Overactive Bladder, Overactive Bladder Syndrome, Urinary Incontinence, Urologic Diseases
Conditions
Brief 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.
Detailed 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.
Interventions
DRUGOnabotulinumtoxinA
Intra-detrusor OnabotulinumtoxinA is commonly known as botox
Sponsors
Northwestern University
University of Calgary
Ohio State University
University of Alberta
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
MALE
Age
18 Years to 89 Years
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 with a history of bladder cancer with or without BCG therapy * Patients who lack decisional capacity * Active urinary tract infection
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improve Overactive Bladder Symptoms (OAB) utilizing botox injections into the bladder. | 12 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Difference in safety/ adverse effects | 90 days | Identifying changes in post-op urinary retention, gross hematuria, UTI, ED visits and any additional complications. |
| Difference in patient REDCap surveys (gross hematuria dysuria, incontinence) | 6 months | Identifying symptom resolution at different time points (1 month, 3 months, 6 months) |
| Difference in efficacy endpoints (3-month clinic/telephone follow-up) | 3 months | Identifying efficacy endpoints as they relate to the use of anti-cholinergics, incontinence survey, post void residuals, continence pads requirements if any. |
Countries
United States
Contacts
CONTACTAlyssa McDonald
CONTACTAllaa Fadl-Alla
PRINCIPAL_INVESTIGATORAmy Krambeck, MD
Northwestern University
Outcome results
None listed