NCT04984317

Feasibility of BOTOX Injection on Improving Female Stress Urinary Incontinence

Feasibility of Onabotulinumtoxin A Injection on Improving Female Stress Urinary Incontinence

• Status: Suspended
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Northwell Health · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to assess the effect of onabotulinumtoxin A (BOTOX) injection into the detrusor muscle on increasing bladder compliance to reduce urinary leakage in women suffering from stress urinary incontinence (SUI).

Detailed description

The study involves a single-time injection of 100 units of onabotulinumtoxin A into the detrusor muscle of the bladder. Cystoscopy, which is the insertion of a scope with a small camera inside a tube into the participant's urethra. Then the doctor fills the participant's bladder with water or saline and sees detailed images of the injection site in the bladder while administrating the injection.

Conditions

• Stress Urinary Incontinence

Interventions

Type	Name	Description
DRUG	onabotulinumtoxin A	One-time injection of 100U BOTOX

Timeline

• Start date: 2022-02-14
• Primary completion: 2026-12-01
• Completion: 2027-08-01
• First posted: 2021-07-30
• Last updated: 2026-01-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study