Sling vs Botox for Mixed Incontinence (MUSA)

Treatment for Mixed Urinary Incontinence: Mid-urethral Sling vs. Botox A

The primary aim is to compare the effectiveness of intradetrusor injection of 100 unit injection of Botulinum toxin A to mid-urethral sling for change in MUI symptoms 6 months following treatment.

Study Overview

• Status: Completed
• Conditions: Urinary Incontinence, Stress; Urinary Incontinence, Urge
• Intervention / Treatment: Drug: Botox® injection; Device: Mid-urethral sling

Detailed Description

Mixed urinary incontinence (MUI), defined as the presence of both stress urinary incontinence (SUI) and urgency urinary incontinence (UUI), is a challenging condition for which clinicians frequently use multiple sequential treatments that have undergone limited evaluation in rigorous clinical trials. The Mixed Urinary Incontinence: Mid-urethral Sling vs. Botox A (MUSA) trial will estimate the effect of Botulinum toxin A (Botox A ®) compared to mid-urethral sling for the treatment of MUI symptoms in 146 women. MUSA is a randomized 2-arm clinical trial.

The purpose of MUSA is to:

• compare treatment with either Botulinum toxin A (Botox A ®) or mid-urethral sling for women with MUI
• characterize patient characteristics associated with treatment response

The primary objective is to estimate the effect of intradetrusor injections Botulinum toxin A (Botox A ®) compared to mid-urethral sling for treatment of MUI in 146 women 6 months after treatment. The change in severity of MUI symptoms will be measured using the Urogenital Distress Inventory.

Secondary outcomes include:

• Urogenital Distress Inventory Stress and Irritative subscales

Other outcomes include:

• Urogenital Distress Inventory Obstructive subscale
• Patient bladder diary metrics including numbers of daily incontinence episodes and voids and voiding frequency
• Other patient reported outcomes/validated instruments and associated scales and subscales: EQ-5D, IIQ-LF, OABq-LF, OAB-SATq, PISQ-IR, PGI-I, PGI-S, PGSC, and SF-36
• Physical measures of effectiveness: Postvoid Residual Volume

The study will continue with an additional 6 month observational period until 12 months post treatment.

A supplemental study will characterize baseline putative proteins/protein pathways in women with MUI associated with change in UDI after treatment with MUS or onabotulinum toxin A. Those results are not reported with this record.

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35249
      • University of Alabama at Birmingham, Department of Obstetrics and Gynecology
  • California
    • La Jolla, California, United States, 92037-0974
      • University of California at San Diego
    • San Diego, California, United States, 92110
      • Kaiser Permanente
  • North Carolina
    • Durham, North Carolina, United States, 27707
      • Duke University, Duke Division of Urogynecology and Reconstructive Pelvic Surgery
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • Magee-Women's Hospital, Department of Obstetrics and Gynecology
  • Rhode Island
    • Providence, Rhode Island, United States, 02903
      • Brown/ Women and Infants Hospital of Rhode Island, Center for Women's Pelvic Medicine and Reconstructive Surgery
  • Texas
    • Dallas, Texas, United States, 75390
      • University of Texas Southwestern Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Reporting at least "moderate bother" from UUI item on UDI

   * "Do you experience urine leakage associated with a feeling of urgency?"

2. Reporting at least "moderate bother" from SUI item on UDI

   * "Do you experience urine leakage related to physical activity, coughing, or sneezing?"

3. Diagnosis of SUI defined by a positive cough stress test (CST) or UDE within the past 18 months
4. Presence of UUI on bladder diary with > 4 Urgency IE/3-day diary
5. Urinary symptoms >3 months
6. Persistent symptoms despite at least one or more conservative treatments (e.g. supervised behavioral therapy, physical therapy) as determined adequate by the physician.

7. Inadequate response to oral overactive bladder medications (including anti-cholinergic and/or beta-mimetic medication) unless patient is

   1. intolerant of oral overactive bladder medications, or
   2. oral overactive bladder medications are contraindicated as determined by the treating provider.
8. Urodynamics within past 18 months
9. Demonstrates ability (or have caregiver demonstrate ability) to perform clean intermittent self-catheterization.

