Water Vapor Thermal Therapy Versus Ejaculation-Sparing Bipolar Transurethral Enucleation for Benign Prostatic Hyperplasia
Recruiting · NCT07648888 · Interventional (participants receive a specific treatment) · Lead sponsor: Beni-Suef University
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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.
Where it is running
1 location listed.
- Department of Urology- Beni-Suef University Hospitals - Banī Suwayf, Beni Suweif Governorate, Egypt