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NCT Number: NCT07629479

Ejaculation-Preserving Versus Standard Bipolar TUEP for BPH

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.

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Key information

Age range

50 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Department of Urology- Beni-Suef University Hospitals

Banī Suwayf, Beni Suweif Governorate, Egypt

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

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

    Time frame: 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.

Secondary outcomes

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

    Time frame: 6 months postoperatively

    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.

  2. Preservation of Antegrade Ejaculation at 6 Months

    Time frame: 6 months postoperatively

    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.

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

    Time frame: Baseline and 6 months postoperatively

    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.

  4. Change in International Prostate Symptom Score From Baseline to 6 Months

    Time frame: Baseline and 6 months postoperatively

    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.

  5. Change in Maximum Urinary Flow Rate From Baseline to 6 Months

    Time frame: Baseline and 6 months postoperatively

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Hany F Badawy, MD

CONTACT

[email protected]

+201149525028

Sponsors and collaborators

Lead sponsor

Beni-Suef University

Other

Registry information

Official study title

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

Acronym: EP-BTUEP

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 5, 2026
Registry last updated
Jun 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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