Extended-Release Oxybutynin for the Treatment of Neurogenic Detrusor Overactivity
Condition: Detrusor Function, Overactive
MeSH terms: Urinary Bladder, Overactive
Intervention: Oxybutinin Extended-Release
Intervention description: Oxybutynin chloride 5, 10, 15 milligram (mg) per tablet 10-30 mg per day orally
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 17.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Detrusor function, overactive; Urinary incontinence; Oxybutynin; Lyrinel

Summary:

      The purpose of this study is to evaluate the effects and tolerability (how well a participant
      can stand a particular medicine or treatment) of flexible dose Oxybutynin Extended-Release
      (OXY-ER, Lyrinel) including safety and quality of life assessment in participants with
      neurogenic detrusor overactivity (NDO - the nerves mediating the detrusor muscle do not work
      properly leading to frequent feeling of need to urinate during the day, night, or both).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of overactive bladder as a result of neurogenic condition, for example
             following spinal cord injury, multiple sclerosis (slowly worsening disorder of the
             central nervous system that causes symptoms such as weakness, incoordination,
             numbness, problems talking and problems seeing), Parkinson's disease (a progressive
             disorder of the central nervous system, seen usually in older persons, in which there
             is slow movement [due to muscle weakness], trembling and sweating), or cerebrovascular
             accidents (CVAs - stroke-sudden loss of blood supply to brain)

          -  Women must not be pregnant and be of either non-childbearing potential or is using
             adequate means of birth control

          -  Overactive bladder symptoms and/or has urge incontinence episodes

          -  Must have normal results on urine culture tests and on urinalysis

          -  ECOG (Eastern Cooperative Oncology Group) performance status score of less than or
             equal to 3

        Exclusion Criteria:

          -  Participants with 1 or more treatable or conditions, other than neurogenic bladder
             dysfunction, that may cause urinary incontinence or urgency

          -  Any medical or unstable condition that precludes their participation in the study or
             may confound the outcome of the study (participants with or at risk for urinary
             retention, gastric retention or uncontrolled narrow angle; heart failure or kidney
             failure; diabetes mellitus; abnormal muscle weakness [myasthenia gravis]; paralysis or
             inactivity in the intestines that prevents material moving through the gut [intestinal
             atony or paralytic ileus]; severe inflammation of the bowel [ulcerative colitis]
             sudden expansion of the large intestine seen in advanced ulcerative colitis or Crohn's
             disease [toxic megacolon]; history of major lower urinary tract surgery [transurethral
             resection will be excluded])

          -  Hypersensitivity to the investigational drug or any of its ingredients (eg, lactose)

          -  Pregnant or breast feeding female

          -  Significant bacteriuria (presence of bacteria in the urine) or pyuria (presence of
             white blood cells) in the urine