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

Официальное название

Water Vapor Thermal Therapy Versus Ejaculation-Sparing Bipolar Transurethral Enucleation of the Prostate for Benign Prostatic Hyperplasia: A Prospective Comparative Study

Обзор

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.

Подробное описание

Benign prostatic hyperplasia is a common cause of male lower urinary tract symptoms and may affect quality of life, sleep, daily activity, and sexual health. In sexually active men, preservation of antegrade ejaculation is an important factor in treatment selection and postoperative satisfaction.

Water Vapor Thermal Therapy, commercially known as Rezum, is a minimally invasive transurethral treatment that delivers radiofrequency-generated water vapor into hyperplastic prostatic tissue. It aims to improve bladder outlet obstruction while minimizing sexual adverse effects. Ejaculation-Sparing Bipolar Transurethral Enucleation of the Prostate is an anatomical endoscopic enucleation technique modified to preserve peri-montanal, supra-montanal, ejaculatory hood, and bladder-neck related structures in an attempt to preserve antegrade ejaculation while achieving effective de-obstruction.

This study is designed as a prospective, controlled, non-randomized comparative clinical study. Eligible patients will be enrolled into one of two treatment cohorts: Water Vapor Thermal Therapy/Rezum or Ejaculation-Sparing Bipolar Transurethral Enucleation of the Prostate. Treatment allocation will not be randomized. The final treatment decision will be made through shared decision-making between the patient and treating surgeon after standardized counseling regarding the expected benefits, limitations, anesthesia requirements, catheterization, recovery, possible complications, urinary outcomes, sexual outcomes, and retreatment risk of both procedures.

Baseline assessment will include medical and urological history, sexual history, physical examination, digital rectal examination, urinalysis, urine culture when indicated, complete blood count, serum creatinine, coagulation profile, prostate-specific antigen, pelvic-abdominal ultrasound, transrectal ultrasound for prostate volume, uroflowmetry, post-void residual urine measurement, International Prostate Symptom Score, International Index of Erectile Function-5, and Male Sexual Health Questionnaire-Ejaculatory Dysfunction Short Form.

Patients will be followed after treatment at 1 month, 3 months, 6 months, and 12 months. Follow-up assessments will include urinary symptom scores, quality-of-life score, maximum urinary flow rate, post-void residual urine volume, erectile function, ejaculatory function, antegrade ejaculation status, complications, restart of benign prostatic hyperplasia medication, and any retreatment or reintervention.

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. Secondary outcomes will include change in ejaculation bother, preservation of antegrade ejaculation, change in erectile function, change in International Prostate Symptom Score, change in quality-of-life score, change in maximum urinary flow rate, change in post-void residual urine volume, operative time, catheterization duration, hospital stay, hemoglobin drop, postoperative urinary retention, hematuria or clot retention, urinary tract infection, dysuria, urgency or urge urinary incontinence, stress urinary incontinence, urethral stricture, bladder neck contracture, overall complications graded by the Clavien-Dindo classification, restart of benign prostatic hyperplasia medication, and retreatment or reintervention during 12-month follow-up.

Because this is a non-randomized comparative study, baseline differences between the two cohorts will be addressed using multivariable regression and propensity-score-based analysis where appropriate.

Вмешательства

• Процедура Water Vapor Thermal Therapy
  Transurethral 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.
• Процедура Ejaculation-Sparing Bipolar Transurethral Enucleation of the Prostate
  Ejaculation-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.

Первичные конечные точки

• Change in MSHQ-EjD-SF Function Domain Score [Срок оценки: Baseline and 12 months after intervention]

Вторичные конечные точки (6)

• Change in MSHQ-EjD-SF Bother Item Score [Срок оценки: Baseline and 12 months after intervention]
• Preservation of Antegrade Ejaculation [Срок оценки: 12 months after intervention]
• Change in IIEF-5 Score [Срок оценки: Baseline and 12 months after intervention]
• Change in International Prostate Symptom Score [Срок оценки: Baseline, 1 month, 3 months, 6 months, and 12 months after intervention]
• Change in Maximum Urinary Flow Rate [Срок оценки: Baseline, 1 month, 3 months, 6 months, and 12 months after intervention]
• Change in Post-Void Residual Urine Volume [Срок оценки: Baseline, 1 month, 3 months, 6 months, and 12 months after intervention]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Египет · 1 центр

• Department of Urology- Beni-Suef University Hospitals — Banī Suwayf

Идентификаторы

NCT: NCT07648888 · BSU-REZ-ESBTUEP-2026

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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