Benign Prostate Hyperplasia
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male, aged 40-85 years(including 40 and 85 years of age); 2. The International Prostate Symptom Score(IPSS) > 12; 3. The maximum urinary flow rate (Qmax) is less than 15ml/s; 4. Diagnosis of benign prostatic hyperplasia with lower urinary tract symptoms; 5. Patients voluntarily participate in study and sign informed consent.
Exclusion criteria
Exclusion criteria: 1. Prostate volume>100 mL. 2. Difficulty in inserting instruments. 3. Patient with prostate cancer or bladder cancer. 4. Intravescical Prostatic Protrusion(IPP)>1cm.. 5. Bladder dysfunction caused by neurogenic bladder or other factors. 6. urinary incontinence ISI>4 points. 7. Patient with Coagulation disorders. 8. Patients with allergies to nickel, titanium or stainless steel. 9. Operation History of benign prostatic hyperplasia. 10. The patient has participated in other drug or medical device clinical trials within 3 months. 11. Other circumstances that the investigator considers inappropriate for participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| BPH6 composite index; | — |
Secondary
| Measure | Time frame |
|---|---|
| Qmax;QoL; | — |
Countries
China