A Phase 3 interventional study of Botox® injection and Mid-urethral sling in Urinary Incontinence, Stress and Urinary Incontinence, Urge, sponsored by NICHD Pelvic Floor Disorders Network. Completed at 8 sites in United States. Open to female participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2025-06-03.
Sponsored by NICHD Pelvic Floor Disorders Network · Phase 3, Interventional, and Treatment
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.
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:
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:
Other outcomes include:
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.
1,363 studies on the registry are indexed under Urinary Incontinence; 228 are open to participants now.
This study's enrollment of 150 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.
Reporting at least "moderate bother" from UUI item on UDI
* "Do you experience urine leakage associated with a feeling of urgency?"
Reporting at least "moderate bother" from SUI item on UDI
* "Do you experience urine leakage related to physical activity, coughing, or sneezing?"
Inadequate response to oral overactive bladder medications (including anti-cholinergic and/or beta-mimetic medication) unless patient is
Exclusion Criteria:
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
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
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
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
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.
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.
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.
Time frame: 3, 6, 9, and 12 Months
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.
Time frame: 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.
Time frame: 3, 6, 9, and 12 Months
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 0.5 Months (2 Weeks) and 3, 6, 9, and 12 months
Postvoid Residual Volume
Postvoid Residual Volume
Time frame: Baseline, 3, 6, and 12 Months
| Milestone | Botox A | Mid-Urethral Sling |
|---|---|---|
| Started | 72 | 78 |
| Received treatment | 71 | 69 |
| Provided follow-up data | 71 | 66 |
| Completed | 66 | 63 |
| Not completed | 6 | 15 |
| Withdrew: Lost to follow-up | 4 | 5 |
| Withdrew: Consent only through 6 months | 1 | 1 |
| Withdrew: Insurance did not cover procedure | 0 | 1 |
| Withdrew: Physician decision | 0 | 3 |
| Withdrew: Withdrawal by subject | 1 | 5 |
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.
| units on a scale | Botox A | Mid-Urethral Sling |
|---|---|---|
| 3.0 | -82.2 (-100 to -64.4) | -84.6 (-101 to -68.3) |
| 6.0 | -74.9 (-93.6 to -56.1) | -89.1 (-104.7 to -73.5) |
| 9.0 | -63.1 (-81.8 to -44.5) | -85.6 (-102.7 to -68.6) |
| 12.0 | -67.7 (-85.7 to -49.8) | -89.2 (-107.5 to -70.9) |
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.
| units on a scale | Botox A | Mid-Urethral Sling |
|---|---|---|
| 3.0 | -27.9 (-37.7 to -18.1) | -46.4 (-55.4 to -37.3) |
| 6.0 | -30.2 (-39.6 to -20.9) | -45.1 (-53.6 to -36.7) |
| 9.0 | -20.2 (-30.1 to -10.4) | -42.3 (-53.1 to -31.4) |
| 12.0 | -24.3 (-34.6 to -14.1) | -44.4 (-53.8 to -35.1) |
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.
| units on a scale | Botox A | Mid-Urethral Sling |
|---|---|---|
| 3.0 | -40.8 (-47.3 to -34.2) | -28.1 (-35.6 to -20.6) |
| 6.0 | -35.8 (-43.3 to -28.3) | -30.6 (-37.4 to -23.8) |
| 9.0 | -32.7 (-40.5 to -25) | -30.8 (-38.8 to -22.7) |
| 12.0 | -31.6 (-39 to -24.2) | -33 (-41.4 to -24.6) |
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.
| units on a scale | Botox A | Mid-Urethral Sling |
|---|---|---|
| 3.0 | -13.5 (-18.8 to -8.1) | -10.1 (-14.6 to -5.7) |
| 6.0 | -8.9 (-13.8 to -4) | -13.4 (-17.5 to -9.3) |
| 9.0 | -10.2 (-15.7 to -4.7) | -12.6 (-17 to -8.2) |
| 12.0 | -11.8 (-16.4 to -7.2) | -11.7 (-16.5 to -6.9) |
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.
| incontinence episodes/day | Botox A | Mid-Urethral Sling |
|---|---|---|
| 3.0 | -0.4 (-0.90 to 0.00) | -0.4 (-0.90 to 0.10) |
| 6.0 | -0.2 (-0.50 to 0.10) | -0.7 (-1.10 to -0.30) |
| 12.0 | -0.2 (-0.60 to 0.20) | -0.7 (-1.30 to -0.20) |
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.
