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OpenTrials
Completed

NCT Number: NCT04171531

Sling vs Botox for Mixed Incontinence

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.

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Key information

Age range

21 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

University of Alabama at Birmingham, Department of Obstetrics and Gynecology, Birmingham, Alabama, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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?"
  • Diagnosis of SUI defined by a positive cough stress test (CST) or UDE within the past 18 months
  • Presence of UUI on bladder diary with > 4 Urgency IE/3-day diary
  • Urinary symptoms >3 months
  • Persistent symptoms despite at least one or more conservative treatments (e.g. supervised behavioral therapy, physical therapy) as determined adequate by the physician.
  • Inadequate response to oral overactive bladder medications (including anti-cholinergic and/or beta-mimetic medication) unless patient is
  • intolerant of oral overactive bladder medications, or
  • oral overactive bladder medications are contraindicated as determined by the treating provider.
  • Urodynamics within past 18 months
  • Demonstrates ability (or have caregiver demonstrate ability) to perform clean intermittent self-catheterization.

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
  • Women undergoing hysterectomy for any indication will be excluded
  • Active pelvic organ malignancy
  • Age <21 years
  • Pregnant or plans for future pregnancy in next 6 months, or within 12 months post-partum
  • Post-void residual >150 cc on 2 occasions within the past 6 months, or current catheter use
  • Participation in other trial that may influence results of this study
  • Unevaluated hematuria
  • Prior sling, synthetic mesh for prolapse, implanted nerve stimulator for urinary incontinence
  • Spinal cord injury or advanced/severe neurologic conditions including Multiple Sclerosis, Parkinsons, Myasthenia Gravis, Charcot-Marie-Tooth
  • Women on overactive bladder medication/therapy will be eligible after 3 week wash-out period
  • Non-ambulatory
  • History of serious adverse reaction to synthetic mesh
  • Not able to complete study assessments per clinician judgment, or not available for 6 month follow-up
  • Diagnosis of and/or history of bladder pain or chronic pelvic pain
  • Women who had intravesical Botox injection within the past 12 months
  • Women who have undergone anterior or apical pelvic organ prolapse repair within the past 6 months

Treatment and study plan

Botox® injection

Drug

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

Device

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.

Primary outcomes

  1. UDI-LF Total Score Change From Baseline

    Time frame: 3, 6, 9, and 12 Months

    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.

Secondary outcomes

  1. UDI-LF Stress Score Change From Baseline

    Time frame: 3, 6, 9, and 12 Months

    The Urogenital Distress Inventory is a standardized a measure of overactive bladder symptoms and health-related quality of life. The UDI Stress subscale has a range from 0 to 100 with higher scores indicating greater distress. The outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline.

  2. UDI-LF Irritative Score Change From Baseline

    Time frame: 3, 6, 9, and 12 Months

    The Urogenital Distress Inventory is a standardized a measure of overactive bladder symptoms and health-related quality of life. The UDI Irritative subscale has a range from 0 to 100 with higher scores indicating greater distress. The outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline.

Other outcomes

  1. UDI-LF Obstructive Score Change From Baseline

    Time frame: 3, 6, 9, and 12 Months

    The Urogenital Distress Inventory is a standardized a measure of overactive bladder symptoms and health-related quality of life. The UDI Obstructive subscale has a range from 0 to 100 with higher scores indicating greater distress. The outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline.

  2. Average Daily Frequency of Combined Mixed Stress/Urge and Non-categorized Incontinence Epsiodes Change From Baseline

    Time frame: 3, 6, and 12 Months

    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. Average Daily Frequency of All Incontinence Epsiodes Change From Baseline

    Time frame: 3, 6, and 12 Months

    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.

  4. Average Daily Frequency of Diurnal Voids Change From Baseline

    Time frame: 3, 6, and 12 Months

    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.

  5. Average Daily Frequency of Nocturnal Voids Change From Baseline

    Time frame: 3, 6, and 12 Months

    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.

  6. Average Daily Frequency of All Voids Change From Baseline

    Time frame: 3, 6, and 12 Months

    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.

  7. Normalization of Voiding Frequency

    Time frame: 3, 6, and 12 Months

    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

  8. Improvement of 50% or More in Voiding Frequency Post Baseline

    Time frame: 3, 6, and 12 Months

    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

  9. Worsening Voiding Frequency Post Baseline

    Time frame: 3, 6, and 12 Months

    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

  10. Change From Baseline EQ-5D Visual Analog Score

    Time frame: 0.5 Months (2 Weeks) and 3, 6, and 12 Months

    EQ-5D is a standardized instrument developed by the EuroQol Group as a measure of health-related quality of life. The visual analog scale (VAS) score ranges from 0 to 100 with higher scores indicating a better quality of life. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline.

  11. Change From Baseline EQ-5D Index Score

    Time frame: 0.5 Months (2 Weeks) and 3, 6, and 12 Months

    EQ-5D is a standardized instrument developed by the EuroQol Group as a measure of health-related quality of life. The index score ranges from 0 to 1 with higher scores indicating a better quality of life. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline.

