Efficacy and safety of oxybutynin transdermal system in spinal cord injury patients with neurogenic detrusor overactivity and incontinence: an open-label, dose-titration study.
OBJECTIVE
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 > or = 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 + or - 2.2; P = .0036) from baseline (2.4 + or - 1.8) to 8 weeks (3.9 + or - 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.
Kennelly
Michael J
MJ
Carolinas Healthcare System, 1100 Blythe Boulevard, Charlotte, NC 28203, USA. mkennelly@carolinas.org
Lemack
Gary E
GE
Foote
Jenelle E
JE
Trop
Cynthia S
CS
D000279:Administration, Cutaneous; D000328:Adult; D054796:Drug Dosage Calculations; D005260:Female; D006801:Humans; D008297:Male; D008333:Mandelic Acids / Q000008:administration & dosage*; D008875:Middle Aged; D018727:Muscarinic Antagonists / Q000008:administration & dosage*; D013119:Spinal Cord Injuries / Q000150:complications*; D001750:Urinary Bladder, Neurogenic / Q000150:complications / Q000188:drug therapy* / Q000209:etiology*; D053201:Urinary Bladder, Overactive / Q000188:drug therapy* / Q000209:etiology*; D014549:Urinary Incontinence / Q000150:complications / Q000188:drug therapy* / Q000209:etiology*; D055815:Young Adult
D008333:Mandelic Acids; D018727:Muscarinic Antagonists; C005419:oxybutynin