Water Vapor Therapy versus Ejaculation-Preserving HoLEP for Benign Prostatic Hyperplasia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, non-randomized, controlled study conducted at Beni-Suef University Hospital. Eligible participants are sexually active men aged 50 and older with BPH, prostate volume 30–80 mL, IPSS of 13 or higher, Qmax ≤15 mL/s, and preserved antegrade ejaculation at baseline. After standardized counseling, treatment choice is made by shared decision-making between the patient and physician, not by random assignment. The primary outcome is change in ejaculatory function at 12 months using the MSHQ-EjD-SF Function domain; secondary outcomes include urinary symptoms, quality of life, peak flow, post-void residual, erectile function, and antegrade ejaculation preservation. Interventions are Water Vapor Thermal Therapy (Rezum) and Ejaculation-Preserving HoLEP. The study aims to inform whether a less invasive option or a nerve-sparing enucleation approach better preserves ejaculation while reducing obstruction.

Why it matters

Who can join: the full rules

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 anejaculation or severe ejaculatory dysfunction.
* No sexual activity during the previous 3 months.
* Chronic indwelling urethral or suprapubic catheter.
* Suspected detrusor underactivity requiring urodynamic clarification.
* Post-void residual urine volume more than 250 mL.
* Uncontrolled coagulopathy.
* Anticoagulation or antiplatelet therapy that cannot be safely managed perioperatively.
* Unfitness for anesthesia or intervention.
* Inability or unwillingness to comply with follow-up.

Where it's running

• Department of Urology- Beni-Suef University Hospitals
  Banī Suwayf, Beni Suweif Governorate, Egypt Recruiting

Study contacts

• Study coordinator: Hany F Badawy, MD
• Email: HANYFATHY86@GMAIL.COM
• Phone: +201149525028

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.