Water Vapor Thermal Therapy Versus Ejaculation-Preserving HoLEP for Benign Prostatic Hyperplasia

NCT07648875 | Recruiting

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

Brief Summary

This prospective comparative study will evaluate Water Vapor Thermal Therapy (Rezum) versus ejaculation-preserving Holmium Laser Enucleation of the Prostate (EP-HoLEP) in sexually active men with symptomatic benign prostatic hyperplasia and prostate volume 30-80 mL. Eligible patients will not be randomized. The treatment option will be selected through shared decision-making between the patient and treating physician after standardized counseling about the expected benefits, risks, recovery, catheter duration, urinary outcomes, durability, and potential effects on ejaculation and sexual function. The main objective is to compare the change in ejaculatory function from baseline to 12 months using the Male Sexual Health Questionnaire-Ejaculatory Dysfunction-Short Form (MSHQ-EjD-SF) Function domain. Secondary outcomes will include urinary symptom improvement, quality of life, maximum urinary flow rate, post-void residual urine volume, erectile function, antegrade ejaculation preservation, catheterization duration, hospital stay, complications, restart of benign prostatic hyperplasia medication, and retreatment or reintervention within 12 months.

Conditions

Benign Prostatic Hyperplasia; Lower Urinary Tract Symptoms

Keywords

Water Vapor Thermal Therapy; Rezum; Ejaculation-Preserving HoLEP; Male Sexual Health Questionnaire

Outcome Measures

Primary Outcomes (1)

• Change in Male Sexual Health Questionnaire-Ejaculatory Dysfunction-Short Form Function Domain Score

  Change from baseline to 12 months in the Function domain score of the Male Sexual Health Questionnaire-Ejaculatory Dysfunction-Short Form (MSHQ-EjD-SF). The Function domain consists of three items assessing ejaculation frequency, ejaculation force, and ejaculation volume. The score ranges from 1 to 15, with higher scores indicating better ejaculatory function.

  Baseline and 12 months after the procedure

Secondary Outcomes (5)

• Change in Male Sexual Health Questionnaire-Ejaculatory Dysfunction-Short Form Bother Item Score

  Baseline and 12 months after the procedure

• Change in International Index of Erectile Function-5 Score

  Baseline and 12 months after the procedure

• Change in International Prostate Symptom Score

  Baseline, 1 month, 3 months, 6 months, and 12 months after the procedure

• Change in Maximum Urinary Flow Rate

  Baseline, 1 month, 3 months, 6 months, and 12 months after the procedure

• Change in Post-Void Residual Urine Volume

  Baseline, 1 month, 3 months, 6 months, and 12 months after the procedure

Study Arms (2)

Water Vapor Thermal Therapy

ACTIVE COMPARATOR

Patients in this group will undergo transurethral convective radiofrequency water vapor thermal therapy using the Rezum system for symptomatic benign prostatic hyperplasia. Vapor injections will be delivered into the obstructing prostatic tissue according to prostate configuration and prostatic urethral length. Median lobe treatment will be performed when present and technically suitable. A Foley catheter will be inserted at the end of the procedure.

Procedure: Water Vapor Thermal Therapy

Ejaculation-Preserving Holmium Laser Enucleation of the Prostate

ACTIVE COMPARATOR

Patients in this group will undergo Holmium Laser Enucleation of the Prostate using an ejaculation-preserving modification. The technique will aim to preserve supramontanal and perimontanal tissue near the verumontanum and preserve bladder-neck fibers when technically feasible, while performing anatomical enucleation of the obstructing prostatic adenoma. A Foley catheter will be inserted at the end of the procedure.

Procedure: Ejaculation-Preserving Holmium Laser Enucleation of the Prostate

Interventions

Water Vapor Thermal Therapy PROCEDURE

Transurethral convective radiofrequency water vapor thermal therapy for symptomatic benign prostatic hyperplasia. Water vapor injections will be delivered into the obstructing prostatic tissue according to prostate configuration and prostatic urethral length. Median lobe treatment will be performed when present and technically suitable. A Foley catheter will be inserted at the end of the procedure.

Water Vapor Thermal Therapy

Ejaculation-Preserving Holmium Laser Enucleation of the Prostate PROCEDURE

Holmium Laser Enucleation of the Prostate using an ejaculation-preserving modification for symptomatic benign prostatic hyperplasia. The technique will aim to preserve supramontanal and perimontanal tissue near the verumontanum and preserve bladder-neck fibers when technically feasible, while performing anatomical enucleation of the obstructing prostatic adenoma. A Foley catheter will be inserted at the end of the procedure.

Ejaculation-Preserving Holmium Laser Enucleation of the Prostate

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) of 13 or higher.
• Prostate volume 30 to 80 mL measured by transrectal ultrasound.
• Maximum urinary flow rate (Qmax) of 15 mL/s or less with voided volume of at least 150 mL.
• Post-void residual urine volume of 250 mL or less.
• Failure, intolerance, or unwillingness 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.
• 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

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

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: Open-label study. Masking is not feasible because the two procedures differ in technique, anesthesia, postoperative recovery, catheterization duration, and follow-up care.
• 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: Prospective, non-randomized, parallel-group comparative study. Eligible patients with symptomatic benign prostatic hyperplasia will choose either Water Vapor Thermal Therapy (Rezum) or ejaculation-preserving Holmium Laser Enucleation of the Prostate after standardized counseling and shared decision-making with the treating physician. Outcomes will be compared between the two treatment groups during 12 months of follow-up.

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)