| incontinence episodes/day | Botox A | Mid-Urethral Sling |
|---|---|---|
| 3.0 | -4 (-4.90 to -3.20) | -3.9 (-5.00 to -2.80) |
| 6.0 | -3.2 (-3.90 to -2.40) | -4.1 (-5.20 to -3.10) |
| 12.0 | -3.6 (-4.70 to -2.60) | -4.5 (-5.80 to -3.20) |
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.
| diurnal voids/day | Botox A | Mid-Urethral Sling |
|---|---|---|
| 3.0 | -1.2 (-1.70 to -0.70) | 0 (-0.60 to 0.60) |
| 6.0 | -0.8 (-1.30 to -0.20) | -0.2 (-0.90 to 0.60) |
| 12.0 | -0.8 (-1.50 to -0.20) | -0.3 (-1.00 to 0.40) |
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.
| nocturnal voids/day | Botox A | Mid-Urethral Sling |
|---|---|---|
| 3.0 | -0.5 (-0.70 to -0.20) | -0.5 (-0.80 to -0.10) |
| 6.0 | -0.3 (-0.60 to -0.10) | -0.2 (-0.50 to 0.20) |
| 12.0 | -0.4 (-0.70 to -0.10) | -0.4 (-0.90 to 0.00) |
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.
| voids/day | Botox A | Mid-Urethral Sling |
|---|---|---|
| 3.0 | -1.6 (-2.20 to -1.00) | -0.4 (-1.10 to 0.20) |
| 6.0 | -1.1 (-1.70 to -0.50) | -0.4 (-1.10 to 0.40) |
| 12.0 | -1.2 (-2.00 to -0.50) | -0.7 (-1.60 to 0.10) |
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
| Participants | Botox A | Mid-Urethral Sling |
|---|---|---|
| 3.0 — No | 17 | 24 |
| 3.0 — Yes | 23 | 13 |
| 6.0 — No | 17 | 25 |
| 6.0 — Yes | 18 | 10 |
| 12.0 — No | 13 | 21 |
| 12.0 — Yes | 24 | 12 |
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
| Participants | Botox A | Mid-Urethral Sling |
|---|---|---|
| 3.0 — No | 60 | 61 |
| 3.0 — Yes | 1 | 0 |
| 6.0 — No | 53 | 59 |
| 6.0 — Yes | 0 | 1 |
| 12.0 — No | 50 | 54 |
| 12.0 — Yes | 3 | 2 |
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
| Participants | Botox A | Mid-Urethral Sling |
|---|---|---|
| 3.0 — No | 49 | 39 |
| 3.0 — Yes | 12 | 22 |
| 6.0 — No | 36 | 32 |
| 6.0 — Yes | 17 | 28 |
| 12.0 — No | 37 | 34 |
| 12.0 — Yes | 16 | 22 |
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 | Botox A | Mid-Urethral Sling |
|---|---|---|
| 0.5 | 3.1 (-0.6 to 6.8) | 9.3 (4.7 to 13.8) |
| 3.0 | 2.2 (-2.1 to 6.5) | 6.7 (1.9 to 11.5) |
| 6.0 | 1.5 (-2.9 to 5.9) | 7.1 (3 to 11.3) |
| 9.0 | 1.4 (-3.6 to 6.4) | 6.9 (2.8 to 11.1) |
| 12.0 | 1.6 (-2.7 to 5.8) | 7.4 (2.3 to 12.5) |
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 | Botox A | Mid-Urethral Sling |
|---|---|---|
| 0.5 | 0 (0 to 0) | 0 (0 to 0) |
| 3.0 | 0 (0 to 0.1) | 0 (0 to 0.1) |
| 6.0 | 0 (0 to 0.1) | 0 (0 to 0.1) |
| 9.0 | 0 (-0.1 to 0) | 0 (0 to 0.1) |
| 12.0 | 0 (0 to 0.1) | 0 (0 to 0.1) |
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 | Botox A | Mid-Urethral Sling |
|---|---|---|
| 3.0 | -19.5 (-27.1 to -12) | -20.3 (-28 to -12.6) |
| 6.0 | -20.7 (-26.2 to -15.2) | -21.1 (-28.5 to -13.8) |
| 9.0 | -16.9 (-23.2 to -10.6) | -21.2 (-29 to -13.4) |
| 12.0 | -18.1 (-24.5 to -11.7) | -25.3 (-32.9 to -17.8) |
