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Recruiting NCT07648888

Water Vapor Thermal Therapy Versus Ejaculation-Sparing Bipolar Transurethral Enucleation for Benign Prostatic Hyperplasia

Conditions: Benign Prostatic Hyperplasia, Lower Urinary Tract Symptoms, Ejaculatory Dysfunction

Sex: Male
Ages: 50 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 120
Sponsor: Beni-Suef University

Location: Department of Urology- Beni-Suef University Hospitals Banī Suwayf Beni Suweif Governorate

Summary

This prospective comparative study will evaluate Water Vapor Thermal Therapy (WVTT/Rezum) versus Ejaculation-Sparing Bipolar Transurethral Enucleation of the Prostate (ES-B-TUEP) in sexually active men with symptomatic benign prostatic hyperplasia. Eligible patients will have moderate-to-severe lower urinary tract symptoms, preserved antegrade ejaculation at baseline, and will be candidates for procedural treatment after failure, intolerance, or unwillingness to continue medical therapy. This is not a randomized study. Treatment selection will be based on shared decision-making between the patient and the treating surgeon after standardized counseling about both procedures. The study will compare ejaculatory function, urinary symptom improvement, urinary flow, post-void residual urine, erectile function, perioperative outcomes, complications, catheterization duration, hospital stay, medication restart, and retreatment or reintervention during follow-up. The primary outcome will be the change in the Male Sexual Health Questionnaire-Ejaculatory Dysfunction Short Form Function domain score from baseline to 12 months.

Eligibility Criteria

Inclusion Criteria: * Male patients aged 50 years or older. * Symptomatic benign prostatic hyperplasia with moderate-to-severe lower urinary tract symptoms. * International Prostate Symptom Score (IPSS) 13 or higher. * Prostate volume 30 to 80 mL measured by transrectal ultrasound. * Maximum urinary flow rate (Qmax) 15 mL/s or less with voided volume 150 mL or more. * Post-void residual urine volume 250 mL or less. * Failed, intolerant, or unwilling to continue medical therapy for benign prostatic hyperplasia. * Sexually active within the previous 3 months. * Preserved antegrade ejaculation at baseline. * Patient wishes to preserve ejaculation. * Ability to complete the International Prostate Symptom Score (IPSS), International Index of Erectile Function-5 (IIEF-5), and Male Sexual Health Questionnaire-Ejaculatory Dysfunction Short Form (MSHQ-EjD-SF). * Written informed consent. Exclusion Criteria: * Suspected or confirmed prostate cancer. * Abnormal prostate-specific antigen or digital rectal examination suspicious for malignancy unless prostate cancer has been excluded according to standard clinical practice. * Previous prostate surgery. * Previous urethral surgery likely to affect instrumentation or study outcomes. * Urethral stricture disease. * Neurogenic bladder dysfunction. * Active urinary tract infection until adequately treated. * Bladder stones requiring concomitant surgery. * Prostate volume less than 30 mL or more than 80 mL. * Baseline anejaculation or severe ejaculatory dysfunction. * No sexual activity during the previous 3 months. * Chronic indwelling urethral or suprapubic catheter. * Recurrent urinary retention or suspected detrusor underactivity requiring urodynamic clarification. * Post-void residual urine volume more than 250 mL. * Uncontrolled coagulopathy. * Anticoagulation or antiplatelet therapy that cannot be safely managed perioperatively. * Unfitness for anesthesia or intervention. * Inability or unwillingness to comply with follow-up.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07648888). StuddyBuddy aggregates publicly available trial information.