Prostate Enucleation With Intravesical Botox Injections in Treating BPH and Bladder Overactivity

• Status: Not yet recruiting
• Trial end date: 2024-08-01
• Target enrollment: 0
• Participant gender: Male

Summary

The aim of this study is to evaluate the effect of intravesical Botox injections on lower urinary tract symptoms (LUTS) when administered during ThuLEP surgery in patients with bladder outlet obstruction (BOO) and overactive bladder symptoms (OAB).

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Menoufia University

Criteria

Inclusion Criteria:

• Males age > 40

• Patients diagnosed with Benign Prostatic Hyperplasia (BPH) and referred for ThuLEP surgery

• Lower urinary tract symptoms (LUTS) of Overactive Bladder Syndrome (OABS) frequency - urgency - urge incontinence episodes - dysuria - nocturia and eligible for bladder botox injections

• International Prostate Symptom Score (IPSS) ≥ 17

• Overactive Bladder Symptom Score (OABSS) ≥ 7

• Participants have failed, are intolerant, or bad candidates for anticholinergic medication treatment for OAB

Exclusion Criteria:

• History of bladder/prostate cancer

• History of pelvic radiotherapy

• History of neurological diseases

• Presence of active Urinary Tract Infection (UTI)

• Previous Bladder Outlet Procedure (Transurethral resection of prostate (TURP) Transurethral Incision of Prostate (TUIP) - UroLift, etc..)

• History of adverse reaction to Botox injections

• Post-void residual (PVR) greater than 300 ml

• History of clean intermittent catheterization

• Patients unable to stop anticoagulation of antiplatelet inhibitors 3 days prior to procedure