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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
80
Intra-detrusor OnabotulinumtoxinA is commonly known as botox
Northwestern Medicine
Chicago, Illinois, United States
RECRUITINGImprove Overactive Bladder Symptoms (OAB) utilizing botox injections into the bladder.
Examine the safety and effect of intra-detrusor botulinum toxin injections at the time of helium laser enucleation of the prostate (HoLEP) in men with overactive bladder symptoms with and without urge incontinence.
Time frame: 12 months
Difference in safety/ adverse effects
Identifying changes in post-op urinary retention, gross hematuria, UTI, ED visits and any additional complications.
Time frame: 90 days
Difference in patient REDCap surveys (gross hematuria dysuria, incontinence)
Identifying symptom resolution at different time points (1 month, 3 months, 6 months)
Time frame: 6 months
Difference in efficacy endpoints (3-month clinic/telephone follow-up)
Identifying efficacy endpoints as they relate to the use of anti-cholinergics, incontinence survey, post void residuals, continence pads requirements if any.
Time frame: 3 months
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