這是一項採用非劣效性設計的隨機對照試驗,受試者按1:1隨機分配至水蒸氣熱療(REZUM)組或經尿道前列腺切除術(TURP)組。
適應症:Prostate Cancer
收案條件
納入條件
- Men 50-80 years
- Refractory urinary retention related to benign prostatic hyperplasia (BPH)
- On urethral Foley's catheter before treatment
- Prostate size 30-80ml on ultrasound
排除條件
- Prior prostate operation
- Past or current history of prostate cancer
- Strong suspicion of prostate cancer (e.g. Elevated PSA before urinary retention or abnormal prostate on DRE without workup for prostate cancer)
- Known Urethral stricture / Bladder stone / Hypocontractile bladder
- Known neurological diseases which may affect bladder function (e.g. Parkinsonism, stroke)
- Contraindicated to undergo TURP or REZUM (e.g. not fit for GA/SA, active urinary tract infection, fail to be placed in lithotomy position, uncorrectable coagulopathy, antiplatelet or anticoagulant which cannot be stopped)
收案條件維持 ClinicalTrials.gov 原始英文登錄資料,實際收案資格以研究團隊的正式評估與受試者同意書為準。資料來源:ClinicalTrials.gov,每兩週自動更新,最後同步:2026年10月8日。