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Validation of pelvic floor related symptom and Quality of Life questionnaires in Dutch patients.


- candidate number8099
- NTR NumberNTR2355
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR28-mei-2010
- Secondary IDs2008-376 / NL25341.078.08 ; METC / CCMO
- Public TitleValidation of pelvic floor related symptom and Quality of Life questionnaires in Dutch patients.
- Scientific TitleValidation of pelvic floor related symptom and Quality of Life questionnaires in Dutch patients.
- ACRONYM
- hypothesisPelvic floor related symptom and Quality of Life questionnaires (IIQ-7, UDI-6, IIEF-5, PISQ-12, PFIQ-7, PFDI-20, FISI, FIQL) in Dutch are valid instruments, which can be used reliably in daily practice and clinical research.
- Healt Condition(s) or Problem(s) studiedUrinary incontinence, Fecal incontinence, Pelvic organ prolaps, Erectile dysfunction
- Inclusion criteria1. Aged 18 years or older;
2. Urinary incontinence and/or pelvic organ prolapse (stadium 2 or higher) and/or erectile dysfunction and/or fecal incontinence for at least 3 months.
- Exclusion criteria1. Malignancy;
2. Demention;
3. Mental retardation.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-jun-2010
- planned closingdate1-jun-2012
- Target number of participants650
- InterventionsDutch version of the questionnaires:
1. Incontinence Impact Questionnaire Short Form (IIQ-7);
2. Urogenital Distress Inventory Short Form (UDI-6);
3. International Index of Erectile Function short form (IIEF-5);
4. Pelvic Floor Distress Inventory Short Form (PFDI-20);
5. Pelvic Floor Impact Questionnaire Short Form (PFIQ-7);
6. Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire Short Form (PISQ-12);
7. Fecal Incontinence Quality of Life Scale (FIQL);
8. Fecal Incontinence Severity Index (FISI).
- Primary outcomeQuestionnaires' Psychometric Properties:
1. Reliability: internal consistency;
2. Reproducibility: test-retest reliability;
3. Validity: convergent validity;
4. Responsiveness: sensivity of change.
- Secondary outcomeN/A
- Timepoints1. Baseline;
2. +1 week;
3. Three months after therapy.
- Trial web siteN/A
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIESDrs. E. Utomo
- CONTACT for SCIENTIFIC QUERIESDr. B.F.M. Blok
- Sponsor/Initiator Erasmus Medical Center, Department of Urology
- Funding
(Source(s) of Monetary or Material Support)
Erasmus Medical Center, Department of Urology
- PublicationsN/A
- Brief summaryThe objective of this study is to validate the Dutch versions of Pelvic Floor Related Questionnaires (Urogenital Distress Inventory Short Form: UDI-6; Incontinence Impact Questionnaire Short Form: IIQ-7, International Index of Erectile Function short form: IIEF-5, Pelvic Floor Distress Inventory Short Form: PFDI-20, Pelvic Floor Impact Questionnaire Short Form: PFIQ-7, Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire Short Form: PISQ-12, Fecal Incontinence Quality of Life Scale: FIQL, Fecal Incontinence Severity Index: FISI).

The linguistic validation of the questionnaires will be performed through a multistep process: backward and forward translations coordinated by clinical investigators, followed by a pretest. The final versions will be administered to a larger sample of patients, aged 18 years or older, with complaints for at least 3 months. To evaluate test-retest relaibility, patients will be re-rated after 1 week. To test the questionnaires' capacity to discriminated patients with or without symptoms (cases and controls, respectively) a sample of 50 healthy patients will be enrolled.
To test for convergent validity, a voiding diary, defecation diary, SF-12 and EuroQol-5 will be used.
To measure the sensitivity of change; questionnaires will be filled out 3 months post therapy.

Hypothesis: Pelvic floor related symptom and Quality of Life questionnaires (IIQ-7, UDI-6, IIEF-5, PISQ-12, PFIQ-7, PFDI-20, FISI, FIQL) in Dutch are valid instruments, which can be used reliably in daily practice and clinical research.
- Main changes (audit trail)
- RECORD28-mei-2010 - 5-aug-2012


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