The Zenflow Spring System Feasibility and Safety Study

Study Overview
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Brief Summary
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This is a First in Human study to assess the feasibility, safety and effectiveness of the Zenflow Spring System in relieving the symptoms of obstructive Benign Prostatic Hyperplasia (BPH).

Detailed Description
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The purpose of the Zenflow Study is to evaluate the feasibility and safety of a novel prostatic urethral implant for the treatment of Lower Urinary Tract Symptoms (LUTS) that arise due to bladder outlet obstruction (BOO), secondary to the presence of Benign Prostatic Hypertrophy (BPH). Effectiveness will also be measured. It is intended that the features of the Zenflow Spring will provide an effective office-based treatment and management therapy for BPH with little or no side effects.

Official Title
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The Zenflow Spring System Feasibility and Safety Study (ZEST)

Conditions
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Benign Prostatic Hyperplasia

Intervention / Treatment
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* Device: Zenflow Spring System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 50 to 80 years of age Baseline IPSS score > 13, and a baseline Quality of Life (Qol) question score > 3 Prostate volume 25 - 80 cc by Trans Rectal Ultrasound (TRUS), measured within past 90 days Anterior prostatic urethral length 2.5 - 4.0 cm by cystoscopy, as measured from bladder neck to verumontanum. TRUS will be accepted as a primary screening measure. Failed or intolerant to medication regimen for the treatment of LUTS. Exclusion Criteria: New Zealand only: A maximum of 5 participants in acute or chronic urinary retention may be included in the study provided they meet other entry criteria. Exclusion exemptions for these patients are described in 4a, 5a and they are exempt from #6. Participants will be excluded from participating in this trial if they meet any of the following criteria: Obstructive median prostatic lobe or high bladder neck Urethral stricture, meatal stenosis, or bladder neck obstruction - either current, or recurrent requiring 2 or more dilatations Elevated Prostate Specific Antigen (PSA) (age 50-70 PSA ≥4; age 70+ PSA ≥6.5) unless negative biopsy within last 3 months, or a positive biopsy Post-void residual volume (PVR) > 250 ml, if not in acute retention 4a. No maximum post void residual volume required if patient in acute or chronic urinary retention. (New Zealand Only, up to 5 patients) Peak urinary flow rate > 12 ml/second, with ≥ 125 ml voided volume at baseline. 5a. No maximum urinary flow or minimum voided volume required if participant in acute or chronic urinary retention. (New Zealand Only, up to 5 patients) History of chronic urinary retention. (New Zealand Only, up to 5 patients) History of neurogenic bladder Compromised renal function (e.g., serum creatinine > 1.8 mg/dl) Concomitant Urinary Tract Infection (UTI) Concomitant bladder stones Confirmed or suspected prostate/bladder cancer Previous pelvic irradiation or radical pelvic surgery Previous prostate surgery, stent implantations, laser prostatectomy, hyperthermia or another invasive treatment to the prostate Chronic prostatitis, or recurring prostatitis within the past 12 months Serious concurrent medical conditions such as uncontrolled diabetes Known allergy to nickel Life expectancy less than 12 months Use of concomitant medications (e.g., anticholinergics, antispasmodics or antidepressants) affecting bladder function Anti-coagulant, anti-platelet, or thrombolytic medication other than Acetylsalicylic Acid (ASA) or Clopidogrel. ASA and Clopidogrel must be ceased 7 days prior to the procedure. 5--reductase inhibitors within 6 months of pre-treatment evaluation unless evidence of same drug dose for at least 6 months with a stable voiding pattern (the drug dose should not be altered or discontinued for entrance into or throughout the study). -blockers within 2 weeks of pre-treatment evaluation unless evidence of same drug dose for at least 6 months with a stable voiding pattern (the drug dose should not be altered or discontinued for entrance into or throughout the study). Future fertility concerns Any severe illness that might prevent study completion or would confound study results

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment Group<br>Receives intervention with the Zenflow Spring System. | Device: Zenflow Spring System<br>* The Zenflow Spring is a nitinol urethral implant for the treatment of Lower Urinary Tract Symptoms (LUTS) that arise due to bladder outlet obstruction (BOO), secondary to the presence of Benign Prostatic Hypertrophy (BPH). The device is intended to be a permanent implant however it may be removed if necessary.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Device Success defined as both 1) deliverability of the implant and 2) freedom from unanticipated adverse events (UAEs) not listed in the protocol or AEs that meet the protocol definition of Serious AEs. | Frequency of Device Success is assessed by subject, for both successful device placement in the target anatomy and absence of serious or unanticipated adverse events through discharge. | Intraoperative | 
| Occurrence of device and/or procedure related Adverse Events as determined by investigator and independent medical reviewer | Frequency and severity of any device or procedure related adverse events, by subject. | Intraoperative | 
| Occurrence of Adverse Event specific to indwelling catheterization, descriptive analysis | Frequency of indwelling catheterization = or > 7 days following placement of the investigational device. | Seven days following implantation of the investigational device | 
| Effectiveness of implant measured through symptom improvement (International Prostate Symptom Score - IPSS) | Subjects should demonstrate improvement of > or = to 3 point reduction from baseline measurement. | 3 months following device placement | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of Sexual Health using the Sexual Health in Men (SHIM) questionnaire | Observational assessment of subject scores on SHIM at the 6 months and 12 months visit, compared to baseline. | 6 months, 12-,24-,36-, months post implantation | 
| Assessment of Incontinence, using the Incontinence Severity Index (ISI) questionnaire | Observational assessment of subject scores on ISI at 2 weeks, 1 month and 3 months compared to baseline. | 2 weeks, 1 month, 3 months | 
| Observation of pain using a validated Visual Analogue Scale (VAS) questionnaire | Observational assessment of subject reports of pain on the VAS questionnaire, at discharge and follow up visits up to 3 months, compared to baseline. | through 3 month follow-up | 
| Improvement in Uroflowmetry compared to baseline | Uroflowmetry is measured at 3 months post implantation and compared to baseline | 3-, 6-, 12-, 24-, 36-months post implantation | 
| Effectiveness of implant measured through symptom improvement (International Prostate Symptom Score - IPSS) | Observation of IPSS scores compared to baseline at 12 months follow up. | 12 months 24 months and 36 months | 
| Effectiveness of the treatment by assessing need for further treatment to alleviate symptoms of BPH. | Observation of incidence of repeat invasive treatment for LUTS through 12 months post-procedure | 12 months 24 months and 36 months |