An interventional study of Holmium Laser Enucleation of the Prostate (HoLEP) and Water Vapor Thermal Therapy in Benign Prostate Hypertrophy(BPH), sponsored by Beni-Suef University. Completed at 1 site in Egypt. Open to male participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2026-05-05.
Sponsored by Beni-Suef University · Not applicable, Interventional, and Treatment
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.
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.
783 studies on the registry are indexed under Prostatic Hyperplasia; 174 are open to participants now.
This study's enrollment of 110 is above the median of 97 across 593 interventional studies indexed under Prostatic Hyperplasia.
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Exclusion Criteria:
Patients undergoing holmium laser enucleation of the prostate for management of benign prostatic hyperplasia.
Procedure: Holmium Laser Enucleation of the Prostate (HoLEP)
Patients undergoing water vapor thermal therapy (Rezum) for management of benign prostatic hyperplasia.
Procedure: Water Vapor Thermal Therapy
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 (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.
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.
Time frame: 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.
Time frame: Baseline and 6 months after treatment
Change in Lower Urinary Tract Symptoms Score (IPSS)
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.
Time frame: Baseline and 6 months after treatment
Plan to share: Yes
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This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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Beni-Suef University