To determine the performance (safety and effectiveness) of miniaturo*-I for the treatment of urinary urge incontinence.
ID
Source
Brief title
Condition
- Bladder and bladder neck disorders (excl calculi)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Improvement in number of incontinence episodes per day.
Secondary outcome
Clinical success rate at 3 months, 6 months and 12 months; number of serious
adverse events.
Background summary
Urge incontinence is due detrusor overactivity. Urgeincontinence is a disabling
condition influencing quality of life. Treatment is not causative, often not
effective and often has many side effects.
Electrical stimulation of the pelvic floor muscles diminishes detrusor
overactivity and in that way improves urge incontinence.
Study objective
To determine the performance (safety and effectiveness) of miniaturo*-I for the
treatment of urinary urge incontinence.
Study design
Prospective
Intervention
Electrical stimulation of the pelvic floor by an implantable electrostimulator
and lead.
Study burden and risks
At least 5 visits to the outpatient clinic are required and 2 admissions,
taking approximately 15 hours plus 2 x 3 days in hospital. Before implantation
a urodynamic test is performed and patients have to fill out questionnaires
into quality of life and symptoms and need to keep a voiding diary every visit.
There is a risk for infection or erosion of the implant, feeling of an
electrical shock in the stimulation area, and urinary retention.
10700 Bren Road West
Minnetonka MN 55343
United States of America
10700 Bren Road West
Minnetonka MN 55343
United States of America
Listed location countries
Age
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
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
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| Other | cp 01017 |
| CCMO | NL14669.041.06 |