Enlarged Prostate (BPH) Clinical Trials

Find Enlarged Prostate (BPH) Clinical Trials Near You

Water Vapor Thermal Therapy Versus Ejaculation-Sparing Bipolar Transurethral 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 (WVTT/Rezum) versus Ejaculation-Sparing Bipolar Transurethral Enucleation of the Prostate (ES-B-TUEP) in sexually active men with symptomatic benign prostatic hyperplasia. Eligible patients will have moderate-to-severe lower urinary tract symptoms, preserved antegrade ejaculation at baseline, and will be candidates for procedural treatment after failure, intolerance, or unwillingness to continue medical therapy. This is not a randomized study. Treatment selection will be based on shared decision-making between the patient and the treating surgeon after standardized counseling about both procedures. The study will compare ejaculatory function, urinary symptom improvement, urinary flow, post-void residual urine, erectile function, perioperative outcomes, complications, catheterization duration, hospital stay, medication restart, and retreatment or reintervention during follow-up. The primary outcome will be the change in the Male Sexual Health Questionnaire-Ejaculatory Dysfunction Short Form Function domain score from baseline to 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) 13 or higher.

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

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

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

• Failed, intolerant, or unwilling 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 / Rezum
Patients in this arm will undergo transurethral convective radiofrequency water vapor thermal therapy using the Rezum system for symptomatic benign prostatic hyperplasia. Treatment will be performed according to standard procedural principles, including cystoscopic assessment, delivery of water vapor injections into the obstructing prostatic tissue, treatment of the median lobe when present and technically suitable, and Foley catheter placement at the end of the procedure.
Active_comparator: Ejaculation-Sparing Bipolar Transurethral Enucleation
Patients in this arm will undergo ejaculation-sparing bipolar transurethral enucleation of the prostate for symptomatic benign prostatic hyperplasia. The procedure will be performed using a standardized anatomy-adapted technique aiming to remove the obstructing adenoma while preserving peri-montanal, supra-montanal, ejaculatory hood, and bladder-neck related structures whenever technically feasible, followed by Foley catheter placement at the end of the procedure.
Related Therapeutic Areas
Sponsors
Leads: Beni-Suef University

This content was sourced from clinicaltrials.gov