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Trial · Interventional

CompletedPhase 3Results postedRegistry data

Sling vs Botox for Mixed Incontinence

Short name MUSA

NCTNCT04171531 (opens ClinicalTrials.gov in a new tab)Other idPFDN-31P01Other idU24HD069031-06Other idUG1HD069013-06Other idUG1HD041267-18

This trial does not test a peptide that PepBank tracks.

  • Names Methylene blue, does not test it. It appears in the description.

Overview

Status
Completed
Phase
Phase 3
Enrollment
150 participants (actual)
Sponsor
NICHD Pelvic Floor Disorders Network · Network
Design
Randomized · Open label (no masking)
Countries
1 country

United States

Start
8 Jun 2020
Primary completion
12 Feb 2024
Completion
12 Feb 2024
First posted
21 Nov 2019
Last update posted
3 Jun 2025
Conditions
Urinary Incontinence, Stress · Urinary Incontinence, Urge

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
202020212022202320242025
  1. Ph 3

    MUSA

    NCT04171531

    8 Jun 2020 to 12 Feb 2024

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • Botox® injectionDrug
  • Mid-urethral slingDevice

Arms2

  • Active comparator

    Botox A® injection

    A dose of 100 units of Botulinum toxin A will be injected into the bladder. Follow up visits at 2 weeks, 3 and 6 months post intervention to collect clinical and patient-reported outcomes.

  • Active comparator

    Mid-urethral sling

    Mid-urethral Sling Procedure includes retropubic as well as transobturator full length slings. Follow up visits at 2 weeks, 3 and 6 months post intervention to collect clinical and patient-reported outcomes.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. UDI-LF Total Score Change From Baseline

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

    Registry description

    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(2)
  1. UDI-LF Stress Score Change From Baseline

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

    Registry description

    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

    Registry description

    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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· 3, 6, 9, and 12 Months

UDI-LF Total Score Change From Baseline

GroupValue (units on a scale)
Botox A-82.2
Mid-Urethral Sling-84.6
Secondary and other outcome results(7)
Secondary outcomeMean· 3, 6, 9, and 12 Months

UDI-LF Stress Score Change From Baseline

GroupValue (units on a scale)
Botox A-27.9
Mid-Urethral Sling-46.4
Secondary outcomeMean· 3, 6, 9, and 12 Months

UDI-LF Irritative Score Change From Baseline

GroupValue (units on a scale)
Botox A-40.8
Mid-Urethral Sling-28.1
Other pre specified outcomeMean· 3, 6, 9, and 12 Months

UDI-LF Obstructive Score Change From Baseline

GroupValue (units on a scale)
Botox A-13.5
Mid-Urethral Sling-10.1
Other pre specified outcomeMean· 3, 6, and 12 Months

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

GroupValue (incontinence episodes/day)
Botox A-0.4
Mid-Urethral Sling-0.4
Other pre specified outcomeMean· 3, 6, and 12 Months

Average Daily Frequency of All Incontinence Epsiodes Change From Baseline

GroupValue (incontinence episodes/day)
Botox A-4
Mid-Urethral Sling-3.9
Other pre specified outcomeMean· 3, 6, and 12 Months

Average Daily Frequency of Diurnal Voids Change From Baseline

GroupValue (diurnal voids/day)
Botox A-1.2
Mid-Urethral Sling0
Other pre specified outcomeMean· 3, 6, and 12 Months

Average Daily Frequency of Nocturnal Voids Change From Baseline

GroupValue (nocturnal voids/day)
Botox A-0.5
Mid-Urethral Sling-0.5

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Botox AUp to 2 administrations of Botulinum Toxin A0 / 713 / 7140 / 71
Mid-Urethral SlingMid-Urethral Sling for treatment of urinary incont0 / 698 / 6941 / 69

