Examining the Effects of Intra-detrusor Botox at Time of HoLEP in Men With Overactive Bladder Symptoms
Recruiting
Phase 2
Phase 3
Interventional Study
Urinary Incontinence
Overactive Bladder Syndrome
Overactive Bladder
Urologic Diseases
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 89
- Sex
- Male
- Trial phase
- Phase 2/3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 66 (estimated)
- Sponsor
- Northwestern University · Other
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About This Trial
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.
Trial Locations
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Eligibility Criteria
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 hy…
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