Study Investigating the Impact Burden of Nocturia Using the Nocturia Impact Diary

Summary

The purpose of this study is to assess psychometric properties (reliability and validity) of the Nocturia Impact (NI) diary. To assess the association between reduction of number of nocturnal voids and the mean changes in NI scores (sensitivity of the NI total score to change in nocturia). To assess which NI diary items account for the main difference in change in total NI score in treatment versus placebo.

Timeline

Start

2012-03

Primary completion

2012-05

Completion

2012-06

Outcome

Mixed primary results

registry MEAN Non-Responders: Nocturia Impact (NI) Total Score (Q1-Q11): -2.6 (Standard Deviation 6.8) units on a scale NCT01552343 ↗

registry MEAN Responders: Nocturia Impact (NI) Total Score (Q1-Q11): -13.3 (Standard Deviation 17.9) units on a scale NCT01552343 ↗

registry analysis (superiority or other test); Non-Responders vs Responders; Mean Difference (Net) 10.7 (95% CI 2.7 to 18.8) NCT01552343 ↗

registry analysis (superiority or other test); Non-Responders vs Responders; Mean Difference (Net) -0.0 (95% CI -9.6 to 9.6) NCT01552343 ↗

Publications

• Results Holm-Larsen T, Andersson F, van der Meulen E, Yankov V, Rosen RC, Norgaard JP. The Nocturia Impact Diary: a self-reported impact measure to complement the voiding diary. Value Health. 2014 Sep;17(6):696-706. doi: 10.1016/j.jval.2014.06.007. Epub 2014 Aug 20.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Desmopressin	Peptide	25 ug	Oral
Subject	Desmopressin	Peptide	75 ug	Oral

Indications