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

NCT ID: NCT05878951

Last Updated: 2026-01-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2/PHASE3

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-13

Study Completion Date

2026-08-24

Brief Summary

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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.

Detailed Description

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Patients with significant preoperative urgency and/or urge urinary incontinence (UUI) along with lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH) may require post-HoLEP anticholinergic, B-3 agonist, or intravesical OnabotulinumtoxinA administration. This injection is a guideline recommended for treatment in patients with severe irritative LUTS (urgency, UUI) and overactive bladder.

Conditions

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Urinary Incontinence Overactive Bladder Syndrome Overactive Bladder Urologic Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Intra-detrusor OnabotulinumtoxinA Injection

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

Group Type EXPERIMENTAL

OnabotulinumtoxinA

Intervention Type DRUG

Intra-detrusor OnabotulinumtoxinA is commonly known as botox

No intra-detrusor OnabotulinumtoxinA Injection

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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OnabotulinumtoxinA

Intra-detrusor OnabotulinumtoxinA is commonly known as botox

Intervention Type DRUG

Other Intervention Names

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Botox

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

89 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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University of Calgary

OTHER

Sponsor Role collaborator

Ohio State University

OTHER

Sponsor Role collaborator

University of Alberta

OTHER

Sponsor Role collaborator

Northwestern University

OTHER

Sponsor Role lead

Responsible Party

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Amy Krambeck

Professor of Urology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Amy Krambeck, MD

Role: PRINCIPAL_INVESTIGATOR

Northwestern University

Locations

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Northwestern Medicine

Chicago, Illinois, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Alyssa McDonald

Role: CONTACT

312-695-8146

Allaa Fadl-Alla

Role: CONTACT

312-695-8146

Facility Contacts

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Alyssa McDonald

Role: primary

Other Identifiers

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STU00218130

Identifier Type: -

Identifier Source: org_study_id

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