Sling vs Botox for Mixed Incontinence

Completed · Phase 3

Conditions studied: Urinary Incontinence, Stress, Urinary Incontinence, Urge

In brief

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.

Key facts

Study ID

NCT04171531

Run by

NICHD Pelvic Floor Disorders Network

People needed

150

Starts

2020-06-08

Expected to finish

2024-02-12

Last updated by the study team

2025-06-03

Who can join

Age: 21 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• University of Alabama at Birmingham, Department of Obstetrics and Gynecology — Birmingham, Alabama, United States
• University of California at San Diego — La Jolla, California, United States
• Kaiser Permanente — San Diego, California, United States
• Duke University, Duke Division of Urogynecology and Reconstructive Pelvic Surgery — Durham, North Carolina, United States
• University of Pennsylvania — Philadelphia, Pennsylvania, United States
• Magee-Women's Hospital, Department of Obstetrics and Gynecology — Pittsburgh, Pennsylvania, United States
• Brown/ Women and Infants Hospital of Rhode Island, Center for Women's Pelvic Medicine and Reconstructive Surgery — Providence, Rhode Island, United States
• University of Texas Southwestern Medical Center — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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