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RECRUITING

NCT07648888

Water Vapor Thermal Therapy Versus Ejaculation-Sparing Bipolar Transurethral Enucleation for Benign Prostatic Hyperplasia

Sponsor: Beni-Suef University

View on ClinicalTrials.gov

Summary

This prospective comparative study will evaluate Water Vapor Thermal Therapy (WVTT/Rezum) versus Ejaculation-Sparing Bipolar Transurethral Enucleation of the Prostate (ES-B-TUEP) in sexually active men with symptomatic benign prostatic hyperplasia. Eligible patients will have moderate-to-severe lower urinary tract symptoms, preserved antegrade ejaculation at baseline, and will be candidates for procedural treatment after failure, intolerance, or unwillingness to continue medical therapy. This is not a randomized study. Treatment selection will be based on shared decision-making between the patient and the treating surgeon after standardized counseling about both procedures. The study will compare ejaculatory function, urinary symptom improvement, urinary flow, post-void residual urine, erectile function, perioperative outcomes, complications, catheterization duration, hospital stay, medication restart, and retreatment or reintervention during follow-up. The primary outcome will be the change in the Male Sexual Health Questionnaire-Ejaculatory Dysfunction Short Form Function domain score from baseline to 12 months.

Official title: Water Vapor Thermal Therapy Versus Ejaculation-Sparing Bipolar Transurethral Enucleation of the Prostate for Benign Prostatic Hyperplasia: A Prospective Comparative Study

Key Details

Gender

MALE

Age Range

50 Years - Any

Study Type

INTERVENTIONAL

Enrollment

120

Start Date

2026-06-08

Completion Date

2027-12

Last Updated

2026-06-15

Healthy Volunteers

Conditions

Benign Prostatic Hyperplasia Lower Urinary Tract Symptoms Ejaculatory Dysfunction

Interventions

PROCEDURE

Water Vapor Thermal Therapy

Transurethral convective radiofrequency water vapor thermal therapy will be performed for symptomatic benign prostatic hyperplasia. The procedure includes cystoscopic assessment and delivery of water vapor injections into the obstructing prostatic tissue, including median lobe treatment when present and technically suitable. A Foley catheter will be inserted at the end of the procedure.

PROCEDURE

Ejaculation-Sparing Bipolar Transurethral Enucleation of the Prostate

Ejaculation-sparing bipolar transurethral enucleation of the prostate will be performed for symptomatic benign prostatic hyperplasia using an anatomy-adapted endoscopic technique. The procedure aims to remove the obstructing adenoma while preserving peri-montanal, supra-montanal, ejaculatory hood, and bladder-neck related structures whenever technically feasible. A Foley catheter will be inserted at the end of the procedure.

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) 13 or higher. * Prostate volume 30 to 80 mL measured by transrectal ultrasound. * Maximum urinary flow rate (Qmax) 15 mL/s or less with voided volume 150 mL or more. * Post-void residual urine volume 250 mL or less. * Failed, intolerant, or unwilling 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. * Recurrent urinary retention or 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.

Locations (1)

Department of Urology- Beni-Suef University Hospitals

Banī Suwayf, Beni Suweif Governorate, Egypt