ProVee Urethral Expander System for Benign Prostatic Hyperplasia
(ProVIDE Trial)

Recruiting in Palo Alto (17 mi)

+16 other locations

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: ProVerum Medical

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial is testing a new device called the ProVee Urethral Expander System. It aims to help men who have trouble urinating because of an enlarged prostate. The device works by widening the urethra, making it easier for urine to pass through.

Research Team

Eligibility Criteria

Men with symptoms of urinary obstruction due to benign prostatic hyperplasia (BPH), who haven't had prostate/bladder cancer, urinary stones, blood in urine recently, or prior prostate procedures. Candidates should not be on medications like finasteride or dutasteride for urination issues and have a prostate size between 30 cc and 80 cc.

Inclusion Criteria

I have been diagnosed with an enlarged prostate.

I have not had any procedures done on my prostate.

I have tried and cannot tolerate medication for urinary symptoms, or I choose not to take them.

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Exclusion Criteria

I have taken medication to help with urination, like Proscar, Avodart, or Jalyn.

The length of a specific part of your prostate called the prostatic urethra is longer than 3.75cm, as measured by a special ultrasound exam called TRUS.

I have had procedures done on my prostate.

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Treatment Details

Interventions

ProVee Urethral Expander System (Urethral Expander System)

Trial OverviewThe trial is testing the ProVee Urethral Expander System's safety and effectiveness compared to a standard urethral access sheath in men with BPH-related urinary problems. The goal is to see if this new device can improve symptoms by expanding the urethra.

Participant Groups

3Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: Crossover ProVee Urethral Expander SystemExperimental Treatment1 Intervention

All subjects shall be unblinded following the 3 month follow-up visit. Those subjects randomized to the Sham Arm will be given the opportunity to "crossover" to the ProVee Urethral Expander System.

Group II: Device: The ProVee Urethral Expander SystemActive Control1 Intervention

The ProVee Urethral Expander System consists of two components: a nitinol Expander implant and a 19Fr Delivery System designed to allow the Expander to be deployed under direct vision for the treatment arm.

Group III: Sham: Ureteroscope and urethral access sheathPlacebo Group1 Intervention

An ureteroscope housed within the inner lumen of an urethral access sheath will be used under direct vision for the Sham procedure.