Feasibility of BOTOX Injection on Improving Female Stress Urinary Incontinence

NCT04984317 | Suspended Early Phase 1 DMC FDA Drug

• 1 other identifier: 20-04021756
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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).

Conditions

Stress Urinary Incontinence

Keywords

Urinary Incontinence; Incontinence

Outcome Measures

Primary Outcomes (1)

• Change in the amount of urinary leakage post-treatment compared to baseline.

  1-hour pad weight, in grams

  Baseline, 1-month, 3-month, 6-month

Secondary Outcomes (9)

• Safety of 100U BOTOX injection as measured by the number of procedure-related adverse events.

  Time of Procedure

• Safety of 100U BOTOX injection as measured by the number of procedure-related adverse events.

  1-month

• Safety of 100U BOTOX injection as measured by the number of procedure-related adverse events.

  3-month

• Safety of 100U BOTOX injection as measured by the number of procedure-related adverse events.

  6-month

• Change in patient-reported symptoms of stress incontinence symptoms via PGI-I.

  1-month, 3-month, 6-month

Study Arms (1)

Botox Injection

EXPERIMENTAL

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

Drug: onabotulinumtoxin A

Interventions

onabotulinumtoxin A DRUG

One-time injection of 100U BOTOX

Also known as: BOTOX

Botox Injection

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Northwell Health: lead
• Allergan: collaborator

Study Sites (1)

Weill Cornell Medicine

New York, New York, 10065, United States

Location

MeSH Terms

Conditions

Urinary Incontinence, Stress; Urinary Incontinence

Interventions

Botulinum Toxins, Type A

Condition Hierarchy (Ancestors)

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

Study Officials

• Bilal Chughtai, MD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2021
• First Posted: July 30, 2021
• Study Start: February 14, 2022
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): August 1, 2027
• Last Updated: January 26, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)