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

NCT01317810 | Withdrawn

• 1 other identifier: 905-UC-060
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Overactive Bladder (OAB)

Keywords

Overactive Bladder (OAB); Observational; Registry

Outcome Measures

Primary Outcomes (2)

• Change in overactive bladder (OAB) medication/ treatment regimen

  6 months

• Reason for change in OAB medication/treatment regimen

  6 months

Secondary Outcomes (3)

• Persistence of use of any OAB medication as reported by the Physician

  6 months

• Change in OAB medication including discontinuation of OAB medication as reported by the Physician

  6 months

• Subject reported efficacy

  6 months

Study Arms (1)

Subjects with Overactive Bladder (OAB)

Combination of new OAB subjects and existing subjects on OAB medication

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects with overactive bladder (OAB)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Astellas Pharma Inc: lead
• GlaxoSmithKline: collaborator

MeSH Terms

Conditions

Urinary Bladder, Overactive

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Use Central Contact

  Astellas Pharma Global Development, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 16, 2011
• First Posted: March 17, 2011
• Last Updated: September 2, 2015

Record last verified: 2015-08