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Neurotoxin

onabotulinumtoxin A for Stress Incontinence

Phase < 1
Waitlist Available
Led By Bilal Chughtai, MD
Research Sponsored by Weill Medical College of Cornell University
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

Study 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 weeks
Treatment ~ Varies
Follow Up ~1-month, 3-month, 6-month
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1-month, 3-month, 6-month for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in the amount of urinary leakage post-treatment compared to baseline.
Secondary outcome measures
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 more

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?

Weill Medical College of Cornell UniversityLead Sponsor
1,054 Previous Clinical Trials
1,316,289 Total Patients Enrolled
AllerganIndustry Sponsor
781 Previous Clinical Trials
276,549 Total Patients Enrolled
Bilal Chughtai, MDPrincipal InvestigatorWeill Medical College of Cornell University
5 Previous Clinical Trials
407 Total Patients Enrolled

Media Library

onabotulinumtoxin A (Neurotoxin) Clinical Trial Eligibility Overview. Trial Name: NCT04984317 — Phase < 1
Stress Incontinence Research Study Groups: Botox Injection
Stress Incontinence Clinical Trial 2023: onabotulinumtoxin A Highlights & Side Effects. Trial Name: NCT04984317 — Phase < 1
onabotulinumtoxin A (Neurotoxin) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04984317 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current capacity of participants in this clinical trial?

"Affirmative. Per the information provided on clinicaltrials.gov, this study is currently looking for participants with recruitment first commencing on February 14th 2022 and last updated February 23rd of that same year. This trial requires 20 individuals to be recruited from a single medical centre."

Answered by AI

Can you please summarize what earlier research has been conducted with onabotulinumtoxin A?

"At present, 61 trials concerning onabotulinumtoxin A are in progress. 20 of these research initiatives have reached Phase 3 and the majority can be found in Farmington Hills, Michigan. Nevertheless, 759 sites across the globe are also conducting studies involving this medication."

Answered by AI

Is this research still accepting participants?

"The trial is still open for recruitment, as described on the clinicaltrials.gov website - where it was first posted on February 14th and last updated February 23rd."

Answered by AI

For what treatments is onabotulinumtoxin A most commonly prescribed?

"Onabotulinumtoxin A is a viable therapy for ameliorating the severity of urinary incontinence, spinal cord injuries, and botox injections."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Feasibility of BOTOX Injection on Improving Female Stress Urinary Incontinence
2022. "Feasibility of BOTOX Injection on Improving Female Stress Urinary Incontinence". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04984317.
~2 spots leftby Aug 2024
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