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

Overactive Bladder (OAB) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01317810
• Other study ID #: 905-UC-060
• Status: Withdrawn
• Phase: N/A
• First received: March 16, 2011
• Last updated: August 31, 2015

Study information

• Verified date: August 2015
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Overactive Bladder (OAB)
• Urinary Bladder, Overactive

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Astellas Pharma Inc	GlaxoSmithKline

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in overactive bladder (OAB) medication/ treatment regimen		6 months	No
Primary	Reason for change in OAB medication/treatment regimen		6 months	No
Secondary	Persistence of use of any OAB medication as reported by the Physician		6 months	No
Secondary	Change in OAB medication including discontinuation of OAB medication as reported by the Physician		6 months	No
Secondary	Subject reported efficacy	Measured by the Subject Survey Questionnaire	6 months	No