  12. Change From Baseline IIQ-LF Physical Activity Score

    Time frame: 3, 6, 9, and 12 Months

    The Incontinence Impact Questionnaire-Long Form is a standardized a measure of health-related quality of life. The IIq-LF Physical Activity score ranges from 0 to 100 with higher scores indicating worse impact. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline.

  13. Change From Baseline IIQ-LF Travel Score

    Time frame: 3, 6, 9, and 12 Months

    The Incontinence Impact Questionnaire-Long Form is a standardized a measure of health-related quality of life. The IIq-LF Travel score ranges from 0 to 100 with higher scores indicating worse impact. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline.

  14. Change From Baseline IIQ-LF Social/Relationships Score

    Time frame: 3, 6, 9, and 12 Months

    The Incontinence Impact Questionnaire-Long Form is a standardized a measure of health-related quality of life. The IIq-LF Social Relationship score ranges from 0 to 100 with higher scores indicating worse impact. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline.

  15. Change From Baseline IIQ-LF Emotional Health Score

    Time frame: 3, 6, 9, and 12 Months

    The Incontinence Impact Questionnaire-Long Form is a standardized a measure of health-related quality of life. The IIq-LF Emotional Health score ranges from 0 to 100 with higher scores indicating worse impact. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline.

  16. Change From Baseline IIQ-LF Total Score

    Time frame: 3, 6, 9, and 12 Months

    The Incontinence Impact Questionnaire-Long Form is a standardized a measure of health-related quality of life. The IIq-LF Total score ranges from 0 to 400 with higher scores indicating worse impact. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline.

  17. Change From Baseline OABq-LF Symptom Severity Score

    Time frame: 3, 6, 9, and 12 Months

    The Overactive Bladder Questionnaire-Long Form is a standardized a measure of overactive bladder symptoms and health-related quality of life. The OABq-LF Symptom Severity score ranges from 0 to 100 with higher score indicating worse quality of life. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline.

  18. Change From Baseline OABq-LF Coping Score

    Time frame: 3, 6, 9, and 12 Months

    The Overactive Bladder Questionnaire-Long Form is a standardized a measure of overactive bladder symptoms and health-related quality of life. The OABq-LF Coping score ranges from 0 to 100 with higher score indicating better quality of life. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline.

  19. Change From Baseline OABq-LF Concern Score

    Time frame: 3, 6, 9, and 12 Months

    The Overactive Bladder Questionnaire-Long Form is a standardized a measure of overactive bladder symptoms and health-related quality of life. The OABq-LF Concern score ranges from 0 to 100 with higher score indicating better quality of life. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline.

  20. Change From Baseline OABq-LF Sleep Score

    Time frame: 3, 6, 9, and 12 Months

    The Overactive Bladder Questionnaire-Long Form is a standardized a measure of overactive bladder symptoms and health-related quality of life. The OABq-LF Sleep score ranges from 0 to 100 with higher score indicating better quality of life. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline.

  21. Change From Baseline OABq-LF Social Score

    Time frame: 3, 6, 9, and 12 Months

    The Overactive Bladder Questionnaire-Long Form is a standardized a measure of overactive bladder symptoms and health-related quality of life. The OABq-LF Social score ranges from 0 to 100 with higher score indicating better quality of life. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline.

  22. Change From Baseline OABq-LF HRQL Total Score

    Time frame: 3, 6, 9, and 12 Months

    The Overactive Bladder Questionnaire-Long Form is a standardized a measure of overactive bladder symptoms and health-related quality of life. The OABq-LF HRQL score ranges from 0 to 100 with higher score indicating better quality of life. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline.

  23. OAB-SATq-LF Satisfaction Score

    Time frame: 3, 6, 9, and 12 Months

    The Overactive Bladder Satisfaction with Treatment Questionnaire is a standardized a measure of satisfaction with treatment for overactive bladder symptoms. The OAB-SATq Satisfaction score ranges from 0 to 100 with higher scores indicating higher satisfaction.

  24. OAB-SATq-LF Side Effects Score

    Time frame: 3, 6, 9, and 12 Months

    The Overactive Bladder Satisfaction with Treatment Questionnaire is a standardized a measure of satisfaction with treatment for overactive bladder symptoms. The OAB-SATq Side Effect score ranges from 0 to 100 with higher scores indicating fewer side effects.

  25. OAB-SATq-LF Endorsement Score

    Time frame: 3, 6, 9, and 12 Months

    The Overactive Bladder Satisfaction with Treatment Questionnaire is a standardized a measure of satisfaction with treatment for overactive bladder symptoms. The OAB-SATq Endorsement score ranges from 0 to 100 with higher scores indicating greater endorsement.

  26. OAB-SATq-LF Convenience Score

    Time frame: 3, 6, 9, and 12 Months

    The Overactive Bladder Satisfaction with Treatment Questionnaire is a standardized a measure of satisfaction with treatment for overactive bladder symptoms. The OAB-SATq Convenience score ranges from 0 to 100 with higher scores indicating greater convenience.