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 | Botox A | Mid-Urethral Sling |
|---|---|---|
| 3.0 | -19.6 (-27.6 to -11.7) | -22.2 (-30.5 to -13.9) |
| 6.0 | -23.3 (-29.4 to -17.1) | -25.4 (-33.7 to -17.1) |
| 9.0 | -14.3 (-21 to -7.7) | -25.8 (-34.5 to -17) |
| 12.0 | -19.7 (-26.2 to -13.3) | -28.1 (-36.7 to -19.6) |
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 | Botox A | Mid-Urethral Sling |
|---|---|---|
| 3.0 | -15.7 (-22.6 to -8.7) | -18.9 (-26.8 to -11) |
| 6.0 | -16.9 (-22.8 to -11) | -20.3 (-27.8 to -12.8) |
| 9.0 | -10.3 (-15.8 to -4.7) | -19.9 (-27.8 to -12) |
| 12.0 | -15.7 (-21.8 to -9.5) | -22.3 (-30.7 to -13.9) |
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 | Botox A | Mid-Urethral Sling |
|---|---|---|
| 3.0 | -17.7 (-24.8 to -10.6) | -19.5 (-26 to -12.9) |
| 6.0 | -20.2 (-26.5 to -13.9) | -21.5 (-28.3 to -14.8) |
| 9.0 | -12.5 (-19.4 to -5.6) | -19.7 (-26 to -13.5) |
| 12.0 | -17.5 (-24.5 to -10.5) | -26.8 (-35.2 to -18.4) |
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 | Botox A | Mid-Urethral Sling |
|---|---|---|
| 3.0 | -72.9 (-99.5 to -46.2) | -80.8 (-108.4 to -53.2) |
| 6.0 | -81.1 (-101.3 to -60.9) | -88.4 (-115.4 to -61.4) |
| 9.0 | -54 (-75.7 to -32.2) | -86.6 (-113.9 to -59.3) |
| 12.0 | -71 (-93.4 to -48.6) | -102.5 (-133.1 to -71.9) |
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 | Botox A | Mid-Urethral Sling |
|---|---|---|
| 3.0 | -41 (-47.9 to -34) | -28.7 (-36.6 to -20.7) |
| 6.0 | -34.3 (-41 to -27.6) | -32 (-39.6 to -24.3) |
| 9.0 | -26.7 (-33.9 to -19.4) | -28.8 (-37.5 to -20.1) |
| 12.0 | -30.6 (-38.3 to -22.8) | -36.1 (-44.3 to -27.9) |
The Overactive Bladder Questionnaire-Long Form is a standardized a measure of overactive bladder symptoms and health-related quality of life. The OABq-LF 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 | Botox A | Mid-Urethral Sling |
|---|---|---|
| 3.0 | 29.7 (21.7 to 37.8) | 29.5 (21.9 to 37.1) |
| 6.0 | 24.3 (17.2 to 31.4) | 29.8 (22 to 37.5) |
| 9.0 | 18.8 (11.8 to 25.8) | 26.4 (18 to 34.9) |
| 12.0 | 24.7 (17.9 to 31.5) | 34.4 (25.6 to 43.2) |
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 | Botox A | Mid-Urethral Sling |
|---|---|---|
| 3.0 | 32.3 (24.6 to 40) | 29.6 (22.3 to 36.9) |
| 6.0 | 26.1 (19.7 to 32.5) | 31.2 (23.7 to 38.7) |
| 9.0 | 16.7 (9.2 to 24.2) | 28.2 (20.3 to 36.1) |
| 12.0 | 24.5 (16.8 to 32.2) | 35.6 (27.1 to 44.1) |
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 | Botox A | Mid-Urethral Sling |
|---|---|---|
| 3.0 | 23.8 (16.3 to 31.3) | 20.7 (12.4 to 29) |
| 6.0 | 21.6 (14.4 to 28.8) | 18.4 (10.8 to 25.9) |
| 9.0 | 15.6 (8.4 to 22.7) | 19 (11.4 to 26.7) |
| 12.0 | 16.8 (9.3 to 24.3) | 19.8 (9.7 to 29.8) |
The Overactive Bladder Questionnaire-Long Form is a standardized a measure of overactive bladder symptoms and health-related quality of life. The OABq-LF 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 | Botox A | Mid-Urethral Sling |
