NCT07648888Recruiting
Water Vapor Thermal Therapy Versus Ejaculation-Sparing Bipolar Transurethral Enucleation for Benign Prostatic Hyperplasia
Water Vapor Thermal Therapy Versus Ejaculation-Sparing Bipolar Transurethral Enucleation of the Prostate for Benign Prostatic Hyperplasia: A Prospective Comparative Study
Source: ClinicalTrials.gov · Last updated 15 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- First submitted
- 10 Jun 2026
- Start date
- 8 Jun 2026
- Primary completion date
- Nov 2027
- Lead sponsor
- Beni-Suef University
- NCT number
- NCT07648888
What you commit to
- Study type: Interventional
- Planned participants: 120
- From 8 Jun 2026 to the primary completion date, Nov 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous prostate surgery.
- Previous urethral surgery likely to affect instrumentation or study outcomes.
- Bladder stones requiring concomitant surgery.
- No sexual activity during the previous 3 months.
- Anticoagulation or antiplatelet therapy that cannot be safely managed perioperatively.
Other illness
- 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.
- Urethral stricture disease.
- Active urinary tract infection until adequately treated.
Other
- Neurogenic bladder dysfunction.
- Prostate volume less than 30 mL or more than 80 mL.
- Baseline anejaculation or severe ejaculatory dysfunction.
- 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.
- Unfitness for anesthesia or intervention.
- Inability or unwillingness to comply with follow-up.
Who the study is looking for
- 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.
Age in the registry: 50 years to - · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of Urology- Beni-Suef University Hospitals Coordinator of this site? Confirm its status | Banī Suwayf | Egypt | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.