No registrations found.
ID
Source
Brief title
Health condition
Urge incontinence caused by detrusor overactivity
Sponsors and support
10700 Bren Road West
Minnetonka, MN 55343 USA
Tel: 952-930-6000
Fax: 952-930-6007
Intervention
Outcome measures
Primary outcome
Improvement in number of leaking episodes/day.
Secondary outcome
Clinical success rate at 3 months, 6 months and 12 months; number of serious adverse events.
Background summary
Title:
Performance of the miniaturo™-I system for treatment of overactive bladder
Running title: miniaturo™-I study for Urinary Urge Incontinence.
Design:
Prospective, interventional and feasibility study.
Number of patients:
Up to 30.
Patients:
Patients with Urinary Urge Incontinence.
Clinical sites:
Up to 10 sites.
Purpose:
To determine the performance (safety and effectiveness) of miniaturo™-I for the treatment of UUI.
Primary endpoint:
Improvement in number of leaking episodes/day.
Secondary endpoints:
Clinical success rate at 3 months, 6 months and 12 months; number of serious adverse events.
Methods:
Urodynamic test, Voiding diary, Test stimulation, Device implantation, Incontinence and Quality of life questionnaires.
Clinical Follow-up:
1, 3, 6 and 12 months.
Study objective
urge incontinence is caused by overactivity of the detrusor muscle of the urinary bladder. Electrical stimulation of the pelvic floor muscles can suppress detrusor overactivity. The miniaturo tm-i system is designed to deliver mild electrical stimulation to the pelvic floor muscles in a minimally invasive way.
Study design
N/A
Intervention
Electrical stimulation of the pelvic floor muscles by an implantable electrical device.
Department of Urology,
Heidelberglaan 100
J.L.H.R. Bosch
Utrecht 3584 CX
The Netherlands
+31 (0)30 2508079
Department of Urology,
Heidelberglaan 100
J.L.H.R. Bosch
Utrecht 3584 CX
The Netherlands
+31 (0)30 2508079
Inclusion criteria
1. Females > 18 years;
2. Failed conservative treatment for > 6 mnths;
3. Detrusor overactivity on urodynamic study;
4. Urinary urge incontinence > 5 episodes a day;
5. Urinary frequency > 10/day and > 3/night;
6. Competent sphincter mechanism;
7. Normal upper tract;
8. Passing MST-I session.
Exclusion criteria
1. Participation in another study < 3 mnths;
2. Any active implant;
3. Incontinence surgery < 3 mnths;
4. Spinal or genital surgery < 6 mnths;
5. Post void residual > 100 ml;
6. Leak point pressure > 100 cm H2O;
7. Pelvic pain syndrome;
8. Stress incontinence;
9. Cystocele/rectocele/enterocele grade 3 or 4;
10. Neurological disease;
11. Morbid obesity;
12. Severe uncontrolled diabetes;
13. Severe heart disease;
14. Requiring frequent MRI exams;
15. Pregnancy or ettemp to get pregnant;
16. Uncontrolled bleeding coagulopathy.
Design
Recruitment
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 |
|---|---|
| NTR-new | NL767 |
| NTR-old | NTR778 |
| Other | : CP-01-017 |
| ISRCTN | ISRCTN08364639 |