|---|---|---|
| 3.0 | 15.1 (8.7 to 21.5) | 20 (13 to 27) |
| 6.0 | 11.8 (5.5 to 18) | 19.6 (13.4 to 25.8) |
| 9.0 | 4.8 (-0.5 to 10.1) | 18.4 (10.9 to 26) |
| 12.0 | 11 (4.7 to 17.4) | 21 (13.6 to 28.4) |
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 | Botox A | Mid-Urethral Sling |
|---|---|---|
| 3.0 | 26.4 (19.8 to 33) | 25.9 (19.2 to 32.6) |
| 6.0 | 21.8 (16 to 27.5) | 25.9 (19.4 to 32.3) |
| 9.0 | 14.8 (9.2 to 20.4) | 23.9 (16.8 to 30.9) |
| 12.0 | 20.3 (14.3 to 26.4) | 29.1 (21.4 to 36.9) |
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 | Botox A | Mid-Urethral Sling |
|---|---|---|
| 3.0 | 65.7 (58.7 to 72.7) | 60.1 (51.9 to 68.3) |
| 6.0 | 64.5 (57.6 to 71.3) | 60.3 (52.5 to 68.2) |
| 9.0 | 64.4 (57.5 to 71.2) | 57.5 (48.8 to 66.2) |
| 12.0 | 60.4 (53 to 67.8) | 56.3 (46.8 to 65.9) |
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 | Botox A | Mid-Urethral Sling |
|---|---|---|
| 3.0 | 91.9 (87.5 to 96.4) | 93.5 (89.7 to 97.3) |
| 6.0 | 89 (83.5 to 94.5) | 87.4 (81.5 to 93.4) |
| 9.0 | 90.2 (84.4 to 95.9) | 86.3 (79.7 to 92.9) |
| 12.0 | 91.8 (87 to 96.6) | 88.5 (82.2 to 94.8) |
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 | Botox A | Mid-Urethral Sling |
|---|---|---|
| 3.0 | 74.3 (67.8 to 80.9) | 67.9 (59.8 to 76) |
| 6.0 | 72 (64.4 to 79.6) | 68.3 (60.5 to 76) |
| 9.0 | 77.7 (70.5 to 84.9) | 73.6 (65.6 to 81.7) |
| 12.0 | 71.7 (63.8 to 79.5) | 68.2 (59 to 77.3) |
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 | Botox A | Mid-Urethral Sling |
|---|---|---|
| 3.0 | 64.2 (57.6 to 70.7) | 64.1 (56.7 to 71.4) |
| 6.0 | 66.5 (59.3 to 73.6) | 66.8 (60 to 73.5) |
| 9.0 | 67.6 (62.5 to 72.8) | 64.7 (58.1 to 71.3) |
| 12.0 | 65.6 (59.7 to 71.4) | 66.3 (58.5 to 74.2) |
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 | Botox A | Mid-Urethral Sling |
|---|---|---|
| 3.0 — Unknown | 16 | 24 |
| 3.0 — No | 5 | 5 |
| 3.0 — Yes | 47 | 35 |
| 6.0 — Unknown | 17 | 21 |
| 6.0 — No | 6 | 8 |
| 6.0 — Yes | 41 | 36 |
| 9.0 — Unknown | 17 | 15 |
| 9.0 — No | 5 | 5 |
| 9.0 — Yes | 33 | 36 |
| 12.0 — Unknown | 15 | 19 |
| 12.0 — No | 10 | 7 |
| 12.0 — Yes | 36 | 34 |
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 | Botox A | Mid-Urethral Sling |
|---|---|---|
| 3.0 — No | 28 | 30 |
| 3.0 — Yes | 40 | 34 |
| 6.0 — No | 25 | 33 |
| 6.0 — Yes | 39 | 32 |
| 9.0 — No | 22 | 25 |
| 9.0 — Yes | 34 | 31 |
| 12.0 — No | 35 | 31 |
| 12.0 — Yes | 26 | 29 |
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 | Botox A | Mid-Urethral Sling |
|---|---|---|
| Baseline — No | 57 | 53 |
| Baseline — Yes | 13 | 10 |
| 3.0 — No | 29 | 30 |
| 3.0 — Yes | 39 | 34 |
| 6.0 — No | 29 | 29 |
| 6.0 — Yes | 35 | 36 |
| 9.0 — No | 27 | 24 |
| 9.0 — Yes | 29 | 32 |
| 12.0 — No | 28 | 24 |
| 12.0 — Yes | 33 | 36 |
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).
