Loyola University Medical Center

Gottlieb Memorial Hospital

MacNeal Hospital

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NCT06849258

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

Official 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

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.

Eligibility

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)

Disease(s) and\or Condition(s)

Benign Prostatic Hyperplasia

Primary Purpose
  • TREATMENT
Intervention/Treatment
    • Type: DEVICE
    • Name: FloStent
    • Description: Flexible cystoscopy to deploy medical device used to treat BPH
    • Arm Group Labels: Treatment - FloStent
    • Type: DEVICE
    • Name: Sham (Control)
    • Description: Flexible Cystoscopy without deployment of medical device used to treat BPH
    • Arm Group Labels: Sham Control
Sponsor
  • Rivermark Medical