Efficacy and safety of oxybutynin transdermal system in spinal cord injury patients with neurogenic detrusor overactivity and incontinence: an open-label, dose-titration study.

Full Abstract

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 > 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.

Author information

Author/s: Kennelly, Michael J (MJ); Lemack, Gary E (GE); Foote, Jenelle E (JE); Trop, Cynthia S (CS);

Affiliation: Carolinas Healthcare System, 1100 Blythe Boulevard, Charlotte, NC 28203, USA. mkennelly(-atsign-)carolinas.org

Journal and publication information

Publication Type: Journal Article; Multicenter Study; Research Support, Non-U.S. Gov't

Journal: Urology (Urology), published in United States. (Language: eng)

Reference: 2009-Oct; vol 74 (issue 4) : pp 741-5

Dates: Created 2009/10/05; Completed 2009/10/23;

PMID: 19628264, status: MEDLINE (last retrieval date: 10/23/2009, IMS Date: )

Sourced from the National Library of Medicine. Abstract text and other information may be subject to copyright.

External Links for this article
(including full text providers, if available):

Click Electronic Full-text Provider Links to see options for finding the electronic full text links to this article. Note there may be a subscription or fee required for access to the full text. See our FAQ for information on finding FREE full text articles.

This article may also be located in paper journal collections available in many libraries. Use the Journal and Publication Information above to find the full article.