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

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Northwestern University
Study ID
NCT05878951
Phase
PHASE2/PHASE3
Status
Recruiting
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Conditions

  • Overactive Bladder
  • Overactive Bladder Syndrome
  • Urinary Incontinence
  • Urologic Diseases

Eligibility Criteria

Sex
MALE
Age
18 Years - 89 Years
Healthy Volunteers
Not accepted

Interventions

  • OnabotulinumtoxinA — DRUG
    Intra-detrusor OnabotulinumtoxinA is commonly known as botox

Study Details

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.

Key Dates

Start date
Jul 13, 2023
Status verified
May 2026
Primary completion
Sep 1, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
66 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Intra-detrusor OnabotulinumtoxinA Injection
    Injection of intra-detrusor OnabotulinumtoxinA into the bladder will be performed.
  • No Intervention: No intra-detrusor OnabotulinumtoxinA Injection
    Injection of intra-detrusor OnabotulinumtoxinA into the bladder will not be performed.

Primary Outcome Measure

Improve Overactive Bladder Symptoms (OAB) utilizing botox injections into the bladder. [ Time Frame: 12 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Northwestern MedicineChicagoIllinois60611
Alyssa McDonald

Find similar trials in Chicago, IL

By research site
Northwestern Medicine· Chicago, IL

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