What side effects are associated with this type of intervention?

Common treatments for Benign Prostatic Hyperplasia (BPH) include medications such as alpha blockers and 5-alpha-reductase inhibitors, minimally invasive procedures like transurethral resection of the prostate (TURP), and mechanical devices such as urethral expanders. Alpha blockers can cause dizziness, fatigue, and hypotension. 5-alpha-reductase inhibitors may lead to sexual dysfunction, including decreased libido and erectile dysfunction. TURP can result in bleeding, infection, and retrograde ejaculation. Mechanical expansion devices, like the ProVee Urethral Expander System, may cause urinary tract infections, discomfort, and the need for reintervention. Patients should discuss these potential side effects with their healthcare provider to determine the best treatment option.

What prior FDA approvals exist?

The FDA has approved several treatments for Benign Prostatic Hyperplasia (BPH), including medications and mechanical devices. Medications such as alpha blockers (e.g., tamsulosin) and 5-alpha reductase inhibitors (e.g., finasteride) are commonly used to manage symptoms. For mechanical expansion of the urethra, the FDA has approved devices like the UroLift System, which uses small implants to lift and hold the enlarged prostate tissue out of the way, thus relieving urethral obstruction. These treatments aim to improve urinary flow and reduce BPH symptoms.

What other types of research exist?

Promising novel alternatives to the ProVee Urethral Expander System for BPH include the modified prostatic UroLume Wallstent, which has shown significant improvement in mean peak flow rates and residual urine volumes, and the Urocross Expander System, which has demonstrated feasibility, safety, and a strong signal of efficacy in treating lower urinary tract symptoms secondary to BPH.

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Urethral Expander System

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

Verified Trial

N/A

Recruiting

Research Sponsored by ProVerum Medical

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Have you been told that you have an enlarged prostate?

Do you live full-time in the zip code that you provided?

Must not have

Have you had any procedures performed on your prostate?

Have you had urinary stones or blood in the urine in the past 3 months?

Timeline

Screening 3 weeks

Treatment Varies

Follow Up procedure to 12 months

Summary

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.

Who is the study for?

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.

What is being tested?

The 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.

What are the potential side effects?

Potential side effects may include discomfort during insertion, risk of infection, possible injury to the urethra or surrounding tissues, bleeding, and temporary increased difficulty with urination.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with an enlarged prostate.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had procedures done on my prostate.

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I have not had urinary stones or blood in my urine in the last 3 months.

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I have had prostate or bladder cancer.

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ procedure - 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~procedure - 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and procedure - 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Placebos

Effectiveness: Symptoms Improvement

Safety: Device or Procedure Related Serious Adverse Events

+1 more

Trial Design

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.

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Benign Prostatic Hyperplasia (BPH) include alpha-adrenergic blockers, 5-alpha reductase inhibitors, and mechanical interventions like the ProVee Urethral Expander System. Alpha-adrenergic blockers work by relaxing the smooth muscles of the prostate and bladder neck, improving urine flow. 5-alpha reductase inhibitors reduce the size of the prostate by inhibiting the conversion of testosterone to dihydrotestosterone. Mechanical interventions, such as the ProVee Urethral Expander System, physically expand the urethra to relieve obstruction caused by an enlarged prostate. These treatments are crucial for BPH patients as they alleviate symptoms like difficulty in urination, reduce the risk of urinary retention, and improve overall quality of life.

[Position statement for the diagnosis and treatment of men with benign prostate enlargement and lower urinary tract symptoms].