| Participants | Botox A | Mid-Urethral Sling |
|---|---|---|
| 3.0 — No | 32 | 28 |
| 3.0 — Yes | 36 | 36 |
| 6.0 — No | 30 | 33 |
| 6.0 — Yes | 34 | 32 |
| 9.0 — No | 28 | 27 |
| 9.0 — Yes | 28 | 29 |
| 12.0 — No | 33 | 24 |
| 12.0 — Yes | 29 | 36 |
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.
| units on a scale | Botox A | Mid-Urethral Sling |
|---|---|---|
| 3.0 | 0.3 (-0.1 to 0.7) | 0.3 (0.1 to 0.5) |
| 6.0 | 0 (-0.4 to 0.4) | 0.3 (0 to 0.6) |
| 9.0 | 0.1 (-0.3 to 0.6) | 0.1 (-0.3 to 0.5) |
| 12.0 | 0.3 (0 to 0.6) | 0.1 (-0.3 to 0.4) |
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.
| units on a scale | Botox A | Mid-Urethral Sling |
|---|---|---|
| 3.0 | -0.2 (-0.5 to 0) | -0.1 (-0.5 to 0.2) |
| 6.0 | -0.2 (-0.7 to 0.2) | 0 (-0.3 to 0.4) |
| 9.0 | -0.2 (-0.4 to 0.1) | -0.1 (-0.4 to 0.2) |
| 12.0 | 0.2 (-0.1 to 0.6) | -0.3 (-0.7 to 0.2) |
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.
| units on a scale | Botox A | Mid-Urethral Sling |
|---|---|---|
| 3.0 | -0.1 (-0.5 to 0.2) | -0.3 (-0.6 to 0.1) |
| 6.0 | -0.3 (-0.8 to 0.2) | -0.3 (-0.8 to 0.1) |
| 9.0 | -0.2 (-0.8 to 0.4) | -0.4 (-0.8 to -0.1) |
| 12.0 | -0.4 (-0.9 to 0.1) | -0.2 (-0.7 to 0.2) |
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.
| units on a scale | Botox A | Mid-Urethral Sling |
|---|---|---|
| 3.0 | -0.3 (-0.6 to 0) | -0.4 (-0.8 to 0) |
| 6.0 | -0.3 (-0.7 to 0.1) | -0.3 (-0.8 to 0.1) |
| 9.0 | -0.3 (-0.8 to 0.1) | -0.2 (-0.7 to 0.2) |
| 12.0 | -0.2 (-0.5 to 0.1) | -0.4 (-0.8 to 0) |
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.
| units on a scale | Botox A | Mid-Urethral Sling |
|---|---|---|
| 3.0 | 0 (-0.1 to 0.2) | -0.1 (-0.5 to 0.3) |
| 6.0 | 0 (-0.2 to 0.2) | 0.1 (-0.2 to 0.3) |
| 9.0 | -0.1 (-0.4 to 0.2) | 0.1 (-0.2 to 0.3) |
| 12.0 | 0 (-0.3 to 0.3) | 0 (-0.3 to 0.2) |
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.
| units on a scale | Botox A | Mid-Urethral Sling |
|---|---|---|
| 3.0 | 0 (-0.3 to 0.2) | 0 (-0.3 to 0.2) |
| 6.0 | 0 (-0.2 to 0.3) | 0.1 (-0.2 to 0.5) |
| 9.0 | -0.1 (-0.3 to 0.2) | -0.3 (-0.6 to 0) |
| 12.0 | -0.1 (-0.5 to 0.2) | -0.1 (-0.4 to 0.1) |
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.
| units on a scale | Botox A | Mid-Urethral Sling |
|---|---|---|
| 3.0 | 0.5 (0.2 to 0.7) | 0.5 (0.1 to 0.8) |
| 6.0 | 0.3 (0 to 0.6) | 0.6 (0.1 to 1) |
| 9.0 | 0.3 (-0.1 to 0.6) | 0.2 (-0.4 to 0.8) |
| 12.0 | 0.3 (-0.1 to 0.6) | 0.4 (-0.2 to 1.1) |
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.
