Enlarged Prostate (BPH) Clinical Trials

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Water Vapor Thermal Therapy Versus Ejaculation-Preserving Holmium Laser Enucleation of the Prostate for Benign Prostatic Hyperplasia: A Prospective Comparative Study

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

This prospective comparative study will evaluate Water Vapor Thermal Therapy (Rezum) versus ejaculation-preserving Holmium Laser Enucleation of the Prostate (EP-HoLEP) in sexually active men with symptomatic benign prostatic hyperplasia and prostate volume 30-80 mL. Eligible patients will not be randomized. The treatment option will be selected through shared decision-making between the patient and treating physician after standardized counseling about the expected benefits, risks, recovery, catheter duration, urinary outcomes, durability, and potential effects on ejaculation and sexual function. The main objective is to compare the change in ejaculatory function from baseline to 12 months using the Male Sexual Health Questionnaire-Ejaculatory Dysfunction-Short Form (MSHQ-EjD-SF) Function domain. Secondary outcomes will include urinary symptom improvement, quality of life, maximum urinary flow rate, post-void residual urine volume, erectile function, antegrade ejaculation preservation, catheterization duration, hospital stay, complications, restart of benign prostatic hyperplasia medication, and retreatment or reintervention within 12 months.

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 50
Healthy Volunteers: f
View:

• Male patients aged 50 years or older.

• Symptomatic benign prostatic hyperplasia with moderate-to-severe lower urinary tract symptoms.

• International Prostate Symptom Score (IPSS) of 13 or higher.

• Prostate volume 30 to 80 mL measured by transrectal ultrasound.

• Maximum urinary flow rate (Qmax) of 15 mL/s or less with voided volume of at least 150 mL.

• Post-void residual urine volume of 250 mL or less.

• Failure, intolerance, or unwillingness to continue medical therapy for benign prostatic hyperplasia.

• Sexually active within the previous 3 months.

• Preserved antegrade ejaculation at baseline.

• Patient wishes to preserve ejaculation.

• Ability to complete the International Prostate Symptom Score (IPSS), International Index of Erectile Function-5 (IIEF-5), and Male Sexual Health Questionnaire-Ejaculatory Dysfunction-Short Form (MSHQ-EjD-SF).

• Written informed consent.

Locations
Other Locations
Egypt
Department of Urology- Beni-Suef University Hospitals
RECRUITING
Banī Suwayf
Contact Information
Primary
Hany F Badawy, MD
HANYFATHY86@GMAIL.COM
+201149525028
Time Frame
Start Date: 2026-06-08
Estimated Completion Date: 2027-12
Participants
Target number of participants: 120
Treatments
Active_comparator: Water Vapor Thermal Therapy
Patients in this group will undergo transurethral convective radiofrequency water vapor thermal therapy using the Rezum system for symptomatic benign prostatic hyperplasia. Vapor injections will be delivered into the obstructing prostatic tissue according to prostate configuration and prostatic urethral length. Median lobe treatment will be performed when present and technically suitable. A Foley catheter will be inserted at the end of the procedure.
Active_comparator: Ejaculation-Preserving Holmium Laser Enucleation of the Prostate
Patients in this group will undergo Holmium Laser Enucleation of the Prostate using an ejaculation-preserving modification. The technique will aim to preserve supramontanal and perimontanal tissue near the verumontanum and preserve bladder-neck fibers when technically feasible, while performing anatomical enucleation of the obstructing prostatic adenoma. A Foley catheter will be inserted at the end of the procedure.
Related Therapeutic Areas
Sponsors
Leads: Beni-Suef University

This content was sourced from clinicaltrials.gov