A Phase 3 interventional study of Miduretheral Sling and Miduretheral Sling with behavioral/pelvic floor therapy in Urinary Incontinence, Stress and Urinary Incontinence, Urge, sponsored by NICHD Pelvic Floor Disorders Network. Completed at 10 sites in United States. Open to female participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2020-05-14.
Sponsored by NICHD Pelvic Floor Disorders Network · Phase 3, Interventional, and Treatment
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.
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.
1,363 studies on the registry are indexed under Urinary Incontinence; 228 are open to participants now.
This study's enrollment of 480 is above the median of 66 across 1,011 interventional studies indexed under Urinary Incontinence.
Browse Urinary Incontinence studies →NICHD Pelvic Floor Disorders Network is the lead sponsor of 17 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Presence of both SUI and UUI on bladder diary; and > 2 IEs/3 days
Exclusion Criteria:
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
Planned concomitant surgery for anterior vaginal wall or apical prolapse > 0
a)Women undergoing only rectocele repair are eligible
Miduretheral Sling (Control)
Procedure: Miduretheral Sling
Miduretheral Sling with behavioral/pelvic floor therapy
Other: Miduretheral Sling with behavioral/pelvic floor therapy
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).
Also known as: MUS
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.
Also known as: MUS + BPTx
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
| Milestone | MUS Only | MUS+BPTx |
|---|---|---|
| Started | 238 | 242 |
| Completed | 229 | 235 |
| Not completed | 9 | 7 |
| Withdrew: Protocol violation | 9 | 7 |
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.
| units on a scale | MUS Only | MUS+BPTx |
|---|---|---|
| 3 Months | -138.8 (-145.9 to -131.7) | -142.7 (-150.7 to -134.8) |
| 6 Months | -137 (-145 to -128.9) | -147.4 (-155.4 to -139.4) |
| 12 Months | -137.9 (-145.9 to -129.8) | -147.7 (-156.4 to -139) |
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.
| units on a scale | MUS Only | MUS+BPTx |
|---|---|---|
| 3 Months | -70.6 (-74.1 to -67.1) | -72.5 (-76.4 to -68.6) |
| 6 Months | -69.5 (-73.8 to -65.2) | -72.8 (-76.7 to -68.8) |
| 12 Months | -69.3 (-73.7 to -65) | -73.8 (-78 to -69.6) |
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.
| units on a scale | MUS Only | MUS+BPTx |
|---|---|---|
| 3 Months | -49.7 (-53.3 to -46.2) | -50.1 (-53.6 to -46.6) |
| 6 Months | -49.5 (-53.2 to -45.7) | -53.5 (-56.9 to -50.1) |
| 12 Months | -50 (-53.6 to -46.4) | -53.5 (-57.1 to -49.9) |
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.
| units on a scale | MUS Only | MUS+BPTx |
|---|---|---|
| 3 Months | -18.5 (-20.9 to -16) | -20.2 (-23.4 to -16.9) |
| 6 Months | -18 (-20.6 to -15.4) | -21.1 (-24.2 to -18) |
| 12 Months | -18.5 (-21.1 to -15.9) | -20.3 (-23.7 to -17) |
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.
| number of episodes | MUS Only | MUS+BPTx |
|---|---|---|
| 0.5 Months | -2.2 (-2.4 to -1.9) | -2.2 (-2.6 to -1.9) |
| 2 Months | -2.3 (-2.6 to -2.1) | -2.4 (-2.7 to -2) |
| 6 Months | -2.3 (-2.6 to -2) | -2.3 (-2.6 to -2) |
| 12 Months | -2.2 (-2.5 to -2) | -2.2 (-2.6 to -1.9) |
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.