Exclusion Criteria:

1. Anterior or apical compartment prolapse at or beyond the hymen (>0 on POPQ), regardless if patient is symptomatic

   * 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

   * Women undergoing only rectocele repair or other repair unrelated to anterior or apical compartment 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 6 months, or within 12 months post-partum
7. Post-void residual >150 cc on 2 occasions within the past 6 months, 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 urinary incontinence
11. Spinal cord injury or advanced/severe neurologic conditions including Multiple Sclerosis, Parkinsons, Myasthenia Gravis, Charcot-Marie-Tooth
12. Women on overactive bladder medication/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 6 month follow-up
16. Diagnosis of and/or history of bladder pain or chronic pelvic pain
17. Women who had intravesical Botox injection within the past 12 months
18. Women who have undergone anterior or apical pelvic organ prolapse repair within the past 6 months

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Botox A® injection; A dose of 100 units of Botulinum toxin A will be injected into the bladder. Follow up visits at 2 weeks, 3 and 6 months post intervention to collect clinical and patient-reported outcomes.	Drug: Botox® injection; Botulinum toxin A will be prepared by dissolving 100 units of botulinum toxin A into 10 ml of injectable saline. Indigo carmine or methylene blue 0.1 ml will be added to each syringe of botulinum toxin A. The treating physician will inject a total of 10 ml of the Botox A® into approximately 15 to 20 different detrusor muscle sites under direct visualization.
Active Comparator: Mid-urethral sling; Mid-urethral Sling Procedure includes retropubic as well as transobturator full length slings. Follow up visits at 2 weeks, 3 and 6 months post intervention to collect clinical and patient-reported outcomes.	Device: Mid-urethral sling; Mid-urethral Sling Procedure includes retropubic as well as transobturator full length slings. "Mini-sling" and "single-incision" sling will not be allowed due to potential risk for higher failure rate.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
UDI-LF Total Score Change From Baseline	The Urogenital Distress Inventory 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 outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline.	3, 6, 9, and 12 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
UDI-LF Stress Score Change From Baseline	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 outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline.	3, 6, 9, and 12 Months
UDI-LF Irritative Score Change From Baseline	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 outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline.	3, 6, 9, and 12 Months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
UDI-LF Obstructive Score Change From Baseline	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 outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline.	3, 6, 9, and 12 Months
Average Daily Frequency of Combined Mixed Stress/Urge and Non-categorized Incontinence Epsiodes Change From Baseline	Based on data collected from participant-completed diaries, average daily frequency of combined mixed stress/urge and non-categorized incontinence epsiodes. The outcome variable is computed as the difference in number of episodes at 3, 6, and 12 months and the number of episodes at baseline.	3, 6, and 12 Months
Average Daily Frequency of All Incontinence Epsiodes Change From Baseline	Based on data collected from participant-completed diaries, average daily frequency of all incontinence epsiodes. The outcome variable is computed as the difference in number of episodes at 3, 6, and 12 months and the number of episodes at baseline.	3, 6, and 12 Months
Average Daily Frequency of Diurnal Voids Change From Baseline	Based on data collected from participant-completed diaries, average daily frequency of diurnal voids. The outcome variable is computed as the difference in number of voids at 3, 6, and 12 months and the number of voids at baseline.	3, 6, and 12 Months
Average Daily Frequency of Nocturnal Voids Change From Baseline	Based on data collected from participant-completed diaries, average daily frequency of nocturnal voids. The outcome variable is computed as the difference in number of voids at 3, 6, and 12 months and the number of voids at baseline.	3, 6, and 12 Months
Average Daily Frequency of All Voids Change From Baseline	Based on data collected from participant-completed diaries, average daily frequency of all voids. The outcome variable is computed as the difference in number of voids at 3, 6, and 12 months and the number of voids at baseline.	3, 6, and 12 Months
Normalization of Voiding Frequency	Based on data collected from participant-completed diaries at baseline and 3, 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	3, 6, and 12 Months
Improvement of 50% or More in Voiding Frequency Post Baseline	Based on data collected from participant-completed diaries at baseline and 3, 6, and 12 months, the outcome is calculated as Yes=at least 50% reduction in the number of voids between the timepoint and baseline, No=Otherwise	3, 6, and 12 Months
Worsening Voiding Frequency Post Baseline	Based on data collected from participant-completed diaries at baseline and 3, 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	3, 6, and 12 Months
Change From Baseline EQ-5D Visual Analog 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.	0.5 Months (2 Weeks) and 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.	0.5 Months (2 Weeks) and 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.	3, 6, 9, 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.	3, 6, 9, and 12 Months
