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Completed

NCT Number: NCT02678377

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

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.

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Key information

Conditions

Mixed Urinary Incontinence Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Stress Urinary Incontinence Urgency Incontinence Urinary Incontinence Urinary Incontinence, Stress Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Northwestern Medicine Integrated Pelvic Health Clinic

Chicago, Illinois, 60611, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Undergoing mid-urethral sling surgery
  • Have symptoms of both stress and urgency urinary incontinence
  • Able to consent, fill out study documents, and complete all study procedures and follow-up visits
  • At least 18 years of age
  • English speaking
  • Be able and willing to learn clean intermittent self catheterization technique

Exclusion criteria

  • History of recurrent UTI (defined as three culture proven UTIs within last 12 months)
  • Systemic neuromuscular disease known to affect the lower urinary tract
  • Undergoing concomitant prolapse surgery
  • Previous incontinence surgery
  • Treatment with anticholinergic medication in the last 2 months
  • Previous bladder injection with onabotulinumtoxinA
  • Prisoner Status
  • Pregnancy

Treatment and study plan

OnabotulinumtoxinA (Botox ®) Injections

Drug

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

Other names: Botox ®

Saline Injections

Drug

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

Primary outcomes

  1. Number of Participants With Self-reported Mixed Urinary Incontinence Symptoms

    Time frame: 3 months after surgery

    Mixed urinary incontinence symptoms will be assessed by the Patient Global Assessment of Improvement (PGI-I) survey, a patient oriented outcome

Secondary outcomes

  1. Incontinence Episode Frequency

    Time frame: 3 months after surgery

    Incontinence episode frequency will be assessed by a self-report 3-day urinary diary completed by the subject

  2. Urinary Incontinence Symptoms and Quality of Life

    Time frame: 3 months after surgery

    Urinary incontinence symptoms and quality of life will be assessed by a satisfaction survey completed by the subject. The scale is 0-100. and higher scores indicate worse outcomes.

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Collaborators

  • Friends of Prentice

Registry information

Important dates

Study start
2016
Primary completion
2021
Study completion
2021
First posted
Feb 9, 2016
Registry last updated
Mar 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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