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

  • DerivedHarvie HS, Menefee SA, Richter HE, Sung VW, Chermansky CJ, Rahn DD, Amundsen CL, Arya LA, Rhodes E, Mazloomdoost D, Thomas S; National Institute of Child Health and Human Development Pelvic Floor Disorders Network. Midurethral Sling vs OnabotulinumtoxinA in Females With Urinary Incontinence: The MUSA Randomized Clinical Trial. JAMA. 2025 Jun 3;333(21):1887-1896. doi: 10.1001/jama.2025.4682. PMID 40323617
  • DerivedHarvie HS, Richter HE, Sung VW, Chermansky CJ, Menefee SA, Rahn DD, Amundsen CL, Arya LA, Huitema C, Mazloomdoost D, Thomas S; NICHD Pelvic Floor Disorders Network. Trial Design for Mixed Urinary Incontinence: Midurethral Sling Versus Botulinum Toxin A. Urogynecology (Phila). 2024 May 1;30(5):478-488. doi: 10.1097/SPV.0000000000001422. Epub 2024 Jan 11. PMID 38212101
  • DerivedHarvie HS, Sung VW, Neuwahl SJ, Honeycutt AA, Meyer I, Chermansky CJ, Menefee S, Hendrickson WK, Dunivan GC, Mazloomdoost D, Bass SJ, Gantz MG; Eunice Kennedy Shriver National Institute of Child Health and Human Development Pelvic Floor Disorders Network. Cost-effectiveness of behavioral and pelvic floor muscle therapy combined with midurethral sling surgery vs surgery alone among women with mixed urinary incontinence: results of the Effects of Surgical Treatment Enhanced With Exercise for Mixed Urinary Incontinence randomized trial. Am J Obstet Gynecol. 2021 Dec;225(6):651.e1-651.e26. doi: 10.1016/j.ajog.2021.06.099. Epub 2021 Jul 6. PMID 34242627

Eligibility

Who could join, as posted.

Sex
Female
Age
from 21 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: 1. Reporting at least "moderate bother" from UUI item on UDI \* "Do you experience urine leakage associated with a feeling of urgency?" 2. Reporting at least "moderate bother" from SUI item on UDI \* "Do you experience urine leakage related to physical activity, coughing, or sneezing?" 3. Diagnosis of SUI defined by a positive cough stress test (CST) or UDE within the past 18 months 4. Presence of UUI on bladder diary with \> 4 Urgency IE/3-day diary 5. Urinary symptoms \>3 months 6. Persistent symptoms despite at least one or more conservative treatments (e.g. supervised behavioral therapy, physical therapy) as determined adequate by the physician. 7. Inadequate response to oral overactive bladder medications (including anti-cholinergic and/or beta-mimetic medication) unless patient is 1. intolerant of oral overactive bladder medications, or 2. oral overactive bladder medications are contraindicated as determined by the treating provider. 8. Urodynamics within past 18 months 9. Demonstrates ability (or have caregiver demonstrate ability) to perform clean intermittent self-catheterization. Exclusion Criteria: 1. Anterior or apical compartment prolapse at or beyond the hymen (\>0 on POPQ), regardless if patient is symptomatic \* Women with anterior or apical prolapse above the hymen (\<0) who do not report vaginal bulge symptoms will be eligible 2. Planned concomitant surgery for anterior vaginal wall or apical prolapse \> 0 \* Women undergoing only rectocele repair or other repair unrelated to anterior or apical compartment are eligible 3. Women undergoing hysterectomy for any indication will be excluded 4. Active pelvic organ malignancy 5. Age \<21 years 6. Pregnant or plans for future pregnancy in next 6 months, or within 12 months post-partum 7. Post-void residual \>150 cc on 2 occasions within the past 6 months, or current catheter use 8. Participation in other trial that may influence results of this study 9. Unevaluated hematuria 10. Prior sling, synthetic mesh for prolapse, implanted nerve stimulator for urinary incontinence 11. Spinal cord injury or advanced/severe neurologic conditions including Multiple Sclerosis, Parkinsons, Myasthenia Gravis, Charcot-Marie-Tooth 12. Women on overactive bladder medication/therapy will be eligible after 3 week wash-out period 13. Non-ambulatory 14. History of serious adverse reaction to synthetic mesh 15. Not able to complete study assessments per clinician judgment, or not available for 6 month follow-up 16. Diagnosis of and/or history of bladder pain or chronic pelvic pain 17. Women who had intravesical Botox injection within the past 12 months 18. Women who have undergone anterior or apical pelvic organ prolapse repair within the past 6 months

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