What is the mechanism of action of this treatment?

The most common treatments for an enlarged prostate (BPH) include physical interventions and pharmacological therapies. Physical treatments, such as the Zenflow Spring System, transurethral resection of the prostate (TURP), and prostatic urethral lift, work by physically removing or compressing prostate tissue to relieve urinary obstruction, thereby improving urine flow and reducing symptoms like frequent urination and nocturia. Pharmacological treatments, including alpha-1-adrenergic antagonists (e.g., tamsulosin) and 5-alpha reductase inhibitors (e.g., finasteride), work by relaxing the smooth muscles of the prostate and bladder neck or by shrinking the prostate over time, respectively. These treatments are crucial for BPH patients as they directly address the underlying obstruction, significantly improving urinary function and quality of life.

What side effects are associated with this type of intervention?

Common treatments for an enlarged prostate (BPH) that provide physical relief of urinary obstruction include transurethral resection of the prostate (TURP), laser therapy, and prostatic urethral lift (PUL). Known side effects of these treatments can include urinary tract infections, bleeding, retrograde ejaculation, erectile dysfunction, and incontinence. Minimally invasive procedures like the Zenflow Spring System aim to reduce these side effects while effectively relieving urinary obstruction.

What prior FDA approvals exist?

FDA-approved treatments for enlarged prostate (BPH) that focus on physical relief of urinary obstruction include minimally invasive surgical therapies such as transurethral resection of the prostate (TURP), laser therapies (e.g., GreenLight laser), and the prostatic urethral lift (UroLift). These treatments aim to alleviate urinary symptoms by physically removing or displacing prostate tissue to reduce obstruction. The Zenflow Spring System, currently under study, is similar in that it also aims to provide physical relief of urinary obstruction in BPH.

What other types of research exist?

Promising alternatives to the Zenflow Spring System for BPH treatment include GreenLight laser vaporization, which has shown efficacy and safety in multiple studies, and transurethral microwave therapy, which has demonstrated long-term efficacy in reducing outflow obstruction. Additionally, bipolar plasma vaporization and transurethral resection of the prostate (TURP) are established methods with proven outcomes.

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Device

Zenflow Spring System for Enlarged Prostate

N/A

Recruiting

Research Sponsored by Zenflow, Inc.

Eligibility Criteria Checklist

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

Must have

≥ 45 years of age

Failed, intolerant, or patient choice to not take a medication regimen for the treatment of LUTS

Must not have

Use of concomitant medications (e.g., anticholinergics, antispasmodics or tricyclic antidepressants) affecting bladder function

Other condition or disease that might cause urinary retention

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to test the safety and effectiveness of the Zenflow Spring System, a device designed to help men with an enlarged prostate urinate more easily. The spring is placed in the urinary tract to keep it open, reducing symptoms with minimal side effects. The target group is men who suffer from urinary problems due to an enlarged prostate.

Who is the study for?

Men over 45 with enlarged prostate (BPH) who have an IPSS score >13, a prostate volume of 25-80 cc, and urethral length of 2.5-4.5 cm. Candidates should not be on BPH medications or prefer not to take them and must consent to study requirements. Exclusions include those with urinary flow rate >15 ml/second, prior prostate treatments, certain medications within specific timeframes before the trial, nickel allergy, or life expectancy less than 24 months.

What is being tested?

The Zenflow Spring System is being tested for its safety and effectiveness in relieving symptoms caused by BPH. The device aims to improve urinary flow without medication or invasive surgery.

What are the potential side effects?

Potential side effects may include discomfort during urination, urinary tract infection risk increase due to the procedure, possible allergic reactions if sensitive to nickel which is part of the device material, and other complications related to minimally invasive procedures.

Eligibility Criteria

Inclusion Criteria

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

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I am 45 years old or older.

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

Exclusion Criteria

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

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I am taking medication that affects bladder function.

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I have a condition that could cause difficulty in emptying my bladder.

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

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I have bladder stones along with my current condition.

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I have had surgery or other invasive treatments on my prostate.

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I can't fully empty my bladder, leaving at least 125 ml of urine.

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My PSA level is above 10 ng/mL or I might have prostate cancer.

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

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I have a history of diseases that affect my ability to urinate.

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I have had chronic or recurring prostatitis in the last year.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Effectiveness of the Spring Implant in reducing symptoms of Benign Prostatic Hyperplasia (BPH) using the International Prostate Symptom Score

Incidence of procedure or device related serious adverse events

Need for urinary catheterization

+1 more

Secondary study objectives

Assessment of Adverse Events

Assessment of Clavien-Dindo events

Assessment of PSA

+3 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment GroupExperimental Treatment1 Intervention

Receives intervention with the Zenflow Spring System.

0 / 12Eligibility 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

The most common treatments for an enlarged prostate (BPH) include physical interventions and pharmacological therapies. Physical treatments, such as the Zenflow Spring System, transurethral resection of the prostate (TURP), and prostatic urethral lift, work by physically removing or compressing prostate tissue to relieve urinary obstruction, thereby improving urine flow and reducing symptoms like frequent urination and nocturia. Pharmacological treatments, including alpha-1-adrenergic antagonists (e.g., tamsulosin) and 5-alpha reductase inhibitors (e.g., finasteride), work by relaxing the smooth muscles of the prostate and bladder neck or by shrinking the prostate over time, respectively. These treatments are crucial for BPH patients as they directly address the underlying obstruction, significantly improving urinary function and quality of life.