OBJECTIVES: To develop and validate a disease-specific questionnaire to measure the impact of urinary incontinence (UI) in women’s quality of life (QoL). This questionnaire is aimed at measuring all types of incontinence in clinical trials. A urinary urge incontinence (UUI) questionnaire already available and fully validated was used as a basis. METHODS: 1) Identification of additional measurement concepts, during 12 interviews. 2) Item generation following existing questionnaire format. 3) Content and face validity in additional interviews. 4) Cross-sectional validation study: to allow item reduction (based on homogeneity of the domains, item rank and fit in the Rasch modeling), internal consistency and clinical validity. 5) Test-retest reliability study. RESULTS: In this study, 104 patients with urge, stress, and mixed UI filled in the specific questionnaire once. Patients were 50 years old on average, 40% had urge-related urinary leakage several times a week, 34% had micturitions at night, 73% had stress-related leakage during light and moderate efforts. The initial 50-item questionnaire was reduced to 28 items gathered in six dimensions: daily activities, effort situation, self-image, emotional impact, sexuality, and global QoL. Item grouping hypotheses proved relevant based on item convergent and divergent validity and internal reliability (Cronbach’s alpha > 0.76). Clinical validity was demonstrated by the significant impairment of QoL in patients reporting urinary leaks, greater urge-related and stress-related urinary handicap (p <0.0005). Fifty-eight stable women filled in the questionnaire twice. Intraclass Correlation Coefficients ranged from 0.87 to 0.94, showing good test-retest reproducibility. CONCLUSION: At this stage, the CONTILIFE questionnaire can be used in trials to assess the impact of all types of UI on QoL. Its responsiveness over time is still to be determined.