{
  "FullStudy":{
    "Rank":217873,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01515722",
          "OrgStudyIdInfo":{
            "OrgStudyId":"2010-05-106"
          },
          "Organization":{
            "OrgFullName":"Samsung Medical Center",
            "OrgClass":"OTHER"
          },
          "BriefTitle":"Interventions to Enhance Medication Persistence and Compliance in Patients With Overactive Bladder",
          "OfficialTitle":"Interventions to Enhance Medication Persistence and Compliance in Patients With Overactive Bladder : 6-month, Randomized, Open-label, Multi-center Trial"
        },
        "StatusModule":{
          "StatusVerifiedDate":"January 2012",
          "OverallStatus":"Completed",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"December 2010"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"December 2011",
            "PrimaryCompletionDateType":"Actual"
          },
          "CompletionDateStruct":{
            "CompletionDate":"June 2012",
            "CompletionDateType":"Actual"
          },
          "StudyFirstSubmitDate":"July 22, 2011",
          "StudyFirstSubmitQCDate":"January 23, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 24, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"March 18, 2020",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"March 20, 2020",
            "LastUpdatePostDateType":"Actual"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Sponsor"
          },
          "LeadSponsor":{
            "LeadSponsorName":"Samsung Medical Center",
            "LeadSponsorClass":"OTHER"
          },
          "CollaboratorList":{
            "Collaborator":[
              {
                "CollaboratorName":"Pfizer",
                "CollaboratorClass":"INDUSTRY"
              }
            ]
          }
        },
        "OversightModule":{
          "OversightHasDMC":"Yes"
        },
        "DescriptionModule":{
          "BriefSummary":"Study Objectives: To explore the effectiveness of adjunctive intervention to enhance the medication compliance and persistence in patients with Overactive Bladder (OAB), thereby to improve treatment outcomes\n\nStudy Hypothesis: Health Education Intervention (HEI) can enhance the medication compliance and persistence, thereby can improve the treatment outcomes in conjunction with pharmacological therapy in OAB patients\n\nStudy Design: 6-month, randomized, open-label, multi-center trial at 13 university hospitals",
          "DetailedDescription":"Treatment - Fesoterodine (Toviaz) 4 or 8mg\n\nInterventions (2 arms)\n\n- Arm 1: No intervention\n\nPatients in this arm will not be given HEI in conjunction with pharmacotherapy (Toviaz) which was developed for this trial.\n\n- Arm 2: Health education intervention (HEI)\n\nHEI will be performed by trained study coordinators with the leaflet designed for this trial composed of 4 parts.\n\nPart 1: Understanding OAB Physiology of bladder Definition, symptom and prevalence of OAB OAB in a treatable condition. There are many options that may help your symptoms. Lifestyle change Medications Bladder training Pelvic floor muscle exercise\nPart 2: Behavioral/lifestyle modification Modification of dietary habits Limit bladder irritants- caffeine (coffee, tea, coke...), juice, chemical flavors, spicy food. etc. Altering fluid intake Weight management Learn how weight can affect their condition Stop smoking Constipation management\n\nPart 3: Bladder training Timed voiding- Goal is urinating every 3 or 4 hours during the day without fear of wetting accidents.\n\nUrgency suppression Pelvic muscle contraction, count backwards from 100 by 7seconds, etc Pelvic floor muscle exercise Contraction (fast and slow) and relax the muscle for a count of 3. Repeat the fast and slow contractions 10 - 15 times. Do those at least 3 times a day.\n\nPart 4: Understanding antimuscarinics How the medicine works How to take it Tips that may help manage side effects- dry mouth, constipation Therapy expectations\nHEI include 3-day voiding diary for self tracking method."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Overactive Bladder"
            ]
          },
          "KeywordList":{
            "Keyword":[
              "Medication Persistence",
              "Compliance",
              "Health Education Intervention (HEI)"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Interventional",
          "PhaseList":{
            "Phase":[
              "Not Applicable"
            ]
          },
          "DesignInfo":{
            "DesignAllocation":"Randomized",
            "DesignInterventionModel":"Parallel Assignment",
            "DesignPrimaryPurpose":"Treatment",
            "DesignMaskingInfo":{
              "DesignMasking":"None (Open Label)"
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"692",
            "EnrollmentType":"Actual"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"Health education intervention (HEI)",
                "ArmGroupType":"Experimental",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Behavioral: Health education intervention (HEI)"
                  ]
                }
              },{
