UnknownNot 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 range

40 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

View on ClinicalTrials.gov More BPH trials