MedTrace Logo

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

NCT00313924 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2007-02-21

No results posted yet for this study

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.

Conditions

Interventions

DRUG

DETRUSITOL

Sponsors & Collaborators

  • Pfizer

    collaborator INDUSTRY

  • Rambam Health Care Campus

    lead OTHER

Principal Investigators

  • Ilan Gruenwald, MD · Rambam Health Care Campus

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-02-28
Completion
2006-03-31

Countries

  • Israel

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00313924 on ClinicalTrials.gov