                "ArmGroupLabel":"No intervention",
                "ArmGroupType":"No Intervention"
              }
            ]
          },
          "InterventionList":{
            "Intervention":[
              {
                "InterventionType":"Behavioral",
                "InterventionName":"Health education intervention (HEI)",
                "InterventionDescription":"<Part 1> Understanding OAB\n<Part 2> Behavioral/lifestyle modification\n<Part 3> Bladder training\n<Part 4> Understanding antimuscarinics",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Health education intervention (HEI)"
                  ]
                }
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"Difference in the % of patients maintaining persistence between no intervention and HEI group",
                "PrimaryOutcomeDescription":"Definition of \"Maintaining Persistence\"= a gap of ≤ 30 days between successive prescription fills",
                "PrimaryOutcomeTimeFrame":"6 months"
              }
            ]
          },
          "SecondaryOutcomeList":{
            "SecondaryOutcome":[
              {
                "SecondaryOutcomeMeasure":"Difference in the % of patients maintaining persistence between no intervention and HEI group",
                "SecondaryOutcomeTimeFrame":"1, 2 and 4 months"
              },{
                "SecondaryOutcomeMeasure":"Difference in the % of the patients with the compliance rate ≥ 80% between no intervention and HEI group",
                "SecondaryOutcomeDescription":"Calculation of Compliance (%)= (total no. of drug prescribed - no. of remained drug)/total no. of drug prescribed x 100",
                "SecondaryOutcomeTimeFrame":"1, 2, 4, and 6 months"
              },{
                "SecondaryOutcomeMeasure":"Difference in the compliance rate between no intervention and HEI group",
                "SecondaryOutcomeTimeFrame":"1, 2, 4 and 6 months"
              },{
                "SecondaryOutcomeMeasure":"Difference in changes in OAB symptoms between no intervention and HEI group",
                "SecondaryOutcomeDescription":"OABSS OAB-q short form questionnaire",
                "SecondaryOutcomeTimeFrame":"1, 2, 4, and 6 months"
              },{
                "SecondaryOutcomeMeasure":"Difference in the treatment satisfaction between no intervention and HEI group",
                "SecondaryOutcomeTimeFrame":"1, 2, 4, and 6 months"
              },{
                "SecondaryOutcomeMeasure":"Reasons for non-persistence",
                "SecondaryOutcomeDescription":"Definition of non-persistence = a gap of > 30 days between successive prescription fills\n\nExamples\n\nInsufficient clinical response\nAdverse event\nSatisfied with treatment response\nLaboratory abnormality\nSubject died\nProtocol violation\nLost to F/U\nSubject no longer willing to participate in study\nPregnancy\nHigh patient out-pocket cost\nOthers (provide detailed reason)",
                "SecondaryOutcomeTimeFrame":"1, 2, 4, and 6 months"
              },{
                "SecondaryOutcomeMeasure":"Adverse events",
                "SecondaryOutcomeTimeFrame":"1, 2, 4, and 6 months"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nFemale aged ≥ 18 years with OAB symptoms for ≥ 3 months\nThe sum score of the OABSS ≥ 3 with the score of the question no.3 (urgency) ≥ 2\nThe sum score of the OAB V8 ≥ 8\n\nExclusion Criteria:\n\nAny condition that would contraindication of anticholinergic treatment\nSymptomatic acute UTI during the run-in period\nDiagnosed or suspected interstitial cystitis\nTreatment with anticholinergic drugs within 12 months prior to Screening and persist over 3 months\nTreatment within the 14 days preceding Screening, or expected to initiate treatment during the study with any other treatment for overactive bladder.\nAn indwelling catheter or practicing intermittent self-catheterization\nPregnant or nursing women",
          "HealthyVolunteers":"No",
          "Gender":"Female",
          "MinimumAge":"18 Years",
          "StdAgeList":{
            "StdAge":[
              "Adult",
              "Older Adult"
            ]
          }
        },
        "ContactsLocationsModule":{
          "OverallOfficialList":{
            "OverallOfficial":[
              {
                "OverallOfficialName":"Kyu-Sung Lee, MD, PhD",
                "OverallOfficialAffiliation":"Samsung Medical Center, Sungkyunkwan University School of Medicine",
                "OverallOfficialRole":"Principal Investigator"
              }
            ]
          },
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"Bucheon St. Mary's Hospital, The Catholic University of Korea",
                "LocationCity":"Bucheon",
                "LocationZip":"420-717",
                "LocationCountry":"Korea, Republic of"
              },{
                "LocationFacility":"Bucheon Hospital, Soonchunhyang University College of Medicine",
                "LocationCity":"Bucheon",
                "LocationZip":"420-767",
                "LocationCountry":"Korea, Republic of"
              },{
                "LocationFacility":"Samsung Changwon Hospital, Sungkyunkwan University School of Medicine",
