Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:45 AM
Ignite Modification Date:
2025-12-25 @ 1:45 AM
NCT ID:
NCT03019094
Eligibility Criteria:
Inclusion Criteria:
1. Signed written informed consent.
2. Patient who is mentally competent with the ability to understand and comply with the requirements of the study.
3. Patient agrees to attend all follow-up evaluations and is willing to completely and accurately fill out voiding diaries and questionnaires, and is willing to complete required exams and tests.
4. Patients with overactive bladder symptoms including:
* Urinary frequency greater than or equal to 8 voids/24 hours and less than 16 voids/24 hours AND/OR
* Urinary urge incontinence of at least 2 incontinence episodes on a 3-Day voiding diary
5. If used, patients should be on stable dose of antimuscarinics and/or beta-3 adrenergic agonists for at least 6 weeks prior to enrollment and agree not to change their dose until the 3-month follow-up visit.
6. If used, patients should be on a stable dose of tricyclic antidepressants and Flomax for at least 6 weeks prior to enrollment and agree not to change their dose until the 3-month follow-up visit.
7. Patient who has failed conservative treatments after at least 6 months of treatment (i.e. lifestyle modification-fluid consumption, behavioral modification, and pharmacological therapy).
8. Patients with no clinical evidence of a tibial motor sensory deficit.
9. Patients with competent sphincter mechanism.
10. Patients with normally functioning upper urinary tract and no renal failure.
11. Leg circumference in the range of 20-30 cm at implantation site.
12. Patients with a standard 3-Day voiding diary at baseline.
Exclusion Criteria:
1. Previous participation in another study with any investigational drug or device within the past 90 days.
2. Any metal or other implant in the area of BlueWind RENOVA implantation site.
3. Patients who have not had stable OAB medications for at least 6 weeks.
4. Patients with neurogenic bladder.
5. Patients who are taking diuretics.
6. Patients who have received botulinum toxin injections within the past 12 months.
7. Patients who have received or are receiving nerve stimulation therapies for OAB treatment, including Sacral Nerve Stimulation (and are still implanted) or Posterior Tibial Nerve Stimulation (during the last 3 months).
8. Current pregnancy or attempting to get pregnant.
9. Previous urinary incontinence surgery or implantation of artificial graft material.
10. Any spinal or genitourinary surgery within the last 6 months.
11. Previous abdominoperineal resection of the rectum or radical hysterectomy (female)/ prostatectomy (male).
12. Skin, orthopedic or neurologic anatomical limitations that preclude implantation or/and use of the device.
13. Pelvic pain disorders.
14. Obvious clinically demonstrated genuine stress incontinence including mixed incontinence.
15. Any neurological disease or disorder including Alzheimer's, Parkinson, Multiple Sclerosis, neuropathy or injury resulting in neuropathy.
16. Current or recurrent urinary tract infection (3 or more infections in the last 6 months), or urinary tract obstruction such as benign prostatic hypertrophy, cancer, urethral stricture or presence of urinary stone.
17. History of Pelvic radiotherapy and chemotherapy.
18. Severe uncontrolled diabetes.
19. Patients anticipating magnetic resonance imaging (MRI) exams that are not allowed in the device labeling.
20. Presence of cystocele, enterocele or rectocele of grade 2 or more.
21. Patients with a documented history of allergic response to Platinum iridium, Titanium, Zirconia and Parylene.
22. Another active implant.
23. Have a life expectancy of less than 1 year
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT03019094
Study Brief:
Protocol Section:
NCT03019094