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Recruiting Not applicable

Ejaculation-Preserving Versus Standard Bipolar TUEP for BPH

NCT07629479 · tracked via the Priya Life Science Egypt tracker
Phase
Not applicable
Started
2025-09-08
Last updated
2026-06-05

Condition(s) studied

Benign Prostatic HyperplasiaLower Urinary Tract SymptomsBenign Prostatic Obstruction

Investigational drug(s) / intervention(s)

Ejaculation-Preserving Bipolar Transurethral Enucleation of the ProstateStandard Bipolar Transurethral Enucleation of the Prostate

Ejaculation-Preserving Bipolar Transurethral Enucleation of the Prostate: Ejaculation-preserving bipolar transurethral enucleation of the prostate will be performed with preservation of the paracollicular tissue, the area approximately 1 cm proximal to the verumontanum, and bladder neck fibers, while avoiding deep enucleation behind the verumontanum.

Standard Bipolar Transurethral Enucleation of the Prostate: Standard bipolar transurethral enucleation of the prostate will be performed according to the conventional surgical technique without preservation of the paracollicular tissue and the area approximately 1 cm proximal to the verumontanum.

Study summary

This prospective randomized controlled trial will compare ejaculation-preserving bipolar transurethral enucleation of the prostate with standard bipolar transurethral enucleation of the prostate in sexually active men with benign prostatic hyperplasia and lower urinary tract symptoms after failed medical treatment. Participants will be randomly assigned to either ejaculation-preserving B-TUEP or standard B-TUEP. The study will evaluate preservation of ejaculatory function, erectile function, urinary symptom improvement, uroflowmetry outcomes, post-void residual urine, perioperative complications, and need for retreatment during follow-up.

Eligibility

Sex
MALE
Min age
50 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Male patients with lower urinary tract symptoms secondary to benign prostatic obstruction after failed medical treatment for at least 3 months. * Sexually active patients with a continuous relationship with the same partner. * International Prostate Symptom Score of 8 or greater. * Transrectal ultrasound-estimated prostate size between 40 and 100 cc. * Eligible for bipolar transurethral enucleation of the prostate. * Ability to complete the required sexual and urinary function questionnaires. * Ability to provide written informed consent. Exclusion Criteria: * Preoperative sexual dysfunction. * Preoperative ejaculatory dysfunction. * Diagnosis or suspicion of prostate cancer. * Neurological disorders affecting lower urinary tract or sexual function. * Detrusor hypocontractility. * Catheter-dependent patients. * Patients with bladder stones. * Inability or refusal to provide informed consent.

Primary outcome measure(s)

  • Change in Male Sexual Health Questionnaire Ejaculatory Dysfunction Short Form Function Score From Baseline to 6 Months — Baseline and 6 months postoperatively
    Ejaculatory function will be assessed using the Male Sexual Health Questionnaire Ejaculatory Dysfunction Short Form function score. The function score is based on three ejaculatory function items assessing ejaculation frequency, ejaculation force, and ejaculation volume. The total function score ranges from 1 to 15, with higher scores indicating better ejaculatory function. The outcome will be calculated as the 6-month postoperative score minus the baseline score. A smaller decrease or a positive change indicates better preservation of ejaculatory function.

Trial sites (1)

FacilityCityRegionStatus
Department of Urology- Beni-Suef University Hospitals Banī Suwayf Beni Suweif Governorate Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07629479 on ClinicalTrials.gov ↗ ← All trials in Egypt