Optimizing Overactive Bladder Treatment

Treatment success at 4 weeks after initiation of anticholinergic of beta-3 agonist therapy. Treatment success will be defined as a response of "very much better" or "much better" on the Patient Global Impression of Improvement (PGI-I), which is a single item questionnaire that asks respondents to rate their improvement after undergoing treatment on a 7-point Likert scale ranging from "very much worse" to "very much better." Statistical analysis will be by intention-to-treat for the primary outcome. A chi-square test will be utilized to determine if there is a statistically significant difference between the two cohorts and sensitivity analyses will be performed using logistic regression analysis.

Each participants' urinary microbiome composition will be analyzed at baseline and at week 4 to determine changes in the microbiome that occur over the study period. The correlation between changes in the urinary microbiome over 4 weeks and study drug allocation (probiotic vs placebo) will be assessed via Chi-square testing.

The correlation between the presence of Lactobacillus in the urine at baseline and treatment success at week 4 will be analyzed via Chi-Square testing to assess for predictors of response to therapy in women (i.e. treatment success or lack of treatment success based on the primary outcome definition of treatment success as above).

Individual participant change score on the Overactive Bladder Questionnaire short-form (OAB-q SF) will be compared between the two cohorts by student's t-test. The OAB-q SF is utilized to assess the impact of OAB symptoms on the patient's life, and has been shown to be responsive to reductions in urinary urgency, frequency and incontinence during anticholinergic therapy. The OAB-q SF questionnaire consists of 19 items divided into a 6-item symptom severity (SS) scale and a 13-item health-related quality of life (HRQL) scale, with both scales ranging from 0 to 100. For the OAB-q SS scale a higher score indicates worse symptom severity while for the OAB-q HRQL scale a higher score indicates better quality of life.

Treatment Satisfaction Questionnaire for Medication version 2 (TQSM-II) score, the TQSM-II is comprised of 12 questions assessing treatment satisfaction with medication intended for use with a wide variety of medications and illness conditions that specifically assesses the three most common dimensions on which patients evaluate their medication: effectiveness, side effects of use, and convenience of use. TSQM Scale scores range from 0 to 100 with a higher score indicating better satisfaction with treatment. The TQSM-II score at the week 4 visit will be compared between the two cohorts by student's t-test.

Treatment success will be defined as a response of "very much better" or "much better" on the Patient Global Impression of Improvement (PGI-I), which is a single item questionnaire that asks respondents to rate their improvement after undergoing treatment on a 7-point Likert scale ranging from "very much worse" to "very much better." The correlation between race/ethnicity and treatment response will be analyzed using chi-square or fisher's exact test.

The correlation between the presence of Lactobacillus in the urinary microbiome and dose of OAB medication at 4 weeks (i.e. low dose vs high dose) will be analyzed via Chi-square or fishers exact test.

Treatment success will be defined as a response of "very much better" or "much better" on the Patient Global Impression of Improvement (PGI-I), which is a single item questionnaire that asks respondents to rate their improvement after undergoing treatment on a 7-point Likert scale ranging from "very much worse" to "very much better." A per protocol analysis of treatment success at 4 weeks (the primary outcome) will also be performed using a chi-square test to determine if there is a statistically significant difference between the two cohorts in treatment success and sensitivity analyses may be performed using logistic regression analysis.