Benign Prostate Hyperplasia
Conditions
Interventions
control group:Prostatic Urethral Lift after 3 months
Sponsors
the Second Hospital of Tianjin Medical University
Eligibility
Sex/Gender
Male
Age
45 Years to 90 Years
Inclusion criteria
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=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
Exclusion criteria
Exclusion criteria: (1) No portion of midlobe hyperplastic tissue could be pressed into the prostatic fossa, as judged by the study physician (2) PSA > 10ng/mL, unless a negative prostate biopsy is reported (3) difficult to insert the instrument due to urethral stricture or bladder neck contracture (4) severe coagulation dysfunction (5) acute urinary tract infection (6) Lower urinary tract symptoms not caused by prostatic hyperplasia (7) History of bladder dysfunction caused by neurogenic or other factors (8) History of prostate cancer and bladder tumor (9) urinary incontinence due to decreased sphincter function (10) Gross hematuria (11) history of urinary calculi within 3 months (12) History of bacterial prostatitis within 6 months (13) history of lower urinary tract injury or prostate urethral surgery (14) had a history of allergy to nickel, titanium, and stainless steel (15) patients with advanced malignant tumors (16) patients with cognitive disorders that affect understanding, compliance, and adherence to research (17) poor compliance and inability to cooperate with follow-up (18) other conditions considered by the investigator to be inappropriate for participating in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| IPSS (3 months);Incidence of device-related serious complications (within 3 months after surgery); | — |
Secondary
| Measure | Time frame |
|---|---|
| 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; | — |
Countries
China
Contacts
Public ContactNiuyuanjie
The Second Hospital of Tianjin Medical University
Outcome results
None listed