| number of episodes | MUS Only | MUS+BPTx |
|---|---|---|
| 0.5 Months | -1.8 (-2.2 to -1.5) | -1.7 (-2 to -1.4) |
| 2 Months | -2 (-2.3 to -1.7) | -2 (-2.3 to -1.8) |
| 6 Months | -2 (-2.4 to -1.6) | -2 (-2.3 to -1.7) |
| 12 Months | -1.9 (-2.3 to -1.5) | -2.2 (-2.5 to -1.8) |
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.
| number of episodes | MUS Only | MUS+BPTx |
|---|---|---|
| 0.5 Months | -0.2 (-0.3 to 0) | -0.4 (-0.5 to -0.2) |
| 2 Months | -0.3 (-0.5 to -0.2) | -0.4 (-0.6 to -0.2) |
| 6 Months | -0.3 (-0.4 to -0.2) | -0.4 (-0.6 to -0.2) |
| 12 Months | -0.3 (-0.4 to -0.1) | -0.4 (-0.6 to -0.2) |
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.
| number of episodes | MUS Only | MUS+BPTx |
|---|---|---|
| 0.5 Months | -4.2 (-4.7 to -3.7) | -4.3 (-4.8 to -3.8) |
| 2 Months | -4.7 (-5.1 to -4.2) | -4.8 (-5.2 to -4.3) |
| 6 Months | -4.6 (-5.1 to -4.1) | -4.7 (-5.2 to -4.3) |
| 12 Months | -4.4 (-4.9 to -3.9) | -4.8 (-5.3 to -4.3) |
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.
| number of pads | MUS Only | MUS+BPTx |
|---|---|---|
| 0.5 Months | -2 (-2.3 to -1.7) | -2.2 (-2.6 to -1.8) |
| 2 Months | -2.4 (-2.7 to -2.1) | -2.7 (-3.1 to -2.2) |
| 6 Months | -2.2 (-2.6 to -1.8) | -2.7 (-3.1 to -2.2) |
| 12 Months | -2.2 (-2.6 to -1.9) | -2.7 (-3.1 to -2.2) |
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.
| number of pads | MUS Only | MUS+BPTx |
|---|---|---|
| 0.5 Months | -1.6 (-1.9 to -1.3) | -1.9 (-2.3 to -1.5) |
| 2 Months | -2.2 (-2.6 to -1.9) | -2.7 (-3.1 to -2.2) |
| 6 Months | -2.2 (-2.6 to -1.8) | -2.8 (-3.3 to -2.3) |
| 12 Months | -2.3 (-2.7 to -2) | -2.7 (-3.2 to -2.3) |
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.
| number of voids | MUS Only | MUS+BPTx |
|---|---|---|
| 0.5 Months | -0.6 (-1 to -0.3) | -0.8 (-1.2 to -0.4) |
| 2 Months | -0.7 (-1 to -0.3) | -1.6 (-1.9 to -1.2) |
| 6 Months | -1.1 (-1.4 to -0.7) | -2.2 (-2.5 to -1.8) |
| 12 Months | -1.2 (-1.6 to -0.8) | -2 (-2.4 to -1.7) |
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.
