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

NCT07648888 | Recruiting

• 1 other identifier: BSU-REZ-ESBTUEP-2026
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Benign Prostatic Hyperplasia; Lower Urinary Tract Symptoms; Ejaculatory Dysfunction

Keywords

Water Vapor Thermal Therapy; Ejaculation-Sparing; MSHQ-EjD-SF

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Change in MSHQ-EjD-SF Bother Item Score

  Baseline and 12 months after intervention

• Preservation of Antegrade Ejaculation

  12 months after intervention

• Change in IIEF-5 Score

  Baseline and 12 months after intervention

• Change in International Prostate Symptom Score

  Baseline, 1 month, 3 months, 6 months, and 12 months after intervention

• Change in Maximum Urinary Flow Rate

  Baseline, 1 month, 3 months, 6 months, and 12 months after intervention

Study Arms (2)

Water Vapor Thermal Therapy / Rezum

ACTIVE COMPARATOR

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

Ejaculation-Sparing Bipolar Transurethral Enucleation

ACTIVE COMPARATOR

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

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.

Water Vapor Thermal Therapy / Rezum

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.

Ejaculation-Sparing Bipolar Transurethral Enucleation

Eligibility Criteria

• Age: 50 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beni-Suef University: lead

Study Sites (1)

Department of Urology- Beni-Suef University Hospitals

Banī Suwayf, Beni Suweif Governorate, 02456, Egypt

RECRUITING

MeSH Terms

Conditions

Prostatic Hyperplasia; Lower Urinary Tract Symptoms; Ejaculatory Dysfunction

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sexual Dysfunction, Physiological

Study Officials

• Hany F Badawy, MD

  Faculty of Medicine, Beni-Suef University hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hany F Badawy, MD

CONTACT

+201149525028; HANYFATHY86@GMAIL.COM

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessment will be performed by an independent assessor who will not be involved in treatment selection or operative management. The assessor will collect follow-up questionnaires and functional outcomes using standardized forms without access to the operative treatment group whenever feasible.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Urology, Faculty of Medicine, Beni-Suef University

Model Details: This is a prospective, non-randomized, parallel-group comparative study. Eligible patients will be enrolled into one of two treatment groups: Water Vapor Thermal Therapy/Rezum or Ejaculation-Sparing Bipolar Transurethral Enucleation of the Prostate. Treatment allocation will not be randomized and will be based on shared decision-making between the patient and the treating surgeon after standardized counseling about both procedures.

Study Record Dates

• First Submitted: June 10, 2026
• First Posted: June 15, 2026
• Study Start: June 8, 2026
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: June 15, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)