A Study to Evaluate Response of Over Active Bladder Symptom Score to Solifenacin Treatment (RESORT-2)

July 9, 2014 updated by: Astellas Pharma Inc

Reproducibility Study of OABSS and Its Response to Solifenacin Treatment (RESORT) and Validity in Korean Populations; Part 2: Responsiveness and Validity

This study is to evaluate change of over active bladder symptom scores (OABSS) between, before and after solifenacin treatment to OAB subjects.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 4

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

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Symptoms of OAB for 3 months or longer
  • At least 1 urgency episode in last 3 days

  • Symptoms of OAB as verified by the screening 3-day bladder diary, defined by:

    • a. Number of micturition ≥8 times/day
    • b. Number of urgency episodes in 3 days ≥3

Exclusion Criteria:

  • Significant stress incontinence or mixed stress/urge incontinence
  • Subject with indwelling catheters or practicing intermittent self-catheterization
  • Symptomatic urinary tract infection, chronic inflammation
  • Diabetic neuropathy
  • Subjects who are prohibited from taking solifenacin as contraindications
  • Drug or non-drug treatment for OAB was started, quitted or changed in 4 weeks
  • Participation in any clinical trial in 30 days except for Part-1 of RESORT
  • Diabetic neuropathy

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

  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: sofilenacin group
Drug: solifenacin
oral
Other Names:
  • Vesicare
No Intervention: control group
age and sex matched patients without OAB symptom who will answer demographic questionaire and OABSS once

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Changes from baseline to week 4 in Over-Active Bladder Symptom Score (OABSS)
Time Frame: week 0 (baseline) and week 4
week 0 (baseline) and week 4
Changes from baseline to week 12 in OABSS
Time Frame: week 0 (baseline) and week 12
week 0 (baseline) and week 12

Secondary Outcome Measures

Outcome Measure
Time Frame
Changes from baseline in International Prostate Symptom Score (IPSS) at week 4
Time Frame: week 0 (baseline) and week 4
week 0 (baseline) and week 4
Changes from baseline in IPSS at week 12
Time Frame: week 0 (baseline) and week 12
week 0 (baseline) and week 12
Changes from baseline in Quality of Life (QoL) Score at week 4
Time Frame: week 0 (baseline) and week 4
week 0 (baseline) and week 4
Changes from baseline in QoL Score at week 12
Time Frame: week 0 (baseline) and week 12
week 0 (baseline) and week 12
Changes from baseline in Patient Perception of Bladder Condition (PPBC) at week 4
Time Frame: week 0 (baseline) and week 4
week 0 (baseline) and week 4
Changes from baseline in PPBC at week 12
Time Frame: week 0 (baseline) and week 12
week 0 (baseline) and week 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.

Investigators

  • Principal Investigator: Use Central Contact, Bundang Seoul National University Hospital, Seong Jin Jeong, MD.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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

April 1, 2010

Primary Completion (Actual)

September 1, 2011

Study Completion (Actual)

September 1, 2011

Study Registration Dates

First Submitted

March 17, 2011

First Submitted That Met QC Criteria

March 17, 2011

First Posted (Estimate)

March 21, 2011

Study Record Updates

Last Update Posted (Estimate)

July 10, 2014

Last Update Submitted That Met QC Criteria

July 9, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OABSSVSK-002

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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