Recruiting
Phase 2
Phase 3

Botox

Sponsor:

Northwestern University

Code:

NCT05878951

Conditions

Urinary Incontinence

Overactive Bladder Syndrome

Overactive Bladder

Urologic Diseases

Eligibility Criteria

Sex: Male

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

OnabotulinumtoxinA

Study Details

Brief 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.

Conditions

Urinary Incontinence

Overactive Bladder Syndrome

Overactive Bladder

Urologic Diseases

Study ID

NCT05878951

Start date

Jul 13, 2023

Status verified date

May, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Sep 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 Criteria:

  • 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

Study Design

Enrollment

66 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

OnabotulinumtoxinA

Intra-detrusor OnabotulinumtoxinA is commonly known as botox

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Alyssa McDonald

312-695-8146Alyssa.McDonald@northwestern.edu

Allaa Fadl-Alla

312-695-8146Allaa.Fadlalla@northwestern.edu

Locations

Northwestern Medicine

Recruiting

Chicago, Illinois, United States, 60611

More Information

Sponsor

Northwestern University

Last update posted

Jun 4, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Northwestern University on 2026-06-04.