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Neurotoxin

Botox for Overactive Bladder

Phase 2 & 3

Recruiting

Led By Amy Krambeck, MD

Research Sponsored by Northwestern University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Males 18-89 undergoing HoLEP

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

Study Summary

This trial will study the safety and effectiveness of a Botox-like injection to treat overactive bladder in men during a prostate surgery.

Who is the study for?

This trial is for men aged 18-89 who are undergoing HoLEP surgery and have overactive bladder symptoms, including frequent urination, nighttime urination, urgency, or urge-related incontinence. Participants must be able to understand and fill out questionnaires. Men with allergies to Botox, other surgeries at the same time as HoLEP, prior pelvic radiation or bladder cancer history, decision-making impairments, or active urinary infections cannot join.Check my eligibility

What is being tested?

The study is testing the safety and effectiveness of injecting OnabotulinumtoxinA (Botox) into the bladder muscle during a prostate surgery called HoLEP in men with overactive bladder symptoms. It's a multi-center study where participants are randomly chosen to receive either Botox injections or not during their procedure.See study design

What are the potential side effects?

Possible side effects from OnabotulinumtoxinA injections may include pain at injection site, urinary retention requiring catheterization, blood in urine post-procedure, increased risk of urinary tract infections and general weakness.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am a man aged 18-89 scheduled for HoLEP surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Improve Overactive Bladder Symptoms (OAB) utilizing botox injections into the bladder.

Secondary outcome measures

Difference in efficacy endpoints (3-month clinic/telephone follow-up)

Difference in patient REDCap surveys (gross hematuria dysuria, incontinence)

Difference in safety/ adverse effects

Side effects data

From 2014 Phase 4 trial • 250 Patients • NCT02096081

Headache

Facial Asymmetry

Human ehrlichiosis

100%

80%

60%

40%

20%

Study treatment Arm

IncobotulinumtoxinA

OnabotulinumtoxinA

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Intra-detrusor OnabotulinumtoxinA InjectionExperimental Treatment1 Intervention

Injection of intra-detrusor OnabotulinumtoxinA into the bladder will be performed.

Group II: No intra-detrusor OnabotulinumtoxinA InjectionActive Control1 Intervention

Injection of intra-detrusor OnabotulinumtoxinA into the bladder will not be performed.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

OnabotulinumtoxinA

2014

Completed Phase 4

~3920

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Northwestern UniversityLead Sponsor

1,589 Previous Clinical Trials

917,046 Total Patients Enrolled

6 Trials studying Urinary Incontinence

343 Patients Enrolled for Urinary Incontinence

University of CalgaryOTHER

792 Previous Clinical Trials

869,074 Total Patients Enrolled

3 Trials studying Urinary Incontinence

443 Patients Enrolled for Urinary Incontinence

Ohio State UniversityOTHER

830 Previous Clinical Trials

505,540 Total Patients Enrolled

1 Trials studying Urinary Incontinence

Media Library

OnabotulinumtoxinA (Neurotoxin) Clinical Trial Eligibility Overview. Trial Name: NCT05878951 — Phase 2 & 3

Urinary Incontinence Research Study Groups: Intra-detrusor OnabotulinumtoxinA Injection, No intra-detrusor OnabotulinumtoxinA Injection

Urinary Incontinence Clinical Trial 2023: OnabotulinumtoxinA Highlights & Side Effects. Trial Name: NCT05878951 — Phase 2 & 3

OnabotulinumtoxinA (Neurotoxin) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05878951 — Phase 2 & 3

Frequently Asked Questions

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

Are elderly people over 80 years of age qualified to participate in this research endeavor?

"The accepted age range for this research trial is 18 to 89 years old. There are 27 trials for minors and 197 studies targeting the elderly population."

Answered by AI

Am I eligible to enlist in this medical experiment?

"To partake in this trial, the patient must have urinary incontinence and fall within the ages of 18-89. The program will accept 80 individuals in total."

Answered by AI

Are there still opportunities to join this experiment for those seeking treatment?

"Per the clinicaltrials.gov website, this trial is actively recruiting patients. The listing was first published on June 1st 2023 and recently updated on May 24th 2023."

Answered by AI

How many participants are being administered treatment in this trial?

"Affirmative. Clinicaltrials.gov has evidence that this medical trial is actively recruiting participants, having been first posted on June 1st 2023 and most recently updated on May 24th 2023. 80 individuals are being recruited for the study at a single site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Examining the Effects of Intra-detrusor Botox at Time of HoLEP in Men With Overactive Bladder Symptoms

Amy Krambeck 2023. "Examining the Effects of Intra-detrusor Botox at Time of HoLEP in Men With Overactive Bladder Symptoms". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05878951.

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