A Multicenter Randomized Controlled Trial Examining the Effects of Intra-detrusor Botulinum Toxin at Time of Holmium Laser Enucleation of the Prostate (HoLEP) in Men With Overactive Bladder (OAB) Symptoms
Northwestern University
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.
Description
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.
Eligibility
- Age range
- 18–89 years
- Sex
- Male
- Healthy volunteers
- No
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 w…
Interventions
- DrugOnabotulinumtoxinA
Intra-detrusor OnabotulinumtoxinA is commonly known as botox
Location
- Northwestern MedicineChicago, Illinois