Evaluation of Adherence to Solifenacin Treatment in Overactive Bladder Patients

Completed

• Conditions: Urinary Bladder, Overactive; Overactive Bladder
• Interventions: Drug: Solifenacin

• Registration Number: NCT00985387
• Lead Sponsor: Astellas Pharma Inc

Brief Summary

The purpose of the study is to assess patient's persistency in maintaining solifenacin treatment for overactive bladder.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-08
• Study First Submitted: 2009-09-25
• Study First Submitted QC: 2009-09-25
• Study First Posted: 2009-09-28
• Primary Completion: 2011-08
• Study Completion: 2011-08
• Status Verified: 2011-10
• Last Update Submitted: 2011-10-11
• Last Update Posted: 2011-10-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1215

Inclusion Criteria

• Overactive bladder symptoms lasting for more than 3 months
• The question 3 score of the overactive bladder symptom score(OABSS)≥ 2 and the sum score of OABSS ≥ 3
• Symptoms of urinary urgency defined as a level of 1 to 2 in a 3-point Urgency Perception Scale (UPS)

Exclusion Criteria

• Any condition that would contraindicate their usage of anticholinergic treatment, including: urinary retention, gastric retention, uncontrolled narrow angle glaucoma, myasthenia gravis
• Symptomatic acute urinary tract infection (UTI)
• Diagnosed or suspected of interstitial cystitis
• Treatment with anticholinergic drugs for over 3 months within 12 months prior to the study
• Pregnant or nursing women
• Treatment within the 14 days before the study or expected to initiate treatment during the study with any anticholinergic drugs other than solifenacin or treatment for overactive bladder with other drugs
• Any other condition which, in the opinion of the investigator, makes the patient unsuitable for inclusion

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Solifenacin treatment	Solifenacin	Male and female OAB patients who were treated with solifenacin

Primary Outcome Measures

Name	Time	Method
percentage of patients who are maintaining solifenacin treatment	Month 0, Month 1, Month 3, Month 6, Month 9 and Month 12

Secondary Outcome Measures

Name	Time	Method
percentage of patients who discontinued solifenacin treatment	Month 0, Month 1, Month 3, Month 6, Month 9 and Month 12
percentage of patients who switched to other OAB medication	Month 0, Month 1, Month 3, Month 6, Month 9 and Month 12