Efficacy and Safety of Oxybutynin Transdermal System in Spinal Cord Injury Patients With Neurogenic Detrusor Overactivity and Incontinence: An Open-label, Dose-titration Study - 06/08/11
, Gary E. Lemack b, Jenelle E. Foote c, Cynthia S. Trop d
Reprint requests: Michael J. Kennelly, M.D., Carolinas Rehabilitation, Carolinas Healthcare System, 1100 Blythe Boulevard, Charlotte, NC 28203Résumé |
Objectives |
To evaluate the efficacy and safety of oxybutynin transdermal system (oxybutynin-TDS) in spinal cord injury patients with neurogenic detrusor overactivity and incontinence despite use of clean intermittent catheterization (CIC).
Methods |
This multicenter, open-label, dose-titration study included patients ≥ 18 years old. During an 8-week dose-titration period, oxybutynin-TDS doses were adjusted every 2 weeks, depending on symptoms. The primary efficacy end point was a change in daily number of CIC periods without leakage, from baseline to 8 weeks or last observation. Outcome parameters included 3-day voiding diary, CIC volume, and urodynamic parameters. Changes from baseline were analyzed with paired t tests.
Results |
Of 24 study participants (mean age, 41.9 years), 18 (75.0%) completed the study. Final oxybutynin-TDS doses were 7.8, 9.1, and 11.7 mg/d for 4, 9, and 11 patients, respectively. Daily number of CIC periods without leakage increased significantly (mean change, 1.5 ± 2.2; P = .0036) from baseline (2.4 ± 1.8) to 8 weeks (3.9 ± 1.9). CIC volume (P = .0029), reflex volume (P = .0466), maximal cystometric bladder capacity (P = .0009), and residual urine volume (P = .0023) all increased significantly, whereas detrusor pressure at maximal bladder capacity decreased significantly (P = .0457). The most common adverse events were application site reaction (12.5% of patients), dry mouth (8.3%), and abnormal vision (8.3%). No patient discontinued treatment because of an adverse event.
Conclusions |
Oxybutynin-TDS was efficacious in spinal cord injury patients with neurogenic detrusor overactivity and was well tolerated at up to 3 times the standard dose.
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| This study was supported by Watson Laboratories, Inc, Morristown, New Jersey. |
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| Editorial assistance was provided by Scientific Connexions, Newtown, Pennsylvania. |
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| Relevant financial disclosures and conflicts of interest: Michael J. Kennelly. Watson Laboratories, Allergan, Pfizer–Study investigator and consultant and educator/speaker; GSK, Astellas, Novartis—Consultant and educator/speaker; Gary E. Lemack. Allergan–Research support/study site for clinical research; Astellas–Speaker; Novartis–Consultant and speaker; Pfizer–Consultant and speaker; Watson Laboratories–Study investigator (at the time of this study); Jenelle E. Foote. Pfizer–Detrol LA; Astellas/GSK–Vesicare advisory board, speakers bureau; Novartis–Enablex research support, speakers bureau; Allergan–Botox study research support; Pfizer–Fesoterodine research support, speakers bureau; Cynthia S. Trop. Watson Laboratories–Study investigator; Allergan–Botox study investigator. |
Vol 74 - N° 4
P. 741-745 - octobre 2009 Retour au numéro
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