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

miniaturo™-I study for Urinary Urge Incontinence.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON23310

Enrollment

Registered

2006-09-25

Start date

2006-12-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urge incontinence caused by detrusor overactivity

Interventions

Electrical stimulation of the pelvic floor muscles by an implantable electrical device.

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 1. Participation in another study 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.

Design outcomes

Primary

Measure	Time frame
Improvement in number of leaking episodes/day.	—

Secondary

Measure	Time frame
Clinical success rate at 3 months, 6 months and 12 months; number of serious adverse events.	—

Contacts

Public ContactJ.L.H.R. Bosch

University Medical Center Utrecht (UMCU), Department of Urology, Heidelberglaan 100

+31 (0)30 2508079

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)