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