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

ISRCTN	ISRCTN63527489
DOI	https://doi.org/10.1186/ISRCTN63527489
Secondary identifying numbers	UDIIIQ-1

Submission date: 07/11/2016
Registration date: 15/12/2016
Last edited: 12/12/2016

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Urological and Genital Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

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?
Answering questionnaires

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
dirk.deridder@uzleuven.be

Contact information

Prof Dirk De Ridder
Scientific

Urology
University Hospitals KU Leuven
Herestraat 49
Leuven
3000
Belgium

ORCID ID	0000-0001-6914-0077

Study information

Study design	Observational study
Primary study design	Observational
Secondary study design	Cohort study
Study setting(s)	Hospital
Study type	Quality of life
Participant information sheet	Not available in web format, please use contact details to request a participant information sheet.
Scientific title	Validation of the UDI- and IIQ-7 questionnaire in Lingala and Kikongo in an obstetric fistula population - an observational study
Study objectives	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.
Ethics approval(s)	Internal Review Board of the Hospital St. Luc, Kisantu, RD Congo
Health condition(s) or problem(s) studied	Vesicovaginal fistula due to obstetric complications in a rural hospital in DR Congo
Intervention	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.
Intervention type	Other
Primary outcome measure	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 study start date	01/10/2013
Completion date	01/01/2017

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target number of participants	60
Key inclusion criteria	Female patient with a vesicovaginal fistula due to obstetric complications.
Key exclusion criteria	1. Male 2. Unable to fill in a questionnaire 3. Fistula not due to obstetric complications
Date of first enrolment	01/10/2014
Date of final enrolment	31/12/2016

Locations

Countries of recruitment

Congo, Democratic Republic

Study participating centre

Hôpital St. Luc

Kisantu
Inkisi
Province du Bas-Congo
Kisantu
NA
Congo, Democratic Republic

Sponsor information

KU Leuven - dept. of urology
University/education

Herestraat 49
3000
3000
Belgium

"ROR"	https://ror.org/05f950310

Funders

Funder type

University/education

Investigator initiated and self funded

No information available

Results and Publications

Intention to publish date	02/02/2017
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
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 dirk.deridder@uzleuven.be.