Purpose

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.

Conditions

Eligibility

Eligible Ages
Over 21 Years
Eligible Genders
Female
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention 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.
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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.
  • Drug: Botox® injection
    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.
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.
  • Device: Mid-urethral sling
    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.

Recruiting Locations

University of Alabama at Birmingham, Department of Obstetrics and Gynecology
Birmingham, Alabama 35249
Contact:
Holly Richter, PhD, MD
205-934-1704
hrichter@uabmc.edu

More Details

Status
Recruiting
Sponsor
NICHD Pelvic Floor Disorders Network

Study Contact

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 objectives include identifying predictors of treatment failure and cost-effectiveness of treatments in this MUI population. 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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.