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

Beni-Suef University

Status: Completed

Conditions: Benign Prostate Hypertrophy(BPH)

Treatments: Procedure: Water Vapor Thermal Therapy; Procedure: Holmium Laser Enucleation of the Prostate (HoLEP)

Study type: Interventional

Funder types: Other

Identifiers

NCT07566689

FMBSUREC/03032024/Salem

Details and patient eligibility

About

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.

Full 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.

Enrollment: 110 patients

Sex: Male

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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110 participants in 2 patient groups

HoLEP Group

Experimental group

Description:

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

Treatment:

Procedure: Holmium Laser Enucleation of the Prostate (HoLEP)

Rezum Group

Experimental group

Description:

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

Treatment:

Procedure: Water Vapor Thermal Therapy