores indicating greater convenience.
Time frame: 3, 6, and 12 Months
Population: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. Data that was collected after a participant was retreated for urinary incontinence was excluded from the analysis.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| MUS Only | OAB-SATq Convenience Score | 3 Months | 18.8 units on a scale |
| MUS Only | OAB-SATq Convenience Score | 6 Months | 19.1 units on a scale |
| MUS Only | OAB-SATq Convenience Score | 12 Months | 19.7 units on a scale |
| MUS+BPTx | OAB-SATq Convenience Score | 3 Months | 25.8 units on a scale |
| MUS+BPTx | OAB-SATq Convenience Score | 6 Months | 26.2 units on a scale |
| MUS+BPTx | OAB-SATq Convenience Score | 12 Months | 21.3 units on a scale |
Other Pre-specified
OAB-SATq Endorsement Score
The Overactive Bladder Satisfaction with Treatment Questionnaire is a standardized a measure of satisfaction with treatment for overactive bladder symptoms. The OAB-SATq Endorsement score ranges from 0 to 100 with higher scores indicating greater endorsement.
Time frame: 3, 6, and 12 Months
Population: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. Data that was collected after a participant was retreated for urinary incontinence was excluded from the analysis.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| MUS Only | OAB-SATq Endorsement Score | 3 Months | 10.6 units on a scale |
| MUS Only | OAB-SATq Endorsement Score | 6 Months | 11.2 units on a scale |
| MUS Only | OAB-SATq Endorsement Score | 12 Months | 10.7 units on a scale |
| MUS+BPTx | OAB-SATq Endorsement Score | 3 Months | 8.8 units on a scale |
| MUS+BPTx | OAB-SATq Endorsement Score | 6 Months | 6.6 units on a scale |
| MUS+BPTx | OAB-SATq Endorsement Score | 12 Months | 8.9 units on a scale |
Other Pre-specified
OAB-SATq Preference Score
The Overactive Bladder Satisfaction with Treatment Questionnaire is a standardized a measure of satisfaction with treatment for overactive bladder symptoms. The preference score is a binary \[yes/no\] indicator as to whether a subject indicated slight or definite preference for the treatment among women that have had previous treatment for overactive bladder. The outcome is the percentage of participants that prefer the current treatment to previous treatments.
Time frame: 3, 6, and 12 Months
Population: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. Data that was collected after a participant was retreated for urinary incontinence was excluded from the analysis.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| MUS Only | OAB-SATq Preference Score | 3 Months | Yes | 111 Participants |
| MUS Only | OAB-SATq Preference Score | 3 Months | No | 12 Participants |
| MUS Only | OAB-SATq Preference Score | 6 Months | Yes | 101 Participants |
| MUS Only | OAB-SATq Preference Score | 6 Months | No | 3 Participants |
| MUS Only | OAB-SATq Preference Score | 12 Months | Yes | 98 Participants |
| MUS Only | OAB-SATq Preference Score | 12 Months | No | 11 Participants |
| MUS+BPTx | OAB-SATq Preference Score | 12 Months | Yes | 107 Participants |
| MUS+BPTx | OAB-SATq Preference Score | 3 Months | Yes | 109 Participants |
| MUS+BPTx | OAB-SATq Preference Score | 6 Months | No | 5 Participants |
| MUS+BPTx | OAB-SATq Preference Score | 3 Months | No | 9 Participants |
| MUS+BPTx | OAB-SATq Preference Score | 12 Months | No | 9 Participants |
| MUS+BPTx | OAB-SATq Preference Score | 6 Months | Yes | 112 Participants |
Other Pre-specified
OAB-SATq Satisfaction Score
The Overactive Bladder Satisfaction with Treatment Questionnaire is a standardized a measure of satisfaction with treatment for overactive bladder symptoms. The OAB-SATq Satisfaction score ranges from 0 to 100 with higher scores indicating higher satisfaction.
Time frame: 3, 6, and 12 Months
Population: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. Data that was collected after a participant was retreated for urinary incontinence was excluded from the analysis.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| MUS Only | OAB-SATq Satisfaction Score | 3 Months | 19.3 units on a scale |
| MUS Only | OAB-SATq Satisfaction Score | 6 Months | 19.8 units on a scale |
| MUS Only | OAB-SATq Satisfaction Score | 12 Months | 18.1 units on a scale |
| MUS+BPTx | OAB-SATq Satisfaction Score | 3 Months | 18.2 units on a scale |
| MUS+BPTx | OAB-SATq Satisfaction Score | 6 Months | 18.7 units on a scale |
| MUS+BPTx | OAB-SATq Satisfaction Score | 12 Months | 17.3 units on a scale |
Other Pre-specified
OAB-SATq Side Effect Score
The Overactive Bladder Satisfaction with Treatment Questionnaire is a standardized a measure of satisfaction with treatment for overactive bladder symptoms. The OAB-SATq Side Effect score ranges from 0 to 100 with higher scores indicating fewer side effects.
