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 tm-i system is designed to deliver mild electrical…
ID
Bron
Verkorte titel
Aandoening
Urge incontinence caused by detrusor overactivity
Ondersteuning
10700 Bren Road West
Minnetonka, MN 55343 USA
Tel: 952-930-6000
Fax: 952-930-6007
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Improvement in number of leaking episodes/day.
Achtergrond van het onderzoek
Title:
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.
Doel van het onderzoek
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 tm-i system is designed to deliver mild electrical stimulation to the pelvic floor muscles in a minimally invasive way.
Onderzoeksopzet
N/A
Onderzoeksproduct en/of interventie
Electrical stimulation of the pelvic floor muscles by an implantable electrical device.
Publiek
Department of Urology,
Heidelberglaan 100
J.L.H.R. Bosch
Utrecht 3584 CX
The Netherlands
+31 (0)30 2508079
Wetenschappelijk
Department of Urology,
Heidelberglaan 100
J.L.H.R. Bosch
Utrecht 3584 CX
The Netherlands
+31 (0)30 2508079
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. 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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. 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.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
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Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL767 |
| NTR-old | NTR778 |
| Ander register | : CP-01-017 |
| ISRCTN | ISRCTN08364639 |