To evaluate the safety and efficacy of the Prostate Lift System for the treatment of lower urinary tract obstruction caused by benign prostatic hyperplasia: a prospective, multicenter, parallel-controlled, randomized, superiority clinical study

Authors
Category Primary study
Registry of TrialsChinese Clinical Trial Register
Year 2023
INTERVENTION: experimental group:Prostatic Urethral Lift;control group:Prostatic Urethral Lift after 3 months; CONDITION: Benign Prostate Hyperplasia PRIMARY OUTCOME: IPSS (3 months);Incidence of device‐related serious complications (within 3 months after surgery); SECONDARY OUTCOME: QOL;Qmax;PVR;IIEF‐5;MSHQ‐EjD‐SF;QOR‐VAS;EQ‐5D‐5L;The excellence/yield of instrument operation evaluation;IPSS(1?6?12 Months);Incidence of adverse events/serious adverse events;Incidence of device defects; INCLUSION CRITERIA: (1) Agree to sign the informed consent form (2) Male patients aged over 45 years old (including 45 years old) and under 90 years old (including 90 years old) (3) BPH diagnostic criteria were met (4) IPSS score > 12 points (5) Qmax<=12mL/s (urine volume >=150mL) (6) Prostate volume 30mL<=PV<=80mL reported by imaging examination Patients who were deemed by the investigator to be suitable candidates for surgical treatment with the trial device
Epistemonikos ID: f7adb28254d0696ab72d581556bec07f8542bf4f
First added on: Feb 20, 2024