An Efficacy and Safety Study of Oxybutynin Chloride Oral Osmotic Therapeutic System (OROS) in Korean Overactive Bladder Participants
Condition: Urinary Bladder, Overactive
MeSH terms: Urinary Bladder, Overactive
Intervention: Oxybutynin chloride OROS
Intervention description: Participants will receive oxybutynin chloride OROS tablet at starting dose of 10 milligram (mg) orally once daily. The dose will be adjusted by 10 mg every 2 weeks up to first 6 weeks, based on the criteria for evaluation of optimal dose. The optimal dose obtained in first 6 weeks will be continued up to Week 12. Maximum allowed dose will be 30 mg per day.
Intervention MeSH terms: Oxybutynin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 345.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Overactive bladder; Oxybutynin chloride; OROS

Summary:

      The objective of this study is to evaluate the efficacy of oxybutynin chloride oral osmotic
      therapeutic system (OROS) on patient-reported outcomes after 12 weeks of treatment by dose
      escalation in participants with overactive bladder.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants who fulfilled all of the following criteria in their micturition charts
             completed for 3 days prior to visit 2 (Baseline): mean voiding frequency greater than
             or equal to 8 times per 24 hours and mean frequency of urinary urgency greater than or
             equal to 2 times per 24 hours (urgency means sudden and strong urge to urinate and a
             urinary sensation scale score greater than or equal to 3 in the micturition chart)

          -  Participants with overactive bladder symptoms lasting for 3 months or longer prior to
             study initiation

          -  Participants who were capable of completing micturition chart and survey
             questionnaires and provided informed consent to complete them

          -  Participants who could sign on the informed consent form after fully listening to and
             understanding about characteristics, risks and benefits of the study

        Exclusion Criteria:

          -  Participants with stress urinary incontinence (not able to control bladder actions) or
             participants with complicated incontinence dominantly presenting stress urinary
             incontinence when judging based on medical history

          -  Participants with a hepatic (pertaining to liver) or renal (pertaining to kidneys)
             disease indicating serum aspartate transaminase (AST [SGOT]), alanine transaminase
             (ALT [SGPT]), alkaline phosphatase or creatinnine concentration twice or more of
             normal upper limit

          -  Participants contraindicated to use anticholinergics including uncontrolled narrow
             angle glaucoma (increased pressure inside the eye that causes visual problems),
             urinary retention or gastrointestinal tract retention

          -  Participants experiencing a symptom of acute urinary tract infection (UTI) during the
             run-in period

          -  Participants with recurrent UTI who had medical history of treatment for UTI symptom 5
             times or more in the past one year