| number of voids | MUS Only | MUS+BPTx |
|---|---|---|
| 0.5 Months | -0.2 (-0.4 to -0.1) | -0.4 (-0.6 to -0.2) |
| 2 Months | -0.4 (-0.6 to -0.3) | -0.7 (-0.8 to -0.5) |
| 6 Months | -0.5 (-0.7 to -0.4) | -0.8 (-0.9 to -0.6) |
| 12 Months | -0.4 (-0.6 to -0.2) | -0.8 (-0.9 to -0.6) |
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 voids | MUS Only | MUS+BPTx |
|---|---|---|
| 0.5 Months | -1.1 (-2.3 to 0.1) | -0.8 (-2.2 to 0.6) |
| 2 Months | -1.6 (-3 to -0.3) | -4.3 (-5.8 to -2.8) |
| 6 Months | -3.5 (-4.9 to -2.1) | -4.8 (-6.4 to -3.1) |
| 12 Months | -3.9 (-5.5 to -2.4) | -5.1 (-6.6 to -3.7) |
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
| Participants | MUS Only | MUS+BPTx |
|---|---|---|
| 0.5 Months — Yes | 48 | 59 |
| 0.5 Months — No | 82 | 68 |
| 2 Months — Yes | 49 | 81 |
| 2 Months — No | 76 | 43 |
| 6 Months — Yes | 46 | 79 |
| 6 Months — No | 56 | 33 |
| 12 Months — Yes | 48 | 80 |
| 12 Months — No | 57 | 29 |
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
| Participants | MUS Only | MUS+BPTx |
|---|---|---|
| 0.5 Months — Yes | 1 | 8 |
| 0.5 Months — No | 198 | 190 |
| 2 Months — Yes | 2 | 13 |
| 2 Months — No | 189 | 177 |
| 6 Months — Yes | 6 | 15 |
| 6 Months — No | 152 | 155 |
| 12 Months — Yes | 8 | 15 |
| 12 Months — No | 153 | 150 |
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
| Participants | MUS Only | MUS+BPTx |
|---|---|---|
| 0.5 Months — Yes | 124 | 104 |
| 0.5 Months — No | 75 | 94 |
| 2 Months — Yes | 111 | 68 |
| 2 Months — No | 80 | 122 |
| 6 Months — Yes | 81 | 43 |
| 6 Months — No | 77 | 127 |
| 12 Months — Yes | 79 | 43 |
| 12 Months — No | 82 | 122 |
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.
| units on a scale | MUS Only | MUS+BPTx |
|---|---|---|
| 3 Months | 7.1 (-0.8 to 15) | -8.8 (-16.6 to -1.1) |
| 6 Months | 5.5 (-2.9 to 13.8) | 2.5 (-7.6 to 12.6) |
| 12 Months | 3.3 (-6.9 to 13.6) | 2.3 (-5.8 to 10.4) |
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.
| units on a scale | MUS Only | MUS+BPTx |
|---|---|---|
| 3 Months | -16.8 (-26.1 to -7.5) | -20.3 (-27.1 to -13.4) |
| 6 Months | -18.9 (-29.7 to -8) | -16.4 (-25.8 to -7.1) |
| 12 Months | -13.5 (-24.7 to -2.3) | -9.9 (-20.9 to 1.2) |
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.
| units on a scale | MUS Only | MUS+BPTx |
|---|---|---|
| 3 Months | -10 (-16.9 to -3.1) | -14.8 (-22.2 to -7.3) |
| 6 Months | -9.8 (-17.8 to -1.9) | -15.3 (-24.9 to -5.8) |
| 12 Months | -9.1 (-17.1 to -1) | -16.5 (-26 to -7) |
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.
| units on a scale | MUS Only | MUS+BPTx |
|---|---|---|
| 3 Months | -25.2 (-33.6 to -16.8) | -27.9 (-37.8 to -17.9) |
| 6 Months | -32.1 (-40.7 to -23.5) | -23.8 (-35.1 to -12.5) |
| 12 Months | -28.8 (-38.7 to -19) | -33 (-44.6 to -21.4) |
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.
| units on a scale | MUS Only | MUS+BPTx |
|---|---|---|
| 3 Months | 6.8 (3.7 to 9.9) | 10.8 (7.8 to 13.8) |
| 6 Months | 6.5 (2.9 to 10.1) | 12.1 (8.9 to 15.3) |
| 12 Months | 9.2 (6 to 12.4) | 9.6 (6.6 to 12.6) |
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.
| units on a scale | MUS Only | MUS+BPTx |
|---|---|---|
| 3 Months | 5.2 (1.8 to 8.5) | 7 (3.1 to 11) |
| 6 Months | 4.9 (1.2 to 8.5) | 6.3 (2.1 to 10.6) |
| 12 Months | 2.3 (-1.7 to 6.3) | 4.6 (-0.3 to 9.5) |
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.
