Skip to main content
MedPath Trial logoMedPath TrialMedPath Trial Home
Clinical Trials/NCT01317810
NCT01317810WithdrawnNot Applicable

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

Astellas Pharma Inc0 sitesStarted: March 17, 2011Last updated:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Withdrawn
Primary Endpoint
Reason for change in OAB medication/treatment regimen
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

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

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 Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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)

Outcomes

Primary Outcomes

Reason for change in OAB medication/treatment regimen

Time Frame: 6 months

Change in overactive bladder (OAB) medication/ treatment regimen

Time Frame: 6 months

Secondary Outcomes

  • 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)

Investigators

Sponsor Class
Industry

Similar Trials

Completed
Not Applicable
A Registry Study of Patients Initiating a Course of Drug Therapy for Overactive Bladder in Taiwan, Korea and ChinaOveractive Bladder (OAB)
NCT03572231Astellas Pharma Singapore Pte. Ltd.805
Terminated
Not Applicable
A Pilot Trial in a Sleep Laboratory Setting to Observe Night Time Bladder Function of Subjects With Overactive Bladder (OAB)Bladder Function
NCT01099345Astellas Pharma Inc15
Completed
Phase 4
Reproducibility Study of OABSS and Its Response to TreatmentOveractive Bladder
NCT02667470Astellas Pharma Inc50
Completed
Not Applicable
Comparison of the Transcutaneous Tibial Nerve Stimulation and Drug Treatment' Effects in Women With Overactive BladderOveractive Bladder SyndromeOveractive Bladder
NCT06024005Ege University34
Completed
Not Applicable
Overactive Bladder (OAB) Voiding Diary and Urodynamics Correlation StudyOveractive Bladder
NCT03473782NYU Langone Health123