What side effects are associated with this type of intervention?

Common treatments for an enlarged prostate, such as the Mercury Expander system, which physically expands the urinary tract, generally have minimal side effects. However, other treatments like alpha-1-adrenergic antagonists can cause dizziness, fatigue, and orthostatic hypotension. 5-alpha reductase inhibitors may lead to sexual dysfunction, including decreased libido and erectile dysfunction. Surgical options, such as transurethral resection of the prostate (TURP), can result in urinary incontinence, retrograde ejaculation, and, rarely, severe bleeding or infection.

What prior FDA approvals exist?

FDA-approved treatments for an enlarged prostate (BPH) primarily include medications such as alpha-1-adrenergic antagonists (e.g., alfuzosin, tamsulosin) 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. While the Mercury Expander system focuses on physical expansion to alleviate urinary obstruction, similar FDA-approved physical treatments include minimally invasive surgical options like transurethral resection of the prostate (TURP) and laser therapies. These procedures physically remove or reduce prostate tissue to improve urine flow.

What other types of research exist?

Promising novel alternatives to the Mercury Expander system for treating an enlarged prostate include: 1) UroLift System, which uses implants to lift and hold the enlarged prostate tissue out of the way, 2) Thulium Laser Enucleation of the Prostate (ThuLEP), a laser-based procedure to remove prostate tissue, and 3) Prostatic Artery Embolization (PAE), a non-surgical procedure that reduces blood flow to the prostate, causing it to shrink. These alternatives have shown effectiveness and safety in recent studies.

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Expander System

XFLO Expander System for Enlarged Prostate (EXPANDER-1 Trial)

Q: What is the mechanism of action of this treatment?

Common treatments for an enlarged prostate (BPH) include pharmacological and physical interventions. Alpha-blockers, like alfuzosin, relax the smooth muscles in the prostate and bladder neck, improving urine flow. 5-alpha reductase inhibitors, such as finasteride, reduce prostate size by inhibiting the conversion of testosterone to dihydrotestosterone (DHT). Physical interventions, like the Mercury Expander system, physically expand the urinary tract to alleviate obstruction by widening the urethra. Understanding these mechanisms helps patients and healthcare providers choose the most appropriate treatment based on symptom severity and overall health.

N/A

Waitlist Available

Led By Henry Woo, MD

Research Sponsored by MedeonBio, Inc.

Eligibility Criteria Checklist

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

Must have

Age ≥ 50 years

Patients with symptomatic BPH and related lower urinary tract symptoms (LUTS): With International Prostate Symptom Score (IPSS) > 13; Qmax < 12 mL/sec on a voided volume ≥125 mL; Post-void residual (PVR) < 250 mL; QoL score ≥ 3

Must not have

Current or recent Urinary Tract Infection (UTI) or disease

Urethral stricture, meatal stenosis, or bladder neck obstruction - either current, or recurrent requiring 2 or more dilatations

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 and 12 months (arm-2)

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new device called the Mercury Expander system, which aims to help men who have trouble urinating because of an enlarged prostate. The device works by opening up the blocked area in the urinary tract, making it easier for urine to pass through. The Mercury Expander System is a novel implantable device designed to treat lower urinary tract symptoms due to benign prostatic hyperplasia.

Who is the study for?

Men over 50 with benign prostatic hyperplasia (BPH) causing urinary issues, who haven't taken BPH meds in the last 6 months or have a stable pattern on current meds. They should have a prostate size of 30-80 cc and meet specific criteria for urinary flow and symptoms. Excluded are those with other health conditions that could affect results, previous BPH procedures, certain medication use, or allergies to nickel.

What is being tested?

The trial is testing the XFLO Expander System's safety and ability to treat lower urinary tract symptoms due to BPH. Participants will undergo a procedure using this system to see if it improves their symptoms without causing significant complications.

What are the potential side effects?

While not explicitly listed here, potential side effects may include discomfort at the site of insertion, infection risk from the procedure, possible allergic reactions especially in individuals sensitive to nickel which is part of exclusion criteria.

Eligibility Criteria

Inclusion Criteria

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

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I am 50 years old or older.

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I have severe urinary symptoms from an enlarged prostate, with specific test scores.

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I am male.

Exclusion Criteria

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

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I currently have, or recently had, a urinary tract infection.

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

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I have had a procedure for an enlarged prostate.

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My kidney function is impaired due to high creatinine or upper-tract disease.

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I have a history of bladder control issues with significant urine retention.

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I am currently experiencing blood in my urine.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 and 12 months (arm-2)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 and 12 months (arm-2)

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 and 12 months (arm-2) for reporting.

Treatment Details

Study Objectives

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

Secondary study objectives

Change in International Prostate Symptom Score (IPSS)

Freedom from Unanticipated adverse device effects (UADEs)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Group I: Arm-3: Device implantation for 12 monthsExperimental Treatment1 Intervention

Treatment group receives intervention with the XFLO Expander System implantation for 12 months, and then retrieved.

Group II: Arm-2: Device implantation for 6 monthsExperimental Treatment1 Intervention

Treatment group receives intervention with the XFLO Expander System implantation for 6 months, and then retrieved.

Group III: Arm-1: Device implantation for 1 monthExperimental Treatment1 Intervention

Treatment group receives intervention with the XFLO Expander System implantation for 1 month, and then retrieved.

0 / 9Eligibility 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 pharmacological and physical interventions. Alpha-blockers, like alfuzosin, relax the smooth muscles in the prostate and bladder neck, improving urine flow. 5-alpha reductase inhibitors, such as finasteride, reduce prostate size by inhibiting the conversion of testosterone to dihydrotestosterone (DHT). Physical interventions, like the Mercury Expander system, physically expand the urinary tract to alleviate obstruction by widening the urethra. Understanding these mechanisms helps patients and healthcare providers choose the most appropriate treatment based on symptom severity and overall health.

The influence of the medical treatment of LUTS on benign prostatic hyperplasia surgery: do we operate too late?Pharmacological therapy of benign prostatic hyperplasia/lower urinary tract symptoms: an overview for the practising clinician.