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

Northwestern University

Status and phase: Enrolling; Phase 3; Phase 2

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

Treatments: Drug: OnabotulinumtoxinA

Study type: Interventional

Funder types: Other

Identifiers

NCT05878951

STU00218130

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: Male

Ages: 18 to 89 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 2 patient groups

Intra-detrusor OnabotulinumtoxinA Injection

Experimental group

Description:

Injection of intra-detrusor OnabotulinumtoxinA into the bladder will be performed.

Treatment:

Drug: OnabotulinumtoxinA

No intra-detrusor OnabotulinumtoxinA Injection

No Intervention group

Description:

Injection of intra-detrusor OnabotulinumtoxinA into the bladder will not be performed.