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


- candidate number2260
- NTR NumberNTR778
- ISRCTNISRCTN08364639
- Date ISRCTN created28-dec-2006
- date ISRCTN requested18-dec-2006
- Date Registered NTR25-sep-2006
- Secondary IDsCP-01-017 
- Public TitlePerformance of the miniaturo™-I system for treatment of overactive bladder.
- Scientific Titleminiaturo™-I study for Urinary Urge Incontinence.
- ACRONYMN/A
- hypothesisurge 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.
- Healt Condition(s) or Problem(s) studiedUrge incontinence
- Inclusion criteria1. 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 criteria1. 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.
- mec approval receivedno
- multicenter trialyes
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeintervention
- planned startdate 1-dec-2006
- planned closingdate30-nov-2007
- Target number of participants30
- InterventionsElectrical stimulation of the pelvic floor muscles by an implantable electrical device.
- Primary outcomeImprovement in number of leaking episodes/day.
- Secondary outcomeClinical success rate at 3 months, 6 months and 12 months; number of serious adverse events.
- TimepointsN/A
- Trial web siteN/A
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIESProf. Dr. J.L.H.R. Bosch
- CONTACT for SCIENTIFIC QUERIES S. Segal or Designee
- Sponsor/Initiator University Medical Center Utrecht (UMCU), Department of Urology
- Funding
(Source(s) of Monetary or Material Support)
American Medical Systems, Inc.
- PublicationsN/A
- Brief summaryTitle:
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.
- Main changes (audit trail)
- RECORD25-sep-2006 - 13-jan-2010


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