Predictive parameters of response to XXXX in primary nocturnal enuresis.

@entity1 @entity7062 @entity2316 @entity2011
INTRODUCTION/BACKGROUND: Many recent treatment guidelines have advocated the importance of a full noninvasive medical evaluation. To individualize treatment, special emphasis must be put on recording of the maximum voided volume (MVV) and nocturnal diuresis in a diary or frequency/volume chart. OBJECTIVE: The aim of this study was to identify any possible predictive factors to @entity7062 response. STUDY DESIGN: This study is a re-analysis of a prospective, open-label, multinational, phase-IV study evaluating  <=6 months of treatment with @entity7062 tablets for @entity1 with primary nocturnal enuresis. The @entity1 were enrolled between April 2002 and December 2004 from 86 centers in four countries: UK, Canada, Germany and France. A total of 936 @entity1 were screened; 744 @entity1 aged 5-15 years participated in the study. Of these, 471 @entity1 completed the study with 6 months follow-up and recording in a frequency/volume chart. All @entity1 experienced six or more wet nights during the 14-day screening period. Exclusion criteria were: organic pathology, treatment for enuresis within the past year, previous treatment for enuresis for >4 weeks, diurnal symptoms, @entity2316 and the use of systemic antibiotics or other drugs known to affect @entity7062 activity. The predictive value of number of wet nights a week, fluid intake, daytime voiding frequency and diuresis was investigated by performing a multinomial logistic regression. RESULTS: Of the demographic variables, age was the only significant predictor for response to @entity7062 . Controlling for age, the significant predictive variables were: number of wet nights a week, average voided volume daytime, maximum voided volume daytime, total daytime diuresis, nocturnal diuresis (see Figure), maximum voided volume 24  h and total 24  h diuresis. More than 80% of the @entity1 had no nocturnal @entity2011 and a low maximum voided volume. DISCUSSION: Performing a secondary analysis is a limitation because the original study was not designed for that. A new prospective study is ethically hardly defendable for @entity1 if data are available from previous literature [1]; therefore, a re-analysis was the appropriate choice. The study confirms the predictive value of age, number of wet nights a week and nocturnal diuresis [1,2]. CONCLUSIONS: The study demonstrates that @entity7062 response rates are higher in @entity1 with greater age, limited number of wet nights a week and nocturnal @entity2011 . Only a minority of a primary nocturnal enuresis population, based on history alone, had nocturnal @entity2011 . The majority had a low maximum voided volume. The results clearly stress the importance of a frequency/volume chart for individualizing therapy to the characteristics, thereby resulting in elevated success rates. Registration number of clinical trial: Clinical Trials.gov NCT00245479.
