Condition category
Urological and Genital Diseases
Date applied
07/11/2016
Date assigned
15/12/2016
Last edited
12/12/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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?
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

Trial website

Contact information

Type

Scientific

Primary contact

Prof Dirk De Ridder

ORCID ID

http://orcid.org/0000-0001-6914-0077

Contact details

Urology
University Hospitals KU Leuven
Herestraat 49
Leuven
3000
Belgium

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

UDIIIQ-1

Study information

Scientific title

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

Acronym

Study hypothesis

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

Internal Review Board of the Hospital St. Luc, Kisantu, RD Congo

Study design

Observational study

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Hospitals

Trial type

Quality of life

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet.

Condition

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

Phase

Drug names

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

01/10/2013

Overall trial end date

01/01/2017

Reason abandoned

Eligibility

Participant inclusion criteria

Female patient with a vesicovaginal fistula due to obstetric complications.

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

60

Participant exclusion criteria

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

Recruitment start date

01/10/2014

Recruitment end date

31/12/2016

Locations

Countries of recruitment

Congo, Democratic Republic

Trial participating centre

Hôpital St. Luc
Kisantu Inkisi Province du Bas-Congo
Kisantu
NA
Congo, Democratic Republic

Sponsor information

Organisation

KU Leuven - dept. of urology

Sponsor details

Herestraat 49
3000
3000
Belgium

Sponsor type

University/education

Website

Funders

Funder type

University/education

Funder name

Investigator initiated and self funded

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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 dirk.deridder@uzleuven.be.

Intention to publish date

02/02/2017

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes