1418

Transdermal Oxybutynin Treatment for Neurogenic Bladder: Patient Safety and QOL

Diane K. Newman, RNC, MSN, CRNP, FAAN, University of Pennsylvania Medical Center, Co-Director, Penn Center for Continence and Pelvic Health, Philadelphia, PA 19104, Michael J. Kennelly, MD, McKay Department of Urology, Carolinas Medical Center, Head, Section of Voiding Dysfunction and Female Urology, 1023 Edgehill Road South, Charlotte, NC 28207, Gary E. Lemack, MD, University of Texas Southwestern Medical Center, Associate Professor of Urology, Director of Neurourology, and Marilyn McIlwain, BS, Watson Laboratories, Associate Director, Clinical Affairs.

Purpose/rationale:

Neurogenic overactive bladder (NGB) is a frequent outcome of spinal cord injury (SCI). Clinical management, aimed at preserving renal function and establishing urinary continence to improve patient quality of life, consists of a combination of clean intermittent catheterization (CIC) and pharmacotherapy. Oral oxybutynin is effective in improving continence in these patients, but anticholinergic side effects (e.g., dry mouth and constipation) are more common and severe at the high doses needed (≤30 mg/day), frequently causing discontinuation. Transdermal (TDS) delivery of oxybutynin offers several advantages over oral, including less frequent dosing, potential for improved patient adherence, and lower incidence and severity of anticholinergic side effects. The study objective was to evaluate QoL and safety in patients using higher doses of Oxybutynin-TDS* (≤11.7 mg/day) in order to reduce leaking accidents between catheterizations.

Methodology:

Adult patients with NGB resulting from SCI were eligible for this 8-week, multi-center, open-label, dose-titration study if they were using CIC and had urinary incontinence between catheterizations. While keeping the daily number of catheterizations constant, the Oxybutynin-TDS dose could be adjusted every 2-weeks by increasing/decreasing one dose level, as appropriate. QoL was evaluated with a validated instrument specific for SCI patients with urinary disorders (Qualiveen questionnaire).

Results:

Most participants (mean age 42.2 ±10.77y) were male (19/22; 86.4%) and African-American (12/22; 54.5%). Improvement occurred in the Specific Impact of Urinary Problems on QoL index (SIUP), as well as in 3 of 4 subscales (inconvenience, fears and impact on daily life). The QoL Index of items not associated with urinary problems remained unchanged. Adverse event rates did not increase with increasing dose. No participant discontinued because of a drug-related adverse event.

Conclusion:

Oxybutynin-TDS is associated with improved QoL in patients with NGB resulting from SCI, and is well tolerated at up to 3-times the usual dose.

*Oxytrol®, Watson Pharma, Corona, Calif.


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