CompletedPhase 3

Sling vs Botox for Mixed Incontinence

United States150 participantsStarted 2020-06-08

Plain-language 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.

Who can participate

Age range21 Years

SexFEMALE

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Inclusion criteria

✓. Reporting at least "moderate bother" from UUI item on UDI
✓. Reporting at least "moderate bother" from SUI item on UDI
✓. 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

Exclusion criteria

✕. Anterior or apical compartment prolapse at or beyond the hymen (\>0 on POPQ), regardless if patient is symptomatic
✕. Planned concomitant surgery for anterior vaginal wall or apical prolapse \> 0
✕. 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

What they're measuring

UDI-LF Total Score Change From Baseline

Timeframe: 3, 6, 9, and 12 Months

Trial details

NCT IDNCT04171531

SponsorNICHD Pelvic Floor Disorders Network

Sponsor typeNETWORK

Study typeINTERVENTIONAL

Primary completion2024-02-12

Results submitted2025-02-12

View on ClinicalTrials.gov More Urinary Incontinence, Stress trials