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NCT Number: NCT07566689

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.

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Key information

Conditions

Benign Prostate Hypertrophy(BPH) Genital Diseases Genital Diseases, Male Male Urogenital Diseases Prostatic Diseases Prostatic Hyperplasia Urogenital Diseases

Age range

50 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Beni-Suef University Hospital

Banī Suwayf, 62511, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Beni-Suef University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
May 5, 2026
Registry last updated
May 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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