| units on a scale | MUS Only | MUS+BPTx |
|---|---|---|
| 3 Months | 21.1 (16.9 to 25.4) | 28.2 (23.3 to 33) |
| 6 Months | 20 (15.1 to 24.9) | 28.9 (23.7 to 34.1) |
| 12 Months | 24.2 (19.3 to 29.1) | 26.3 (21.6 to 31) |
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.
| units on a scale | MUS Only | MUS+BPTx |
|---|---|---|
| 3 Months | 13.5 (8.4 to 18.6) | 18.3 (13.5 to 23) |
| 6 Months | 12.1 (6.5 to 17.7) | 19 (14.1 to 24) |
| 12 Months | 19 (13.9 to 24.1) | 13.5 (7.9 to 19) |
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.
| units on a scale | MUS Only | MUS+BPTx |
|---|---|---|
| 3 Months | 28.4 (22.5 to 34.3) | 33.6 (27.6 to 39.5) |
| 6 Months | 28.9 (22.5 to 35.3) | 35.3 (28.9 to 41.7) |
| 12 Months | 31.7 (24.7 to 38.7) | 35.5 (29.4 to 41.7) |
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.
| units on a scale | MUS Only | MUS+BPTx |
|---|---|---|
| 3 Months | 3.8 (0.8 to 6.9) | 7.1 (4.4 to 9.7) |
| 6 Months | 0.4 (-3.1 to 3.8) | 5.4 (2.7 to 8.1) |
| 12 Months | 2.7 (-0.7 to 6) | 2.5 (-0.8 to 5.7) |
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.
| units on a scale | MUS Only | MUS+BPTx |
|---|---|---|
| 3 Months | 0 (0 to 0.1) | 0 (0 to 0.1) |
| 6 Months | 0 (0 to 0.1) | 0 (0 to 0.1) |
| 12 Months | 0 (0 to 0) | 0 (0 to 0.1) |
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.
| units on a scale | MUS Only | MUS+BPTx |
|---|---|---|
| 3 Months | 0.3 (-2.5 to 3.1) | 4 (1 to 7) |
| 6 Months | 2.5 (-0.8 to 5.8) | 3.1 (-0.5 to 6.7) |
| 12 Months | 1.2 (-1.8 to 4.2) | 4.8 (1.6 to 7.9) |
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.
| units on a scale | MUS Only | MUS+BPTx |
|---|---|---|
| 3 Months | -45.3 (-48.7 to -41.8) | -46.9 (-50.2 to -43.7) |
| 6 Months | -45.4 (-49.2 to -41.6) | -47.2 (-50.8 to -43.6) |
| 12 Months | -45.7 (-49.6 to -41.8) | -48.5 (-52.2 to -44.8) |
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.
| units on a scale | MUS Only | MUS+BPTx |
|---|---|---|
| 3 Months | 43.1 (39.1 to 47.1) | 48.2 (44.4 to 52) |
| 6 Months | 43.3 (38.9 to 47.6) | 48.4 (44.6 to 52.2) |
| 12 Months | 43.9 (39.6 to 48.2) | 47.9 (43.9 to 52) |
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.
| units on a scale | MUS Only | MUS+BPTx |
|---|---|---|
| 3 Months | 47.6 (43.8 to 51.4) | 51.2 (47.2 to 55.1) |
| 6 Months | 47 (42.8 to 51.1) | 51.1 (47.3 to 54.9) |
| 12 Months | 46.9 (42.6 to 51.2) | 50.4 (46.4 to 54.5) |
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.
| units on a scale | MUS Only | MUS+BPTx |
|---|---|---|
| 3 Months | 31.7 (27.8 to 35.6) | 31.6 (27.4 to 35.8) |
| 6 Months | 31.3 (27.2 to 35.3) | 31.9 (27.5 to 36.3) |
| 12 Months | 31.8 (27.5 to 36.2) | 32.7 (28.1 to 37.3) |
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.
