Hypothesis / aims of study
Recurrent urinary tract infections (rUTI) affect more than 20% of post-menopausal women. Vaginal estrogen is first-line prevention therapy; however, adherence to vaginal estrogen cream can be a barrier to treatment success. Integrating patient preference into clinical care guidelines may improve adherence and thus increase the likelihood of successful treatment. In this study we aimed to compare patient preference and treatment satisfaction between vaginal estradiol tablet and cream formulations for rUTI prevention. We hypothesized that patient preference would be associated with ease of use of the medication.
Study design, materials and methods
This crossover randomized controlled trial enrolled post-menopausal women with rUTI. Participants were randomized to a 12-week treatment period of vaginal estradiol tablet and cream, separated by immediate crossover. At 6 months, participants stated their overall preference, which was the primary outcome. Secondary outcomes included: satisfaction and convenience (Treatment Satisfaction Questionnaire for Medication, TSQM), side effects, effectiveness, and compliance (Medication Adherence Questionnaire, MAQ) and lower urinary tract symptoms (LURN Symptom Index-10, LURN SI-10). The primary outcome of preference was analyzed using a one-sample exact binomial test (α=0.05). Secondary outcomes used linear mixed effects models for continuous outcomes, and logistic mixed effects models for binary outcomes.
Results
A total of 22 post-menopausal women (mean age 69± 6 years) were randomized; 11 (50%) completed both treatment periods. Dropouts cited satisfaction with initial formulation (n=2, both using cream), unwillingness to continue vaginal estrogen (n=4), or were lost to follow-up (n=5). Of the participants who completed the study, 9/11 (81.8%, 95% CI 48.2%, 97.7%) preferred the tablet formulation versus 2/11 (18.2%; 95% CI 2.3%, 51.8%) preferred cream (p=0.065). To determine satisfaction of individual formulations and lower urinary tract symptoms of patients prior to drop out, we report results from linear mixed effect models which revealed that participants in the tablet group did not have significantly different LURN SI-10, or TSQM domain scores compared to those in the cream group, all p>0.05 (Table 1). Similarly, treatment adherence, measured by the MAQ, was not significantly different between tablet and cream (p=0.553).
Interpretation of results
This pilot study notably showed 50% attrition, with dropouts citing either satisfaction with their initial formulation or unwillingness to continue vaginal estrogen. Among completers, a clinically meaningful preference trend favored tablets despite comparable side effects and convenience between formulations.