Actively Recruiting

Phase Not Applicable
Age: 50Years +
MALE
ID07629479

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

Led by Beni-Suef University · Updated on 2026-06-05

60

Participants Needed

1

Research Sites

4 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to compare two surgical methods for treating benign prostatic hyperplasia (BPH) in sexually active men who have lower urinary tract symptoms and have not improved with medical treatment. It evaluates whether a new ejaculation-preserving bipolar transurethral enucleation of the prostate technique can maintain ejaculatory function while still relieving urinary symptoms. The trial also looks at erectile function, urinary flow, residual urine after urination, complications around surgery, and the need for further treatment. Participants will be randomly assigned to receive either the ejaculation-preserving bipolar transurethral enucleation of the prostate, which preserves specific prostate tissues near the verumontanum to protect ejaculation, or the standard bipolar transurethral enucleation without these modifications. Both procedures are surgical techniques performed endoscopically. The study compares these two approaches to assess their effects on sexual and urinary function over time. During the study, men will be assessed before and after surgery using questionnaires on sexual and urinary function, as well as objective urinary tests such as uroflowmetry and measurements of post-void residual urine. Follow-up will focus on changes in ejaculatory function, erectile function, symptom scores, surgical complications, and retreatment rates. The main outcome is the change in ejaculatory function score from baseline to six months after surgery, with additional assessments made at the same intervals.

CONDITIONS

Brief Title

Ejaculation-Preserving Versus Standard Bipolar TUEP for BPH

Who Can Participate

Age: 50Years +
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • 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.
Not Eligible

You will not qualify if you...

  • 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.

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery and Immediate Post-operative Care

Duration - Day of surgery and immediate recovery period

Participants undergo either ejaculation-preserving or standard bipolar transurethral enucleation of the prostate surgery for benign prostatic hyperplasia.

1 surgery visit and immediate post-operative care

Post-operative Follow-up

Duration - Up to 6 months postoperatively

Participants are followed to assess sexual and urinary function, including ejaculatory function, erectile function, symptom scores, and urinary parameters.

Visits at baseline and 6 months postoperatively

Trial Site Locations

Total: 1 location

1

Department of Urology- Beni-Suef University Hospitals

Banī Suwayf, Beni Suweif Governorate, Egypt

Actively Recruiting

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Research Team

H

Hany F Badawy, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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