Lower Urinary Tract Symptoms due to Benign Prostatic Hyperplasia
Conditions
Interventions
Test Group:Investigational Medical Device (HEALINNO(BEIJING)MEDICAL TECHNOLOGY CO.,LTD.):
Prostate Surgical Targeted Resection Waterjet System (metaFlow)
Disposable Prostatic Surgery Hydrodynamic Hand
Control Group:Bipolar Transurethral Resection of the Prostate (B-TURP)
Sponsors
Beijing Hospital
Eligibility
Sex/Gender
Male
Age
52 Years to 84 Years
Inclusion criteria
Inclusion criteria: (1) Male subjects aged 45 to 85 years inclusive. (2) Subjects requiring surgical resection of glandular tissue for benign prostatic hyperplasia (BPH), with an International Prostate Symptom Score (IPSS) >= 8. (3) Subjects with a maximum urinary flow rate (Qmax) = 125 ml) or with urinary retention requiring an indwelling catheter. (4) Prostate volume between 30 ml and 80 ml inclusive. (5) Subjects or their legal guardians who are able to understand the purpose of the study, demonstrate sufficient compliance with the study protocol, and sign the Informed Consent Form (ICF).
Exclusion criteria
Exclusion criteria: (1) Known prostate cancer, or a history of bladder cancer within 5 years, or suspicion of the above diseases. (2) Presence of neurogenic bladder. (3) Urethral stricture that prevents the insertion of surgical instruments. (4) Presence of bladder stones that cannot be managed concomitantly. (5) Post-void residual urine volume (PVR) > 300 ml (except in cases of urinary retention with an indwelling catheter). (6) Previous prostate surgery (except for prostate biopsy). (7) Suspected bowel perforation or an intra-abdominal foreign body that has not been removed. (8) Presence or suspicion of severe inflammation, adhesions, or stenosis in the anus, rectum, or colon. (9) Presence of major medical or surgical conditions that would prevent tolerance of surgery. (10) Allergy to anesthetic agents, lubricants, device materials, or other substances used during the surgical procedure. (12) Mental or intellectual impairment that prevents cooperation with treatment and evaluation. (13) Participation in another clinical trial involving drugs, biologics, or medical devices within 30 days prior to screening (excluding in vitro diagnostic reagents with no intervention on the subject). (14) Other conditions that, in the investigator’s judgment, make the subject unsuitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| International Prostate Symptom Score (IPSS);Incidence of severe device-related complications; | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in International Prostate Symptom Score (IPSS) from baseline;Re-intervention rate;Quality of Life score (QoL) ;Maximum urinary flow rate (Qmax);Post-void residual urine volume (PVR) measurement;Surgical duration;Duration of prostatic tissue resection;Device performance assessment using a Likert scale(Test Group only);Change in prostate volume (to be evaluated in no fewer than 30 confirmatory trial subjects); Incidence of severe device-related complications ;Laboratory tests;Adverse event rate; Severe adverse event (SAE) rate ;Device defect rate (Test Group only); | — |
Countries
China
Contacts
Public ContactMing Liu
Beijing Hospital
Outcome results
None listed