Evaluation of a device for treating urinary symptoms from prostate enlargement

Evaluation of the Safety and Efficacy of the Omega System for the Treatment of Benign Prostatic Hyperplasia

This study is testing a new device that aims to help men with urinary problems caused by prostate enlargement by using an implant to improve urine flow.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 26 (estimated)
• Ages: 50 Years and up
• Sex: Male
• Sponsor: ProArc Medical (industry)
• Locations: 4 sites (Beersheba and 3 other locations)
• Trial ID: NCT04627701 on ClinicalTrials.gov

What this trial studies

The Omega System is designed to treat lower urinary tract symptoms caused by benign prostatic hyperplasia (BPH) in men. This interventional approach involves delivering a permanent implant into the prostate tissue to alleviate obstruction of the urethra. The procedure utilizes a static diathermy incision mechanism to create a circumferential incision, allowing the implant to expand the obstructed area and improve urine flow. The study aims to evaluate the safety and efficacy of this innovative treatment method.

Who should consider this trial

Good fit: Ideal candidates for this study are men aged 50 and older diagnosed with symptomatic BPH and experiencing moderate to severe urinary symptoms.

Not a fit: Patients with significant comorbidities, prostate cancer, or those unable to comply with the study protocol may not benefit from this treatment.

Why it matters

Potential benefit: If successful, this treatment could significantly improve urinary symptoms and quality of life for men suffering from BPH.

How similar studies have performed: While this approach is innovative, similar studies evaluating device-based treatments for BPH have shown promising results.

Eligibility criteria

Inclusion Criteria:

1. Male ≥50 years of age
2. Diagnosed with symptomatic benign prostatic hyperplasia (BPH).
3. International Prostate Symptom Score (IPSS) \>13.
4. Peak flow rate ≤ 12 ml/sec (with voided volume ≥ 125ml).
5. Participant understands and is willing to the informed consent form.
6. Prostate Volume between 30cc and 80cc.
7. Prostate length ≥3cm and ≤5cm

Exclusion Criteria:

1. Concomitant participation in another interventional study.
2. Unable to comply with the clinical protocol including all the follow-up requirements.
3. Vulnerable population such as inmates or developmentally delayed individuals.
4. Significant comorbidities which would affect study participation.
5. Diagnosed or suspected prostate cancer. If suspected, prostate cancer must be ruled out.
6. Any medical condition or treatment, which in the opinion of the investigator may interfere with the procedure, such as:

   * Use of concomitant medications (e.g., anticholinergics, antispasmodics, or antidepressants) affecting bladder function.
   * Patient with coagulopathy due to medications or congenital condition - inability to stop taking anticoagulants and/or antiplatelets for at least 3 days prior to the procedure or coumadin for at least 5 days prior to the procedure; low dose aspirin therapy not prohibited.
   * Alpha-blockers within 2 weeks of pre-treatment (baseline) evaluation.
   * Taking 5-alpha reductase inhibitors (5-ARI) within 6 months (3 months for type II 5-ARI) of pre-treatment (baseline) 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 throughout the study).
   * Patient is taking steroids. \[Note: Patients approved for the trial who are using the above medications will continue using them after the trial, except for Alpha blockers\]
7. Previous prostate surgery such as: TURP, stent implantations, laser prostatectomy, hyperthermia or another invasive treatment to the prostate.
8. Compromised renal function due to obstructive uropathy.
9. Active Urinary Tract Infection (UTI).
10. Obstructive or protruding median lobe
11. American Society of Anaesthesiologists score (ASA) \> 3.
12. Known neurogenic bladder or neurological disorders that might affect bladder or function.
13. Recent myocardial infarction (less than three months).
14. Concomitant bladder stones.
15. Current gross hematuria.
16. Active or history of epididymitis within the past 3 months.
17. Presence of an artificial urinary sphincter or stent(s) in the urethra or prostate.
18. Confirmed or suspected malignancy of bladder.
19. History or presence of strictures in the anterior urethra or bladder neck contracture or detrusor muscle spasms.
20. Other Urethral conditions that may prevent insertion of Delivery Device into prostatic urethra.
21. Bacterial prostatitis within the last 12 months.
22. Previous rectal surgery, other than hemorrhoidectomy.
23. Current uncontrolled diabetes (i.e., hemoglobin A1c ≥ 9%).
24. Known allergy to nickel or titanium or stainless steel.

Where this trial is running

Beersheba and 3 other locations

• Soroka Medical Center — Beersheba, Israel (TERMINATED)
• Carmel Medical Center — Haifa, Israel (TERMINATED)
• Rambam Health Care Campus — Haifa, Israel (TERMINATED)
• Tauranga Urology Research Limited — Tauranga, New Zealand (RECRUITING)

Study contacts

• Study coordinator: Fay Dan

Conditions: Benign Prostatic Hyperplasia, Lower Urinary Tract Symptoms