Change From Baseline IIQ-LF Social/Relationships 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.	3, 6, 9, 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.	3, 6, 9, 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.	3, 6, 9, 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.	3, 6, 9, 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.	3, 6, 9, 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.	3, 6, 9, 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.	3, 6, 9, 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.	3, 6, 9, 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.	3, 6, 9, and 12 Months
OAB-SATq-LF 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.	3, 6, 9, and 12 Months
OAB-SATq-LF Side Effects 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.	3, 6, 9, and 12 Months
OAB-SATq-LF 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.	3, 6, 9, and 12 Months
OAB-SATq-LF 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.	3, 6, 9, and 12 Months
OAB-SAT-q Preference Indicator	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.	3, 6, 9, and 12 Months
PGI-I Score Binary Improvement Indicator	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).	3, 6, 9, and 12 Months
PGI-S Score Binary Condition Severity Indicator	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.	Baseline and 3, 6, 9, and 12 Months
PGSC Score Binary Improvement Indicator	Patient GLobal Impression of Symptom Control(PGSC) is a patient-reported measure of perceived adequate symptom control, as assessed on a scale of 1 (disagree strongly) to 5 (agree strongly). Included here are participants who had adequate control as indicated by a rating of 5 (agree strongly) or 4 (agree).	3, 6, 9, and 12 Months
Change From Baseline PISQ-IR NSA-PR Score	The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised measures the impact of incontinence symptoms on sexual function and satisfaction. The Not Sexually Active-Partner Related (NSA-PR) ranges from 1 to 4 with higher scores indicating greater sexual function. The outcome is calculated as the difference in score at 3, 6, 9, and 12 months and the score at baseline.	3, 6, 9, and 12 months
Change From Baseline PISQ-IR NSA-CS Score	The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised measures the impact of incontinence symptoms on sexual function and satisfaction. The Not Sexually Active-Condition Specific (NSA-CS) ranges from 1 to 4 with higher scores indicating greater sexual function. The outcome is calculated as the difference in score at 3, 6, 9, and 12 months and the score at baseline.	3, 6, 9, and 12 months
Change From Baseline PISQ-IR NSA-GQA Score	The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised measures the impact of incontinence symptoms on sexual function and satisfaction. The Not Sexually Active-Global Quality Rating (NSA-GQA) ranges from 1 to 4.5 with higher scores indicating greater sexual function. The outcome is calculated as the difference in score at 3, 6, 9, and 12 months and the score at baseline.	3, 6, 9, and 12 months
Change From Baseline PISQ-IR NSA-CI Score	The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised measures the impact of incontinence symptoms on sexual function and satisfaction. The Not Sexually Active-Condition Impact (NSA-CI) ranges from 1 to 4 with higher scores indicating greater sexual function. The outcome is calculated as the difference in score at 3, 6, 9, and 12 months and the score at baseline.	3, 6, 9, and 12 months
Change From Baseline PISQ-IR SA-AO Score	The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised measures the impact of incontinence symptoms on sexual function and satisfaction. The Sexually Active-Arousal Orgasm (SA-AO) ranges from 1 to 5 with higher scores indicating greater sexual function. The outcome is calculated as the difference in score at 3, 6, 9, and 12 months and the score at baseline.	3, 6, 9, and 12 months
Change From Baseline PISQ-IR SA-PR Score	The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised measures the impact of incontinence symptoms on sexual function and satisfaction. The Sexually Active-Partner Related (SA-PR) ranges from 1 to 4 with higher scores indicating greater sexual function. The outcome is calculated as the difference in score at 3, 6, 9, and 12 months and the score at baseline.	3, 6, 9, and 12 months
Change From Baseline PISQ-IR SA-CS Score	The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised measures the impact of incontinence symptoms on sexual function and satisfaction. The Sexually Active-Condition Specific (SA-CS) ranges from 1 to 5 with higher scores indicating greater sexual function. The outcome is calculated as the difference in score at 3, 6, 9, and 12 months and the score at baseline.	3, 6, 9, and 12 months
Change From Baseline PISQ-IR SA-GQR Score	The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised measures the impact of incontinence symptoms on sexual function and satisfaction. The Sexually Active-Global Quality Rating (SA-GQR) ranges from 1 to 4.75 with higher scores indicating greater sexual function. The outcome is calculated as the difference in score at 3, 6, 9, and 12 months and the score at baseline.	3, 6, 9, and 12 months
Change From Baseline PISQ-IR SA-CI Score	The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised measures the impact of incontinence symptoms on sexual function and satisfaction. The Sexually Active-Condition Impact (SA-CI) ranges from 1 to 4 with higher scores indicating greater sexual function. The outcome is calculated as the difference in score at 3, 6, 9, and 12 months and the score at baseline.	3, 6, 9, and 12 months
