OBJECTIVES: To conduct a systematic literature review (SLR) on the subjective patient-reported outcomes (PRO) instruments used in observational studies in overactive bladder (OAB).

METHODS: We searched MEDLINE and EMBASE from January 2000 to February 2017 to identify observational studies reporting PROs in a population of adult idiopathic OAB patients. No restrictions on intervention/comparator were applied.

RESULTS: The search strategy yielded 6359 records. We identified 165 eligible studies reporting 86 PRO instruments; 59% of them were used in a single study and 34% of studies reported unnamed instruments. The Urogenital Distress Inventory (UDI-6) and Incontinence Impact Questionnaire (IIQ) were the most commonly used questionnaires (in 22 and 20 studies, respectively), followed by International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF, 14 studies), King's Health Questionnaire (KHQ, 12 studies) and Overactive Bladder Questionnaire Short Form (OAB-q SF, 10 studies). EuroQol Five-Dimensional Questionnaire (EQ-5D), most frequent generic measure, was reported in 7 studies. Most common locations were Europe (45 studies), North America (30 studies), and Asia (23 studies). In terms of design, 74 studies were of cross-sectional design; followed by cohort (66 studies) and case-control (5 studies). The effect of OAB treatments on PROs was investigated in 60 studies; 90% of them were non-comparative studies of previously treated patients. A significant improvement from baseline was shown in 75% and 83% of non-comparative studies reporting UDI-6 and IIQ, respectively. In the comparatives studies assessing treated versus untreated patients, significantly better quality of life was observed for treated patients.

CONCLUSIONS: Our study provided an overview of the PRO instruments used in observational studies in OAB patients. Treatments improved the quality of life of OAB patients.