CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 100 enrolled
Drug / intervention
OnabotulinumtoxinA (Botox ®) Injections +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02678377
NCT02678377Phase 4Completed

The SLIM Study: Sling and Botox® Injection for Mixed Urinary Incontinence

Northwestern University·interventional·Posted Feb 9, 2016·Updated Mar 14, 2023

In Brief

A Phase 4 clinical trial evaluating OnabotulinumtoxinA (Botox ®) Injections and Saline Injections for Mixed Urinary Incontinence and 2 related conditions. Completed, enrolled 100 participants across 1 site.

Detailed Summary

This double-blind randomized controlled trial seeks to find a better treatment for women with mixed urinary incontinence (both stress and urgency incontinence). The primary aim is to determine whether midurethral sling surgery combined with injections of onabotulinumtoxinA (Botox®) into the detrusor muscle of the bladder improves symptoms of mixed urinary incontinence better than sling surgery alone.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsFriends of Prentice

Timeline

Phase 4CompletedFinished
20162017201820192020202120222023202420252026
First PostedFeb 9, 2016
Enrollment StartFeb 1, 2016
Primary CompletionJul 26, 2021
TodayJul 2, 2026
Enrollment to primary: 5.5 yearsPosted 10.4 years ago

Interventions

OnabotulinumtoxinA (Botox ®) Injectionsdrug

OnabotulinumtoxinA (Botox ®) is a neurotoxin, which inhibits acetylcholine release and temporarily relaxes the bladder muscle to inhibit urgency incontinence.

Saline Injectionsdrug

Saline will be injected into the bladder so that investigators are masked to subject randomization.