Performance of the miniaturo™-I system for treatment of overactive bladder
| ISRCTN | ISRCTN08364639 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN08364639 |
| Protocol serial number | CP-01-017 |
| Sponsor | University Medical Center Utrecht (UMCU) (The Netherlands) |
| Funder | American Medical Systems, Inc. (USA) |
- 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
Scientific
University Medical Center Utrecht (UMCU)
Department of Urology
Heidelberglaan 100
Utrecht
3584 CX
Netherlands
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Prospective, interventional, feasibility study |
| Secondary study design | Multi-centre |
| Scientific title | |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Urge incontinence |
| Intervention | Electrical stimulation of the pelvic floor muscles by an implantable electrical device. |
| Intervention type | Other |
| Primary outcome measure(s) |
Improvement in number of leaking episodes/day |
| Key secondary outcome measure(s) |
1. Clinical success rate at three months, six months and 12 months |
| Completion date | 30/11/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target sample size at registration | 30 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/12/2006 |
| Date of final enrolment | 30/11/2007 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
University Medical Center Utrecht (UMCU)
Utrecht
3584 CX
Netherlands
3584 CX
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
