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Neurotoxin
Sling vs Botox for Urinary Incontinence (MUSA Trial)
Phase 3
Waitlist Available
Led By Heidi S Harvey, MD
Research Sponsored by NICHD Pelvic Floor Disorders Network
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Reporting at least 'moderate bother' from UUI item on UDI: 'Do you experience urine leakage associated with a feeling of urgency?'
Diagnosis of SUI defined by a positive cough stress test (CST) or UDE within the past 18 months
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months and 6 months
Awards & highlights
MUSA Trial Summary
This trial is testing whether Botox or a mid-urethral sling is more effective in treating MUI symptoms.
Who is the study for?
This trial is for women over 21 with mixed urinary incontinence, who've had symptoms for more than 3 months and haven't improved after trying conservative treatments or medications. They should be able to self-catheterize if needed, not pregnant, planning pregnancy soon, or recently post-partum. Women with certain neurological conditions or active pelvic cancer are excluded.Check my eligibility
What is being tested?
The study compares two treatments for mixed urinary incontinence: a mid-urethral sling procedure versus Botox injections into the bladder muscle. The main goal is to see which treatment better reduces symptoms after six months.See study design
What are the potential side effects?
Possible side effects of the Botox injection include difficulty urinating requiring catheterization, urinary tract infections, and blood in urine. The sling procedure may lead to pain at the incision site, bleeding complications, infection risk and potential need for reoperation.
MUSA Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
You report feeling bothered by leaking urine when you feel the need to go urgently.
Select...
You have been diagnosed with stress urinary incontinence (SUI) based on a positive cough stress test or urodynamic evaluation within the past 18 months.
Select...
You feel bothered by urine leakage when you do physical activities, cough, or sneeze.
Select...
You have been experiencing urinary symptoms for more than 3 months.
Select...
You still have symptoms even after trying different treatments recommended by your doctor.
Select...
You have not responded well to oral medications for overactive bladder, unless you cannot tolerate them or your doctor says you shouldn't take them.
Select...
You have had a test to check your bladder function in the past 18 months.
MUSA Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 months and 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months and 6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Urogenital Distress Inventory (UDI) Total Score at 6 Months
Secondary outcome measures
Change in Urogenital Distress Inventory (UDI) Irritative Sub-Score at 12 Months
Change in Urogenital Distress Inventory (UDI) Irritative Sub-Score at 6 Months
Change in Urogenital Distress Inventory (UDI) Stress Subscore at 12 Months
+3 moreOther outcome measures
Change from baseline Total Number of Incontinence Episodes
Change in Overactive Bladder Satisfaction with Treatment Questionnaire (OAB-SATq) Satisfaction Score
European Quality of Life-5 Dimensions (EQ-5D) Index Score
+11 moreMUSA Trial Design
2Treatment groups
Active Control
Group I: Botox A® injectionActive Control1 Intervention
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.
Group II: Mid-urethral slingActive Control1 Intervention
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.
Find a Location
Who is running the clinical trial?
University of Texas Southwestern Medical CenterOTHER
1,047 Previous Clinical Trials
1,053,649 Total Patients Enrolled
NICHD Pelvic Floor Disorders NetworkLead Sponsor
13 Previous Clinical Trials
4,145 Total Patients Enrolled
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
1,964 Previous Clinical Trials
2,674,580 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have cancer in your pelvic organs that is currently growing.You are younger than 21 years old.You are scheduled to have surgery for a certain type of prolapse in the vaginal area.Women who have had Botox injected into their bladder in the past year.Women who are having their uterus removed for any reason.You have been diagnosed with stress urinary incontinence (SUI) based on a positive cough stress test or urodynamic evaluation within the past 18 months.You have a serious spinal cord injury or advanced neurological conditions like Multiple Sclerosis, Parkinson's, Myasthenia Gravis, or Charcot-Marie-Tooth disease.You are unable to walk.You have been diagnosed with or have a history of bladder pain or chronic pelvic pain.Women who have had surgery to fix a certain type of pelvic organ prolapse in the last 6 months.You report feeling bothered by leaking urine when you feel the need to go urgently.You have a certain type of pelvic organ prolapse that extends beyond a specific point, even if you don't have symptoms.You have had trouble emptying your bladder completely, or you are currently using a catheter.You have not been checked for blood in your urine.You feel bothered by urine leakage when you do physical activities, cough, or sneeze.You have had surgery for urinary incontinence or prolapse using certain types of materials.You have urinary urgency and frequency based on a bladder diary.You have been experiencing urinary symptoms for more than 3 months.You still have symptoms even after trying different treatments recommended by your doctor.You have not responded well to oral medications for overactive bladder, unless you cannot tolerate them or your doctor says you shouldn't take them.You have had a test to check your bladder function in the past 18 months.
Research Study Groups:
This trial has the following groups:- Group 1: Botox A® injection
- Group 2: Mid-urethral sling
Awards:
This trial has 3 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
At how many different hospitals is this medical study being run today?
"Currently, there are 8 active sites for this trial; however, the locations of these centres (e.g. Birmingham, Providence, Philadelphia) may be far from where potential patients live. It is worth considering enrolling at a site that is close to your residences to limit travel difficulty and demands."
Answered by AI
How many people have signed up for this research project?
"That is correct. The clinical trial was originally posted on 6/8/2020 and is still recruiting patients. Last edited on 8/10/2022, the study needs a total of 146 subjects from 8 different sites."
Answered by AI
Are there many published papers on Botox A® injection?
"Botox A® was first trialled in 2012 at Rothman Institute. As of now, 459 clinical trials have completed with Botox A®, 68 of which are still recruiting patients. Many of these active studies are based in Birmingham, Alabama."
Answered by AI
Has the FDA okayed Botox A® as a therapeutic injection?
"There is some clinical data supporting Botox A®'s efficacy and multiple rounds of safety trials have been completed, so it received a score of 3."
Answered by AI
What are patients most often using Botox A® injections for?
"Botox A® injection is most often used to treat urinary incontinence. Other potential conditions that this medication can help alleviate include spinal cord, botox, and overactive bladder syndrome (oabs)."
Answered by AI
Are people still able to sign up for this experiment?
"The trial is still active and presently looking for participants. According to the information found on clinicaltrials.gov, the trial was originally posted on 6/8/2020, with the most recent edit taking place on 8/10/2022."
Answered by AI
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