Performance of the miniaturo™-I system for treatment of overactive bladder

ISRCTN ISRCTN08364639
DOI https://doi.org/10.1186/ISRCTN08364639
Secondary identifying numbers CP-01-017
Submission date
28/12/2006
Registration date
28/12/2006
Last edited
04/01/2007
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Urological and Genital Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof J L H R Bosch
Scientific

University Medical Center Utrecht (UMCU)
Department of Urology
Heidelberglaan 100
Utrecht
3584 CX
Netherlands

Study information

Study designProspective, interventional, feasibility study
Primary study designInterventional
Secondary study designMulti-centre
Study setting(s)Not specified
Study typeTreatment
Scientific title
Study objectivesUrge 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(s)Not provided at time of registration
Health condition(s) or problem(s) studiedUrge incontinence
InterventionElectrical stimulation of the pelvic floor muscles by an implantable electrical device.
Intervention typeOther
Primary outcome measureImprovement in number of leaking episodes/day
Secondary outcome measures1. Clinical success rate at three months, six months and 12 months
2. Number of serious adverse events
Overall study start date01/12/2006
Completion date30/11/2007

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexFemale
Target number of participants30
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment01/12/2006
Date of final enrolment30/11/2007

Locations

Countries of recruitment

  • Netherlands

Study participating centre

University Medical Center Utrecht (UMCU)
Utrecht
3584 CX
Netherlands

Sponsor information

University Medical Center Utrecht (UMCU) (The Netherlands)
Hospital/treatment centre

Department of Urology
P.O. Box 85500
Utrecht
3508 GA
Netherlands

Website http://www.umcutrecht.nl/zorg/
ROR logo "ROR" https://ror.org/0575yy874

Funders

Funder type

Industry

American Medical Systems, Inc. (USA)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan