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Trial registered on ANZCTR


Registration number
ACTRN12623000678695
Ethics application status
Approved
Date submitted
1/06/2023
Date registered
23/06/2023
Date last updated
4/08/2024
Date data sharing statement initially provided
23/06/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Early Feasibility Clinical Study of the FloStent™ System
Scientific title
Safety and feasibility clinical study of the FloStent implant on lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH) in adult men
Secondary ID [1] 309808 0
RCT-01b
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Benign Prostatic Hyperplasia 330223 0
Condition category
Condition code
Renal and Urogenital 327093 327093 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 326240 0
Treatment: Devices
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 334955 0
To assess the efficacy of the FloStent implant in alleviating lower urinary tract symptoms via the International Prostate Symptom Score (IPSS) validated questionnaire.
Timepoint [1] 334955 0
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).
Primary outcome [2] 334956 0
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).
Timepoint [2] 334956 0
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).
Primary outcome [3] 335054 0
To assess the feasibility of the FloStent implant via the reported device deficiencies through the completion of device deficiency forms by the study team.
Timepoint [3] 335054 0
Implant Day (Day 1) and yearly throughout the long term follow-up period (up to 5 years post-procedure).
Secondary outcome [1] 422534 0
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.
Timepoint [1] 422534 0
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).

Eligibility
Key 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.
Minimum age
45 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
20/07/2023
Actual
20/07/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
27
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 24833 0
Wollongong Private Hospital - Wollongong
Recruitment hospital [2] 26901 0
Austin Health - Austin Hospital - Heidelberg
Recruitment postcode(s) [1] 40482 0
2500 - Wollongong
Recruitment postcode(s) [2] 42959 0
3084 - Heidelberg
Recruitment outside Australia
Country [1] 25569 0
New Zealand
State/province [1] 25569 0
Tauranga

Funding & Sponsors
Funding source category [1] 313992 0
Commercial sector/Industry
Name [1] 313992 0
Rivermark Medical AU
Country [1] 313992 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Rivermark Medical AU
Address
Level 7, 330 Collins St.
Melbourne VIC 3000
Country
Australia
Secondary sponsor category [1] 315875 0
None
Name [1] 315875 0
Address [1] 315875 0
Country [1] 315875 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313128 0
Bellberry Human Research Ethics. Committee
Ethics committee address [1] 313128 0
123 Glen Osmond Rd,
Eastwood SA 5063
Ethics committee country [1] 313128 0
Australia
Date submitted for ethics approval [1] 313128 0
Approval date [1] 313128 0
15/03/2023
Ethics approval number [1] 313128 0
Ethics committee name [2] 313131 0
Central Health and Disability Ethics Committees
Ethics committee address [2] 313131 0
133 Molesworth Street
Thorndon
Wellington 6011
Ethics committee country [2] 313131 0
New Zealand
Date submitted for ethics approval [2] 313131 0
Approval date [2] 313131 0
21/03/2023
Ethics approval number [2] 313131 0

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 127098 0
A/Prof Peter Chin
Address 127098 0
South Coast Urology
91 Burelli St,
Wollongong NSW 2500
Country 127098 0
Australia
Phone 127098 0
+61 02 42716644
Fax 127098 0
Email 127098 0
[email protected]
Contact person for public queries
Name 127099 0
Flora Yuen
Address 127099 0
Avania Pty Ltd
13/76 Reserve Rd,
Artarmon NSW 2064
Country 127099 0
Australia
Phone 127099 0
+61294606688
Fax 127099 0
Email 127099 0
[email protected]
Contact person for scientific queries
Name 127100 0
Flora Yuen
Address 127100 0
Avania Pty Ltd
13/76 Reserve Rd,
Artarmon NSW 2064
Country 127100 0
Australia
Phone 127100 0
+61294606688
Fax 127100 0
Email 127100 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.