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Efficacy and tolerability of propiverine hydrochloride extended-release compared with immediate-release in patients with neurogenic detrusor overactivity.
MedLine Citation:
PMID:  23338657     Owner:  NLM     Status:  Publisher    
Abstract/OtherAbstract:
Study design:Double-blind, randomised, multicentre study.Objectives:Efficacy and tolerability of propiverine extended-release (ER) compared with immediate-release (IR) were evaluated in patients with proven neurogenic detrusor overactivity (NDO).Setting:Six Spinal Cord Injury Units located in Austria, Germany and Romania.Methods:Propiverine ER 45 mg s.i.d. or IR 15 mg t.i.d. were administered in patients with proven NDO. Outcomes were assessed at baseline (V1), and after 21 days of treatment (V2): Reflex volume served as primary, leak point volume and maximum detrusor pressure as secondary efficacy outcomes, treatment-related adverse events as tolerability outcomes.Results:Sixty-six patients with proven NDO were enrolled. Reflex volume (ml) increased significantly in the IR (V1: 100.9, V2: 202.9) and in the ER (V1: 89.8, V2: 180.3) group, no significant intergroup difference. Leak point volume increased, and maximum detrusor pressure decreased significantly in both groups, no significant intergroup differences. The percentage of patients presenting with incontinence was reduced by 14% in the IR and by 39% in the ER group, the difference is significant. Treatment-related adverse events manifested in 42 and 36% following propiverine IR and ER, respectively.Conclusion:The urodynamic efficacy outcomes demonstrated both galenic formulations to be equieffective. However, following propiverine ER 45 mg s.i.d. higher continence rates compared with propiverine IR 15 mg t.i.d. were achieved, possibly indicative of more balanced plasma-levels. A slight tendency for superior tolerability outcomes of propiverine ER compared with IR was demonstrated.Sponsorship:The study was sponsored by an unrestricted educational grant of APOGEPHA Arzneimittel GmbH, Dresden, Germany.Spinal Cord advance online publication, 22 January 2013; doi:10.1038/sc.2012.174.
Authors:
M Stöhrer; G Mürtz; G Kramer; W Warnack; G Primus; V Jinga; A Manu-Marin; N Calomfirescu; G Strugala
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Publication Detail:
Type:  JOURNAL ARTICLE     Date:  2013-1-22
Journal Detail:
Title:  Spinal cord     Volume:  -     ISSN:  1476-5624     ISO Abbreviation:  Spinal Cord     Publication Date:  2013 Jan 
Date Detail:
Created Date:  2013-1-22     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  9609749     Medline TA:  Spinal Cord     Country:  -    
Other Details:
Languages:  ENG     Pagination:  -     Citation Subset:  -    
Affiliation:
Department of Urology and Paediatric Urology, Universität Essen, Essen, Germany.
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