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

Water Vapor Thermal Therapy Versus Ejaculation-Preserving Holmium Laser Enucleation of the Prostate for Benign Prostatic Hyperplasia: A Prospective Comparative Study

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.

Study Overview

• Status: Recruiting
• Conditions: Lower Urinary Tract Symptoms; Benign Prostatic Hyperplasia
• Intervention / Treatment: Procedure: Water Vapor Thermal Therapy; Procedure: Ejaculation-Preserving Holmium Laser Enucleation of the Prostate

Detailed Description

Benign prostatic hyperplasia is a common cause of male lower urinary tract symptoms. Treatment selection depends on symptom severity, prostate volume, degree of obstruction, comorbidities, patient preference, expected durability, perioperative morbidity, and the patient's wish to preserve sexual and ejaculatory function.

Water Vapor Thermal Therapy, commercially known as Rezum, is a minimally invasive transurethral therapy that uses convective radiofrequency-generated water vapor to ablate obstructing prostatic tissue. It is commonly used for men with moderate-to-severe lower urinary tract symptoms due to benign prostatic hyperplasia and is considered attractive for patients wishing to preserve sexual and ejaculatory function.

Holmium Laser Enucleation of the Prostate is an effective endoscopic anatomical enucleation procedure for benign prostatic obstruction. Conventional HoLEP provides strong de-obstructive efficacy but may be associated with ejaculatory dysfunction. Ejaculation-preserving HoLEP uses technical modifications aiming to preserve antegrade ejaculation while maintaining adequate relief of obstruction.

This study is a prospective, controlled, non-randomized comparative clinical study conducted at the Department of Urology, Beni-Suef University Hospital, Egypt. Sexually active men aged 50 years or older with symptomatic benign prostatic hyperplasia, prostate volume 30-80 mL, International Prostate Symptom Score of 13 or higher, maximum urinary flow rate of 15 mL/s or less, preserved antegrade ejaculation at baseline, and desire to preserve ejaculation will be eligible.

Patients will not be randomly allocated. Each eligible patient will receive standardized counseling about both treatment options, including the mechanism of action, anesthesia, expected urinary improvement, potential effect on ejaculation and erectile function, catheterization duration, hospital stay, possible complications, retreatment risk, and alternative management options. The final treatment decision will be made through shared decision-making between the patient and treating physician.

Patients selecting Water Vapor Thermal Therapy will undergo transurethral convective water vapor treatment using the Rezum system according to standard procedural principles. Vapor injections will be delivered into 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.

Patients selecting ejaculation-preserving HoLEP will undergo Holmium Laser Enucleation of the Prostate using a standardized ejaculation-sparing 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 adenoma. A standardized operative checklist will document whether the ejaculation-preserving steps were fully, partially, or not successfully achieved.

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

Participants will be followed at 1, 3, 6, and 12 months after the procedure. Follow-up assessment will include urinary symptoms, quality of life, maximum urinary flow rate, post-void residual urine volume, erectile function, ejaculatory function, antegrade ejaculation status, adverse events, complications, restart of benign prostatic hyperplasia medication, and any retreatment or reintervention.

The primary outcome is the change in the MSHQ-EjD-SF Function domain score from baseline to 12 months. Secondary outcomes include change in MSHQ-EjD-SF Bother score, change in International Index of Erectile Function-5 score, proportion of patients preserving antegrade ejaculation, change in International Prostate Symptom Score, change in IPSS 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 within 12 months.

Because this is a non-randomized comparative study, baseline differences between groups will be assessed. Adjusted analyses using multivariable regression and propensity-score methods may be performed to reduce allocation bias.

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

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.
• 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; 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; 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.
Active Comparator: Ejaculation-Preserving Holmium Laser Enucleation of the Prostate; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Male Sexual Health Questionnaire-Ejaculatory Dysfunction-Short Form Bother Item Score	Change from baseline to 12 months in the Bother item score of the Male Sexual Health Questionnaire-Ejaculatory Dysfunction-Short Form (MSHQ-EjD-SF). The Bother item assesses the degree of bother related to ejaculatory dysfunction and will be scored according to the validated questionnaire scoring system used in the study.	Baseline and 12 months after the procedure
Change in International Index of Erectile Function-5 Score	Change from baseline to 12 months in the International Index of Erectile Function-5 (IIEF-5) score. The IIEF-5 assesses erectile function. The total score ranges from 5 to 25, with higher scores indicating better erectile function.	Baseline and 12 months after the procedure
Change in International Prostate Symptom Score	Change from baseline in the International Prostate Symptom Score (IPSS). The IPSS assesses lower urinary tract symptom severity. The total score ranges from 0 to 35, with higher scores indicating worse urinary symptoms.	Baseline, 1 month, 3 months, 6 months, and 12 months after the procedure
Change in Maximum Urinary Flow Rate	Change from baseline in maximum urinary flow rate (Qmax), measured by uroflowmetry and reported in mL/s. Higher values indicate better urinary flow.	Baseline, 1 month, 3 months, 6 months, and 12 months after the procedure
Change in Post-Void Residual Urine Volume	Change from baseline in post-void residual urine volume (PVR), measured by ultrasound and reported in mL. Lower values indicate better bladder emptying.	Baseline, 1 month, 3 months, 6 months, and 12 months after the procedure

Collaborators and Investigators

• Sponsor: Beni-Suef University

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: Rezum; Water Vapor Thermal Therapy; Ejaculation-Preserving HoLEP; Male Sexual Health Questionnaire
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Urological Manifestations; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Prostatic Hyperplasia; Lower Urinary Tract Symptoms
• Other Study ID Numbers: BSU-REZUM-EJPHOLEP-2026

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be publicly shared. Study results will be reported in aggregate form only. Participant data will be coded and kept confidential according to institutional ethics requirements and written informed consent.

Drug and device information, study documents

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