Efficacy, safety, and tolerability of intravesically administered 0.1% oxybutynin hydrochloride solution in adult patients with neurogenic bladder: A randomized, prospective, controlled multi‐center trial. Issue 5 (8th March 2015)

• Record Type: Journal Article
• Authors: Schröder, Annette; Albrecht, Uwe; Schnitker, Jörg; Reitz, André; Stein, Raimund
• Is Part Of: Neurourology and urodynamics. Volume 35:Issue 5(2016:Jun.)
• Page Start: 582
• Page End: 588
• Publication Date: 2015-03-08
• Subjects: bladder capacity -- catheterization -- neurogenic detrusor -- randomized clinical trial -- ready‐to use oxybutynin; Urinary organs -- Periodicals; Urodynamics -- Periodicals; Urology -- Periodicals; 616.6
• DOI: 10.1002/nau.22755
• Languages: English
• ISSNs: 0733-2467

Abstract

Abstract : Aims: To verify the efficacy, safety and tolerability of intravesical administration of 0.1% oxybutynin hydrochloride compared to its oral administration for treatment of neurogenic detrusor overactivity (NDO) in a randomized, prospective, controlled, open‐label, multi‐center trial in 35 adult patients. Methods: NDO was confirmed within the previous 24 months by urodynamic studies (UDS). Group 1 (n = 18) received 10 ml 0.1% oxybutynin hydrochloride intravesically three times per day and group 2 (n = 17) 5 mg oxybutynin hydrochloride orally three times per day for a period of 28 days. Primary efficacy criterion was the change in the maximum bladder capacity between the beginning of the study and after 4 weeks as assessed by UDS. Adverse drug reactions (ADR) were collected and an evaluation of anticholinergic effects was conducted. Results: The increase in maximum bladder capacity was 117 ml with intravesical application ( P = 0.0002) versus 18 ml with the oral application ( P = 0.51). The difference was statistically significant ( P = 0.0086). ADR were reported by 10 (55.6%) of patients with intravesical administration, and by 14 (82.4%) of patients with oral administration. Significant differences in favor of the intravesical application were observed in ADR affecting vision (1/10 vs. 9/14), gastrointestinal tract (8/10 vs. 14/14), nervous system (2/10 vs. 8/14), and skin and subcutis (1/10 vs. 6/14). No serious adverse drug reactions were reported. Conclusions: This study demonstrates the efficacy and safety of intravesical 0.1% oxybutynin hydrochloride in the treatment of NDO with respect to the increase in maximum bladder capacity. Neurourol. Urodynam. 35:582–588, 2016 . © 2015 Wiley Periodicals, Inc.