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Ejaculation-Preserving Versus Standard Bipolar TUEP for BPH

ConditionsBenign Prostatic HyperplasiaLower Urinary Tract SymptomsBenign Prostatic Obstruction
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age50+
SponsorBeni-Suef University

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Preoperative sexual dysfunction.

Preoperative ejaculatory dysfunction.

Diagnosis or suspicion of prostate cancer.

Neurological disorders affecting lower urinary tract or sexual function.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Ejaculation-Preserving Bipolar Transurethral Enucleation of the Prostate

    Procedure/Surgery

    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/Surgery

    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.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Ejaculation-Preserving B-TUEPExperimental treatment 1 intervention
Group B: Standard B-TUEPActive comparator 1 intervention

Trial outcomes

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.

Time frame
Baseline and 6 months postoperatively

Secondary outcomes

1

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.

Time frame
6 months postoperatively
2

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.

Time frame
6 months postoperatively
3

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.

Time frame
Baseline and 6 months postoperatively
4

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.

Time frame
Baseline and 6 months postoperatively

Other outcomes

Sponsors and contacts

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Beni-Suef University

Lead sponsor

Source ClinicalTrials.gov
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