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Botox Injections for Overactive Bladder During HoLEP Surgery

This study is looking at whether injecting OnabotulinumtoxinA (commonly known as Botox) into the bladder during HoLEP surgery (a procedure for an enlarged prostate) can help men with overactive bladder symptoms. These symptoms can include needing to urinate often, waking up at night to urinate, sudden urges to urinate, and accidental urine leakage. The study aims to see if Botox injections are safe and effective in improving these symptoms. You may be able to join if you are a man between 18 and 89 years old, are having HoLEP surgery, and have overactive bladder symptoms. The study will measure improvements in your symptoms over 12 months. The current recruitment status is unclear.

Study design
This is a multi-center randomized single-blind study with a planned enrollment of 66 men.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your overactive bladder symptoms will be measured for 12 months after the injection.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05878951

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

Recruiting
PHASE2Ages 18–89InterventionalTreatment
Northwestern University
~66 participants
Updated 2026-06-04 on ClinicalTrials.gov
What's tested:OnabotulinumtoxinA

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Improve Overactive Bladder Symptoms (OAB) utilizing botox injections into the bladder.
Measured over 12 months

Conditions

Urinary Incontinence
Overactive Bladder Syndrome
Overactive Bladder
Urologic Diseases

Explore related trials

Overactive bladder syndromeUrinary Incontinence

Where it's being run

1 sites across 1 states
Illinois1

Study leadership

  • Amy Krambeck, MD · PRINCIPAL_INVESTIGATOR · Northwestern University

Who to contact

Alyssa McDonald
[email protected]
312-695-8146
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Males 18 -89 undergoing HoLEP
Component of OAB symptoms including frequency, nocturia, urgency, and/or urge related incontinence
Willing to sign the Informed Consent Form
Able to read, understand, and complete patient questionnaires.

Exclusion

Allergy or hypersensitivity to OnabotulinumtoxinA injections
Patients having a concurrent ureteroscopy +/- laser lithotripsy, percutaneous nephrolithotomy, or non-urologic surgery at the time of their HoLEP
Anticipated need for perineal urethrostomy at the time of HoLEP
Prior pelvic radiation or patients with a history of bladder cancer with or without BCG therapy
Patients who lack decisional capacity
Active urinary tract infection

What this trial measures

  • Improve Overactive Bladder Symptoms (OAB) utilizing botox injections into the bladder.12 months

    Examine the safety and effect of intra-detrusor botulinum toxin injections at the time of helium laser enucleation of the prostate (HoLEP) in men with overactive bladder symptoms with and without urge incontinence.