Validation of the UDI- and IIQ-7 questionnaire in Lingala and Kikongo in an obstetric fistula populatio

Completed

• Conditions: Vesicovaginal fistula due to obstetric complications in a rural hospital in DR Congo; Urological and Genital Diseases; Vesicovaginal fistula

• Registration Number: ISRCTN63527489
• Lead Sponsor: KU Leuven - dept. of urology

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-12-15
• Last Update Posted: 6 February 2017

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

Female patient with a vesicovaginal fistula due to obstetric complications.

Exclusion Criteria

1. Male
2. Unable to fill in a questionnaire
3. Fistula not due to obstetric complications

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Validation parameters: Crohnbach alpha, reliability, responsiveness

Secondary Outcome Measures

Name	Time	Method
1. Fistula closure rate - number of healed fistula vs the number of persistent fistula after fistula surgery. This is assessed by clinical examination after 3 weeks. <br>2. Incontinence rate - number of patients with urinary incontinence ( stress and/or urgency incontinence) while the fistula is healed. This is assessed by clinical examination at 3 weeks and 3 months after surgery. <br>