drugset / Trial / NCT00313924

Assessing the OAB-8 Questionnaire as a Tool to Measure Treatment Outcome

NCT00313924

Phase 4 Unknown 100 enrolled Rambam Health Care Campus Pfizer · collab
Non-randomizedSingle-groupOpen-labelTreatment

Summary

OAB is a widespread medical problem affecting 6- 30% of the population (both sexes and all age groups) in Europe1 and 16%2-18%3 of the US and Canadian population. Nevertheless only a small proportion of this group turns to seek medical help. Once treated, evaluation of treatment outcome is problematic since outcome measures for success vary widely (i.e. improvement in number of incontinence episodes, number of urge episodes, change in frequency and nocturia etc) but do not include measures of patient reported outcomes. The OAB Assessment Tool is a self-administered questionnaire (8-question self-filled survey) primarily intended to identify patients with symptoms of OAB. The same comparable information could be obtained after a certain treatment period, thus providing accurate and precise measures of success. It could also offer insight to the changes of the different parameters that make up the problem. Due to its ease of administration and its high specificity in assessing OAB, the OAB Assessment Tool seems to be optimal for this objective.

Timeline

Start
2006-02
Primary completion
Completion
2006-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Tolterodine Small molecule 4 mg

Indications