Change From Baseline PISQ-IR SA-D Score	The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised measures the impact of incontinence symptoms on sexual function and satisfaction. The Sexually Active-Desire (SA-D) ranges from 1 to 5 with higher scores indicating greater sexual function. The outcome is calculated as the difference in score at 3, 6, 9, and 12 months and the score at baseline.	3, 6, 9, and 12 months
Change From Baseline PISQ-IR SA Average Score	The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised measures the impact of incontinence symptoms on sexual function and satisfaction. The Sexually Active-Average (SA-AVG) ranges from 1 to 5 with higher scores indicating greater sexual function. The outcome is calculated as the difference in score at 3, 6, 9, and 12 months and the score at baseline.	3, 6, 9, and 12 months
SF-36 Physical Functioning Score	SF-36 is a standardized survey evaluating 8 domains of functional health and wellbeing: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for physical function domain was an average of the individual question scores of this domain, which are scaled 0-100 (100=highest level of functioning). The outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline.	0.5 Months (2 Weeks) and 3, 6, 9, and 12 months
SF-36 Role Physical Score	SF-36 is a standardized survey evaluating 8 domains of functional health and wellbeing: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for physical role limitations domain was an average of the individual question scores of this domain, which are scaled 0-100 (100=highest level of functioning). The outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline.	0.5 Months (2 Weeks) and 3, 6, 9, and 12 months
SF-36 Bodily Pain Score	SF-36 is a standardized survey evaluating 8 domains of functional health and wellbeing: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for bodily pain domain was an average of the individual question scores of this domain, which are scaled 0-100 (100=highest level of functioning). The outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline.	0.5 Months (2 Weeks) and 3, 6, 9, and 12 months
SF-36 General Health Score	SF-36 is a standardized survey evaluating 8 domains of functional health and wellbeing: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for general health domain was an average of the individual question scores of this domain, which are scaled 0-100 (100=highest level of functioning). The outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline.	0.5 Months (2 Weeks) and 3, 6, 9, and 12 months
SF-36 Vitality Score	SF-36 is a standardized survey evaluating 8 domains of functional health and wellbeing: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for vitality domain was an average of the individual question scores of this domain, which are scaled 0-100 (100=highest level of functioning). The outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline.	0.5 Months (2 Weeks) and 3, 6, 9, and 12 months
SF-36 Social Functioning Score	SF-36 is a standardized survey evaluating 8 domains of functional health and wellbeing: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for social functioning domain was an average of the individual question scores of this domain, which are scaled 0-100 (100=highest level of functioning). The outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline.	0.5 Months (2 Weeks) and 3, 6, 9, and 12 months
SF-36 Emotional Role Limitations Score	SF-36 is a standardized survey evaluating 8 domains of functional health and wellbeing: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for emotional role limitation domain was an average of the individual question scores of this domain, which are scaled 0-100 (100=highest level of functioning). The outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline.	0.5 Months (2 Weeks) and 3, 6, 9, and 12 months
SF-36 Mental Health Score	SF-36 is a standardized survey evaluating 8 domains of functional health and wellbeing: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for social functioning domain was an average of the individual question scores of this domain, which are scaled 0-100 (100=highest level of functioning). The outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline.	0.5 Months (2 Weeks) and 3, 6, 9, and 12 months
SF-36 Physical Composite Score	SF-36 is a standardized survey evaluating 8 domains of functional health and well-being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The physical composite score is a normalized t-score which combines the all 8 domains with a mean of 50 and standard deviation of 10 (higher scores indicate greater physical function). A t-score below 50 is a good all-around cutoff for detecting physical condition (per the Ware manual). The outcome is calculated as the difference in score at 2 weeks and 3, 6, or 12 months and the score at baseline.	0.5 Months (2 Weeks) and 3, 6, 9, and 12 months
SF-36 Mental Composite Score	SF-36 is a standardized survey evaluating 8 domains of functional health and well-being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The mental composite score is a normalized t-score which combines the all 8 domains with a mean of 50 and standard deviation of 10 (higher scores indicate greater mental health). A t-score below 52 is a well-documented cutoff for detecting depression (per the Ware manual). The outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline.	0.5 Months (2 Weeks) and 3, 6, 9, and 12 months
Postvoid Residual Volume	Postvoid Residual Volume	Baseline, 3, 6, and 12 Months

