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

Launched by RIVERMARK MEDICAL · Feb 24, 2025

Keywords

ClinConnect Summary

This clinical trial is investigating the safety and effectiveness of a device called the FloStent, which is designed to help men with symptoms of Benign Prostatic Hyperplasia (BPH), a condition where the prostate gland becomes enlarged, causing urinary issues. In this study, some participants will receive the FloStent, while others will undergo a similar procedure without the device, known as a sham procedure. The trial aims to see how well the FloStent works compared to not using it.

To participate in this study, men must be over 45 years old and have specific symptoms related to BPH, which can be measured using a scoring system. They should also have a certain level of urinary flow and prostate size. Participants will undergo a procedure called flexible cystoscopy, where a thin tube is used to look inside the bladder and urethra. This trial is currently looking for volunteers and is an opportunity for men seeking relief from BPH symptoms. If you or someone you know is interested, it’s important to review the eligibility criteria and discuss this with a healthcare provider.

Gender

MALE

Eligibility 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)

Trial Officials