Condition category
Urological and Genital Diseases
Date applied
28/12/2006
Date assigned
28/12/2006
Last edited
04/01/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof J L H R Bosch

ORCID ID

Contact details

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

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 measures

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

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

http://www.umcutrecht.nl/zorg/

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes