Development and validation of a questionnaire for the assessment of bowel and lower urinary tract symptoms in women.

OBJECTIVE: To develop a simple but sensitive instrument to evaluate and document symptoms of both bowel and urinary dysfunction in women. DESIGN: A 22-item questionnaire covering a range of bowel and urinary symptoms was developed and underwent rigorous psychometric testing. SETTING: The gynaecology departments of three hospitals, a urogynaecology clinic, a functional bowel clinic and a general practice. POPULATION: Six hundred and thirty women, comprising four groups: 1. women awaiting hysterectomy (n = 379), 2. women following hysterectomy (n = 45), 3. women referred with functional bowel and/or urinary symptoms (n = 65), 4. asymptomatic controls (n = 141). MAIN OUTCOME MEASURES: The content, construct and criterion validity, internal consistency, reliability and responsiveness of the questionnaire were measured. RESULTS Peer and patient reports and missing data patterns supported face and content validity. Factor analysis showed a clinically relevant four-factor structure with low content replication able to distinguish between patient groups, indicating good internal structure. Comparison with clinical, anorectal physiological, videoproctographic, transit time and urodynamic test results provide provisional indication of criterion validity. Key domain question analysis and Cronbach's alphas showed internal consistency. Kappa values demonstrated good test-retest reliability and key question correlation over time proved responsiveness. CONCLUSIONS: Our findings support the suitability, clinical validity, reliability and responsiveness of a simple questionnaire, which is sensitive to the constraints of clinical practice. The authors recommend its use in health care evaluation research assessing the effects of pelvic surgery and as a useful tool in comparing treatment efficacy.