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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

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

Intervention / Treatment
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* Drug: OnabotulinumtoxinA


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 89 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intra-detrusor OnabotulinumtoxinA Injection<br>Injection of intra-detrusor OnabotulinumtoxinA into the bladder will be performed. | Drug: OnabotulinumtoxinA<br>* Intra-detrusor OnabotulinumtoxinA is commonly known as botox<br>* Other names: Botox;|
| No Intervention: No intra-detrusor OnabotulinumtoxinA Injection<br>Injection of intra-detrusor OnabotulinumtoxinA into the bladder will not be performed. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improve 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. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in safety/ adverse effects | Identifying changes in post-op urinary retention, gross hematuria, UTI, ED visits and any additional complications. | 90 days | 
| Difference in patient REDCap surveys (gross hematuria dysuria, incontinence) | Identifying symptom resolution at different time points (1 month, 3 months, 6 months) | 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. | 3 months |