Not Yet RecruitingNot Applicable

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

100 participantsStarted 2025-01-01

Plain-language summary

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

Who can participate

Age range40 Years

SexMALE

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Inclusion Criteria: * Males age \> 40 * Patients diagnosed with Benign Prostatic Hyperplasia (BPH) and referred for Bipolar enucleation of the prostate ( BipolEP ) 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

What they're measuring

Change in International Prostate Symptom Score (IPSS)

Timeframe: IPSS scores will be recorded before the surgery and at 4 checkpoints after the surgery during every clinical visit: 2 weeks -1 month - 3 months - 6 months postoperatively

Change in Overactive Bladder Symptoms Score (OABSS)

Timeframe: OABSS scores will be recorded before the surgery and at 4 checkpoints after the surgery during every clinical visit: 2 weeks -1 month - 3 months - 6 months postoperatively

Change in Maximum Urinary Flow rate

Timeframe: Uroflowmetry will be performed before the surgery and at 4 checkpoints after the surgery during every clinical visit: 2 weeks -1 month - 3 months - 6 months postoperatively

Change in Post-Void Residual (PVR) Volume

Timeframe: Postvoid residual volume (mL) will be performed before the surgery and at 4 checkpoints after the surgery during every clinical visit: 2 weeks -1 month - 3 months - 6 months postoperatively

Trial details

NCT IDNCT05910983

SponsorMenoufia University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-11-01

Contact for this trial

Mohamed Kamal Omar, MD

+20 106 694 9454 Kimo_81eg@yahoo.com

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