Ejaculation-Preserving Versus Standard Bipolar TUEP for BPH

NCT07629479 | Recruiting

• 1 other identifier: FMBSUREC07092025EjBTUEP
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Benign Prostatic Obstruction; Benign Prostatic Hyperplasia; Lower Urinary Tract Symptoms

Keywords

Bipolar transurethral enucleation of the prostate; B-TUEP; Ejaculation preservation; International Prostate Symptom Score

Outcome Measures

Primary Outcomes (1)

• Change in Male Sexual Health Questionnaire Ejaculatory Dysfunction Short Form Function Score From Baseline to 6 Months

  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.

  Baseline and 6 months postoperatively

Secondary Outcomes (5)

• Male Sexual Health Questionnaire Ejaculatory Dysfunction Short Form Bother Score at 6 Months

  6 months postoperatively

• Preservation of Antegrade Ejaculation at 6 Months

  6 months postoperatively

• Change in International Index of Erectile Function-5 Score From Baseline to 6 Months

  Baseline and 6 months postoperatively

• Change in International Prostate Symptom Score From Baseline to 6 Months

  Baseline and 6 months postoperatively

• Change in Maximum Urinary Flow Rate From Baseline to 6 Months

  Baseline and 6 months postoperatively

Study Arms (2)

Ejaculation-Preserving B-TUEP

EXPERIMENTAL

Participants assigned to this arm will undergo ejaculation-preserving bipolar transurethral enucleation of the prostate. The technique will preserve the paracollicular tissue, the area approximately 1 cm proximal to the verumontanum, and bladder neck fibers, while avoiding deep enucleation behind the verumontanum.

Procedure: Ejaculation-Preserving Bipolar Transurethral Enucleation of the Prostate

Standard B-TUEP

ACTIVE COMPARATOR

Participants assigned to this arm will undergo standard bipolar transurethral enucleation of the prostate without the ejaculation-preserving modifications used in the experimental arm.

Procedure: Standard Bipolar Transurethral Enucleation of the Prostate

Interventions

Ejaculation-Preserving Bipolar Transurethral Enucleation of the Prostate PROCEDURE

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.

Ejaculation-Preserving B-TUEP

Standard Bipolar Transurethral Enucleation of the Prostate PROCEDURE

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.

Standard B-TUEP

Eligibility Criteria

• Age: 50 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beni-Suef University: lead

Study Sites (1)

Department of Urology- Beni-Suef University Hospitals

Banī Suwayf, Beni Suweif Governorate, Egypt

RECRUITING

MeSH Terms

Conditions

Prostatic Hyperplasia; Lower Urinary Tract Symptoms

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Hany F Badawy, MD

  Faculty of medicine Beni-Suef University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hany F Badawy, MD

CONTACT

+201149525028; HANYFATHY86@GMAIL.COM

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The operating surgeon cannot be blinded because the surgical technique differs between groups. Participants and postoperative outcome assessors will be blinded to treatment allocation whenever feasible.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Urology, Faculty of Medicine, Beni-Suef University

Model Details: Participants will be randomized in a 1:1 ratio to either ejaculation-preserving bipolar transurethral enucleation of the prostate or standard bipolar transurethral enucleation of the prostate.

Study Record Dates

• First Submitted: June 1, 2026
• First Posted: June 5, 2026
• Study Start: September 8, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: June 5, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)