Therapies on Nocturia: A Secondary Data Analysis

Objectives: Despite nocturia being a common symptom in overactive bladder (OAB), there is little data regarding how various OAB treatments effect the incidence of nocturia in women with OAB and urge urinary incontinence (UUI). The objective of this study was to compare the effect of treatment with anticholinergic medication versus onabotulinum toxin A (BTX) versus sacral neuromodulation (SNM) on nocturia in women with moderate to severe urge urinary incontinence (UUI).

Methods: This study is a secondary analysis of women with UUI in the ABC (≥5 UUI episodes/3 days) and ROSETTA (≥6 UUI episodes/3 days) randomized trials using data from the NIH Data and Specimen Hub (DASH) database. Subjects reporting mean > 2 nocturia episodes/night on baseline 3-day diary were included and divided into cohorts by UUI treatment: 1) solifenacin/trospium anticholinergic medication (AC), 2) BTX 100 units, 3) BTX 200 units, and 4) SNM. For the SNM cohort, only test phase treatment responders (≥ 50% improvement in mean UUI episodes/day) were included. The primary outcome was change in mean nocturia episodes per night on a 3-day diary from baseline to 6 months. Continuous variables were analyzed by one-way ANOVA followed by Bonferroni-corrected pairwise comparisons. Categorical data were analyzed by contingency table analysis. Change in nocturia episodes/day from baseline to 6 months was assessed by mixed effects models for repeated measures data. The interaction between treatment cohort and time was included in the mixed effects model to assess whether degree of change from baseline to 6 months differed between cohorts.

Results: 197 subjects were included: 43 (22%) AC, 37 (19%) BTX 100 units, 63 (32%) BTX 200 units, and 54 (27%) SNM. There were no significant differences in baseline mean nocturia episodes, demographics or baseline urodynamics except for younger age of subjects in AC and BTX 100 units cohorts (p = 0.04). At 6 months, the overall study population demonstrated a significant decrease in mean nocturia episodes per night from 2.7±0.4 to 1.6±0.5 (p < 0.001; Figure 1). When comparing cohorts, there was no significant difference in change in mean nocturia episodes per night with a 44% decrease in AC, 46% in 100U BTX, 32% in 200U BTX, and 33% in SNM (p >0.05). 72 subjects had resolution of nocturia (defined as < 1 mean nocturia episode/night on 3-day diary) with 14 (20%) receiving AC, 19 (26%) undergoing 100U BTX, 23 (32%) undergoing 200U BTX and 16 (22%) undergoing SNM (p >0.05 between cohorts).

Conclusions: For women with nocturia ≥2/night and ≥5 UUI episodes on 3-day diary, treatment with solifenacin/trospium anticholinergic medication, BTX (100 or 200 units) or SNM was associated with a significant decrease in nocturia episodes at 6-months follow-up.