The Zenflow Spring System Feasibility and Safety Study
The Zenflow Spring System Feasibility and Safety Study
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).
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.
Inclusion Criteria:

 1. 50 to 80 years of age

 2. Baseline IPSS score > 13, and a baseline Quality of Life (Qol) question score > 3

 3. Prostate volume 25 - 80 cc by Trans Rectal Ultrasound (TRUS), measured within past 90
 days

 4. 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.

 5. 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:

 1. Obstructive median prostatic lobe or high bladder neck

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

 3. 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

 4. 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)

 5. 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)

 6. History of chronic urinary retention. (New Zealand Only, up to 5 patients)

 7. History of neurogenic bladder

 8. Compromised renal function (e.g., serum creatinine > 1.8 mg/dl)

 9. Concomitant Urinary Tract Infection (UTI)

 10. Concomitant bladder stones

 11. Confirmed or suspected prostate/bladder cancer

 12. Previous pelvic irradiation or radical pelvic surgery

 13. Previous prostate surgery, stent implantations, laser prostatectomy, hyperthermia or
 another invasive treatment to the prostate

 14. Chronic prostatitis, or recurring prostatitis within the past 12 months

 15. Serious concurrent medical conditions such as uncontrolled diabetes

 16. Known allergy to nickel

 17. Life expectancy less than 12 months

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

 19. 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.

 20. 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).

 21. -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).

 22. Future fertility concerns

 23. Any severe illness that might prevent study completion or would confound study results