Time frame: 3, 6, and 12 Months
Population: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. Data that was collected after a participant was retreated for urinary incontinence was excluded from the analysis.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| MUS Only | OAB-SATq Side Effect Score | 3 Months | 76 units on a scale |
| MUS Only | OAB-SATq Side Effect Score | 6 Months | 79.7 units on a scale |
| MUS Only | OAB-SATq Side Effect Score | 12 Months | 81 units on a scale |
| MUS+BPTx | OAB-SATq Side Effect Score | 12 Months | 86.3 units on a scale |
| MUS+BPTx | OAB-SATq Side Effect Score | 3 Months | 84.3 units on a scale |
| MUS+BPTx | OAB-SATq Side Effect Score | 6 Months | 87.2 units on a scale |
Other Pre-specified
PGI-I
The Patient Global Impression of Improvement (PGI-I) is a patient-reported measure of perceived improvement with treatment, as assessed on a scale of 1 (very much better) to 7 (very much worse). Included here are participants who had improvement as indicated by a rating of 1 (very much better), 2 (much better).
Time frame: 3, 6, and 12 Months
Population: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. Data that was collected after a participant was retreated for urinary incontinence was excluded from the analysis.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| MUS Only | PGI-I | 3 Months | No Improvement/Worsened | 18 Participants |
| MUS Only | PGI-I | 6 Months | No Improvement/Worsened | 19 Participants |
| MUS Only | PGI-I | 3 Months | Improved | 179 Participants |
| MUS Only | PGI-I | 6 Months | Improved | 156 Participants |
| MUS Only | PGI-I | 12 Months | No Improvement/Worsened | 27 Participants |
| MUS Only | PGI-I | 12 Months | Improved | 147 Participants |
| MUS+BPTx | PGI-I | 12 Months | No Improvement/Worsened | 22 Participants |
| MUS+BPTx | PGI-I | 3 Months | Improved | 178 Participants |
| MUS+BPTx | PGI-I | 3 Months | No Improvement/Worsened | 19 Participants |
| MUS+BPTx | PGI-I | 6 Months | Improved | 168 Participants |
| MUS+BPTx | PGI-I | 6 Months | No Improvement/Worsened | 13 Participants |
| MUS+BPTx | PGI-I | 12 Months | Improved | 159 Participants |
Other Pre-specified
PGI-S
The Patient Global Impression of Severity (PGI-S) is a patient-reported measure of perceived severity of condition, as assessed on a scale of 1 (Normal) to 4 (Severe). Included here are participants who reported Normal or Mild severity as indicated by a rating of 1 or 2.
Time frame: Baseline 3, 6, and 12 Months
Population: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. Data that was collected after a participant was retreated for urinary incontinence was excluded from the analysis.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| MUS Only | PGI-S | 0 Months | Normal/Mild | 41 Participants |
| MUS Only | PGI-S | 0 Months | Moderate/Severe | 188 Participants |
| MUS Only | PGI-S | 3 Months | Normal/Mild | 171 Participants |
| MUS Only | PGI-S | 3 Months | Moderate/Severe | 26 Participants |
| MUS Only | PGI-S | 6 Months | Normal/Mild | 155 Participants |
| MUS Only | PGI-S | 6 Months | Moderate/Severe | 21 Participants |
| MUS Only | PGI-S | 12 Months | Normal/Mild | 155 Participants |
| MUS Only | PGI-S | 12 Months | Moderate/Severe | 19 Participants |
| MUS+BPTx | PGI-S | 12 Months | Moderate/Severe | 16 Participants |
| MUS+BPTx | PGI-S | 0 Months | Normal/Mild | 48 Participants |
| MUS+BPTx | PGI-S | 6 Months | Normal/Mild | 166 Participants |
| MUS+BPTx | PGI-S | 0 Months | Moderate/Severe | 187 Participants |
| MUS+BPTx | PGI-S | 12 Months | Normal/Mild | 164 Participants |
| MUS+BPTx | PGI-S | 3 Months | Normal/Mild | 174 Participants |
| MUS+BPTx | PGI-S | 6 Months | Moderate/Severe | 16 Participants |
| MUS+BPTx | PGI-S | 3 Months | Moderate/Severe | 24 Participants |