Feasibility of BOTOX Injection on Improving Female Stress Urinary Incontinence

Feasibility of Onabotulinumtoxin A Injection on Improving Female Stress Urinary Incontinence

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).

Study Overview

• Status: Suspended
• Conditions: Stress Urinary Incontinence
• Intervention / Treatment: Drug: onabotulinumtoxin A

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.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Andrea Lopez; Phone Number: 6469624495; Email: avl4002@med.cornell.edu
• Study Contact Backup: Name: Bilal Chughtai, MD; Phone Number: (646) 962-4811; Email: bic9008@med.cornell.edu

Study Locations

• United States
  • New York
    • New York, New York, United States, 10065
      • Weill Cornell Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Botox Injection; One-time injection of 100U BOTOX (onabotulinumtoxin A) into the fundus of the bladder under direct visualization via cystoscopy.	Drug: onabotulinumtoxin A; One-time injection of 100U BOTOX; Other Names: BOTOX

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety of 100U BOTOX injection as measured by the number of procedure-related adverse events.	Adverse events may include organ perforation, bleeding, pelvic pain, infection, de novo dyspareunia, urinary retention, recurrent incontinence, other urinary problems and neuromuscular problems	Time of Procedure
Safety of 100U BOTOX injection as measured by the number of procedure-related adverse events.	Adverse events may include organ perforation, bleeding, pelvic pain, infection, de novo dyspareunia, urinary retention, recurrent incontinence, other urinary problems and neuromuscular problems	1-month
Safety of 100U BOTOX injection as measured by the number of procedure-related adverse events.	Adverse events may include organ perforation, bleeding, pelvic pain, infection, de novo dyspareunia, urinary retention, recurrent incontinence, other urinary problems and neuromuscular problems	3-month
Safety of 100U BOTOX injection as measured by the number of procedure-related adverse events.	Adverse events may include organ perforation, bleeding, pelvic pain, infection, de novo dyspareunia, urinary retention, recurrent incontinence, other urinary problems and neuromuscular problems	6-month
Change in patient-reported symptoms of stress incontinence symptoms via PGI-I.	The Patient Global Impression of Improvement (PGI-I) scale is a scale that measures improvement in symptoms and ranges from 1-7, with 1 indicating very much improvement and higher scores indicating less improvement.	1-month, 3-month, 6-month
Change in quality of life impacted by urinary incontinence via UDI-6.	The Urinary Distress Inventory (UDI-6) is an inventory that assess symptoms and urinary incontinence and its severity on a scale of 0 to 3, with higher scores indicating greater symptom severity. IIQ-7 is a 30-item self-report questionnaire on the impact of urinary incontinence on activities roles and emotional states. Assigned values of the questionnaire are 0 for "not at all," 1 for "slightly," 2 for "moderately," and 3 for "greatly.	Baseline, 1-month, 3-month, 6-month
Change in quality of life impacted by urinary incontinence via IIQ-7.	The Incontinence Impact Questionnaire (IIQ-7) is a 30-item self-report questionnaire on the impact of urinary incontinence on activities roles and emotional states. Assigned values of the questionnaire are 0 for "not at all," 1 for "slightly," 2 for "moderately," and 3 for "greatly.	Baseline, 1-month, 3-month, 6-month
Assessment of patient satisfaction post-treatment via SSQ-8.	The Surgical Satisfaction Questionnaire (SSQ-8) is a questionnaire about patient satisfaction after a surgery/procedure. Responses range from "Very unsatisfied" to "Very Satisfied".	1-month
Change in pain post-treatment compared to baseline via VAS.	Scores are measured on a 100mm Visual Analog Scale (VAS). The VAS ranges from 0 to 100 with 0 indicating no pain and higher scores indicating greater pain.	Baseline, Time of Procedure, 1-month

Collaborators and Investigators

• Sponsor: Weill Medical College of Cornell University
• Collaborators: Allergan
• Investigators: Principal Investigator: Bilal Chughtai, MD, Weill Medical College of Cornell University

Study record dates

Study Major Dates

• Study Start (Actual): February 14, 2022
• Primary Completion (Estimated): August 1, 2024
• Study Completion (Estimated): August 1, 2025

Study Registration Dates

• First Submitted: July 29, 2021
• First Submitted That Met QC Criteria: July 29, 2021
• First Posted (Actual): July 30, 2021

Study Record Updates

• Last Update Posted (Actual): October 16, 2023
• Last Update Submitted That Met QC Criteria: October 12, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Incontinence; Urinary Incontinence
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Elimination Disorders; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urinary Incontinence; Enuresis; Urinary Incontinence, Stress; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Cholinergic Agents; Membrane Transport Modulators; Acetylcholine Release Inhibitors; Neuromuscular Agents; Botulinum Toxins, Type A; abobotulinumtoxinA
• Other Study ID Numbers: 20-04021756

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes