Sling vs Botox for Mixed Incontinence

  • STATUS
    Recruiting
  • End date
    Nov 7, 2022
  • participants needed
    146
  • sponsor
    NICHD Pelvic Floor Disorders Network
Updated on 7 July 2021
conservative management
cough
botox
incontinence
behavior modification
urinary symptoms
overactive bladder
stress test
bladder diary
leakage of urine

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.

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.

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.

Details
Condition stress urinary incontinence, Urge Incontinence, Stress incontinence
Treatment Botox® injection, Mid-urethral sling
Clinical Study IdentifierNCT04171531
SponsorNICHD Pelvic Floor Disorders Network
Last Modified on7 July 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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
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

Exclusion Criteria

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
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
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