Collaborators and Investigators

• Sponsor: NICHD Pelvic Floor Disorders Network
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); University of Pennsylvania; University of California, San Diego; University of Alabama at Birmingham; University of Pittsburgh; Duke University; University of Texas Southwestern Medical Center; Kaiser Permanente; Women and Infants Hospital of Rhode Island; RTI International
• Investigators: Principal Investigator: Heidi S Harvey, MD, University of Pennsylvania; Principal Investigator: Marie Gantz, PhD, RTI International

Publications and helpful links

General Publications

• Harvie HS, Sung VW, Neuwahl SJ, Honeycutt AA, Meyer I, Chermansky CJ, Menefee S, Hendrickson WK, Dunivan GC, Mazloomdoost D, Bass SJ, Gantz MG; Eunice Kennedy Shriver National Institute of Child Health and Human Development Pelvic Floor Disorders Network. Cost-effectiveness of behavioral and pelvic floor muscle therapy combined with midurethral sling surgery vs surgery alone among women with mixed urinary incontinence: results of the Effects of Surgical Treatment Enhanced With Exercise for Mixed Urinary Incontinence randomized trial. Am J Obstet Gynecol. 2021 Dec;225(6):651.e1-651.e26. doi: 10.1016/j.ajog.2021.06.099. Epub 2021 Jul 6.

Study record dates

Study Major Dates

• Study Start (Actual): June 8, 2020
• Primary Completion (Actual): February 12, 2024
• Study Completion (Actual): February 12, 2024

Study Registration Dates

• First Submitted: November 18, 2019
• First Submitted That Met QC Criteria: November 19, 2019
• First Posted (Actual): November 21, 2019

Study Record Updates

• Last Update Posted (Actual): June 3, 2025
• Last Update Submitted That Met QC Criteria: May 16, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: urinary incontinence; midurethral sling; Botulinum toxin A (Botox A ®)
• Additional Relevant MeSH Terms: Urogenital Diseases; Mental Disorders; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urination Disorders; Lower Urinary Tract Symptoms; Urological Manifestations; Behavioral Symptoms; Elimination Disorders; Urinary Incontinence; Enuresis; Urinary Incontinence, Stress; Urinary Incontinence, Urge
• Other Study ID Numbers: PFDN-31P01; U24HD069031-06 (U.S. NIH Grant/Contract); UG1HD069013-06 (U.S. NIH Grant/Contract); UG1HD041267-18 (U.S. NIH Grant/Contract); UG1HD069010-07 (U.S. NIH Grant/Contract); UG1HD069006-07 (U.S. NIH Grant/Contract); UG1HD041261-17 (U.S. NIH Grant/Contract); UG1HD054214-12 (U.S. NIH Grant/Contract); UG1HD054241-12 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No