Feasibility of BOTOX Injection on Improving Female Stress Urinary Incontinence

NCT ID: NCT04984317

Last Updated: 2026-01-26

Basic Information

• Recruitment Status: SUSPENDED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-14
• Study Completion Date: 2027-08-31

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Botox Injection

One-time injection of 100U BOTOX (onabotulinumtoxin A) into the fundus of the bladder under direct visualization via cystoscopy.

Group Type: EXPERIMENTAL

onabotulinumtoxin A

Intervention Type: DRUG

One-time injection of 100U BOTOX

Interventions

onabotulinumtoxin A

One-time injection of 100U BOTOX

Intervention Type: DRUG

Other Intervention Names

BOTOX

Eligibility Criteria

Inclusion Criteria

• Must be female sex and at least 18 years of age.
• Must be willing and able to complete all procedures and follow-up visits indicated in the protocol.
• Must have confirmed stress urinary incontinence (SUI) through urodynamic studies.
• Must have failed two non-invasive incontinence therapies (such as behavior modification, Kegel exercises, etc) for > 3 months.

Exclusion Criteria

• Currently suffering from active urogenital infection.
• Has incontinence due to neurogenic causes (such as multiple sclerosis, cerebrovascular accident, spinal cord/brain injury, Parkinson Disease, detrusor-external sphincter dyssynergia, or similar conditions).
• Having concomitant pelvic floor or cystoscopic procedure.
• Has had prior surgical SUI treatment.
• Has had prior radiation therapy or brachy therapy.
• Has an atonic bladder or post-void residual (PVR) above 100cc on two or more occasions.
• Is pregnant or planning to become pregnant during the study duration.
• Has a contraindication to therapeutic BOTOX injections or cystoscopic procedures.
• Is enrolled in a concurrent clinical trial of any treatment (drug or device) that could affect urinary continence or bladder function without the sponsor's approval.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Allergan

INDUSTRY

Sponsor Role: collaborator

Northwell Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bilal Chughtai, MD

Role: PRINCIPAL_INVESTIGATOR

Weill Medical College of Cornell University

Locations

Weill Cornell Medicine

New York, New York, United States

Countries

United States

Other Identifiers

20-04021756

Identifier Type: -

Identifier Source: org_study_id