Ejaculation-Preserving Versus Standard Bipolar TUEP for BPH (EP-BTUEP)

Bipolar Transurethral Enucleation of the Prostate With Preservation of Ejaculation in Patients With Benign Prostatic Hyperplasia: A Randomized Controlled Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Lower Urinary Tract Symptoms; Benign Prostatic Hyperplasia; Benign Prostatic Obstruction
• Intervention / Treatment: Procedure: Ejaculation-Preserving Bipolar Transurethral Enucleation of the Prostate; Procedure: Standard Bipolar Transurethral Enucleation of the Prostate

Detailed Description

Benign prostatic hyperplasia is a common cause of lower urinary tract symptoms in aging men. Surgical treatment is indicated when medical therapy fails or when symptoms remain bothersome. Bipolar transurethral enucleation of the prostate is an established endoscopic surgical technique for benign prostatic obstruction, but standard endoscopic prostate surgery may be associated with loss of antegrade ejaculation.

This study will evaluate whether an ejaculation-preserving modification of bipolar transurethral enucleation of the prostate can preserve ejaculatory function while maintaining effective relief of lower urinary tract symptoms. The ejaculation-preserving 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. The control group will undergo standard bipolar transurethral enucleation of the prostate.

Eligible sexually active men with benign prostatic hyperplasia and lower urinary tract symptoms after failed medical treatment will be randomized in a 1:1 ratio to ejaculation-preserving B-TUEP or standard B-TUEP. Sexual and urinary outcomes will be assessed using validated questionnaires and objective urinary parameters. Follow-up assessments will include ejaculatory function, erectile function, International Prostate Symptom Score, post-void residual urine, uroflowmetry, perioperative complications, and need for retreatment.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hany F Badawy, MD; Phone Number: +201149525028; Email: HANYFATHY86@GMAIL.COM

Study Locations

• Egypt
  • Beni Suweif Governorate
    • Banī Suwayf, Beni Suweif Governorate, Egypt
      • Recruiting
      • Department of Urology- Beni-Suef University Hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ejaculation-Preserving B-TUEP; 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; 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.
Active Comparator: Standard B-TUEP; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Male Sexual Health Questionnaire Ejaculatory Dysfunction Short Form Bother Score at 6 Months	Ejaculatory bother will be assessed using the bother item of the Male Sexual Health Questionnaire Ejaculatory Dysfunction Short Form. The bother score ranges from 0 to 5, with higher scores indicating greater bother related to ejaculatory dysfunction.	6 months postoperatively
Preservation of Antegrade Ejaculation at 6 Months	The proportion of participants with preserved antegrade ejaculation at 6 months after surgery will be compared between the ejaculation-preserving B-TUEP group and the standard B-TUEP group. Preserved antegrade ejaculation will be defined as patient-reported antegrade seminal emission during orgasm after resumption of sexual activity. Participants reporting absent ejaculation, dry ejaculation, or retrograde ejaculation will be considered not to have preserved antegrade ejaculation.	6 months postoperatively
Change in International Index of Erectile Function-5 Score From Baseline to 6 Months	Erectile function will be assessed using the International Index of Erectile Function-5 questionnaire. The total score ranges from 5 to 25, with higher scores indicating better erectile function. The outcome will be calculated as the 6-month postoperative score minus the baseline score.	Baseline and 6 months postoperatively
Change in International Prostate Symptom Score From Baseline to 6 Months	Lower urinary tract symptoms will be assessed using the International Prostate Symptom Score. The total score ranges from 0 to 35, with higher scores indicating more severe urinary symptoms. The outcome will be calculated as the 6-month postoperative score minus the baseline score.	Baseline and 6 months postoperatively
Change in Maximum Urinary Flow Rate From Baseline to 6 Months	Maximum urinary flow rate will be measured by uroflowmetry and reported in milliliters per second. The outcome will be calculated as the 6-month postoperative maximum urinary flow rate minus the baseline maximum urinary flow rate.	Baseline and 6 months postoperatively

Collaborators and Investigators

• Sponsor: Beni-Suef University
• Investigators: Principal Investigator: Hany F Badawy, MD, Faculty of medicine Beni-Suef University

Study record dates

Study Major Dates

• Study Start (Actual): September 8, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: June 1, 2026
• First Submitted That Met QC Criteria: June 1, 2026
• First Posted (Actual): June 5, 2026

Study Record Updates

• Last Update Posted (Actual): June 5, 2026
• Last Update Submitted That Met QC Criteria: June 1, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: International Prostate Symptom Score; Bipolar transurethral enucleation of the prostate; B-TUEP; Ejaculation preservation
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Urological Manifestations; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Prostatic Hyperplasia; Lower Urinary Tract Symptoms
• Other Study ID Numbers: FMBSUREC07092025EjBTUEP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be shared because the study includes individual-level clinical, operative, urinary, and sexual function data from participants undergoing surgery for benign prostatic hyperplasia. Only aggregated, de-identified study results will be reported in publications or presentations. Any future data sharing request will require approval from the Research Ethics Committee, Faculty of Medicine, Beni-Suef University.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No