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

Completed

• Conditions: rge incontinence; Urological and Genital Diseases; Incontinence

• Registration Number: ISRCTN08364639
• Lead Sponsor: niversity Medical Center Utrecht (UMCU) (The Netherlands)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-12-28
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 30

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Improvement in number of leaking episodes/day

Secondary Outcome Measures

Name	Time	Method
1. Clinical success rate at three months, six months and 12 months<br>2. Number of serious adverse events