Plain English Summary
Background and study aims
Obstetric fistula is a hole in the birth canal caused by prolonged and obstructed labour. If left untreated in a patient, this leads to incontinence (constant and uncontrollable leakage of urine or faeces). When obstetric fistula (OF) repair takes place, the results are usually assessed by the surgical team and the patient perspective is often neglected. Urogenital distress inventory (UDI-6) and the impact of incontinence questionnaire (IIQ-7) are two internationally-validated questionnaires.
The aim of this study is to translate them in two Congolese local languages (Lingala and Kikongo) and to check whether that they can be used to assess the symptoms and the impact of urinary incontinence on the quality of life in patients with obstetric fistula.
Who can participate?
Female adults with fistula due to obstetric complications and able to fill in questionnaires
What does the study involve?
What are the possible benefits and risks of participating?
Not provided at time of registration.
Where is the study run from?
Saint Luc Hospital, Kisantu, Democratic Republic of Congo
When is the study starting and how long is it expected to run for?
October 2013 to January 2017
Who is funding the study?
Investigator led and funded. Incidental costs paid by Department of Urology, University Hospitals KU Leuven, Leuven, Belgium.
Who is the main contact?
Professor Dirk De Ridder
Prof Dirk De Ridder
University Hospitals KU Leuven
Validation of the UDI- and IIQ-7 questionnaire in Lingala and Kikongo in an obstetric fistula population - an observational study
Urogenital distress inventory (UDI-6) and the impact of incontinence questionnaire (IIQ-7) are two internationally validated questionnaires on incontinence. It is hypothesised that these questionnaires can be translated and validated in two Congolese local languages (Lingala and Kikongo) and that they can be used to assess the symptoms and the impact on the quality of life of urinary incontinence in patients with obstetric vesicovaginal fistula.
Internal Review Board of the Hospital St. Luc, Kisantu, RD Congo
Primary study design
Secondary study design
Quality of life
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet.
Vesicovaginal fistula due to obstetric complications in a rural hospital in DR Congo
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 an obstetric fistula population for internal consistency and test-retest reliability.
- Responsiveness tested in an obstetric fistula population and effect sizes calculated.
Primary outcome measures
Validation parameters: Crohnbach alpha, reliability, responsiveness
Secondary outcome measures
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.
Overall trial start date
Overall trial end date
Participant inclusion criteria
Female patient with a vesicovaginal fistula due to obstetric complications.
Target number of participants
Participant exclusion criteria
2. Unable to fill in a questionnaire
3. Fistula not due to obstetric complications
Recruitment start date
Recruitment end date
Countries of recruitment
Congo, Democratic Republic
Trial participating centre
Hôpital St. Luc
Kisantu Inkisi Province du Bas-Congo
Congo, Democratic Republic
Investigator initiated and self funded
Funding Body Type
Funding Body Subtype
Results and Publications
Publication and dissemination plan
Publication will be submitted to Neurourology and Urodynamics journal.
IPD Sharing plan:
The datasets generated during and/or analysed during the current study are/will be available upon request from firstname.lastname@example.org.
Intention to publish date
Participant level data
Available on request
Results - basic reporting