overactive bladder Urge incontinence
Conditions
Interventions
Electrical stimulation of the pelvic floor by an implantable electrostimulator
and lead.
Sponsors
American Medical Systems Inc.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. At least 18 years old female and full body development 2. Signed informed consent 3. Normal mental status 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. Patient who failed conservative treatments (i.e. lifestyle modification-fluid consumption, behavioral modification, and pharmacological therapy) for at least 6 months. 6. Overactive detrusor demonstrated on cystometry during the last 6 months or patients who are regarded as sensory urgency 7. Urinary Urge Incontinence greater then 5 episodes per day 8. Urinary frequency greater than 10 times/day and 3 times/night 9. Patients with competent sphincter mechanism 10. Patients with normally functioning upper urinary tract 11. Passing MTS-I session
Exclusion criteria
Exclusion criteria: 1. Previous participation in another study with any investigational drug or device within the past 3 months 2. Any active implant (cardiac or other) 3. Previous urinary incontinence surgery or implantation of artificial graft material within the last 6 months 4. Any spinal or genitourinary surgery within the last 6 months 5. Previous abdominoperineal resection of the rectum or radical hysterectomy within the last 6 months 6. Anatomical defects that preclude use of the device 7. PVR> 100 ml 8. VLPP > 100 cmH2O on urodynamic testing 9. Primary pelvic pain syndrome 10. Obvious clinically demonstrated genuine stress incontinence 11. Presence of cystocele, enterocele or rectocele of grade 3 or 4 (if applicable) 12. Any neurological disease or disorder 13. Current urinary tract infection or chronic inflammation, presence of urinary stone and/or urinary tract malignancy (i.e. tumor, urethritis, vesicourethral reflux, etc.) 14. Pelvic radiotherapy and chemotherapy 15. Morbid obesity 16. Severe uncontrolled diabetes 17. Any severe heart disease 18. Patients requiring frequent magnetic resonance imaging (MRI) exams 19. Current pregnancy or attempting to get pregnant (female patient) 20. Patient with uncontrolled bleeding coagulopathy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement in number of incontinence episodes per day. | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical success rate at 3 months, 6 months and 12 months; number of serious adverse events. | — |
Countries
Netherlands
Outcome results
None listed