  27. OAB-SAT-q Preference Indicator

    Time frame: 3, 6, 9, and 12 Months

    The Overactive Bladder Satisfaction with Treatment Questionnaire is a standardized a measure of satisfaction with treatment for overactive bladder symptoms. The preference score is a binary [yes/no] indicator as to whether a subject indicated slight or definite preference for the treatment among women that have had previous treatment for overactive bladder. The outcome is the percentage of participants that prefer the current treatment to previous treatments.

  28. PGI-I Score Binary Improvement Indicator

    Time frame: 3, 6, 9, and 12 Months

    The Patient Global Impression of Improvement (PGI-I) is a patient-reported measure of perceived improvement with treatment, as assessed on a scale of 1 (very much better) to 7 (very much worse). Included here are participants who had improvement as indicated by a rating of 1 (very much better), 2 (much better).

  29. PGI-S Score Binary Condition Severity Indicator

    Time frame: Baseline and 3, 6, 9, and 12 Months

    The Patient Global Impression of Severity (PGI-S) is a patient-reported measure of perceived severity of condition, as assessed on a scale of 1 (Normal) to 4 (Severe). Included here are participants who reported Normal or Mild severity as indicated by a rating of 1 or 2.

  30. PGSC Score Binary Improvement Indicator

    Time frame: 3, 6, 9, and 12 Months

    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).

  31. Change From Baseline PISQ-IR NSA-PR Score

    Time frame: 3, 6, 9, and 12 months

    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.

  32. Change From Baseline PISQ-IR NSA-CS Score

    Time frame: 3, 6, 9, and 12 months

    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.

  33. Change From Baseline PISQ-IR NSA-GQA Score

    Time frame: 3, 6, 9, and 12 months

    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.

  34. Change From Baseline PISQ-IR NSA-CI Score

    Time frame: 3, 6, 9, and 12 months

    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.

  35. Change From Baseline PISQ-IR SA-AO Score

    Time frame: 3, 6, 9, and 12 months

    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.

  36. Change From Baseline PISQ-IR SA-PR Score

    Time frame: 3, 6, 9, and 12 months

    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.

  37. Change From Baseline PISQ-IR SA-CS Score

    Time frame: 3, 6, 9, and 12 months

    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.

  38. Change From Baseline PISQ-IR SA-GQR Score

    Time frame: 3, 6, 9, and 12 months

    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.

  39. Change From Baseline PISQ-IR SA-CI Score

    Time frame: 3, 6, 9, and 12 months

    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.

  40. Change From Baseline PISQ-IR SA-D Score

    Time frame: 3, 6, 9, and 12 months

    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.

  41. Change From Baseline PISQ-IR SA Average Score

    Time frame: 3, 6, 9, and 12 months

    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.

  42. SF-36 Physical Functioning Score

    Time frame: 0.5 Months (2 Weeks) and 3, 6, 9, and 12 months

    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.

  43. SF-36 Role Physical Score

    Time frame: 0.5 Months (2 Weeks) and 3, 6, 9, and 12 months

    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.

  44. SF-36 Bodily Pain Score

    Time frame: 0.5 Months (2 Weeks) and 3, 6, 9, and 12 months

    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.

  45. SF-36 General Health Score

    Time frame: 0.5 Months (2 Weeks) and 3, 6, 9, and 12 months

    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.

  46. SF-36 Vitality Score

    Time frame: 0.5 Months (2 Weeks) and 3, 6, 9, and 12 months

    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.

  47. SF-36 Social Functioning Score

    Time frame: 0.5 Months (2 Weeks) and 3, 6, 9, and 12 months

    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.

  48. SF-36 Emotional Role Limitations Score

    Time frame: 0.5 Months (2 Weeks) and 3, 6, 9, and 12 months

    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.

  49. SF-36 Mental Health Score

    Time frame: 0.5 Months (2 Weeks) and 3, 6, 9, and 12 months

    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.

  50. SF-36 Physical Composite Score

    Time frame: 0.5 Months (2 Weeks) and 3, 6, 9, and 12 months

    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.

  51. SF-36 Mental Composite Score

    Time frame: 0.5 Months (2 Weeks) and 3, 6, 9, and 12 months

    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.

  52. Postvoid Residual Volume

    Time frame: Baseline, 3, 6, and 12 Months

    Postvoid Residual Volume

Sponsors and collaborators

Lead sponsor

NICHD Pelvic Floor Disorders Network

Network

Collaborators

  • Duke University
  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • Kaiser Permanente
  • RTI International
  • University of Alabama at Birmingham
  • University of California, San Diego
  • University of Pennsylvania
  • University of Pittsburgh
  • University of Texas Southwestern Medical Center
  • Women and Infants Hospital of Rhode Island

Registry information

Official study title

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

Acronym: MUSA

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Nov 21, 2019
Registry last updated
Jun 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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