RESTORE: An RCT to Evaluate the Efficacy of the Revi System

Launched by BLUEWIND MEDICAL · Jan 11, 2024

Keywords

ClinConnect Summary

The RESTORE clinical trial is studying the Revi System, a new treatment option for people experiencing urinary urge incontinence, which is the sudden and strong feeling of needing to urinate that can lead to involuntary leakage. This trial is currently recruiting participants who are at least 21 years old and have been diagnosed with this condition for at least six months. To qualify, participants should have experienced at least four leaking episodes in a day for two consecutive days, and they must agree to continue any current medications for their condition throughout the trial.

If you decide to participate, you will need to attend follow-up visits and fill out diaries and questionnaires about your symptoms. The trial aims to see how effective the Revi System is in reducing the symptoms of urinary urge incontinence. It’s important to note that certain medical conditions or recent treatments may make you ineligible, so discussing your specific situation with your doctor is essential. This trial could potentially help improve the lives of many individuals dealing with this challenging condition.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Signed written informed consent.
• • 2. Subject is at least 21 years old, with no plans to become pregnant during the trial. If of child bearing potential and sexually active, negative pregnancy test and using acceptable contraception.
• • 3. Subject has been diagnosed with UUI for at least 6 months.
• • 4. Subject experiences a minimum of four (4) leaking episodes associated with urgency, with at least one episode per day for 2 days documented on a voiding diary for 3 consecutive days.
• • 5. If used, subject should be on stable dose of antimuscarinics and/or beta-3 adrenergic agonists for at least 1 month prior to baseline and agree to remain on stable medication consumption until the 24-month follow-up visit.
• • 6. If used, subject should be on a stable dose of tricyclic antidepressants, Selective Serotonin Reuptake Inhibitors (SSRI) and Serotonin-Norepinephrine Reuptake Inhibitors (SNRI) for at least 3 months prior to baseline.
• • 7. Subject agrees to attend all follow-up evaluations and is willing and capable to completely and accurately fill out voiding diaries and questionnaires and is willing to complete required exams and test
• Exclusion Criteria:
• • 1. Subject participation in a clinical investigation with an active treatment arm within the past 90 days.
• • 2. Subject is a high surgical risk with multiple illnesses or active general infections that expose them to excessive bleeding or delayed or non-healing wounds. This includes patients who need anticoagulation therapy that cannot be temporarily stopped for the implantation procedure.
• • 3. Subject with BMI \>50.
• • 4. Subject with any metal or other implant within 20cm distance of the area of BlueWind Revi implantation site.
• • 5. Subject variation in diuretics consumption within the last 6 months.
• • 6. Subject has received botulinum toxin injections for OAB within the past 12 months.
• • 7. Subject with previous urinary incontinence surgery or prolapse surgery within the last 12 months.
• • 8. Subject has had any spinal or genitourinary surgery within the last 6 months.
• • 9. Subject had previous abdominoperineal resection of the rectum or radical hysterectomy (female)/ prostatectomy (male).
• • 10. Subject with diagnosis of BPH with outflow/obstructive predominant symptoms.
• • 11. Subject has skin, peripheral edema, orthopedic or neurologic anatomical limitations that preclude implantation or/and use of the device.
• • 12. Subject with Alzheimer's, Parkinson, MS, stroke (CVI), neuropathy or injury resulting in neuropathy and/or suspected neurogenic bladder.
• • 13. Subject has recurrent urinary tract infections (3 or more infections in the last 6 months), or presence of urinary fistula, or urinary tract obstruction such as cancer, urethral stricture or presence of urinary stone.
• • 14. Subject with history of chemotherapy or pelvic radiotherapy that might have affected bladder control or caused neuropathies (i.e. peripheral neuropathy).
• • 15. Male subject who have obstructive Benign Prostatic Hyperplasia (BPH) or other lower urinary tract obstructions.
• • 16. Subject has open wounds or sores on the lower leg or foot or had previous, unhealed trauma in the implant area or has pitting edema (≥2+) in the lower leg.
• • 17. Subject has Venous or Arterial disease/insufficiency in the lower leg or Vasculitis or dermatologic condition in the lower leg or infections near the implantation site in the lower leg.
• • 18. Subject has a documented history of allergic response to Platinum iridium, Titanium, Zirconia, Gold, Silicone or Parylene.
• • 19. Subject has other active implantable electronic device/s regardless of whether stimulation is ON or OFF.
• • 20. Subject has a life expectancy of less than 1 year.