Objectives: To develop and validate a self-completion questionnaire for comprehensive assessment of the severity and impact of vaginal symptoms and related sexual matters, particularly those attributed to pelvic organ prolapse. To provide an instrument that can characterise the severity of these symptoms, measure their impact and evaluate treatment outcome.
Design: Prospective development of the content of the questionnaire and testing of its psychometric properties including validity.
Setting: Two hospital-based urogynaecology clinics and one community general practice in the South of England.
Population: One hundred and forty-one urogynaecology clinic attendees with varying degrees of pelvic organ prolapse and 77 randomly selected women registered with a general practice.
Methods: The questionnaire was developed through a literature review, consultation with clinicians and health scientists and structured interviews with patients. Content validity, construct validity, stability, internal consistency and sensitivity to change were examined by comparing the responses from the urogynaecology clinic with responses from the general community. Sensitivity to change was assessed using responses from women undergoing surgical treatment for pelvic organ prolapse before and 3 months after surgery. A final version of the questionnaire was obtained after factor analysis to assist item reduction and refinement of the scoring system.
Main outcome measures: Content validity, construct validity, stability (test-retest reliability), internal consistency and sensitivity to change.
Results: The questionnaire exhibited good validity, reliability and sensitivity to change. Excellent internal consistency was demonstrated for vaginal (Cronbach's alpha 0.79) and sexual (Cronbach's alpha 0.84) symptoms. Reliability was good. The questionnaire was able to identify changes in symptoms following surgical treatment. The final ICIQ-VS questionnaire had 14 items and a simple scoring system. CONCLUSION; The ICIQ-VS self-completion questionnaire meets the need for a robust instrument for assessing a range of vaginal and sexual symptoms, in particular those of pelvic organ prolapse. It will be of use in both routine clinical practice and epidemiological research, particularly when there is a need to assess the severity of these symptoms or the efficacy of treatment.