Water Vapor Thermal Therapy Versus Ejaculation-Sparing Bipolar Transurethral Enucleation for Benign Prostatic Hyperplasia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age50+
SponsorBeni-Suef University
About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Water Vapor Thermal Therapy
Procedure/SurgeryTransurethral convective radiofrequency water vapor thermal therapy will be performed for symptomatic benign prostatic hyperplasia. The procedure includes cystoscopic assessment and delivery of water vapor injections into the obstructing prostatic tissue, including median lobe treatment when present and technically suitable. A Foley catheter will be inserted at the end of the procedure.
Ejaculation-Sparing Bipolar Transurethral Enucleation of the Prostate
Procedure/SurgeryEjaculation-sparing bipolar transurethral enucleation of the prostate will be performed for symptomatic benign prostatic hyperplasia using an anatomy-adapted endoscopic technique. The procedure aims to remove the obstructing adenoma while preserving peri-montanal, supra-montanal, ejaculatory hood, and bladder-neck related structures whenever technically feasible. A Foley catheter will be inserted at the end of the procedure.
Treatment groups
120 Participants
are divided into 2 treatment groupsGroup A: Water Vapor Thermal Therapy / RezumActive comparator 1 intervention
Group B: Ejaculation-Sparing Bipolar Transurethral EnucleationActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in MSHQ-EjD-SF Function Domain Score
Change from baseline to 12 months in the Male Sexual Health Questionnaire-Ejaculatory Dysfunction Short Form (MSHQ-EjD-SF) Function domain score. The Function domain is calculated as the sum of questions 1-3 assessing ejaculation frequency, ejaculation force, and ejaculation volume. The score ranges from 1 to 15, with higher scores indicating better ejaculatory function. The outcome will compare the change score between the Water Vapor Thermal Therapy/Rezum group and the Ejaculation-Sparing Bipolar Transurethral Enucleation group.
Time frame
Baseline and 12 months after interventionSecondary outcomes
1
Change in MSHQ-EjD-SF Bother Item Score
Change from baseline to 12 months in the Male Sexual Health Questionnaire-Ejaculatory Dysfunction Short Form (MSHQ-EjD-SF) Bother item score. The bother item assesses the degree of bother related to ejaculation difficulties. The score ranges from 0 to 5, with higher scores indicating greater ejaculation-related bother. The outcome will compare the change score between the Water Vapor Thermal Therapy/Rezum group and the Ejaculation-Sparing Bipolar Transurethral Enucleation group.
Time frame
Baseline and 12 months after intervention2
Preservation of Antegrade Ejaculation
Proportion of patients who report preserved antegrade ejaculation at 12 months after intervention. Antegrade ejaculation will be assessed by direct patient report during follow-up and compared between the Water Vapor Thermal Therapy/Rezum group and the Ejaculation-Sparing Bipolar Transurethral Enucleation group.
Time frame
12 months after intervention3
Change in IIEF-5 Score
Change from baseline to 12 months in the International Index of Erectile Function-5 (IIEF-5) score. The IIEF-5 score ranges from 5 to 25, with higher scores indicating better erectile function. The outcome will compare the change score between the Water Vapor Thermal Therapy/Rezum group and the Ejaculation-Sparing Bipolar Transurethral Enucleation group.
Time frame
Baseline and 12 months after intervention4
Change in International Prostate Symptom Score
Change from baseline in the International Prostate Symptom Score (IPSS). The IPSS ranges from 0 to 35, with higher scores indicating more severe lower urinary tract symptoms. The outcome will compare symptom improvement between the Water Vapor Thermal Therapy/Rezum group and the Ejaculation-Sparing Bipolar Transurethral Enucleation group.
Time frame
Baseline, 1 month, 3 months, 6 months, and 12 months after interventionSponsors and contacts
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Source ClinicalTrials.gov