The Open Clinical Trials Journal
3 : 1-5Published online DOI: 10.2174/1876821001103010001
Publisher ID: TOCTJ-3-1
RESEARCH ARTICLE
Flexible Dosing of Trospium Chloride for the Treatment of OAB – Results of a Non-Interventional Study in 4,092 Patients
2 A.CRO Clinical Research Services GmbH, D-65191 Wiesbaden, Germany
3 Department of Medical Science/Clinical Research, Dr. R. Pfleger GmbH, D-96045 Bamberg, Germany
* Address correspondence to this author at the Department of Medical Science/Clinical Research, Clinical Research, Dr. R. Pfleger GmbH, D-96045 Bamberg, Germany; Tel: +49 951 6043 161; Fax: +49 951 6043 226; E-mail: Claudia.neumeister@dr-pfleger.de
ABSTRACT
Introduction& Objectives:
This was a multicenter, non-interventional study performed in urology practices investigating prescribed dosage regimens as well as the efficacy and tolerability of an oral therapy with trospium chloride in patients with overactive bladder (OAB) under routine conditions.
Material and Methods:
Naive or insufficiently treated OAB patients in which oral therapy with trospium chloride1 was prescribed by the physician were eligible to participate. Dosing and duration of treatment were not predetermined. Core symptoms of OAB, a Quality of Life (QoL) score as well as dosage regimens were assessed at the beginning and at two consecutive visits. Adverse events and withdrawals were documented.
Results:
In 4,092 cases pre and post treatment data was available for the evaluation of efficacy; all 4,167 cases were included in the safety analysis. After a mean treatment period of 40 days, all core symptoms of OAB had improved e.g. the median total of micturitions was reduced from 12 to 8 (day) and from 3 to 1 (night). The percentage of incontinent patients dropped from 54.4% to 29.1%. The proportion of patients requiring incontinence pads was reduced from 47.6% to 30.1%. The median QoL score had improved from 3 to 1. Only 20% of the patients were treated with the standard dose of 45mg trospium chloride. Nearly 50% of the patients received 30mg (or less), and 60mg to 90mg were prescribed in 30% of the cases. There were 300 early treatment withdrawals (7.3%) and 54 patients experienced adverse events (1.3%).
Conclusions:
The distinct majority of OAB patients benefit from flexible dosing of trospium chloride, a compound with an equally favorable efficacy and tolerability profile.