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A prospective, multicenter, randomized, controlled, superiority clinical trial to evaluate the safety and efficacy of an implantable prostate lifting system(Urowell) for benign prostatic hyperplasia

A prospective, multicenter, randomized, controlled, superiority clinical trial to evaluate the safety and efficacy of an implantable prostate lifting system(Urowell) for benign prostatic hyperplasia

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200064084
Enrollment
Unknown
Registered
2022-09-26
Start date
2022-09-28
Completion date
Unknown
Last updated
2023-04-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Benign Prostate Hyperplasia

Interventions

control group:Transurethral Plasmakinetic Prostatectomy

Sponsors

Chinese PLA General Hospital
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
40 Years to 85 Years

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

MeasureTime frame
BPH6 composite index;

Secondary

MeasureTime frame
Qmax;QoL;

Countries

China

Contacts

Public ContactXu Zhang
xzhang301@163.com01066936008

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026