RecruitingPhase 2Phase 3NCT05878951

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

A Multicenter Randomized Controlled Trial Examining the Effects of Intra-detrusor Botulinum Toxin at Time of Holmium Laser Enucleation of the Prostate (HoLEP) in Men With Overactive Bladder (OAB) Symptoms


Sponsor

Northwestern University

Enrollment

66 participants

Start Date

Jul 13, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

The objective of our multi-center randomized single-blind study is to examine the safety and effect of intra-detrusor OnabotulinumtoxinA injections at the time of holium laser enucleation of the prostate (HoLEP) in men with overactive bladder symptoms with and without urge incontinence.


Eligibility

Sex: MALEMin Age: 18 YearsMax Age: 89 Years

Plain Language Summary

Simplified for easier understanding

This study is investigating whether injecting Botox (onabotulinumtoxinA) into the bladder wall at the same time as a prostate surgery called HoLEP (Holmium Laser Enucleation of the Prostate) can reduce overactive bladder symptoms in men. HoLEP removes excess prostate tissue that blocks urine flow, but many patients also have overactive bladder symptoms — urgency, frequency, and nighttime urination — that persist even after successful prostate treatment. Adding a Botox injection during the same procedure could address both problems at once. Eligible participants are males between 18 and 89 years old who are already scheduled for HoLEP and have overactive bladder symptoms. You must be willing and able to sign consent and complete questionnaires. Men with Botox allergies, active urinary tract infections, prior pelvic radiation, bladder cancer history, or those undergoing additional simultaneous surgeries are excluded. Participants will be randomly assigned to receive either Botox or no Botox during their HoLEP procedure, and bladder symptoms will be tracked at follow-up visits. This is a smart, practical study: since the patient is already under anesthesia for prostate surgery, adding a Botox injection adds minimal burden while potentially eliminating the need for a separate procedure to treat overactive bladder.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGOnabotulinumtoxinA

Intra-detrusor OnabotulinumtoxinA is commonly known as botox


Locations(1)

Northwestern Medicine

Chicago, Illinois, United States

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NCT05878951


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