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Neurotoxin
Feasibility of BOTOX Injection on Improving Female Stress Urinary Incontinence
Phase < 1
Waitlist Available
Led By Bilal Chughtai, MD
Research Sponsored by Northwell Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1-month, 3-month, 6-month
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing whether Botox injections into the bladder can help reduce urinary leakage in women with stress urinary incontinence.
Eligible Conditions
- Stress Incontinence
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1-month, 3-month, 6-month
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1-month, 3-month, 6-month
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in the amount of urinary leakage post-treatment compared to baseline.
Secondary study objectives
Assessment of patient satisfaction post-treatment via SSQ-8.
Change in pain post-treatment compared to baseline via VAS.
Change in patient-reported symptoms of stress incontinence symptoms via PGI-I.
+3 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Botox InjectionExperimental Treatment1 Intervention
One-time injection of 100U BOTOX (onabotulinumtoxin A) into the fundus of the bladder under direct visualization via cystoscopy.
Find a Location
Who is running the clinical trial?
Northwell HealthLead Sponsor
474 Previous Clinical Trials
469,114 Total Patients Enrolled
Weill Medical College of Cornell UniversityLead Sponsor
1,091 Previous Clinical Trials
1,154,725 Total Patients Enrolled
AllerganIndustry Sponsor
781 Previous Clinical Trials
276,665 Total Patients Enrolled
Bilal Chughtai, MDPrincipal InvestigatorWeill Medical College of Cornell University
5 Previous Clinical Trials
363 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have bladder control problems caused by nerve-related conditions like multiple sclerosis, stroke, spinal cord/brain injury, Parkinson's disease, or similar conditions.You have received radiation therapy or brachytherapy in the past.You have a bladder that doesn't contract properly, or you have leftover urine in your bladder after you pee.You have tried two different non-invasive treatments for bladder control problems (like exercises or behavior changes) for at least 3 months, but they didn't work.
Research Study Groups:
This trial has the following groups:- Group 1: Botox Injection
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.