Evaluation of Adherence to Solifenacin Treatment in Overactive Bladder Patients

October 11, 2011 updated by: Astellas Pharma Inc

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1215

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Bucheon, Korea, Republic of, 420-717
      • Bucheon, Korea, Republic of, 420-767
      • Busan, Korea, Republic of, 602-739
      • Busan, Korea, Republic of, 614-735
      • Busan, Korea, Republic of, 602-715
      • Busan, Korea, Republic of, 602-702
      • Chonju, Korea, Republic of, 361-711
      • Chonju, Korea, Republic of, 380-704
      • Chuncheon, Korea, Republic of, 200-704
      • Daegu, Korea, Republic of, 705-718
      • Daegu, Korea, Republic of, 705-717
      • Daegu, Korea, Republic of, 700-712
      • Daegu, Korea, Republic of, 700-721
      • Daejeon, Korea, Republic of, 301-721
      • Daejeon, Korea, Republic of, 302-718
      • Daejeon, Korea, Republic of, 302-799
      • Gangneung, Korea, Republic of, 201-711
      • Gumi-si, Korea, Republic of, 730-728
      • Gwangju, Korea, Republic of, 501-757
      • Gwangju, Korea, Republic of, 501-717
      • Gwangju, Korea, Republic of, 503-715
      • Gyongju, Korea, Republic of, 780-350
      • Hwasun, Korea, Republic of, 519-809
      • Iksan, Korea, Republic of, 570-160
      • Inchon, Korea, Republic of, 400-711
      • Inchon, Korea, Republic of, 405-760
      • Jeonju, Korea, Republic of, 561-712
      • Masan, Korea, Republic of, 630-522
      • Seongnam, Korea, Republic of, 463-707
      • Seoul, Korea, Republic of, 137-701
      • Seoul, Korea, Republic of, 100-380
      • Seoul, Korea, Republic of, 130-702
      • Seoul, Korea, Republic of, 158-710
      • Seoul, Korea, Republic of, 138-736
      • Seoul, Korea, Republic of, 110-744
      • Seoul, Korea, Republic of, 143-729
      • Seoul, Korea, Republic of, 133-792
      • Seoul, Korea, Republic of, 136-705
      • Seoul, Korea, Republic of, 139-711
      • Suwon, Korea, Republic of, 443-721
      • Ulsan, Korea, Republic of, 682-714

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

OAB patients who were treated with solifenacin

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Solifenacin treatment
Male and female OAB patients who were treated with solifenacin
Drug: Solifenacin
oral
Other Names:
  • Vesicare
  • YM905

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
percentage of patients who are maintaining solifenacin treatment
Time Frame: Month 0, Month 1, Month 3, Month 6, Month 9 and Month 12
Month 0, Month 1, Month 3, Month 6, Month 9 and Month 12

Secondary Outcome Measures

Outcome Measure
Time Frame
percentage of patients who discontinued solifenacin treatment
Time Frame: Month 0, Month 1, Month 3, Month 6, Month 9 and Month 12
Month 0, Month 1, Month 3, Month 6, Month 9 and Month 12
percentage of patients who switched to other OAB medication
Time Frame: Month 0, Month 1, Month 3, Month 6, Month 9 and Month 12
Month 0, Month 1, Month 3, Month 6, Month 9 and Month 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Astellas Pharma Inc

Collaborators

Astellas Pharma Korea, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2009

Primary Completion (Actual)

August 1, 2011

Study Completion (Actual)

August 1, 2011

Study Registration Dates

First Submitted

September 25, 2009

First Submitted That Met QC Criteria

September 25, 2009

First Posted (Estimate)

September 28, 2009

Study Record Updates

Last Update Posted (Estimate)

October 12, 2011

Last Update Submitted That Met QC Criteria

October 11, 2011

Last Verified

October 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SPK-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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