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

Sponsor
Beni-Suef University
Study ID
NCT07648888
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
MALE
Age
50 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Water Vapor Thermal Therapy — PROCEDURE
    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.
  • Ejaculation-Sparing Bipolar Transurethral Enucleation of the Prostate — PROCEDURE
    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.

Study Details

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.

Key Dates

Start date
Jun 8, 2026
Status verified
Jun 2026
Primary completion
Nov 30, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
120 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Water Vapor Thermal Therapy / Rezum
    Patients in this arm will undergo transurethral convective radiofrequency water vapor thermal therapy using the Rezum system for symptomatic benign prostatic hyperplasia. Treatment will be performed according to standard procedural principles, including cystoscopic assessment, delivery of water vapor injections into the obstructing prostatic tissue, treatment of the median lobe when present and technically suitable, and Foley catheter placement at the end of the procedure.
  • Active Comparator: Ejaculation-Sparing Bipolar Transurethral Enucleation
    Patients in this arm will undergo ejaculation-sparing bipolar transurethral enucleation of the prostate for symptomatic benign prostatic hyperplasia. The procedure will be performed using a standardized anatomy-adapted technique aiming to remove the obstructing adenoma while preserving peri-montanal, supra-montanal, ejaculatory hood, and bladder-neck related structures whenever technically feasible, followed by Foley catheter placement at the end of the procedure.

Primary Outcome Measure

Change in MSHQ-EjD-SF Function Domain Score [ Time Frame: Baseline and 12 months after intervention ]

Central Contacts

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