| units on a scale | Botox A | Mid-Urethral Sling |
|---|---|---|
| 3.0 | 0 (-0.4 to 0.3) | 0.3 (-0.1 to 0.7) |
| 6.0 | 0 (-0.3 to 0.4) | 0.2 (-0.2 to 0.5) |
| 9.0 | -0.1 (-0.6 to 0.3) | -0.4 (-0.9 to 0.1) |
| 12.0 | -0.1 (-0.4 to 0.3) | -0.2 (-0.5 to 0.2) |
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.
| units on a scale | Botox A | Mid-Urethral Sling |
|---|---|---|
| 3.0 | 0.4 (0.1 to 0.7) | 0.6 (0.3 to 1) |
| 6.0 | 0.2 (-0.1 to 0.5) | 0.8 (0.4 to 1.1) |
| 9.0 | 0.3 (0 to 0.6) | 0.3 (-0.1 to 0.7) |
| 12.0 | 0.3 (-0.1 to 0.6) | 0.9 (0.5 to 1.4) |
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.
| units on a scale | Botox A | Mid-Urethral Sling |
|---|---|---|
| 3.0 | 0.1 (-0.1 to 0.4) | 0.1 (-0.2 to 0.3) |
| 6.0 | 0 (-0.2 to 0.1) | -0.1 (-0.3 to 0.1) |
| 9.0 | 0 (-0.3 to 0.2) | 0.1 (-0.2 to 0.4) |
| 12.0 | -0.2 (-0.5 to 0.1) | 0 (-0.3 to 0.4) |
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.
| units on a scale | Botox A | Mid-Urethral Sling |
|---|---|---|
| 3.0 | 0.2 (0 to 0.3) | 0.2 (0.1 to 0.4) |
| 6.0 | 0.1 (-0.1 to 0.2) | 0.3 (0.1 to 0.5) |
| 9.0 | 0 (-0.1 to 0.2) | 0 (-0.2 to 0.2) |
| 12.0 | 0 (-0.2 to 0.2) | 0.2 (0 to 0.4) |
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.
| units on a scale | Botox A | Mid-Urethral Sling |
|---|---|---|
| 0.5 | 12.9 (6.3 to 19.5) | 12.2 (6.3 to 18.1) |
| 3.0 | 10.9 (4.8 to 17) | 13.9 (7.1 to 20.6) |
| 6.0 | 10.5 (4.6 to 16.3) | 14 (7.1 to 20.9) |
| 9.0 | 8.9 (1.8 to 15.9) | 9.7 (3.6 to 15.7) |
| 12.0 | 10 (4.1 to 15.9) | 13.3 (6.5 to 20) |
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.
| units on a scale | Botox A | Mid-Urethral Sling |
|---|---|---|
| 0.5 | 14.1 (3.1 to 25.2) | -1.2 (-12.7 to 10.3) |
| 3.0 | 12.5 (2.2 to 22.8) | 11.3 (1.6 to 21.1) |
| 6.0 | 12.3 (1.7 to 22.9) | 12.1 (2 to 22.2) |
| 9.0 | 3.6 (-8.3 to 15.6) | 7.7 (-4.3 to 19.8) |
| 12.0 | 8.6 (-1.2 to 18.4) | 4.9 (-7.3 to 17.1) |
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.
| units on a scale | Botox A | Mid-Urethral Sling |
|---|---|---|
| 0.5 | 2.6 (-3 to 8.2) | 2.4 (-3.6 to 8.5) |
| 3.0 | 5.1 (-0.6 to 10.9) | 0.6 (-5.4 to 6.5) |
| 6.0 | -0.4 (-6.3 to 5.5) | 0.8 (-5.1 to 6.6) |
| 9.0 | -1.6 (-8.1 to 5) | 4.2 (-1.8 to 10.2) |
| 12.0 | -0.8 (-6.9 to 5.2) | 6.4 (0.1 to 12.7) |
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.
