Evaluating the FloStent for treating symptoms of benign prostatic hyperplasia in men
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
This study is testing whether the FloStent can help men over 45 with symptoms of benign prostatic hyperplasia feel better compared to a fake procedure.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 215 (estimated) |
| Ages | 45 Years and up |
| Sex | Male |
| Sponsor | Rivermark Medical Industry-sponsored |
| Locations | 20 sites (Bakersfield, California and 19 other locations) |
| Trial ID | NCT06849258 on ClinicalTrials.gov |
What this trial studies
This clinical study aims to assess the safety and efficacy of the FloStent, a medical device designed to alleviate symptoms associated with benign prostatic hyperplasia (BPH). Male participants over 45 years old with symptomatic BPH will be randomly assigned to receive either the FloStent or a sham procedure, which does not involve the deployment of the device. All participants will undergo a flexible cystoscopy as part of the evaluation process. The study will compare outcomes between the treatment and control groups to determine the effectiveness of the FloStent.
Who should consider this trial
Good fit: Ideal candidates for this study are men over 45 years old who experience significant symptoms of BPH.
Not a fit: Patients with prior prostate interventions, certain medical conditions, or those in vulnerable populations may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new, effective treatment option for men suffering from BPH symptoms.
How similar studies have performed: While the FloStent approach is relatively novel, similar studies evaluating device-based treatments for BPH have shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Bakersfield, California and 19 other locations
- Michael G Oefelein Clinical Trials — Bakersfield, California, United States (Recruiting)
- Comprehensive Urology Medical Group — Beverly Hills, California, United States (Recruiting)
- Atlas Men's Health — La Mesa, California, United States (Recruiting)
- Urology Group of Southern California — Los Angeles, California, United States (Recruiting)
- Prestige Medical Group — Tustin, California, United States (Recruiting)
- Urology Denver — Littleton, Colorado, United States (Recruiting)
- Advanced Urology Institute — Daytona Beach, Florida, United States (Recruiting)
- Duly Health — Lisle, Illinois, United States (Recruiting)
- Loyola Medicine — Maywood, Illinois, United States (Not_yet_recruiting)
- Southern Urology — Lafayette, Louisiana, United States (Recruiting)
- Michigan Institute of Urology — Troy, Michigan, United States (Recruiting)
- Sheldon Freedman Urology — Las Vegas, Nevada, United States (Recruiting)
- Manhattan Medical Research NYU Langone — New York, New York, United States (Recruiting)
- Northwell Health — Syosset, New York, United States (Not_yet_recruiting)
- Associated Urologists of North Carolina — Raleigh, North Carolina, United States (Recruiting)
- Conrad Pearson Clinic — Germantown, Tennessee, United States (Recruiting)
- Midtown Urology Associates — Austin, Texas, United States (Recruiting)
- Urology Austin/Urology America — Austin, Texas, United States (Recruiting)
- Houston Methodist — Houston, Texas, United States (Not_yet_recruiting)
- South Coast Urology — Wollongong, New South Wales, Australia (Not_yet_recruiting)
Study contacts
- Study coordinator: Study Manager Study Director, MD
- Email: info@rivermarkmedical.com
- Phone: 414-758-7948
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.