Benign Prostatic HyperplasiaRAPID-IIINCT06849258
A Clinical Study to Evaluate the Safety and Efficacy of the FloStent in Men With Benign Prostatic Hyperplasia Symptoms
A study testing FloStent in people with Benign Prostatic Hyperplasia, run by Rivermark Medical at 20 sites in 2 countries.
Trial summary
The goal of this study is to determine the safety and effectiveness of the FloStent, a medical device used to treat men with symptoms of Benign Prostatic Hyperplasia, compared to sham (procedure without deployment of the FloStent). Read more about this study
- Who is it for?
- Ages 45 years and older, men only
- Conditions the study is for
- Benign Prostatic Hyperplasia
- What is being tested?
- FloStent
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 215 participants
- Where
- 20 sitesin 2 countries
- Study dates
- 10 Feb 2025to 31 Dec 2032
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male subjects > 45 years of age who have symptomatic BPH
- International Prostate Symptom Score (IPSS) score >13
- Peak urinary flow rate (Qmax): >5 mL/sec and <13 mL/sec with minimum voided volume of >125 mL
- Post-void residual (PVR) <250 mL
- Prostate volume 25 to 80 mL
- Prostatic urethral length 20-50 mm
- Able to complete the study protocol and visits
Who cannot join
- Presence of an artificial urinary sphincter or stent(s) in the urethra or prostate
- Prior minimally invasive intervention or surgical intervention of the prostate or urethra
- PSA >10 ng/mL
- Bladder cancer or bladder stones
- Active urinary tract infection (UTI)
- Uncontrolled diabetes
- Part of a vulnerable population (cognitively challenged or are incarcerated)
Trial locations and contacts
20 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
20 sites in 2 countries
United States19 sites, 19 recruiting
- Recruiting
Midtown Urology Associates
Austin, Texas, 78705
- Recruiting
Urology Austin/Urology America
Austin, Texas, 78759
- Recruiting
Michael G Oefelein Clinical Trials
Bakersfield, California, 93301
- Recruiting
Comprehensive Urology Medical Group
Beverly Hills, California, 90048
- Recruiting
Advanced Urology Institute
Daytona Beach, Florida, 32114
- Recruiting
Conrad Pearson Clinic
Germantown, Tennessee, 38138
- Recruiting
Houston Methodist
Houston, Texas, 77030
- Recruiting
Atlas Men's Health
La Mesa, California, 91942
- Recruiting
Southern Urology
Lafayette, Louisiana, 70508
- Recruiting
Sheldon Freedman Urology
Las Vegas, Nevada, 89144
- Recruiting
Duly Health
Lisle, Illinois, 60532
- Recruiting
Urology Denver
Littleton, Colorado, 80122
- Recruiting
Urology Group of Southern California
Los Angeles, California, 90017
- Recruiting
Alarcon Urology Center
Montebello, California, 90640
- Recruiting
Manhattan Medical Research NYU Langone
New York, New York, 10016
- Recruiting
Associated Urologists of North Carolina
Raleigh, North Carolina, 27612
- Recruiting
Northwell Health
Syosset, New York, 11791
- Recruiting
Michigan Institute of Urology
Troy, Michigan, 48084
- Recruiting
Prestige Medical Group
Tustin, California, 92780
Australia1 site, 1 recruiting
- Recruiting
South Coast Urology
Wollongong, New South Wales, 2500
About this study
Official title: A Prospective, Multicenter, Double Blind, Randomized, Clinical Study to Evaluate the Safety and Efficacy of The FloStent in Men Suffering From Benign Prostatic Hyperplasia Symptoms
The goal of this study is to determine the safety and effectiveness of the FloStent, a medical device used to treat men with symptoms of Benign Prostatic Hyperplasia, compared to sham (procedure without deployment of the FloStent). All participants will undergo a flexible cystoscopy and those randomized to the treatment arm will receive the FloStent, while those randomized to the sham arm will not receive the FloStent.
- Conditions
- Benign Prostatic Hyperplasia
- Being tested
- FloStent, Sham (Control)
- Keywords
- benign prostatic hyperplasia, FloStent, Rivermark Medical, BPH, LUTS, Lower urinary tract symptoms, enlarged prostate
- Medical subject headings
- Prostatic Hyperplasia, Lower Urinary Tract Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FloStentDevice
Flexible cystoscopy to deploy medical device used to treat BPH
Sham (Control)Device
Flexible Cystoscopy without deployment of medical device used to treat BPH
| Study group | Role | What they receive |
|---|---|---|
| Treatment - FloStent | Experimental | Flexible cystoscopy procedure with FloStent implant deployed Receives: Device: FloStent |
| Sham Control | Sham comparator | Flexible cystoscopy procedure without FloStent implant deployed Receives: Device: Sham (Control) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in International Prostate Symptom Score (IPSS)
The International Prostate Symptom Score IPSS is a self-questionnaire (patient reported outcome). It contains 7 questions about symptoms related to BPH and 1 question about the patient's perceived quality of life (QoL).
