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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Lower Urinary Tract Symptoms; Benign Prostatic Hyperplasia; Ejaculatory Dysfunction
• Intervention / Treatment: Procedure: Water Vapor Thermal Therapy; Procedure: Ejaculation-Sparing Bipolar Transurethral Enucleation of the Prostate

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hany F Badawy, MD; Phone Number: +201149525028; Email: HANYFATHY86@GMAIL.COM

Study Locations

• Egypt
  • Beni Suweif Governorate
    • Banī Suwayf, Beni Suweif Governorate, Egypt, 02456
      • Recruiting
      • Department of Urology- Beni-Suef University Hospitals
      • Principal Investigator: Hany F Badawy, MD
      • Contact: Hany F Badawy, MD; Phone Number: 01149525028; Email: HANYFATHY86@GMAIL.COM
      • Contact: Email: HANYFATHY86@GMAIL.COM

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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.
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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in MSHQ-EjD-SF Function Domain Score	Change from baseline to 12 months in the Male Sexual Health Questionnaire-Ejaculatory Dysfunction Short Form (MSHQ-EjD-SF) Function domain score. The Function domain is calculated as the sum of questions 1-3 assessing ejaculation frequency, ejaculation force, and ejaculation volume. The score ranges from 1 to 15, with higher scores indicating better ejaculatory function. The outcome will compare the change score between the Water Vapor Thermal Therapy/Rezum group and the Ejaculation-Sparing Bipolar Transurethral Enucleation group.	Baseline and 12 months after intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in MSHQ-EjD-SF Bother Item Score	Change from baseline to 12 months in the Male Sexual Health Questionnaire-Ejaculatory Dysfunction Short Form (MSHQ-EjD-SF) Bother item score. The bother item assesses the degree of bother related to ejaculation difficulties. The score ranges from 0 to 5, with higher scores indicating greater ejaculation-related bother. The outcome will compare the change score between the Water Vapor Thermal Therapy/Rezum group and the Ejaculation-Sparing Bipolar Transurethral Enucleation group.	Baseline and 12 months after intervention
Preservation of Antegrade Ejaculation	Proportion of patients who report preserved antegrade ejaculation at 12 months after intervention. Antegrade ejaculation will be assessed by direct patient report during follow-up and compared between the Water Vapor Thermal Therapy/Rezum group and the Ejaculation-Sparing Bipolar Transurethral Enucleation group.	12 months after intervention
Change in IIEF-5 Score	Change from baseline to 12 months in the International Index of Erectile Function-5 (IIEF-5) score. The IIEF-5 score ranges from 5 to 25, with higher scores indicating better erectile function. The outcome will compare the change score between the Water Vapor Thermal Therapy/Rezum group and the Ejaculation-Sparing Bipolar Transurethral Enucleation group.	Baseline and 12 months after intervention
Change in International Prostate Symptom Score	Change from baseline in the International Prostate Symptom Score (IPSS). The IPSS ranges from 0 to 35, with higher scores indicating more severe lower urinary tract symptoms. The outcome will compare symptom improvement between the Water Vapor Thermal Therapy/Rezum group and the Ejaculation-Sparing Bipolar Transurethral Enucleation group.	Baseline, 1 month, 3 months, 6 months, and 12 months after intervention
Change in Maximum Urinary Flow Rate	Change from baseline in maximum urinary flow rate (Qmax), measured in milliliters per second by uroflowmetry. Higher Qmax values indicate better urinary flow. The outcome will compare urinary flow improvement between the Water Vapor Thermal Therapy/Rezum group and the Ejaculation-Sparing Bipolar Transurethral Enucleation group.	Baseline, 1 month, 3 months, 6 months, and 12 months after intervention
Change in Post-Void Residual Urine Volume	Change from baseline in post-void residual urine volume (PVR), measured in milliliters by ultrasound. Lower PVR values indicate better bladder emptying. The outcome will compare change in residual urine volume between the Water Vapor Thermal Therapy/Rezum group and the Ejaculation-Sparing Bipolar Transurethral Enucleation group.	Baseline, 1 month, 3 months, 6 months, and 12 months after intervention

Collaborators and Investigators

• Sponsor: Beni-Suef University
• Investigators: Principal Investigator: Hany F Badawy, MD, Faculty of Medicine, Beni-Suef University hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 8, 2026
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: June 10, 2026
• First Submitted That Met QC Criteria: June 10, 2026
• First Posted (Actual): June 15, 2026

Study Record Updates

• Last Update Posted (Actual): June 15, 2026
• Last Update Submitted That Met QC Criteria: June 10, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Water Vapor Thermal Therapy; Ejaculation-Sparing; MSHQ-EjD-SF
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Urological Manifestations; Sexual Dysfunction, Physiological; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Ejaculatory Dysfunction; Prostatic Hyperplasia; Lower Urinary Tract Symptoms
• Other Study ID Numbers: BSU-REZ-ESBTUEP-2026

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be shared because the study includes sensitive urological and sexual-function data, and no specific ethics-approved data sharing agreement is planned. De-identified aggregate results may be published in scientific meetings or peer-reviewed journals.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No