| units on a scale | Botox A | Mid-Urethral Sling |
|---|---|---|
| 0.5 | 5.2 (1.9 to 8.4) | 2.5 (-1.2 to 6.3) |
| 3.0 | 2.4 (-1.3 to 6) | -1.7 (-5.8 to 2.5) |
| 6.0 | 2.6 (-1.4 to 6.7) | -0.6 (-4.4 to 3.2) |
| 9.0 | -1.6 (-6 to 2.7) | -2.2 (-6.5 to 2.2) |
| 12.0 | -1.1 (-5.3 to 3.1) | -0.3 (-4.8 to 4.1) |
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.
| units on a scale | Botox A | Mid-Urethral Sling |
|---|---|---|
| 0.5 | 6.1 (1 to 11.1) | 6.5 (1.8 to 11.3) |
| 3.0 | 3.5 (-1.7 to 8.6) | 5.3 (0.6 to 10.1) |
| 6.0 | 4.7 (-0.1 to 9.5) | 3.4 (-1.2 to 8.1) |
| 9.0 | -0.8 (-5.8 to 4.2) | -1.3 (-6.5 to 4) |
| 12.0 | 2.7 (-2.3 to 7.7) | 0.4 (-5.2 to 6.1) |
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.
| units on a scale | Botox A | Mid-Urethral Sling |
|---|---|---|
| 0.5 | 10.9 (5 to 16.7) | 9.1 (3.2 to 15) |
| 3.0 | 11 (4.9 to 17.2) | 5.7 (-1.4 to 12.7) |
| 6.0 | 11.5 (5.6 to 17.4) | 6.6 (0.1 to 13.2) |
| 9.0 | 4.5 (-1.3 to 10.4) | 12.3 (5 to 19.5) |
| 12.0 | 6.4 (-0.4 to 13.1) | 7.1 (0.3 to 13.8) |
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.
| units on a scale | Botox A | Mid-Urethral Sling |
|---|---|---|
| 0.5 | 16.4 (5.8 to 27) | 12.2 (0.9 to 23.5) |
| 3.0 | 19.9 (9.1 to 30.6) | 14.6 (3 to 26.2) |
| 6.0 | 12.7 (4.7 to 20.7) | 12.5 (0.9 to 24.1) |
| 9.0 | 13 (1.9 to 24.2) | 7.4 (-3.3 to 18.2) |
| 12.0 | 9.8 (1.8 to 17.8) | 13.3 (2 to 24.7) |
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.
| units on a scale | Botox A | Mid-Urethral Sling |
|---|---|---|
| 0.5 | 0.2 (-3.7 to 4.1) | 5 (1.3 to 8.7) |
| 3.0 | 0.8 (-3.1 to 4.7) | 1.8 (-3.4 to 7) |
| 6.0 | -2 (-6.4 to 2.5) | 1 (-3.5 to 5.6) |
| 9.0 | -2.4 (-6.5 to 1.8) | 0.6 (-4.2 to 5.5) |
| 12.0 | -0.7 (-4.8 to 3.3) | 1.3 (-3.7 to 6.2) |
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.
| T-score | Botox A | Mid-Urethral Sling |
|---|---|---|
| 0.5 | 3.9 (1.7 to 6.2) | 1.5 (-0.6 to 3.6) |
| 3.0 | 3.1 (0.8 to 5.3) | 2.6 (0.2 to 5) |
| 6.0 | 3 (0.7 to 5.3) | 3.1 (0.7 to 5.4) |
| 9.0 | 1.1 (-1.6 to 3.8) | 2.2 (-0.5 to 4.9) |
| 12.0 | 2 (-0.2 to 4.2) | 2.8 (0.5 to 5.2) |
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.
