RecruitingNot Applicable

Water Vapor Thermal Therapy Versus Ejaculation-Preserving HoLEP for Benign Prostatic Hyperplasia

Egypt120 participantsStarted 2026-06-08

Plain-language summary

This prospective comparative study will evaluate Water Vapor Thermal Therapy (Rezum) versus ejaculation-preserving Holmium Laser Enucleation of the Prostate (EP-HoLEP) in sexually active men with symptomatic benign prostatic hyperplasia and prostate volume 30-80 mL. Eligible patients will not be randomized. The treatment option will be selected through shared decision-making between the patient and treating physician after standardized counseling about the expected benefits, risks, recovery, catheter duration, urinary outcomes, durability, and potential effects on ejaculation and sexual function. The main objective is to compare the change in ejaculatory function from baseline to 12 months using the Male Sexual Health Questionnaire-Ejaculatory Dysfunction-Short Form (MSHQ-EjD-SF) Function domain. Secondary outcomes will include urinary symptom improvement, quality of life, maximum urinary flow rate, post-void residual urine volume, erectile function, antegrade ejaculation preservation, catheterization duration, hospital stay, complications, restart of benign prostatic hyperplasia medication, and retreatment or reintervention within 12 months.

Who can participate

Age range

50 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: * Male patients aged 50 years or older. * Symptomatic benign prostatic hyperplasia with moderate-to-severe lower urinary tract symptoms. * International Prostate Symptom Score (IPSS) of 13 or higher. * Prostate volume 30 to 80 mL measured by transrectal ultrasound. * Maximum urinary flow rate (Qmax) of 15 mL/s or less with voided volume of at least 150 mL. * Post-void residual urine volume of 250 mL or less. * Failure, intolerance, or unwillingness to continue medical therapy for benign prostatic hyperplasia. * Sexually active within the previous 3 months. * Preserved antegrade ejaculation at baseline. * Patient wishes to preserve ejaculation. * Ability to complete the International Prostate Symptom Score (IPSS), International Index of Erectile Function-5 (IIEF-5), and Male Sexual Health Questionnaire-Ejaculatory Dysfunction-Short Form (MSHQ-EjD-SF). * Written informed consent. Exclusion Criteria: * Suspected or confirmed prostate cancer. * Abnormal prostate-specific antigen or digital rectal examination suspicious for malignancy unless prostate cancer has been excluded according to standard clinical practice. * Previous prostate surgery. * Previous urethral surgery likely to affect instrumentation or study outcomes. * Urethral stricture disease. * Neurogenic bladder dysfunction. * Active urinary tract infection until adequately treated. * Bladder stones requiring concomitant surgery. * Prostate volume less than 30 mL or more than 80 mL. * Baseline anej…

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 Male Sexual Health Questionnaire-Ejaculatory Dysfunction-Short Form Function Domain Score

Timeframe: Baseline and 12 months after the procedure

Trial details

NCT IDNCT07648875

SponsorBeni-Suef University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-11

Contact for this trial

Hany F Badawy, MD

+201149525028 HANYFATHY86@GMAIL.COM

View on ClinicalTrials.gov More Benign Prostatic Hyperplasia trials