Urinary Incontinence, StressPhase 3MUSANCT04171531
Sling vs Botox for Mixed Incontinence
A Phase 3 study testing Botox® injection and Mid-urethral sling in people with Urinary Incontinence, Stress and Urinary Incontinence, Urge, run by NICHD Pelvic Floor Disorders Network at 8 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 21 years and older, women only
- Conditions the study is for
- Urinary Incontinence, Stress, Urinary Incontinence, Urge
- What is being tested?
- Botox® injection and Mid-urethral sling
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 8 sitesUnited States
- Study dates
- 8 Jun 2020to 12 Feb 2024
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 13Show fewer
- 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.
Who cannot join
- 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
Show all 20Show fewer
- 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
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
University of Alabama at Birmingham, Department of Obstetrics and Gynecology
Birmingham, Alabama, 35249
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
Duke University, Duke Division of Urogynecology and Reconstructive Pelvic Surgery
Durham, North Carolina, 27707
University of California at San Diego
La Jolla, California, 92037-0974
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Magee-Women's Hospital, Department of Obstetrics and Gynecology
Pittsburgh, Pennsylvania, 15213
Brown/ Women and Infants Hospital of Rhode Island, Center for Women's Pelvic Medicine and Reconstructive Surgery
Providence, Rhode Island, 02903
Kaiser Permanente
San Diego, California, 92110
About this study
Official title: Treatment for Mixed Urinary Incontinence: Mid-urethral Sling vs. Botox A
The primary aim is to compare the effectiveness of intradetrusor injection of 100 unit injection of Botulinum toxin A to mid-urethral sling for change in MUI symptoms 6 months following treatment.
Read the detailed description
Mixed urinary incontinence (MUI), defined as the presence of both stress urinary incontinence (SUI) and urgency urinary incontinence (UUI), is a challenging condition for which clinicians frequently use multiple sequential treatments that have undergone limited evaluation in rigorous clinical trials. The Mixed Urinary Incontinence: Mid-urethral Sling vs. Botox A (MUSA) trial will estimate the effect of Botulinum toxin A (Botox A ®) compared to mid-urethral sling for the treatment of MUI symptoms in 146 women. MUSA is a randomized 2-arm clinical trial.
The purpose of MUSA is to:
- compare treatment with either Botulinum toxin A (Botox A ®) or mid-urethral sling for women with MUI
- characterize patient characteristics associated with treatment response
The primary objective is to estimate the effect of intradetrusor injections Botulinum toxin A (Botox A ®) compared to mid-urethral sling for treatment of MUI in 146 women 6 months after treatment. The change in severity of MUI symptoms will be measured using the Urogenital Distress Inventory.
Secondary outcomes include:
- Urogenital Distress Inventory Stress and Irritative subscales
Other outcomes include:
- Urogenital Distress Inventory Obstructive subscale
- Patient bladder diary metrics including numbers of daily incontinence episodes and voids and voiding frequency
- Other patient reported outcomes/validated instruments and associated scales and subscales: EQ-5D, IIQ-LF, OABq-LF, OAB-SATq, PISQ-IR, PGI-I, PGI-S, PGSC, and SF-36
- Physical measures of effectiveness: Postvoid Residual Volume
The study will continue with an additional 6 month observational period until 12 months post treatment.
A supplemental study will characterize baseline putative proteins/protein pathways in women with MUI associated with change in UDI after treatment with MUS or onabotulinum toxin A. Those results are not reported with this record.
- Being tested
- Botox® injection, Mid-urethral sling
- Keywords
- urinary incontinence, midurethral sling, Botulinum toxin A (Botox A ®)
- Medical subject headings
- Urinary Incontinence, Stress, Urinary Incontinence, Urge, Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Botox® injectionDrug
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 slingDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Botox A® injection | Active comparator | 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. Receives: Drug: Botox® injection |
| Mid-urethral sling | Active comparator | 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. Receives: Device: Mid-urethral sling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3, 6, 9, and 12 Months
Secondary outcomes (2)
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.
Measured: 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.
Measured: 3, 6, 9, and 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2019
- Study start8 Jun 2020
- Primary completion12 Feb 2024
- Study completion12 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Urinary Incontinence, StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- At 6 months, the effect of treatment with Botox A or mid-urethral sling will be evaluated within a classic RCT model. The analysis will determine the effect of treatment on the primary outcome, change in Urogenital Distress Inventory (UDI) score at 6 months.
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- NICHD Pelvic Floor Disorders Network
- Sponsor type
- Research network
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Women and Infants Hospital of Rhode Island, Duke University, University of Pennsylvania, University of Pittsburgh, University of California, San Diego, Kaiser Permanente, University of Texas Southwestern Medical Center, University of Alabama at Birmingham, RTI International
- Responsible party
- Sponsor
- Investigators
- Heidi S Harvey, MD, Principal investigator, University of PennsylvaniaMarie Gantz, PhD, Principal investigator, RTI International
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04171531
- Sponsor's protocol ID
- PFDN-31P01
- Other IDs
- U24HD069031-06, UG1HD069013-06, UG1HD041267-18, UG1HD069010-07, UG1HD069006-07, UG1HD041261-17, UG1HD054214-12, UG1HD054241-12
- Acronym
- MUSA
- Status last verified
- May 2025
- First submitted
- 18 Nov 2019
- Last updated
- 3 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Harvie 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.
