Safety and feasibility clinical study of the FloStent implant on lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH) in adult men

Rivermark Medical A0 个研究点目标入组 80 人开始时间: 2023年6月23日最近更新: 2024年8月12日

适应症

试验速览

暂无简介。

•1. Males equal to or greater than 45 years of age;
•2. IPSS of greater than 14 & Peak urinary flow rate (Qmax) of equal to or less than 12 mL/s;
•3. IPSS Voiding to Storage Ratio of greater than 1;
•4. Estimated prostate volume of equal to or greater than 25 and equal to or less than 80 cc;
•5. Prostatic urethral length equal to or greater than 2cm and equal to or less than 5cm (by pullback technique during flexible cystoscopy)
•6. Failed, intolerant, or willing to discontinue medications for benign prostatic hyperplasia.

•1. Prostatic urethral length less than 2cm;
•2. Estimated prostatic volume less than 25cc or greater than 80cc;
•3. An obstructing intravesical prostatic median lobe;
•4. Urinary incontinence due to an incompetent external sphincter;
•5. Urethral pathologies that may prevent insertion of delivery system;
•6. A current symptomatic urinary tract infection;
•7. Current significant visible hematuria;
•8. Subjects with known allergy to nickel or titanium;
•9. History of significant medical co-morbidity or prior surgery that may confound the results of the Study;
•10. Another medical condition that would pose an unacceptable patient risk;
•11. Known or suspected urological condition that may affect voiding function;
•12. Neurogenic bladder and/or sphincter abnormalities;
•13. Subjects with cognitive disabilities unable to understand and give informed consent to the research study;
•14. Concomitant use of medications known to affect bladder function (e.g. anticholinergics, beta-3 adrenergic agonists);
•15. Use of alpha blockers within 2 weeks of baseline assessment;
•16. Use of 5-alpha reductase inhibitors within 3 months of baseline assessment;
•17. Subjects who have had any prior prostatic implant(s) other than FloStent; and
•18. Having been in a research study in the last 30 days or currently participating in another research study.

发起方

Rivermark Medical A