Early Feasibility Clinical Study of the FloStent™ System

Not Applicable

Recruiting

Conditions: Benign Prostatic Hyperplasia
Renal and Urogenital - Other renal and urogenital disorders

Registration Number: ACTRN12623000678695

Lead Sponsor: Rivermark Medical A

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Male

Target Recruitment: 80

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess the efficacy of the FloStent implant in alleviating lower urinary tract symptoms via the International Prostate Symptom Score (IPSS) validated questionnaire.[ Baseline, 2 weeks, 12 weeks, 24 weeks, 36 weeks, 52 weeks post-procedure, then 6-monthly throughout the long term follow-up period (up to 5 years post-procedure).];To assess the safety profile associated with the use of the FloStent implant via the reported adverse events (type and frequency). e.g. Urinary urgency assessed using an International Prostate Symptom Score (I-PSS).[ Baseline, 2 weeks, 12 weeks, 24 weeks, 36 weeks, 52 weeks post-procedure, then 6-monthly throughout the long term follow-up period (up to 5 years post-procedure).];To assess the feasibility of the FloStent implant via the reported device deficiencies through the completion of device deficiency forms by the study team.[ Implant Day (Day 1) and yearly throughout the long term follow-up period (up to 5 years post-procedure).]

Secondary Outcome Measures

Name	Time	Method
To determine the basic urodynamic parameters using maximum flow rate (Qmax) and post-void residual (PVR) measurements collected from uroflowmetry. This will be assessed as a composite outcome.[ Uroflowmetry is performed at baseline, 12 weeks, 24 weeks, 36 weeks, 52 weeks post-procedure, then 6-monthly throughout the long term follow-up period (up to 5 years post-procedure).]