Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
CP-01-017
Study information
Scientific title
Acronym
Study hypothesis
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™-I system is designed to deliver mild electrical stimulation to the pelvic floor muscles in a minimally invasive way.
Ethics approval
Not provided at time of registration
Study design
Prospective, interventional, feasibility study
Primary study design
Interventional
Secondary study design
Multi-centre
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Urge incontinence
Intervention
Electrical stimulation of the pelvic floor muscles by an implantable electrical device.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
Improvement in number of leaking episodes/day
Secondary outcome measures
1. Clinical success rate at three months, six months and 12 months
2. Number of serious adverse events
Overall trial start date
01/12/2006
Overall trial end date
30/11/2007
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Females more than 18 years
2. Failed conservative treatment for more than six months
3. Detrusor overactivity on urodynamic study
4. Urinary urge incontinence more than five episodes a day
5. Urinary frequency more than 10/day and more than 3/night
6. Competent sphincter mechanism
7. Normal upper tract
8. Passing MST-I session
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
30
Participant exclusion criteria
1. Participation in another study less than three months
2. Any active implant
3. Incontinence surgery less than three months
4. Spinal or genital surgery less than six months
5. Post void residual less than 100 ml
6. Leak point pressure more than 100 cm Water (H2O)
7. Pelvic pain syndrome
8. Stress incontinence
9. Cystocele/rectocele/enterocele grade three or four
10. Neurological disease
11. Morbid obesity
12. Severe uncontrolled diabetes
13. Severe heart disease
14. Requiring frequent Magnetic Resonance Imaging (MRI) exams
15. Pregnancy or attempt to get pregnant
16. Uncontrolled bleeding coagulopathy
Recruitment start date
01/12/2006
Recruitment end date
30/11/2007
Locations
Countries of recruitment
Netherlands
Trial participating centre
University Medical Center Utrecht (UMCU)
Utrecht
3584 CX
Netherlands
Sponsor information
Organisation
University Medical Center Utrecht (UMCU) (The Netherlands)
Sponsor details
Department of Urology
P.O. Box 85500
Utrecht
3508 GA
Netherlands
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Industry
Funder name
American Medical Systems, Inc. (USA)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list