Extended-Release Oxybutynin for the Treatment of Neurogenic Detrusor Overactivity
Extended-Release Oxybutynin for the Treatment of Neurogenic Detrusor Overactivity
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).
This is an open-label (all people know the identity of the intervention), single arm,
 prospective (study following participants forward in time), multi-center study of
 participants with NDO. The initial dose of Oxybutynin ER will be 10 milligram (mg) and will
 be titrated to a maximum of 30 mg. Dosage will be adjusted in 5-mg increments at
 approximately 14-day intervals until continence is achieved or the participant cannot
 tolerate side effects. The duration of participation in the study will be 12 weeks. The study
 will consist of 6 visits: baseline, Weeks 2, 4, 6, 8 and 12. Week 4 and Week 8 will be
 telephone visits. Overall safety and efficacy of Oxybutinin ER will be assessed as well as
 safety and efficacy during the titration and maintenance phases. The efficacy of treatment
 will be assessed using urodynamic parameters (the force and flow of urine) and clinical
 parameters (voiding diary and catheterization [use or insertion of a tubular device to drain
 the bladder] schedules). The quality of life will also be monitored in the study.
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