None listed
Conditions
Brief summary
The purpose of this study is to evaluate the safety and feasibility of the FloStent implant for the treatment of lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH) in adult men. Who is it for? You may be eligible to participate in this trial if you are a male aged 45 years or over with lower urinary tract symptoms due to benign prostatic hyperplasia. Study Details Eligible participants will be scheduled to undergo a minimally invasive procedure to implanted with the FloStent. Participants will be required to attend up to 7 visits over the course of 12 months monitoring the FloStent position and lower urinary tract symptoms. Participants can choose to remain in the study for an additional 4 years after the 12 months for long term follow up. It is hoped that the findings of this trial will establish the benefits of this devices for males suffering from lower urinary tract symptoms due to benign prostatic hyperplasia.
Interventions
All eligible patients will undergo an outpatient procedure where a nitinol stent (FloStent implant) will be placed during a routine flexible cystoscopy by a urologist. The duration of the procedure is 15 minutes under general, regional, or local anaesthesia or conscious sedation. Once implanted, the FloStent holds the prostatic urethra open which will intent to alleviate lower urinary tract symptoms. The FloStent implant has been designed to be permanent use but may be retrieved if needed.
Pati
All eligible patients will undergo an outpatient procedure where a nitinol stent (FloStent implant) will be placed during a routine flexible cystoscopy by a urologist. The duration of the procedure is 15 minutes under general, regional, or local anaesthesia or conscious sedation. Once implanted, the FloStent holds the prostatic urethra open which will intent to alleviate lower urinary tract symptoms. The FloStent implant has been designed to be permanent use but may be retrieved if needed. Patients will be followed up over the course of 12 months in clinic for review and to check the placement of the stent. Patients will have the option to be followed up for an additional 4 years in a longer term follow up after the first year post-procedure.
Sponsors
Rivermark Medical AU
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
Male
Age
45 Years to No maximum
Healthy volunteers
No
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.
Outcome results
None listed