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

NCT02678377 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2023-03-14

Study results available
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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.

Conditions

  • Mixed Urinary Incontinence
  • Stress Urinary Incontinence
  • Urgency Incontinence

Interventions

DRUG

OnabotulinumtoxinA (Botox ®) Injections

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

DRUG

Saline Injections

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

Sponsors & Collaborators

Principal Investigators

  • Kimberly Kenton, M.D. · Professor, Departments of Obstetrics and Gynecology, Urology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-02-29
Primary Completion
2021-07-26
Completion
2021-07-26

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02678377 on ClinicalTrials.gov