A Study Measuring and Tracking Changes in Overactive Bladder (OAB) Medication

August 31, 2015 updated by: Astellas Pharma Inc

A Phase 4, Observational, Non-interventional Study Measuring and Tracking Changes in Overactive Bladder Medication and/or Overactive Bladder Medication Dose in Subjects With Overactive Bladder

The purpose of this study is to track changes in overactive bladder (OAB) medical regimen and/or OAB medication dosage requirements.

Study Overview

Status

Withdrawn

Conditions

Detailed Description

Subjects will complete a study specific survey questionnaire at Screening and the Month 1 through Month 6 visits. Subjects will be followed for 6 months.

Study Type

Observational

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subjects with overactive bladder (OAB)

Description

Inclusion Criteria:

  • Subject has overactive bladder as determined by their prescribing physician
  • Subject is currently receiving pharmacotherapy for overactive bladder
  • Subject is willing to comply with required protocol/study requirements

Exclusion Criteria:

  • Subject has a history of a clinically significant illness or medical condition prior to screening that would preclude participation in the study
  • Male subjects with Lower Urinary Tract Symptoms (LUTS) or Bladder Outlet Obstruction (BOO)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Subjects with Overactive Bladder (OAB)
Combination of new OAB subjects and existing subjects on OAB medication

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in overactive bladder (OAB) medication/ treatment regimen
Time Frame: 6 months
6 months
Reason for change in OAB medication/treatment regimen
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Persistence of use of any OAB medication as reported by the Physician
Time Frame: 6 months
6 months
Change in OAB medication including discontinuation of OAB medication as reported by the Physician
Time Frame: 6 months
6 months
Subject reported efficacy
Time Frame: 6 months
Measured by the Subject Survey Questionnaire
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Astellas Pharma Inc

Collaborators

GlaxoSmithKline

Investigators

  • Study Director: Use Central Contact, Astellas Pharma Global Development, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

March 16, 2011

First Submitted That Met QC Criteria

March 16, 2011

First Posted (Estimate)

March 17, 2011

Study Record Updates

Last Update Posted (Estimate)

September 2, 2015

Last Update Submitted That Met QC Criteria

August 31, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 905-UC-060

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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