Summary

Eligibility
for females ages 21 years and up (full criteria)
Location
at La Jolla, California and other locations
Dates
study started
estimated completion
Principal Investigator
by Emily Lukacz, MD

Description

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.

Official Title

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

Details

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.

Keywords

Urinary Incontinence, Stress Urinary Incontinence, Urge urinary incontinence midurethral sling Botulinum toxin A (Botox A ®) Enuresis Botox® injection Mid-urethral sling Botox A® injection

Eligibility

You can join if…

Open to females ages 21 years and up

  1. Reporting at least "moderate bother" from UUI item on UDI
  2. "Do you experience urine leakage associated with a feeling of urgency?"
  3. Reporting at least "moderate bother" from SUI item on UDI
  4. "Do you experience urine leakage related to physical activity, coughing, or sneezing?"
  5. Diagnosis of SUI defined by a positive cough stress test (CST) or UDE within the past 18 months
  6. Presence of UUI on bladder diary with > 4 Urgency IE/3-day diary
  7. Urinary symptoms >3 months
  8. Persistent symptoms despite at least one or more conservative treatments (e.g. supervised behavioral therapy, physical therapy) as determined adequate by the physician.
  9. Inadequate response to oral overactive bladder medications (including anti-cholinergic and/or beta-mimetic medication) unless patient is
  10. intolerant of oral overactive bladder medications, or
  11. oral overactive bladder medications are contraindicated as determined by the treating provider.
  12. Urodynamics within past 18 months
  13. Demonstrates ability (or have caregiver demonstrate ability) to perform clean intermittent self-catheterization.

You CAN'T join if...

  1. Anterior or apical compartment prolapse at or beyond the hymen (>0 on POPQ), regardless if patient is symptomatic
  2. Women with anterior or apical prolapse above the hymen (<0) who do not report vaginal bulge symptoms will be eligible
  3. Planned concomitant surgery for anterior vaginal wall or apical prolapse > 0
  4. Women undergoing only rectocele repair or other repair unrelated to anterior or apical compartment are eligible
  5. Women undergoing hysterectomy for any indication will be excluded
  6. Active pelvic organ malignancy
  7. Age <21 years
  8. Pregnant or plans for future pregnancy in next 6 months, or within 12 months post-partum
  9. Post-void residual >150 cc on 2 occasions within the past 6 months, or current catheter use
  10. Participation in other trial that may influence results of this study
  11. Unevaluated hematuria
  12. . Prior sling, synthetic mesh for prolapse, implanted nerve stimulator for urinary incontinence
  13. . Spinal cord injury or advanced/severe neurologic conditions including Multiple Sclerosis, Parkinsons, Myasthenia Gravis, Charcot-Marie-Tooth
  14. . Women on overactive bladder medication/therapy will be eligible after 3 week wash-out period
  15. . Non-ambulatory
  16. . History of serious adverse reaction to synthetic mesh
  17. . Not able to complete study assessments per clinician judgment, or not available for 6 month follow-up
  18. . Diagnosis of and/or history of bladder pain or chronic pelvic pain
  19. . Women who had intravesical Botox injection within the past 12 months
  20. . Women who have undergone anterior or apical pelvic organ prolapse repair within the past 6 months

Locations

  • University of California at San Diego accepting new patients
    La Jolla California 92037-0974 United States
  • Kaiser Permanente accepting new patients
    San Diego California 92110 United States

Lead Scientist at UCSD

  • Emily Lukacz, MD
    Professor, Obstetrics and Gynecology. Authored (or co-authored) 99 research publications.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
NICHD Pelvic Floor Disorders Network
ID
NCT04171531
Phase
Phase 3
Study Type
Interventional
Last Updated