Evaluation of Adherence to Solifenacin Treatment in Overactive Bladder Patients

Overactive Bladder Clinical Trial

Official title:

Persistence of Solifenacin Treatment in Overactive Bladder Patients in Real Life Practice: A 12-month, Prospective, Multicenter, Open-label, Observational Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00985387
• Other study ID #: SPK-1
• Status: Completed
• Phase: N/A
• First received: September 25, 2009
• Last updated: October 11, 2011
• Start date: August 2009
• Est. completion date: August 2011

Study information

• Verified date: October 2011
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1215
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Overactive Bladder
• Urinary Bladder, Overactive

Intervention

Drug:
• Solifenacin
oral

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Astellas Pharma Inc	Astellas Pharma Korea, Inc.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	percentage of patients who are maintaining solifenacin treatment		Month 0, Month 1, Month 3, Month 6, Month 9 and Month 12	No
Secondary	percentage of patients who discontinued solifenacin treatment		Month 0, Month 1, Month 3, Month 6, Month 9 and Month 12	No
Secondary	percentage of patients who switched to other OAB medication		Month 0, Month 1, Month 3, Month 6, Month 9 and Month 12	No