Holmium Laser Enucleation Of the Prostate Versus Water Vapor Therapy Of The Prostate on Sexual Function and Ejaculation

April 30, 2026 updated by: Mahmoud Abdallah, Beni-Suef University

A Comparative Study of the Effect of Holmium Laser Enucleation of the Prostate Versus Water Vapor Therapy of the Prostate on Sexual Function and Ejaculation

This study aims to compare the effect of holmium laser enucleation of the prostate (HoLEP) versus water vapor therapy (Rezum) on sexual function and ejaculation in patients with benign prostatic hyperplasia (BPH).

Benign prostatic hyperplasia is a common condition affecting aging men and may lead to lower urinary tract symptoms requiring surgical intervention. While both HoLEP and Rezum are effective minimally invasive treatments, their impact on sexual function, particularly ejaculation, remains an important concern.

Participants will be assigned to undergo either HoLEP or Rezum therapy. Sexual function and ejaculatory outcomes will be evaluated using validated questionnaires before and after treatment. The study aims to determine which modality provides better preservation of sexual function while maintaining clinical efficacy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Benign prostatic hyperplasia (BPH) is a prevalent condition in aging males and is commonly associated with lower urinary tract symptoms (LUTS) that significantly affect quality of life. Surgical intervention is indicated in patients who fail medical therapy or present with complications.

Holmium laser enucleation of the prostate (HoLEP) is considered a gold standard surgical treatment for BPH, offering durable outcomes and effective removal of prostatic adenoma. However, it is frequently associated with postoperative retrograde ejaculation.

Water vapor thermal therapy (Rezum) is a minimally invasive treatment that uses convective water vapor energy to ablate prostatic tissue, with the potential advantage of preserving sexual and ejaculatory function.

This prospective comparative study aims to evaluate and compare the effects of HoLEP and Rezum on sexual function and ejaculatory outcomes. Eligible patients with BPH will be allocated to one of the two treatment groups according to the study protocol.

Primary outcomes include changes in sexual function and ejaculatory status assessed using validated questionnaires. Secondary outcomes include improvement in urinary symptoms and treatment-related complications.

The findings of this study may help guide clinical decision-making by balancing treatment efficacy with preservation of sexual function.

Study Type

Interventional

Enrollment (Actual)

110

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Banī Suwayf, Egypt, 62511
        • Beni-suef university Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Male patients aged 50 years or older
  • Diagnosed with benign prostatic hyperplasia (BPH)
  • Presence of lower urinary tract symptoms (LUTS)
  • International Prostate Symptom Score (IPSS) ≥ 13
  • Peak urinary flow rate (Qmax) ≤ 15 mL/s
  • Failure of medical therapy for BPH
  • Sexually active and in a stable relationship

Exclusion Criteria:

  • History of prostate cancer
  • Prior prostate surgery
  • Neurogenic bladder dysfunction
  • Urethral stricture disease
  • Active urinary tract infection
  • Severe comorbidities contraindicating surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HoLEP Group
Patients undergoing holmium laser enucleation of the prostate for management of benign prostatic hyperplasia.
Procedure: Holmium Laser Enucleation of the Prostate (HoLEP)
Holmium laser enucleation of the prostate is an endoscopic surgical procedure used for the treatment of benign prostatic hyperplasia. It involves complete enucleation of the prostatic adenoma using a holmium laser, followed by tissue morcellation.
Experimental: Rezum Group
Patients undergoing water vapor thermal therapy (Rezum) for management of benign prostatic hyperplasia.
Procedure: Water Vapor Thermal Therapy
Water vapor thermal therapy (Rezum) is a minimally invasive procedure that uses convective radiofrequency-generated water vapor to ablate hyperplastic prostatic tissue, aiming to relieve lower urinary tract symptoms while preserving sexual function.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Sexual Function
Time Frame: Baseline and 6 months after treatment
Change in sexual function assessed using validated patient-reported outcome measures (e.g., International Index of Erectile Function [IIEF] comparing baseline to post-treatment values.the IIEF score range from 5 to 25 with higher scores indicating better erectile function.
Baseline and 6 months after treatment
Change in ejaculatory function
Time Frame: Baseline and 6 months after treatment
Change in ejaculatory function assessed using validated patient-reported outcome measures (e.g., male sexual health questionnaire-Ejaculatory Dysfunction domain(MSHQ-EjD) comparing baseline to post-treatment values with higher scores indicating better ejaculatory function.
Baseline and 6 months after treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Lower Urinary Tract Symptoms Score (IPSS)
Time Frame: Baseline and 6 months after treatment
Change in lower urinary tract symptoms severity assessed using the International Prostate Symptom Score (IPSS) comparing baseline to post-treatment values. score range from 0 to 35 with higher scores indicating worse symptoms.
Baseline and 6 months after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beni-Suef University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 3, 2024

Primary Completion (Actual)

December 3, 2025

Study Completion (Actual)

January 3, 2026

Study Registration Dates

First Submitted

April 25, 2026

First Submitted That Met QC Criteria

April 30, 2026

First Posted (Actual)

May 5, 2026

Study Record Updates

Last Update Posted (Actual)

May 5, 2026

Last Update Submitted That Met QC Criteria

April 30, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FMBSUREC/03032024/Salem

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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