The 7 questions are scored from 0 to 5. The sum of the 7 items gives the International Prostate Symptom Score in terms of severity (out of 35):
0-7 mildly symptomatic 8-19 moderately symptomatic 20-35 severely symptomatic
Measured: 12 months
Secondary outcomes (3)
Percent responders to IPSS
A responder is defined as a subject who has an IPSS improvement ≥ 30% post-treatment as compared to baseline.
Measured: 3 months
Percent responders to IPSS
A responder is defined as a subject who has an IPSS improvement ≥ 30% post-treatment as compared to baseline.
Measured: 6 months
Percent responders to IPSS
A responder is defined as a subject who has an IPSS improvement ≥ 30% post-treatment as compared to baseline.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2025
- Study start10 Feb 2025
- Primary completion31 Dec 2032 (estimated)
- Study completion31 Dec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Prostatic HyperplasiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Subjects will be randomized in a 2:1 (device:sham) ratio .
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 215 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rivermark Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, MD, Study director, Rivermark Medical, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06849258
- Sponsor's protocol ID
- C0002 Rev. 07
- Acronym
- RAPID-III
- Status last verified
- Jun 2026
- First submitted
- 17 Feb 2025
- Last updated
- 11 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Double Blind, Randomized, Clinical Study to Evaluate the Safety and Efficacy of The FloStent in Men Suffering From Benign Prostatic Hyperplasia Symptoms
- ClinicalTrials.gov ID
- NCT06849258
- Acronym / sponsor ID
- RAPID-III / C0002 Rev. 07
- Conditions
- Benign Prostatic Hyperplasia
- Keywords
- benign prostatic hyperplasia, FloStent, Rivermark Medical, BPH, LUTS, Lower urinary tract symptoms, enlarged prostate
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 215 participants (estimated)
- Lead sponsor
- Rivermark MedicalIndustry (pharma, biotech, devices)
- Study start
- 10 Feb 2025 (actual)
- Primary completion
- 31 Dec 2032 (estimated)
- Study completion
- 31 Dec 2032 (estimated)
- First posted
- 27 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is to determine the safety and effectiveness of the FloStent, a medical device used to treat men with symptoms of Benign Prostatic Hyperplasia, compared to sham (procedure without deployment of the FloStent). All participants will undergo a flexible cystoscopy and those randomized to the treatment arm will receive the FloStent, while those randomized to the sham arm will not receive the FloStent.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Subjects will be randomized in a 2:1 (device:sham) ratio .
| Arm | Type | Receives |
|---|---|---|
| Treatment - FloStent | Experimental | Device: FloStentFlexible cystoscopy procedure with FloStent implant deployed |
| Sham Control | Sham comparator | Device: Sham (Control)Flexible cystoscopy procedure without FloStent implant deployed |
Who may qualify
- Ages
- 45 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male subjects > 45 years of age who have symptomatic BPH
- International Prostate Symptom Score (IPSS) score >13
- Peak urinary flow rate (Qmax): >5 mL/sec and <13 mL/sec with minimum voided volume of >125 mL
- Post-void residual (PVR) <250 mL
- Prostate volume 25 to 80 mL
Key exclusion criteria (7 listed)
- Presence of an artificial urinary sphincter or stent(s) in the urethra or prostate
- Prior minimally invasive intervention or surgical intervention of the prostate or urethra
- PSA >10 ng/mL
- Bladder cancer or bladder stones
- Active urinary tract infection (UTI)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FloStentFlexible cystoscopy to deploy medical device used to treat BPH | Device | Treatment - FloStent |
| Sham (Control)Flexible Cystoscopy without deployment of medical device used to treat BPH | Device | Sham Control |
Primary outcome
Change in International Prostate Symptom Score (IPSS)
Time frame: 12 months
The International Prostate Symptom Score IPSS is a self-questionnaire (patient reported outcome). It contains 7 questions about symptoms related to BPH and 1 question about the patient's perceived quality of life (QoL). The 7 questions are scored from 0 to 5. The sum of the 7 items gives the International Prostate Symptom Score in terms of severity (out of 35): 0-7 mildly symptomatic 8-19 moderately symptomatic 20-35 severely symptomatic
3 secondary outcomes
Percent responders to IPSS
Time frame: 3 months
Percent responders to IPSS
Time frame: 6 months
Percent responders to IPSS
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Study Director, MD study director
Rivermark Medical, Inc.
20 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FloStent in people with Benign Prostatic Hyperplasia, run by Rivermark Medical at 20 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in United States, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Study Manager Study Director, MD (414-758-7948, info@rivermarkmedical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in International Prostate Symptom Score (IPSS) (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2026.