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.
ID
Bron
Aandoening
urinary incontinence, erectile dysfunction, pelvic organ prolapse, fecal incontinence
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Questionnaires' Psychometric Properties:<br>
1. Reliability: internal consistency;<br>
2. Reproducibility: test-retest reliability;<br>
3. Validity: convergent validity;<br>
4. Responsiveness: sensivity of change.
Achtergrond van het onderzoek
The 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.
Doel van het onderzoek
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.
Onderzoeksopzet
1. Baseline;
2. +1 week;
3. Three months after therapy.
Onderzoeksproduct en/of interventie
Dutch 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).
Publiek
E. Utomo
Rotterdam 3015 CE
The Netherlands
+31 (0)10 7030241
e.utomo@erasmusmc.nl
Wetenschappelijk
E. Utomo
Rotterdam 3015 CE
The Netherlands
+31 (0)10 7030241
e.utomo@erasmusmc.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. 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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. Malignancy;
2. Demention;
3. Mental retardation.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
Register | ID |
---|---|
NTR-new | NL2229 |
NTR-old | NTR2355 |
Ander register | METC / CCMO : 2008-376 / NL25341.078.08 ; |
ISRCTN | ISRCTN wordt niet meer aangevraagd. |