| units on a scale | MUS Only | MUS+BPTx |
|---|---|---|
| 3 Months | 25.6 (21.8 to 29.4) | 26.5 (22.7 to 30.4) |
| 6 Months | 23.5 (19.4 to 27.6) | 26.1 (22.2 to 30) |
| 12 Months | 24.1 (19.9 to 28.3) | 25.8 (21.8 to 29.9) |
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.
| units on a scale | MUS Only | MUS+BPTx |
|---|---|---|
| 3 Months | 38.6 (35.1 to 42) | 41.4 (37.9 to 44.8) |
| 6 Months | 38 (34.3 to 41.8) | 41.4 (38 to 44.8) |
| 12 Months | 38.6 (34.8 to 42.4) | 41.1 (37.4 to 44.8) |
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.
| units on a scale | MUS Only | MUS+BPTx |
|---|---|---|
| 3 Months | 19.3 (16 to 22.7) | 18.2 (15.2 to 21.3) |
| 6 Months | 19.8 (15.7 to 23.9) | 18.7 (15.3 to 22.2) |
| 12 Months | 18.1 (14.2 to 22.1) | 17.3 (14 to 20.6) |
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.
| units on a scale | MUS Only | MUS+BPTx |
|---|---|---|
| 3 Months | 76 (70.6 to 81.3) | 84.3 (79.6 to 89) |
| 6 Months | 79.7 (74.3 to 85.1) | 87.2 (82.9 to 91.6) |
| 12 Months | 81 (75.7 to 86.4) | 86.3 (81.7 to 90.8) |
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.
| units on a scale | MUS Only | MUS+BPTx |
|---|---|---|
| 3 Months | 10.6 (8.1 to 13) | 8.8 (6.5 to 11) |
| 6 Months | 11.2 (8 to 14.5) | 6.6 (4.5 to 8.7) |
| 12 Months | 10.7 (7.3 to 14) | 8.9 (6.5 to 11.4) |
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.
| units on a scale | MUS Only | MUS+BPTx |
|---|---|---|
| 3 Months | 18.8 (15.8 to 21.8) | 25.8 (22.8 to 28.9) |
| 6 Months | 19.1 (15.6 to 22.6) | 26.2 (22.8 to 29.6) |
| 12 Months | 19.7 (16 to 23.3) | 21.3 (18.1 to 24.6) |
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.
| Participants | MUS Only | MUS+BPTx |
|---|---|---|
| 3 Months — Yes | 111 | 109 |
| 3 Months — No | 12 | 9 |
| 6 Months — Yes | 101 | 112 |
| 6 Months — No | 3 | 5 |
| 12 Months — Yes | 98 | 107 |
| 12 Months — No | 11 | 9 |
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.
| units on a scale | MUS Only | MUS+BPTx |
|---|---|---|
| 3 Months | -39.2 (-43.2 to -35.3) | -40.9 (-44.7 to -37.1) |
| 6 Months | -39.1 (-43.5 to -34.8) | -42.1 (-46 to -38.1) |
| 12 Months | -42.3 (-46.3 to -38.3) | -42.5 (-46.5 to -38.4) |
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.
| units on a scale | MUS Only | MUS+BPTx |
|---|---|---|
| 3 Months | -33.9 (-38.1 to -29.8) | -38.9 (-43.1 to -34.8) |
| 6 Months | -33.4 (-38 to -28.8) | -40.9 (-45.3 to -36.5) |
| 12 Months | -35.4 (-39.9 to -30.9) | -40.8 (-45.1 to -36.4) |
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.
| units on a scale | MUS Only | MUS+BPTx |
|---|---|---|
| 3 Months | -28.9 (-32.4 to -25.5) | -32.8 (-36.4 to -29.1) |
| 6 Months | -28.6 (-32.4 to -24.9) | -33.7 (-37.4 to -30.1) |
| 12 Months | -30 (-33.8 to -26.1) | -34.1 (-37.9 to -30.2) |
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.
