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

Validation of the UDI- and IIQ-7 questionnaire in Lingala and Kikongo in an obstetric fistula population - an observational study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN63527489

Enrollment

Registered

2016-12-15

Start date

2014-10-01

Completion date

Unknown

Last updated

2017-02-06

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

Conditions

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

Interventions

Questionnaires, according to following methodologies. - UDI-6 and IIQ-7 translated and undergoing content validity checks using focus groups. - Final versions tested in a normal population and in a

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: Female patient with a vesicovaginal fistula due to obstetric complications.

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Validation parameters: Crohnbach alpha, reliability, responsiveness	—

Secondary

Measure	Time frame
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. 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.	—

Countries

Congo, Democratic Republic

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026