What side effects are associated with this type of intervention?

Common treatments for BPH that provide mechanical relief of urinary obstruction, such as Prostatic Urethral Lift (PUL) and Transurethral Resection of the Prostate (TURP), have specific side effects. PUL is generally associated with minimal side effects but may include temporary urinary discomfort, urgency, and a need for reintervention in some cases. TURP, while effective, can lead to more significant side effects such as bleeding, infection, and in rare cases, TUR syndrome (dilutional hyponatremia). Both procedures aim to improve urinary flow but come with varying degrees of risk and potential complications.

What prior FDA approvals exist?

The FDA has approved several treatments for Benign Prostatic Hyperplasia (BPH) that provide mechanical relief of urinary obstruction. These include transurethral resection of the prostate (TURP), which is a surgical procedure to remove parts of the enlarged prostate, and minimally invasive treatments like transurethral microwave thermotherapy (TUMT) and transurethral needle ablation (TUNA). Additionally, laser therapies such as photoselective vaporization of the prostate (PVP) and holmium laser enucleation of the prostate (HoLEP) have been approved. These treatments aim to reduce the size of the prostate or remove obstructive tissue to improve urinary flow.

What other types of research exist?

Promising alternatives to the Zenflow Spring System for BPH treatment include: 1) GreenLight laser vaporization, which has shown efficacy in reducing prostate volume and improving urinary flow with a favorable safety profile. 2) Transurethral resection of the prostate (TURP), a well-established surgical option that remains effective for relieving urinary obstruction. 3) 5-alpha reductase inhibitors (e.g., finasteride, dutasteride), which reduce prostate size and lower the incidence of acute urinary retention, though they require long-term use. 4) Alpha-blockers (e.g., alfuzosin, doxazosin), which improve urinary symptoms by relaxing the muscles in the prostate and bladder neck. 5) Botulinum toxin injections, which have shown promise in reducing symptoms of overactive bladder associated with BPH.

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Implantable Device

Zenflow Spring System for Benign Prostatic Hyperplasia (BREEZE Trial)

N/A

Waitlist Available

Led By Claus Roehrborn, M.D

Research Sponsored by Zenflow, Inc.

Eligibility Criteria Checklist

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

Must have

Prostatic urethral length between 25 and 45 mm, as measured by cystoscopic pull-back

≥ 45 years of age

Must not have

Chronic prostatitis, recurrent prostatitis, chronic pelvic pain syndrome (CPPS), or painful bladder syndrome within the past 12 months

Concomitant bladder stones

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months post procedure through 24 months post procedure

Summary

This trial is testing the Zenflow Spring System, a small device that helps men with urinary problems due to an enlarged prostate. It works by keeping the urinary pathway open, making it easier to urinate. The Zenflow Spring System is a novel device designed to alleviate lower urinary tract symptoms (LUTS) caused by benign prostatic hyperplasia (BPH).

Who is the study for?

Men over 45 with moderate to severe urinary symptoms due to enlarged prostate, not responding well to medications. They should have a prostate size of 25-80 cc and be willing to follow study procedures. Excluded are those allergic to nickel, life expectancy under 5 years, bladder stones, certain medication use affecting bladder function, urethral strictures or anatomical anomalies unsuitable for the implant.

What is being tested?

The trial is testing the Zenflow Spring System's ability to relieve lower urinary tract symptoms caused by benign prostatic hyperplasia (BPH). Participants will either receive this new treatment or a sham procedure (a fake treatment) for comparison.

What are the potential side effects?

Potential side effects may include discomfort at the implant site, possible reaction if allergic to nickel contained in the device, urinary tract infection risk increase post-procedure and potential need for re-treatment if symptom relief isn't achieved.

Eligibility Criteria

Inclusion Criteria

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

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My prostate urethra length is between 25 and 45 mm.

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I am 45 years old or older.

Exclusion Criteria

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

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I have had chronic prostatitis, CPPS, or painful bladder syndrome in the last year.

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I have bladder stones along with my current condition.

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My ultrasound shows a significant prostate enlargement into the bladder.

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I have or had a narrowed urethra or bladder neck.

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I have a condition like diabetes or MS that affects my bladder control.

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I have an overactive bladder without prostate issues.

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

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I have had surgery on my prostate before.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months post procedure through 24 months post procedure

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 months post procedure through 24 months post procedure

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months post procedure through 24 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

Effectiveness of the Spring Implant in reducing symptoms of Benign Prostatic Hyperplasia (BPH) as compared to Sham

Effectiveness- Symptoms Improvement

Safety - The need for urinary catheterization

Secondary study objectives

Effectiveness - Re-intervention (device)

Effectiveness - Re-intervention (drug)

Effectiveness - flow metrics

+8 more

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: Roll-in CohortExperimental Treatment1 Intervention

Each Investigator will be allowed to treat up to 3 roll-in subjects with the Spring Implant prior to initiation of randomization. Roll-in patients will be followed for 60 months.

Group II: Crossover CohortExperimental Treatment1 Intervention

Control Arm (Sham) patients can receive treatment with the Zenflow Spring System after their 3-month follow-up assessments are completed, and their symptoms warrant treatment and enrollment criteria are met. The study visit follow-up schedule will restart and the subject will be followed for 60 months post Zenflow Spring implantation. Unless treated with the Spring System, the subject will be exited from the study once they have completed their 3-month follow-up visit.

Group III: Treatment ArmActive Control1 Intervention

Includes all patients who are randomized and start the treatment procedure. During the procedure the patient will be shielded from the treatment area and cystoscopy screen. The patient and site personnel administering follow-up assessments will be blinded to the study arm through the 3-month follow-up visit. Unblinding will occur at 3 months post-procedure after the assessments are completed. Follow up will continue for 60 months.

Group IV: Control ArmPlacebo Group1 Intervention

Includes all patients who receive a sham procedure. Patients will be shielded from the treatment area and cystoscopy screen. A Foley Catheter is placed into the patient's bladder and inflated. Additionally, devices will be used to produce mock deployment sounds of the Zenflow procedure. Once complete, the balloon will be deflated and the catheter will be removed, completing the procedure. Control arm subjects are followed for 3 months and exited from the study unless they elect and qualify for Crossover.

0 / 10Eligibility 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 Benign Prostatic Hyperplasia (BPH) include alpha-1-adrenergic antagonists, 5-alpha reductase inhibitors, and mechanical interventions like the Prostatic Urethral Lift (PUL). Alpha-1-adrenergic antagonists work by relaxing the smooth muscles in the prostate and bladder neck, improving urine flow. 5-alpha reductase inhibitors reduce the size of the prostate by blocking the conversion of testosterone to dihydrotestosterone. Mechanical interventions, such as the PUL and the Zenflow Spring System, physically open the prostatic urethra to relieve obstruction. These treatments are crucial for BPH patients as they directly address the urinary obstruction, improving symptoms and quality of life.