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NCT Number: NCT06849258

A Clinical Study to Evaluate the Safety and Efficacy of the FloStent in Men With 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.

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Key information

Conditions

Benign Prostatic Hyperplasia Genital Diseases Genital Diseases, Male Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Prostatic Diseases Prostatic Hyperplasia Signs and Symptoms Urogenital Diseases Urological Manifestations

Age range

45 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

South Coast Urology, Wollongong, New South Wales, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

FloStent

Device

Flexible cystoscopy to deploy medical device used to treat BPH

Sham (Control)

Device

Flexible Cystoscopy without deployment of medical device used to treat BPH

Primary outcomes

  1. 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

Secondary outcomes

  1. Percent responders to IPSS

    Time frame: 3 months

    A responder is defined as a subject who has an IPSS improvement ≥ 30% post-treatment as compared to baseline.

  2. Percent responders to IPSS

    Time frame: 6 months

    A responder is defined as a subject who has an IPSS improvement ≥ 30% post-treatment as compared to baseline.

  3. Percent responders to IPSS

    Time frame: 12 months

    A responder is defined as a subject who has an IPSS improvement ≥ 30% post-treatment as compared to baseline.

Study contacts

Contact information is provided by the study sponsor or research team.

Study Manager Study Director, MD

CONTACT

[email protected]

414-758-7948

Sponsors and collaborators

Lead sponsor

Rivermark Medical

Industry

Registry information

Official study 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

Acronym: RAPID-III

Important dates

Study start
2025
Primary completion
2032
Study completion
2032
First posted
Feb 27, 2025
Registry last updated
Jun 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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