A Clinical Study to Evaluate the Safety and Efficacy of the FloStent in Men With Benign Prostatic Hyperplasia Symptoms

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

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06849258

Acronym

RAPID-III

Enrollment

215

Registered

2025-02-27

Start date

2025-02-10

Completion date

2032-12-31

Last updated

2026-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Benign Prostatic Hyperplasia

Keywords

benign prostatic hyperplasia, FloStent, Rivermark Medical, BPH, LUTS, Lower urinary tract symptoms, enlarged prostate

Brief 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). 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.

Interventions

DEVICEFloStent

Flexible cystoscopy to deploy medical device used to treat BPH

DEVICESham (Control)

Flexible Cystoscopy without deployment of medical device used to treat BPH

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Intervention model description

Subjects will be randomized in a 2:1 (device:sham) ratio .

Eligibility

Sex/Gender

MALE

Age

45 Years to No maximum

Healthy volunteers

Inclusion criteria

* 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

Exclusion criteria

* 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)

Design outcomes

Primary

Measure	Time frame	Description
Change in International Prostate Symptom Score (IPSS)	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

Secondary

Measure	Time frame	Description
Percent responders to IPSS	3 months	A responder is defined as a subject who has an IPSS improvement ≥ 30% post-treatment as compared to baseline.

Countries

Australia, United States

Contacts

CONTACTStudy Manager Study Director, MD

info@rivermarkmedical.com414-758-7948

STUDY_DIRECTORStudy Director, MD

Rivermark Medical, Inc.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 12, 2026