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

RecruitingPhase 2, Phase 3

Sponsor: Northwestern University

Conditions: Urinary Incontinence, Overactive Bladder Syndrome, Overactive Bladder, Urologic Diseases

Interventions: OnabotulinumtoxinA

Countries: United States

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.

Eligibility overview

Sex: MALE

Age: 18 Years to 89 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

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 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

Locations (1)

Chicago, Illinois, United States