A Clinical Study to Evaluate the Safety and Efficacy of the FloStent in Men With Benign Prostatic Hyperplasia Symptoms (RAPID-III)

Rivermark Medical

Status: Enrolling

Conditions: Benign Prostatic Hyperplasia

Treatments: Device: Sham (Control); Device: FloStent

Study type: Interventional

Funder types: Industry

Identifiers

NCT06849258

C0002 Rev. 07

Details and patient eligibility

About

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.

Enrollment: 215 estimated patients

Sex: Male

Ages: 45+ years old

Volunteers: No 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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215 participants in 2 patient groups

Treatment - FloStent

Experimental group

Description:

Flexible cystoscopy procedure with FloStent implant deployed

Treatment:

Device: FloStent

Sham Control

Sham Comparator group

Description:

Flexible cystoscopy procedure without FloStent implant deployed

Treatment:

Device: Sham (Control)