Water Vapor Thermal Therapy Versus Ejaculation-Sparing Bipolar Transurethral Enucleation for Benign Prostatic Hyperplasia (REZ-ESBTUEP)

Benign prostatic hyperplasia is a common cause of male lower urinary tract symptoms and may affect quality of life, sleep, daily activity, and sexual health. In sexually active men, preservation of antegrade ejaculation is an important factor in treatment selection and postoperative satisfaction.

Water Vapor Thermal Therapy, commercially known as Rezum, is a minimally invasive transurethral treatment that delivers radiofrequency-generated water vapor into hyperplastic prostatic tissue. It aims to improve bladder outlet obstruction while minimizing sexual adverse effects. Ejaculation-Sparing Bipolar Transurethral Enucleation of the Prostate is an anatomical endoscopic enucleation technique modified to preserve peri-montanal, supra-montanal, ejaculatory hood, and bladder-neck related structures in an attempt to preserve antegrade ejaculation while achieving effective de-obstruction.

This study is designed as a prospective, controlled, non-randomized comparative clinical study. Eligible patients will be enrolled into one of two treatment cohorts: Water Vapor Thermal Therapy/Rezum or Ejaculation-Sparing Bipolar Transurethral Enucleation of the Prostate. Treatment allocation will not be randomized. The final treatment decision will be made through shared decision-making between the patient and treating surgeon after standardized counseling regarding the expected benefits, limitations, anesthesia requirements, catheterization, recovery, possible complications, urinary outcomes, sexual outcomes, and retreatment risk of both procedures.

Baseline assessment will include medical and urological history, sexual history, physical examination, digital rectal examination, urinalysis, urine culture when indicated, complete blood count, serum creatinine, coagulation profile, prostate-specific antigen, pelvic-abdominal ultrasound, transrectal ultrasound for prostate volume, uroflowmetry, post-void residual urine measurement, International Prostate Symptom Score, International Index of Erectile Function-5, and Male Sexual Health Questionnaire-Ejaculatory Dysfunction Short Form.

Patients will be followed after treatment at 1 month, 3 months, 6 months, and 12 months. Follow-up assessments will include urinary symptom scores, quality-of-life score, maximum urinary flow rate, post-void residual urine volume, erectile function, ejaculatory function, antegrade ejaculation status, complications, restart of benign prostatic hyperplasia medication, and any retreatment or reintervention.

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. Secondary outcomes will include change in ejaculation bother, preservation of antegrade ejaculation, change in erectile function, change in International Prostate Symptom Score, change in quality-of-life score, change in maximum urinary flow rate, change in post-void residual urine volume, operative time, catheterization duration, hospital stay, hemoglobin drop, postoperative urinary retention, hematuria or clot retention, urinary tract infection, dysuria, urgency or urge urinary incontinence, stress urinary incontinence, urethral stricture, bladder neck contracture, overall complications graded by the Clavien-Dindo classification, restart of benign prostatic hyperplasia medication, and retreatment or reintervention during 12-month follow-up.

Because this is a non-randomized comparative study, baseline differences between the two cohorts will be addressed using multivariable regression and propensity-score-based analysis where appropriate.