RESUMO
OBJECTIVES: To determine the safety, tolerability, maximal tolerated dose, and efficacy of a concentrated cranberry liquid blend, UTI-STAT with Proantinox, in female patients with a history of recurrent urinary tract infections (rUTIs). METHODS: The study agent was administered orally at 15, 30, 45, 60, and 75 mL daily for 12 weeks to women with a history of 2.78 ± 0.73 rUTIs <6 months. Blood and urine samples were collected at baseline and weeks 4 and 12. The women took daily doses of the agent. The primary endpoints were the safety, tolerability, and maximal tolerated dose. The secondary endpoints were the efficacy with regard to rUTI and quality-of-life (QOL) symptoms. RESULTS: A total of 28 subjects were included in the study. Of these 28 women, the data from 23 were analyzable. The average age was 46.5 ± 12.8 years. The maximal tolerated dose of UTI-STAT was 75 mL/d, and the recommended dose was set at 60 mL/d. The secondary endpoints demonstrated that only 2 (9.1%) of 23 reported a rUTI, a markedly better rate than the historical data. At 12 weeks, the reduction in worry about rUTIs and increased QOL with regard to the physical functioning domain and role limitations from physical health domain, as measured by the Medical Outcomes Study short-form 36-item questionnaire, were significant (P = .0097). A lower American Urological Association Symptom Index indicating greater QOL was also significant (P = .045). CONCLUSIONS: The novel concentrated cranberry liquid blend showed a good safety profile and tolerability in both pre- and postmenopausal women with history of rUTIs. The secondary endpoints demonstrated its effectiveness in reducing the incidence of rUTI and increasing QOL. Given this evidence, supplementation might be beneficial in the prevention of rUTIs in this population.