                "LocationCity":"Changwon",
                "LocationZip":"630-522",
                "LocationCountry":"Korea, Republic of"
              },{
                "LocationFacility":"Daegu Catholic University College of Medicine",
                "LocationCity":"Daegu",
                "LocationZip":"705-034",
                "LocationCountry":"Korea, Republic of"
              },{
                "LocationFacility":"Chungnam National University Hospital",
                "LocationCity":"Daejeon",
                "LocationZip":"301-721",
                "LocationCountry":"Korea, Republic of"
              },{
                "LocationFacility":"Chonnam National University Medical School",
                "LocationCity":"Gwangju",
                "LocationZip":"501-757",
                "LocationCountry":"Korea, Republic of"
              },{
                "LocationFacility":"Pusan National University Hospital",
                "LocationCity":"Pusan",
                "LocationZip":"602-739",
                "LocationCountry":"Korea, Republic of"
              },{
                "LocationFacility":"Cheil General Hospital & Women's Healthcare Center, College of Medicine, Kwandong University",
                "LocationCity":"Seoul",
                "LocationZip":"100-380",
                "LocationCountry":"Korea, Republic of"
              },{
                "LocationFacility":"Seoul National University Hospital",
                "LocationCity":"Seoul",
                "LocationZip":"110-744",
                "LocationCountry":"Korea, Republic of"
              },{
                "LocationFacility":"Yonsei University College of Medicine",
                "LocationCity":"Seoul",
                "LocationZip":"120-752",
                "LocationCountry":"Korea, Republic of"
              },{
                "LocationFacility":"Samsung Medical Center, Sungkyunkwan University School of Medicine",
                "LocationCity":"Seoul",
                "LocationZip":"135-710",
                "LocationCountry":"Korea, Republic of"
              },{
                "LocationFacility":"Anam Hospital, College of Medicine, Korea University",
                "LocationCity":"Seoul",
                "LocationZip":"136-705",
                "LocationCountry":"Korea, Republic of"
              },{
                "LocationFacility":"Asan Medical Center, Ulsan University College of Medicine",
                "LocationCity":"Seoul",
                "LocationZip":"138-736",
                "LocationCountry":"Korea, Republic of"
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        },
        "ConditionBrowseModule":{
          "ConditionMeshList":{
            "ConditionMesh":[
              {
                "ConditionMeshId":"D000053201",
                "ConditionMeshTerm":"Urinary Bladder, Overactive"
              }
            ]
          },
          "ConditionAncestorList":{
            "ConditionAncestor":[
              {
                "ConditionAncestorId":"D000001745",
                "ConditionAncestorTerm":"Urinary Bladder Diseases"
              },{
                "ConditionAncestorId":"D000014570",
                "ConditionAncestorTerm":"Urologic Diseases"
              },{
                "ConditionAncestorId":"D000059411",
                "ConditionAncestorTerm":"Lower Urinary Tract Symptoms"
              },{
                "ConditionAncestorId":"D000020924",
                "ConditionAncestorTerm":"Urological Manifestations"
              },{
                "ConditionAncestorId":"D000012816",
                "ConditionAncestorTerm":"Signs and Symptoms"
              }
            ]
          },
          "ConditionBrowseLeafList":{
            "ConditionBrowseLeaf":[
              {
                "ConditionBrowseLeafId":"M25754",
                "ConditionBrowseLeafName":"Urinary Bladder, Overactive",
                "ConditionBrowseLeafAsFound":"Overactive Bladder",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M3608",
                "ConditionBrowseLeafName":"Urinary Bladder Diseases",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M15902",
                "ConditionBrowseLeafName":"Urologic Diseases",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M28051",
                "ConditionBrowseLeafName":"Lower Urinary Tract Symptoms",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M21243",
                "ConditionBrowseLeafName":"Urological Manifestations",
                "ConditionBrowseLeafRelevance":"low"
              }
            ]
          },
          "ConditionBrowseBranchList":{
            "ConditionBrowseBranch":[
              {
                "ConditionBrowseBranchAbbrev":"BXS",
                "ConditionBrowseBranchName":"Urinary Tract, Sexual Organs, and Pregnancy Conditions"
              },{
                "ConditionBrowseBranchAbbrev":"BC23",
                "ConditionBrowseBranchName":"Symptoms and General Pathology"
              },{
                "ConditionBrowseBranchAbbrev":"All",
                "ConditionBrowseBranchName":"All Conditions"
              }
            ]
          }
        }
      }
    }
  }
}