| T-score | Botox A | Mid-Urethral Sling |
|---|---|---|
| 0.5 | 2.2 (0 to 4.5) | 3.5 (1.2 to 5.8) |
| 3.0 | 2.7 (0.1 to 5.4) | 1.9 (-0.8 to 4.5) |
| 6.0 | 1.6 (-0.8 to 3.9) | 1.2 (-1.2 to 3.6) |
| 9.0 | 0.6 (-1.9 to 3.1) | 1 (-1.8 to 3.7) |
| 12.0 | 0.9 (-1.3 to 3.1) | 1.2 (-1.7 to 4.1) |
Postvoid Residual Volume
| mL | Botox A | Mid-Urethral Sling |
|---|---|---|
| Baseline | 20.4 (14.6 to 26.3) | 22.7 (15.9 to 29.5) |
| 0.5 | 49.4 (33.8 to 65.1) | 26.5 (19.5 to 33.5) |
| 3.0 | 39.4 (25.0 to 53.7) | 27.2 (19.2 to 35.3) |
| 6.0 | 31.7 (19.2 to 44.2) | 37.1 (23.9 to 50.3) |
Collected over 12 Months. Non-serious events are listed at a 0.00% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Botox A | 0/71 (0%) | 3/71 (4.2%) | 40/71 (56.3%) |
| Mid-Urethral Sling | 0/69 (0%) | 8/69 (11.6%) | 41/69 (59.4%) |
| Event | Botox A | Mid-Urethral Sling |
|---|---|---|
| Cardiac failureCardiac disorders | 0/71 | 1/69 |
| Myocardial infarctionCardiac disorders | 0/71 | 1/69 |
| PyelonephritisInfections and infestations | 0/71 | 1/69 |
| ObesityMetabolism and nutrition disorders | 0/71 | 1/69 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 0/71 | 1/69 |
| OsteoarthritisMusculoskeletal and connective tissue disorders | 0/71 | 1/69 |
| Spinal stenosisMusculoskeletal and connective tissue disorders | 0/71 | 1/69 |
| Ischaemic strokeNervous system disorders | 0/71 | 1/69 |
| Chronic obstructive pulmonary diseaseRespiratory, thoracic and mediastinal disorders | 0/71 | 1/69 |
| Cardiac failure congestiveCardiac disorders | 1/71 | 0/69 |
| Event | Botox A | Mid-Urethral Sling |
|---|---|---|
| Urinary tract infectionInfections and infestations | 24/71 | 26/69 |
| Urinary retentionRenal and urinary disorders | 3/71 | 6/69 |
| Coronavirus infectionInfections and infestations | 4/71 | 0/69 |
| Residual urine volumeInvestigations | 3/71 | 0/69 |
| ConstipationGastrointestinal disorders | 0/71 | 2/69 |
| Medical device site erosionGeneral disorders | 0/71 | 2/69 |
| Suprapubic painGeneral disorders | 0/71 | 2/69 |
| CellulitisInfections and infestations | 0/71 | 2/69 |
| Ear infectionInfections and infestations | 0/71 | 2/69 |
| Vulvovaginal mycotic infectionInfections and infestations | 0/71 | 2/69 |
Baseline analysis is limited to those participants that were randomized, received treatment, and provided at least one post-baseline measurement.
| Age, Continuous(years) | Botox A | Mid-Urethral Sling | Total |
|---|---|---|---|
| Mean | 59.1 ± 11.4 | 59 ± 11.7 | 59 ± 11.5 |
| Sex/Gender, Customized(Participants) | Botox A | Mid-Urethral Sling | Total |
|---|---|---|---|
| Female | 71 | 66 | 137 |
| Race/Ethnicity, Customized(Participants) | Botox A | Mid-Urethral Sling | Total |
|---|---|---|---|
| Asian | 2 | 0 | 2 |
| Black/African American | 10 | 10 | 20 |
| Native Hawaiian/Other Pacific Islander | 1 | 1 | 2 |
| Other | 3 | 1 | 4 |
| White | 55 | 54 | 109 |
| Race/Ethnicity, Customized(Participants) | Botox A | Mid-Urethral Sling | Total |
|---|---|---|---|
| Hispanic/Latina | 15 | 6 | 21 |
| Not Hispanic/Not Latina | 56 | 59 | 115 |
| Unknown/Not Reported | 0 | 1 | 1 |
| Menopausal Status, Customized(Participants) | Botox A | Mid-Urethral Sling | Total |
|---|---|---|---|
| Not sure | 8 | 3 | 11 |
| Post-menopausal | 56 | 49 | 105 |
| Pre-menopausal | 7 | 14 | 21 |
| Education(Participants) | Botox A | Mid-Urethral Sling | Total |
|---|---|---|---|
| 4-Year College Degree | 21 | 11 | 32 |
| Associate College Degree | 17 | 13 | 30 |
| Graduate Degree | 8 | 8 | 16 |
| High School/GED | 19 | 29 | 48 |
| Less than High School | 3 | 2 | 5 |
| Unknown/Not Reported | 3 | 3 | 6 |
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NICHD Pelvic Floor Disorders Network