| units on a scale | MUS Only | MUS+BPTx |
|---|---|---|
| 3 Months | -38.4 (-42.2 to -34.5) | -40.7 (-44.5 to -36.9) |
| 6 Months | -38.6 (-42.6 to -34.5) | -41.5 (-45.2 to -37.8) |
| 12 Months | -38.3 (-42.4 to -34.3) | -42.8 (-46.7 to -39) |
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.
| units on a scale | MUS Only | MUS+BPTx |
|---|---|---|
| 3 Months | -140.4 (-154.2 to -126.7) | -153.3 (-167.3 to -139.3) |
| 6 Months | -139.8 (-154.9 to -124.6) | -158.2 (-172.3 to -144.1) |
| 12 Months | -146 (-160.8 to -131.2) | -160.1 (-174.5 to -145.8) |
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.
| units on a scale | MUS Only | MUS+BPTx |
|---|---|---|
| 3 Months | -32.1 (-35.5 to -28.8) | -36.7 (-40 to -33.3) |
| 6 Months | -34.6 (-38.2 to -30.9) | -37.6 (-41 to -34.3) |
| 12 Months | -35.5 (-39.2 to -31.8) | -38.8 (-42.3 to -35.4) |
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.
| units on a scale | MUS Only | MUS+BPTx |
|---|---|---|
| 3 Months | -31.3 (-34.7 to -27.8) | -33.8 (-37.1 to -30.6) |
| 6 Months | -32.5 (-36.1 to -28.8) | -34.5 (-38 to -30.9) |
| 12 Months | -33 (-36.8 to -29.2) | -35.7 (-39.2 to -32.2) |
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.
| units on a scale | MUS Only | MUS+BPTx |
|---|---|---|
| 0.5 Months | 0.5 (0.2 to 0.8) | 0.2 (-0.1 to 0.6) |
| 2 Months | 0.5 (0.2 to 0.8) | 0.6 (0.3 to 0.9) |
| 12 Months | 0.6 (0.2 to 1) | 0.6 (0.3 to 1) |
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.
| cm H2O | MUS Only | MUS+BPTx |
|---|---|---|
| 0.5 Months | 3.7 (1.8 to 5.6) | 0.7 (-1.3 to 2.7) |
| 2 Months | 5 (2.6 to 7.4) | 4.6 (1.9 to 7.3) |
| 12 Months | 4 (1.9 to 6.2) | 4.4 (1.5 to 7.2) |
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).
| Participants | MUS Only | MUS+BPTx |
|---|---|---|
| 3 Months — Improved | 179 | 178 |
| 3 Months — No Improvement/Worsened | 18 | 19 |
| 6 Months — Improved | 156 | 168 |
| 6 Months — No Improvement/Worsened | 19 | 13 |
| 12 Months — Improved | 147 | 159 |
| 12 Months — No Improvement/Worsened | 27 | 22 |
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.
