Patients filled out a 3-day voiding diary that includes fluid intake, frequency of voiding, urine volume in 24 hours (ml), urine volume at night (ml), urge intensity, urge episodes (+-+++), incontinence episodes (y/n), nocturia index (Ni), nocturnal polyuria index, and nocturnal bladder capacity index (NBCi).
The nocturia index (Ni) is calculated as nocturnal urine volume (NUV) divided by the maximal voiding volume for 24 hours; the nocturia index is defined as positive if it is greater than 1 Nocturnal polyuria is defined as NUV >33% of the total 24-h urine volume at the age of 65 years and higher. The NBCi corresponds to the actual number of voids minus the predicted number of voids. The predicted number of voids is obtained by subtracting 1 from the nocturia index (Ni) [34 (link)].
Four detailed questionnaires were filled out by the participants for all 7 days before the treatment with Bryophyllum 50% chewable tablets and during the last days of the 3-week-long treatment. For measuring the primary outcomes, nocturia and sleep quality, the averages of voiding at night from the 3-day voiding diary and the Pittsburgh Sleep Quality Index (PSQI, Questionnaire 1) were used. The PSQI is a self-report questionnaire that assesses sleep quality. It consists of 19 individual items that create 7 components that produce one global score (0–21) and takes 5–10 minutes to complete. These components (each one rated 0–3) are subjective sleep quality (component 1), sleep latency (component 2), sleep duration (component 3), habitual sleep efficiency (component 4), sleep disturbance (component 5), use of sleeping medication (component 6), and daytime dysfunction (component 7). The higher the score, the higher the symptom burden.
For the assessment of the secondary outcomes, the International Consultation on Incontinence Questionnaire-OverActive Bladder (ICIQ-OAB, Questionnaire 2) was used. This is a questionnaire for evaluating overactive bladder, its related impact on quality of life (QoL), and the outcomes of treatments in men and women in research and clinical practice. Higher values in the overall 0–16 score indicate increased symptom severity.
To assess daytime sleepiness as a sequela of night-time sleep disturbance, the Epworth Sleepiness Scale (ESS) (Questionnaire 3), which consists of 8 questions, was used. Adding the scores for each of the 8 questions yields a total score ranging from 0–24. An ESS score >10 suggests excessive daytime sleepiness (EDS); an ESS score ≥16 suggests a high level of EDS and is usually associated with marked sleep disorders, including narcolepsy.
Finally, the patients filled out a customized questionnaire (Questionnaire 4) on a daily basis to record discomforts and adverse events that they thought could be associated with the treatment and to characterize their tablet intake (forgotten tablets had to be registered); this allowed for the assessment of safety parameters and patient compliance.
The nocturia index (Ni) is calculated as nocturnal urine volume (NUV) divided by the maximal voiding volume for 24 hours; the nocturia index is defined as positive if it is greater than 1 Nocturnal polyuria is defined as NUV >33% of the total 24-h urine volume at the age of 65 years and higher. The NBCi corresponds to the actual number of voids minus the predicted number of voids. The predicted number of voids is obtained by subtracting 1 from the nocturia index (Ni) [34 (link)].
Four detailed questionnaires were filled out by the participants for all 7 days before the treatment with Bryophyllum 50% chewable tablets and during the last days of the 3-week-long treatment. For measuring the primary outcomes, nocturia and sleep quality, the averages of voiding at night from the 3-day voiding diary and the Pittsburgh Sleep Quality Index (PSQI, Questionnaire 1) were used. The PSQI is a self-report questionnaire that assesses sleep quality. It consists of 19 individual items that create 7 components that produce one global score (0–21) and takes 5–10 minutes to complete. These components (each one rated 0–3) are subjective sleep quality (component 1), sleep latency (component 2), sleep duration (component 3), habitual sleep efficiency (component 4), sleep disturbance (component 5), use of sleeping medication (component 6), and daytime dysfunction (component 7). The higher the score, the higher the symptom burden.
For the assessment of the secondary outcomes, the International Consultation on Incontinence Questionnaire-OverActive Bladder (ICIQ-OAB, Questionnaire 2) was used. This is a questionnaire for evaluating overactive bladder, its related impact on quality of life (QoL), and the outcomes of treatments in men and women in research and clinical practice. Higher values in the overall 0–16 score indicate increased symptom severity.
To assess daytime sleepiness as a sequela of night-time sleep disturbance, the Epworth Sleepiness Scale (ESS) (Questionnaire 3), which consists of 8 questions, was used. Adding the scores for each of the 8 questions yields a total score ranging from 0–24. An ESS score >10 suggests excessive daytime sleepiness (EDS); an ESS score ≥16 suggests a high level of EDS and is usually associated with marked sleep disorders, including narcolepsy.
Finally, the patients filled out a customized questionnaire (Questionnaire 4) on a daily basis to record discomforts and adverse events that they thought could be associated with the treatment and to characterize their tablet intake (forgotten tablets had to be registered); this allowed for the assessment of safety parameters and patient compliance.
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