PARIS, FRANCE -- July 2, 2001 -- Results of two studies evaluating the safety and efficacy of extended-release oxybutynin (Ditropan XL) to treat overactive bladder in patients with spinal cord injury (SCI) and multiple sclerosis (MS) were presented today at the World Health Organization Second International Consultation on Incontinence in Paris, France.
Michael B. Chancellor, M.D., professor of urology and director of neuro-urology at the University of Pittsburgh Medical Center, served as author and lead investigator for the studies.
These are the first reported results of the drug's efficacy in MS and SCI patients. "Results of these studies show that extended-release oxybutynin can safely and effectively treat patients diagnosed with MS or SCI that experience symptoms of overactive bladder or neurogenic bladder," said Dr. Chancellor. "Through these studies physicians should be encouraged that treating overactive bladder as a secondary condition is an effective measure in improving quality of life for these patients."
Conditions in which the bladder becomes overactive due to lesions on the nervous system, or due to damage to the nervous system are referred to as neurogenic bladder. Extended release oxybutynin is one of the leading medications for overactive bladder, reducing incontinence episodes and frequency of urination, with minimal side effects. Both studies were conducted by researchers at the University of Pittsburgh Medical Center and led by Dr. Michael Chancellor.
Dr. Chancellor, et. al., presented data on an investigational study designed to evaluate the effectiveness of extended-release oxybutynin, inpatients who experienced detrusor hyperrerflexia (DH) or overactive bladder and had some type of SCI.
It was found that up to 30mg of extended-release oxybutynin greatly reduced their frequency of urination or catheterization by an average of two episodes per day. "Patients who are diagnosed with SCI already have difficult challenges in every day life," said Dr. Chancellor. "By treating their overactive bladder symptoms effectively with extended-release oxybutynin, we are allowing them increased freedom, as catheterization and trips to the bathroom decrease."
The results were based on an ongoing 12-week study in which 14 patients with complete or incomplete SCI were enrolled. Eighty percent of the patients were women and the mean age of the patients was approximately 38 years.
The dosing was initiated at 10 milligrams of extended-release oxybutynin per day, and was adjusted weekly by five milligrams, up to 30 milligrams per day. All 4 patients had a dosing regimen over 10 milligrams per day, with six patients using 30 milligrams per day. At one week, a decrease of two voids or catheterizations per day was recorded.
No patients experienced serious adverse events during the study, nor was there a relationship between dosing quantity and severity of side effects, such as dry mouth.
Results of a study involving 40 adult MS patients with neurogenic bladder and a mean age of approximately 43 years indicated that high doses of extended-release oxybutynin can greatly reduce frequency of urination and incontinence episodes in patients with MS. "This study demonstrates that extended-release oxybutynin is safe and effective in decreasing frequency of urination and incontinence episodes, without significantly increasing residual urine volume," said Dr. Chancellor." This is important to MS patients as not only does this treatment increase their quality of life but it does so without compromising their overall bladder health, as increased volume could lead to urinary infections."
In the 12-week study, patients were started with 10 milligrams per day of extended-release oxybutynin. Dosing was increased weekly by five milligrams, up to 30 milligrams per day. More than 80 percent of patients had a final dosing regimen of over 10 milligrams per day, with 20 percent at 30 milligrams per day. At one week, a decrease of two voids or catheterizations per day was recorded.
No patient experienced serious adverse events during the study, nor was there a relationship between dosing quantity and severity of side effects such as dry mouth.
The medical condition known as overactive bladder affects approximately 17 million Americans, making it more prevalent than many commonly discussed conditions, such as diabetes (seven million) and Alzheimer's disease (four million). With symptoms of urinary urge incontinence, involuntary loss of bladder control; urgency, urgent need to urinate; and micturition frequency, urinating more than eight times a day, overactive bladder is one of the most under-diagnosed and under-treated conditions in the United States.
SOURCE: ALZA Pharmaceuticals