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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age50+
SponsorBeni-Suef University

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

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

Treatment groups

120 Participants
are divided into 2 treatment groups

Sponsors and collaborators