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

NCT07566689 | Completed

• 1 other identifier: FMBSUREC/03032024/Salem
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Benign Prostate Hypertrophy(BPH)

Outcome Measures

Primary Outcomes (2)

• Change in Sexual Function

  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

  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 Outcomes (1)

• Change in Lower Urinary Tract Symptoms Score (IPSS)

  Baseline and 6 months after treatment

Study Arms (2)

HoLEP Group

EXPERIMENTAL

Patients undergoing holmium laser enucleation of the prostate for management of benign prostatic hyperplasia.

Procedure: Holmium Laser Enucleation of the Prostate (HoLEP)

Rezum Group

EXPERIMENTAL

Patients undergoing water vapor thermal therapy (Rezum) for management of benign prostatic hyperplasia.

Procedure: Water Vapor Thermal Therapy

Interventions

Holmium Laser Enucleation of the Prostate (HoLEP) PROCEDURE

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.

HoLEP Group

Water Vapor Thermal Therapy PROCEDURE

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.

Rezum Group

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Beni-Suef University: lead

Study Sites (1)

Beni-Suef University Hospital

Banī Suwayf, 62511, Egypt

Location

MeSH Terms

Conditions

Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of urology

Study Record Dates

• First Submitted: April 25, 2026
• First Posted: May 5, 2026
• Study Start: April 3, 2024
• Primary Completion: December 3, 2025
• Study Completion: January 3, 2026
• Last Updated: May 5, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

EG (1)