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
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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RECRUITING
PHASE2/PHASE3
80 participants
INTERVENTIONAL
2023-07-13
2026-08-24
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Intra-detrusor OnabotulinumtoxinA Injection
Injection of intra-detrusor OnabotulinumtoxinA into the bladder will be performed.
OnabotulinumtoxinA
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.
No interventions assigned to this group
Interventions
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OnabotulinumtoxinA
Intra-detrusor OnabotulinumtoxinA is commonly known as botox
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
89 Years
MALE
No
Sponsors
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University of Calgary
OTHER
Ohio State University
OTHER
University of Alberta
OTHER
Northwestern University
OTHER
Responsible Party
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Amy Krambeck
Professor of Urology
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
Countries
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Central Contacts
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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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