What side effects are associated with this type of intervention?

Mechanical expansion of the prostatic urethra, such as with the Urocross Expander System, may involve side effects like urinary tract infections, hematuria, and discomfort during urination. Other common treatments for an enlarged prostate include medications like alpha-blockers and 5-alpha reductase inhibitors, which can cause dizziness, orthostatic hypotension, and sexual dysfunction. Surgical options, such as transurethral resection of the prostate (TURP), may lead to complications like bleeding, infection, and retrograde ejaculation.

What prior FDA approvals exist?

FDA-approved treatments for enlarged prostate (BPH) include medications such as alpha-blockers (e.g., tamsulosin, alfuzosin) and 5-alpha reductase inhibitors (e.g., finasteride, dutasteride). These medications help to relax the muscles of the prostate and bladder neck or shrink the prostate, respectively. Additionally, minimally invasive surgical options like transurethral resection of the prostate (TURP) and laser therapies are also approved. While specific mechanical expansion devices like the Urocross Expander System/Retrieval Sheath are not mentioned, these treatments collectively aim to alleviate urinary symptoms associated with BPH.

What other types of research exist?

Promising alternatives to the Urocross Expander System/Retrieval Sheath for treating an enlarged prostate include: 1) Urolift System, which uses small implants to lift and hold the enlarged prostate tissue out of the way, 2) Rezum Water Vapor Therapy, which uses steam to reduce excess prostate tissue, and 3) Prostatic Artery Embolization (PAE), a minimally invasive procedure that reduces blood flow to the prostate, causing it to shrink. These treatments have shown efficacy and safety in clinical studies and are considered less invasive options.

← Back to Search

Prostate Implant

Urocross Expander System for Enlarged Prostate

N/A

Recruiting

Led By Kevin T. McVary

Research Sponsored by Prodeon Medical, Inc

Eligibility Criteria Checklist

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

Must have

Symptomatic BPH with the following (all must be met):

Subjects must be willing to be off their BPH-related medications from time of enrollment and throughout the study. Note: All subjects on BPH-related medications must start a washout period prior to randomization on the procedure day.

Must not have

Previous BPH procedure intended to disobstruct the bladder outlet

Parkinson's disease or other neurologic disease known to impact bladder function (e.g., stroke, TIA, multiple sclerosis)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months post-procedure

Summary

This trial is testing a new device called the Urocross Expander System/Retrieval Sheath. It is designed to help men with an enlarged prostate (BPH) who have trouble urinating. The device works by widening the urinary passage to make it easier to urinate.

Who is the study for?

Men aged 45 or older with symptomatic Benign Prostatic Hyperplasia (BPH), having a prostate size of 30-80 cc, and experiencing reduced urine flow. Participants must not be on BPH medications during the trial and should have no history of certain neurological diseases, prior prostate surgeries, or conditions like urethral strictures that could affect bladder function.

What is being tested?

The Expander-2 Trial is testing the Urocross Expander System/Retrieval Sheath against a sham-control to treat symptoms of an enlarged prostate. Men will be randomly assigned to receive either the actual device implantation or a simulated procedure without therapeutic effect.

What are the potential side effects?

While specific side effects are not listed here, typical risks may include discomfort at the implant site, potential urinary issues such as infection or irritation, bleeding, and possibly temporary difficulty with urination post-procedure.

Eligibility Criteria

Inclusion Criteria

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

Select...

I have symptoms from an enlarged prostate.

Select...

I agree to stop my BPH medications for the study.

Select...

I am a man aged 45 or older.

Select...

My prostate size is between 30 and 80 cc.

Select...

I am a man aged 45 or older.

Exclusion Criteria

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

Select...

I have had a procedure to improve urine flow from my bladder.

Select...

I have a neurological condition like Parkinson's that affects my bladder.

Select...

I have a growing middle part of the prostate.

Select...

I have had issues with narrowing in my urinary tract needing multiple treatments.

Select...

I have a history of bladder control issues due to nerve problems.

Select...

I had a UTI but it's treated now, or I've had 2 or more UTIs in the past year.

Select...

My kidney function is impaired, with creatinine over 1.8 mg/dl or due to bladder obstruction.

Select...

I do not have any active infections, including prostate infections.

Select...

I have had radiation or major surgery in my pelvic area.

Select...

My bladder neck is higher than usual.

Select...

I have been diagnosed with or suspected to have bladder cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months post-procedure

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 months post-procedure

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

Treatment Details

Study Objectives

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

Primary study objectives

Efficacy of the Urocross Expander Implant as delivered by the Urocross Expander System and the Urocross Retrieval Sheath

Safety of Urocross Expander Implant

Secondary study objectives

Percent change in Total IPSS for subjects randomized to the Urocross Implant

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Urocross implant groupExperimental Treatment1 Intervention

The investigational products in this trial are the Urocross Expander Implant as delivered by the Urocross Expander System and the Urocross Retrieval Sheath used to retrieve the implant after 6 months following its implant.

Group II: Sham-control groupPlacebo Group1 Intervention

The sham-control in this trial is cystoscopy only.

0 / 16Eligibility 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 an enlarged prostate (BPH) include mechanical expansion of the prostatic urethra, such as the Urocross Expander System, which physically widens the urethra to improve urine flow. This provides immediate relief from urinary obstruction. Alpha-blockers like alfuzosin relax the muscles in the prostate and bladder neck, easing urine flow, while 5-alpha reductase inhibitors like finasteride shrink the prostate by inhibiting hormonal changes. These treatments are crucial as they address both symptoms and underlying causes of BPH, improving quality of life and reducing the need for surgery.

[The use of alfuzosin in the treatment of patients with acute urinary retention].Bulking for stress urinary incontinence in men: A systematic review.Minimally invasive surgical therapies for benign prostatic hypertrophy: The rise in minimally invasive surgical therapies.