OAB /Overactive bladder
Conditions
Interventions
The following intervention was part of the initial study. No new patients will
undergo the intervention.
Study Treatment * Study will include two treatment regimens that will be
prescribed for each
Sponsors
BlueWind Medical
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Participation in the original OAB pilot study 2. Signed written informed consent form (ICF) for the study extended FU period amendment The original study consisted of the following inclusion criteria: 1. Signed ICF 2. Male or female aged 18 * 80. 3. Patient who is mentally competent with the ability to understand and comply with the requirements of the study. 4. 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. 5. Patients with overactive bladder symptoms: * Urinary frequency greater than 8 times/24 hours AND/OR * Urinary urgency leaks of at least 2 leaks on 3 day voiding diary 6. Patient who has failed conservative treatments after at least 6 months of treatment (i.e. lifestyle modification-fluid consumption, behavioral modification, and pharmacological therapy) 7. Patient who passes the BlueWind compatibility test. 8. Patients with competent sphincter mechanism. 9. Patients with normally functioning upper urinary tract. 10. Patients with no clinical evidence of a neurological S2-S4 motor sensory deficit. 11. Leg circumference in the range of 20-30 cm at implantation site.
Exclusion criteria
Exclusion criteria: 1. Patients whose BlueWind medical RENOVATM implant had been removed The original study consisted of the following exclusion criteria: 1. Previous participation in another study with any investigational drug or device within the past 90 days. 2. Any metal implant in the area of BlueWind Medical implantation site. 3. Patients who have not had stable OAB medications for at least 30 days. 4. Patients who have received botulinum toxin injections within the past 6 months. 5. Patients who are receiving concomitant nerve stimulation therapies for OAB treatment, except for PTNS maintenance therapy. 6. Current pregnancy or attempting to get pregnant (female patient). 7. Previous urinary incontinence surgery or implantation of artificial graft material within the last 6 months. 8. Any spinal or genitourinary surgery within the last 6 months. 9. Previous abdominoperineal resection of the rectum or radical hysterectomy (female)/ prostatectomy (male) within the last 6 months. 10. Anatomical defects that preclude use of the device. 11. Pelvic pain disorders 12. Obvious clinically demonstrated genuine stress incontinence. 13. Any neurological disease or disorder including neuropathy or injury resulting in neuropathy. 14. Current urinary tract infection, presence of urinary stone and/or urinary tract malignancy (i.e. tumor, vesicourethral reflux, etc.) 15. Pelvic radiotherapy and chemotherapy. 16. Severe uncontrolled diabetes. 17. Patients anticipating magnetic resonance imaging (MRI) exams. 18. Presence of cystocele, enterocele or rectocele of grade 3 or 4.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary study endpoint is composed of: the incidence of serious adverse events (system and/or procedure related events) | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary end point is composed of: a. 36 month clinical improvement compared to baseline will be measured by the effect of BlueWind Medical's therapy on the treatment of the following symptoms: * Number of voids/day * Volume voided/void * Number of leaks per day * Degree of urgency prior to void In the presence of urge incontinence, the following factors should be evaluated compared to baseline; * Leaking episodes/day * Severity of leaking episodes * Absorbent pads replaced due to leaking/day b. Regular measurement of sensory and motor threshold response to acute stimulation (e.g., during parameter settings and at each follow up visit); * Sensation threshold assessment- based on patient report * Motor threshold assessment- based on physician visual observation c. Quality of Life Questionnaire * OAB-q | — |
Countries
Netherlands
Outcome results
None listed