Multi-center Trial to Improve Nocturia and Sleep in Older Adults

Mean Nocturia Frequency

The primary outcome of nocturia frequency will be measured as the average episodes per night at baseline, 2 months, and 4 months through the International Consultation on Incontinence Questionnaire-Overactive Bladder Module (ICIQ-OAB) questionnaire. An adapted version that asks the participant to record the number of nocturia episodes if the "4+" nocturia option is selected will be used. A linear mixed effects model will be used to evaluate the group difference over time in average nocturia frequency per night.

Self-Reported Insomnia Severity Index

The self-reported Insomnia Severity Index is a 7-item instrument with high internal consistency and validity for measures of fatigue, quality of life, anxiety, and depression. The total score is the sum of all seven items and ranges from 0-28 with higher scores indicating greater insomnia severity. The Insomnia Severity Index can also be used as a change score that measures perceived severity of insomnia symptoms. A 0.5 standardized mean difference between treatment and control is considered the clinical significance threshold for studies of chronic insomnia disorder. The Insomnia Severity Index will be modeled similarly with a linear mixed mode. If the distributions of the secondary outcome is skewed and no good transformation is found, the outcome will be categorized into categories based on quantiles or clinically meaningful values and then modeled with generalized linear mixed models using cumulative logit or generalized logit link for multinomial data.

Nocturia-Quality of Life

The Nocturia-Quality of Life (NQOL) questionnaire provides a detailed and robust measure to assess the impact of nocturia on quality of life with particular reference to the effects on persons' lives of nocturia and can be used as an outcome measure to assess impact of different treatment modalities. The NQOL score may be calculated by summing all items, giving a score from 0-58. A greater score indicates a higher impact on QOL. The NQOL will be modeled similarly with linear mixed models in their original scale or transformed scale as appropriate. If the distributions of the NQOL scores are skewed and no good transformation is found, the outcomes will be categorized into categories based on quantiles or clinically meaningful values and then modeled with generalized linear mixed models. Similar secondary analyses as those proposed in assessing mean nocturia frequency will be performed on the secondary outcomes NQOL.