| Participants | MUS Only | MUS+BPTx |
|---|---|---|
| 0 Months — Normal/Mild | 41 | 48 |
| 0 Months — Moderate/Severe | 188 | 187 |
| 3 Months — Normal/Mild | 171 | 174 |
| 3 Months — Moderate/Severe | 26 | 24 |
| 6 Months — Normal/Mild | 155 | 166 |
| 6 Months — Moderate/Severe | 21 | 16 |
| 12 Months — Normal/Mild | 155 | 164 |
| 12 Months — Moderate/Severe | 19 | 16 |
Collected over 12 Months. Non-serious events are listed at a 0.00% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| MUS Only | 0/238 (0%) | 28/238 (11.8%) | 163/238 (68.5%) |
| MUS+BPTx | 0/242 (0%) | 21/242 (8.7%) | 172/242 (71.1%) |
| Event | MUS Only | MUS+BPTx |
|---|---|---|
| Pancreatitis acuteGastrointestinal disorders | 3/238 | 0/242 |
| GastritisGastrointestinal disorders | 2/238 | 0/242 |
| PyelonephritisInfections and infestations | 2/238 | 1/242 |
| Bladder neck suspensionSurgical and medical procedures | 2/238 | 0/242 |
| CellulitisInfections and infestations | 0/238 | 2/242 |
| AsthmaRespiratory, thoracic and mediastinal disorders | 0/238 | 2/242 |
| Acute myocardial infarctionCardiac disorders | 1/238 | 0/242 |
| Angina unstableCardiac disorders | 1/238 | 0/242 |
| Atrial fibrillationCardiac disorders | 1/238 | 0/242 |
| Large intestinal obstructionGastrointestinal disorders | 1/238 | 0/242 |
| Event | MUS Only | MUS+BPTx |
|---|---|---|
| Urinary tract infectionInfections and infestations | 60/238 | 58/242 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 6/238 | 18/242 |
| Back painMusculoskeletal and connective tissue disorders | 12/238 | 18/242 |
| Urinary retentionRenal and urinary disorders | 16/238 | 17/242 |
| Genital painReproductive system and breast disorders | 15/238 | 4/242 |
| ConstipationGastrointestinal disorders | 9/238 | 14/242 |
| DyspareuniaReproductive system and breast disorders | 13/238 | 11/242 |
| Abdominal painGastrointestinal disorders | 11/238 | 11/242 |
| Upper respiratory tract infectionInfections and infestations | 11/238 | 7/242 |
| Pain in extremityMusculoskeletal and connective tissue disorders | 11/238 | 8/242 |
| Age, Continuous(years) | MUS Only | MUS+BPTx | Total |
|---|---|---|---|
| Mean | 53.6 ± 10.4 | 54.3 ± 11 | 54 ± 10.7 |
| Sex/Gender, Customized(Participants) | MUS Only | MUS+BPTx | Total |
|---|---|---|---|
| Female | 229 | 235 | 464 |
| Race/Ethnicity, Customized(Participants) | MUS Only | MUS+BPTx | Total |
|---|---|---|---|
| American Indian/Alaskan Native | 3 | 7 | 10 |
| Asian | 1 | 2 | 3 |
| Black/African American | 19 | 22 | 41 |
| More than one race | 1 | 2 | 3 |
| Other | 23 | 19 | 42 |
| Unknown/Not Reported | 1 | 2 | 3 |
| White | 181 | 181 | 362 |
| Race/Ethnicity, Customized(Participants) | MUS Only | MUS+BPTx | Total |
|---|---|---|---|
| Hispanic/Latina | 56 | 49 | 105 |
| Not Hispanic/Not Latina | 169 | 184 | 353 |
| Unknown/Not Reported | 4 | 2 | 6 |
| Body Mass Index(kg/m^2) | MUS Only | MUS+BPTx | Total |
|---|---|---|---|
| Mean | 32.3 ± 7 | 31.7 ± 7 | 32 ± 7 |
| Current Smoker(Participants) | MUS Only | MUS+BPTx | Total |
|---|---|---|---|
| No | 200 | 203 | 403 |
| Yes | 28 | 32 | 60 |
| Unknown or Not Reported | 1 | 0 | 1 |
| Ever Pregnant(Participants) | MUS Only | MUS+BPTx | Total |
|---|---|---|---|
| No | 10 | 15 | 25 |
| Yes | 218 | 220 | 438 |
| Unknown or Not Reported | 1 | 0 | 1 |
| Number of Vaginal Deliveries(Number of deliveries) | MUS Only | MUS+BPTx | Total |
|---|---|---|---|
| Median | 2 (0 to 13) | 2 (0 to 7) | 2 (0 to 13) |
2 further baseline measures are reported on the registry.
Documents are hosted by the registry — open the source record to download them.
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NICHD Pelvic Floor Disorders Network