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

NCT02678377 | Completed Phase 4 Results

• 1 other identifier: STU00201249
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Self-reported Mixed Urinary Incontinence Symptoms

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

  3 months after surgery

Secondary Outcomes (2)

• Incontinence Episode Frequency

  3 months after surgery

• Urinary Incontinence Symptoms and Quality of Life

  3 months after surgery

Study Arms (2)

OnabotulinumtoxinA injections

ACTIVE COMPARATOR

100 units of OnabotulinumtoxinA (Botox®) injected into the detrusor (large muscle of the bladder) at the time of sling surgery.

Drug: OnabotulinumtoxinA (Botox ®) Injections

Saline injections

SHAM COMPARATOR

100 units of saline injected into the detrusor (large muscle of the bladder) at the time of sling surgery.

Drug: Saline Injections

Interventions

OnabotulinumtoxinA (Botox ®) Injections DRUG

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

Also known as: Botox ®

OnabotulinumtoxinA injections

Saline Injections DRUG

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

Saline injections

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Northwestern University: lead
• Friends of Prentice: collaborator

Study Sites (1)

Northwestern Medicine Integrated Pelvic Health Clinic

Chicago, Illinois, 60611, United States

Location

Related Publications (1)

• Komar A, Bretschneider CE, Mueller MG, Lewicky-Gaupp C, Collins S, Geynisman-Tan J, Tavathia M, Kenton K. Concurrent Retropubic Midurethral Sling and OnabotulinumtoxinA for Mixed Urinary Incontinence: A Randomized Controlled Trial. Obstet Gynecol. 2021 Jan 1;137(1):12-20. doi: 10.1097/AOG.0000000000004198.

  PMID: 33278293 RESULT

MeSH Terms

Conditions

Urinary Incontinence, Stress

Interventions

Botulinum Toxins, Type A; Injections

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors; Drug Administration Routes; Drug Therapy; Therapeutics

Results Point of Contact

• Title: Dr. Kimberly Kenton
• Organization: Northwestern University

kkenton@nm.org

3124723874

Study Officials

• Kimberly Kenton, M.D.

  Professor, Departments of Obstetrics and Gynecology, Urology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Departments of Obstetrics and Gynecology, Urology

Study Record Dates

• First Submitted: February 5, 2016
• First Posted: February 9, 2016
• Study Start: February 1, 2016
• Primary Completion: July 26, 2021
• Study Completion: July 26, 2021
• Last Updated: March 14, 2023
• Results First Posted: March 14, 2023

Record last verified: 2023-02

Locations

US (1)