Department of Urology- Beni-Suef University Hospitals
Banī Suwayf, Beni Suweif Governorate, Egypt
Location status: Recruiting
NCT Number: NCT07629479
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.
Interested in participating?
Request Info50 year and older
Male
Interventional
Not applicable
Banī Suwayf, Beni Suweif Governorate, Egypt
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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 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.
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.
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.
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.
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.
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.
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.
Contact information is provided by the study sponsor or research team.
Beni-Suef University
Other
Bipolar Transurethral Enucleation of the Prostate With Preservation of Ejaculation in Patients With Benign Prostatic Hyperplasia: A Randomized Controlled Trial
Acronym: EP-BTUEP
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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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