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

• Status: Unknown status
• Trial end date: 2006-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rambam Health Care Campus
• Collaborator: Pfizer
• Treatments: Tolterodine Tartrate

Criteria

Inclusion Criteria:

1. OAB score of ≥ 8

2. Age 20-80 years old

3. Patients must comply and agree to the requirement of taking only Detrusitol 4mg and no other new medication affecting the lower urinary tract system

Exclusion criteria:

1. Patients that are on any other treatment (whether medical or conservative) for OAB.

2. Patients with documented UTI.

3. Patients who have demonstrated hypersensitivity to the drug or its ingredients.

4. Where Detrusitol is contraindicated (i.e. patients with severe outlet obstruction, gastric retention, or uncontrolled narrow-angle glaucoma).