OBJECTIVES: Most health-related quality-of-life (HRQL) bladder questionnaires address the impact of incontinence; however, OAB includes frequency and urgency symptoms without incontinence. Thus, a questionnaire was developed to assess the impact of OAB on HRQL in patients with and without incontinence. METHODS: The 61-item self-administered OAB-q contains a symptom and HRQL scale. Both the OAB-q and the SF-36 were completed by participants recruited from: 1) a community sample who screened positive for OAB in a telephone survey and participated in a clinical validation study (n=254); 2) a clinical study for those seeking treatment for OAB symptoms (baseline)(n=736). Item analysis and exploratory factor analysis (EFA) were performed to assess factor structure. Psychometric evaluation was conducted to assess internal reliability and validity. RESULTS: Of the 911 participants, the clinical diagnoses were: normal=130, OAB with incontinence (OAB-I)=552, OAB without incontinence (OAB-C)=229. Mean age=59.5; 74.4% were women. EFA revealed 1 domain for symptom distress and 4 domains for HRQL: coping, concern/emotional, sleep and social interactions. Both OAB-I and OAB-C participants reported significantly greater symptom distress and HRQL impact than normals. Significant differences between OAB-I and OAB-C participants were present in all OAB-q subscales except sleep where both groups were highly affected. Internal consistency reliability of the symptom distress scale was 0.86 and the HRQL subscales ranged from 0.88-0.94. The OAB-q subscales correlated moderately well with the SF-36 subscales (r=0.17 - 0.52) providing validity evidence. The OAB-q was reduced to 34 items: 8 symptom distress and 26 HRQL items. CONCLUSIONS: The OAB-q is a reliable and valid instrument that can discriminate between clinically-diagnosed normal, OAB-I and OAB-C participants. As the first OAB-specific HRQL questionnaire, the OAB-q demonstrates that OAB with and without incontinence causes significant symptom distress and has a negative impact on HRQL.