PubMed 40323617Harvie 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.
PubMed 38212101Harvie 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.
PubMed 34242627
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment for Mixed Urinary Incontinence: Mid-urethral Sling vs. Botox A
- ClinicalTrials.gov ID
- NCT04171531
- Acronym / sponsor ID
- MUSA / PFDN-31P01
- Keywords
- urinary incontinence, midurethral sling, Botulinum toxin A (Botox A ®)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- NICHD Pelvic Floor Disorders NetworkResearch network
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Women and Infants Hospital of Rhode Island, Duke University, University of Pennsylvania, University of Pittsburgh, University of California, San Diego, Kaiser Permanente, University of Texas Southwestern Medical Center, University of Alabama at Birmingham, RTI International
- Study start
- 8 Jun 2020 (actual)
- Primary completion
- 12 Feb 2024 (actual)
- Study completion
- 12 Feb 2024 (actual)
- First posted
- 21 Nov 2019 (actual)
- Results
- Posted 20 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Mixed urinary incontinence (MUI), defined as the presence of both stress urinary incontinence (SUI) and urgency urinary incontinence (UUI), is a challenging condition for which clinicians frequently use multiple sequential treatments that have undergone limited evaluation in rigorous clinical trials. The Mixed Urinary Incontinence: Mid-urethral Sling vs. Botox A (MUSA) trial will estimate the effect of Botulinum toxin A (Botox A ®) compared to mid-urethral sling for the treatment of MUI symptoms in 146 women. MUSA is a randomized 2-arm clinical trial.
The purpose of MUSA is to:
- compare treatment with either Botulinum toxin A (Botox A ®) or mid-urethral sling for women with MUI
- characterize patient characteristics associated with treatment response
The primary objective is to estimate the effect of intradetrusor injections Botulinum toxin A (Botox A ®) compared to mid-urethral sling for treatment of MUI in 146 women 6 months after treatment. The change in severity of MUI symptoms will be measured using the Urogenital Distress Inventory.
Secondary outcomes include:
- Urogenital Distress Inventory Stress and Irritative subscales
Other outcomes include:
- Urogenital Distress Inventory Obstructive subscale
- Patient bladder diary metrics including numbers of daily incontinence episodes and voids and voiding frequency
- Other patient reported outcomes/validated instruments and associated scales and subscales: EQ-5D, IIQ-LF, OABq-LF, OAB-SATq, PISQ-IR, PGI-I, PGI-S, PGSC, and SF-36
- Physical measures of effectiveness: Postvoid Residual Volume
The study will continue with an additional 6 month observational period until 12 months post treatment.
A supplemental study will characterize baseline putative proteins/protein pathways in women with MUI associated with change in UDI after treatment with MUS or onabotulinum toxin A. Those results are not reported with this record.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- At 6 months, the effect of treatment with Botox A or mid-urethral sling will be evaluated within a classic RCT model. The analysis will determine the effect of treatment on the primary outcome, change in Urogenital Distress Inventory (UDI) score at 6 months.
| Arm | Type | Receives |
|---|---|---|
| Botox A® injection | Active comparator | Drug: Botox® injectionA 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. |
| Mid-urethral sling | Active comparator | Device: Mid-urethral slingMid-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. |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Reporting at least "moderate bother" from UUI item on UDI
- Reporting at least "moderate bother" from SUI item on UDI
- 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
Key exclusion criteria (20 listed)
- Anterior or apical compartment prolapse at or beyond the hymen (>0 on POPQ), regardless if patient is symptomatic
- Planned concomitant surgery for anterior vaginal wall or apical prolapse > 0
- Women undergoing hysterectomy for any indication will be excluded
- Active pelvic organ malignancy
- Age <21 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Botox® injectionBotulinum 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. | Drug | Botox A® injection |
| Mid-urethral slingMid-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. | Device | Mid-urethral sling |
Primary outcome
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.
2 secondary outcomes
UDI-LF Stress Score Change From Baseline
Time frame: 3, 6, 9, and 12 Months
UDI-LF Irritative Score Change From Baseline
Time frame: 3, 6, 9, and 12 Months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40323617Harvie 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.
- Derived from this study: PubMed 38212101Harvie 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.
- Derived from this study: PubMed 34242627Harvie 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heidi S Harvey, MD principal investigator
University of Pennsylvania
Marie Gantz, PhD principal investigator
RTI International
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Botox® injection and Mid-urethral sling in people with Urinary Incontinence, Stress and Urinary Incontinence, Urge, run by NICHD Pelvic Floor Disorders Network at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
UDI-LF Total Score Change From Baseline (time frame: 3, 6, 9, and 12 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04171531, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2025.