Efficacy and Safety of Oxybutynin Transdermal System in Spinal Cord Injury Patients With Neurogenic Detrusor Overactivity and Incontinence: An Open-label, Dose-titration Study

Michael J. Kennelly, Gary E. Lemack, Jenelle E. Foote, Cynthia S. Trop

Research output: Contribution to journalArticle

23 Citations (Scopus)

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 ≥ 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.

Original languageEnglish (US)
Pages (from-to)741-745
Number of pages5
JournalUrology
Volume74
Issue number4
DOIs
StatePublished - Oct 2009

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Intermittent Urethral Catheterization
Spinal Cord Injuries
Safety
Urinary Bladder
Residual Volume
Urodynamics
Reflex
Mouth
oxybutynin
Observation
Urine
Pressure

ASJC Scopus subject areas

  • Urology

Cite this

Efficacy and Safety of Oxybutynin Transdermal System in Spinal Cord Injury Patients With Neurogenic Detrusor Overactivity and Incontinence : An Open-label, Dose-titration Study. / Kennelly, Michael J.; Lemack, Gary E.; Foote, Jenelle E.; Trop, Cynthia S.

In: Urology, Vol. 74, No. 4, 10.2009, p. 741-745.

Research output: Contribution to journalArticle

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title = "Efficacy and Safety of Oxybutynin Transdermal System in Spinal Cord Injury Patients With Neurogenic Detrusor Overactivity and Incontinence: An Open-label, Dose-titration Study",
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 ≥ 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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N2 - 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.

AB - 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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