6/28/23, 12:07 AM ALTAR Pathway Feedback Search Clinical Topics Home Studies ALTAR ALTAR Disease Recurrent urinary tract infection Trial question Is methenamine hippurate noninferior to antibiotic prophylaxis in women with recurrent UTIs? Study design Multi-center Open label RCT Population 240 female patients Inclusion criteria: adult women with recurrent UTIs requiring prophylactic treatment Key exclusion criteria: correctable urinary tract abnormalities due to recurrent UTI; neurogenic dysfunction of the lower urinary tract Interventions N=120 methenamine hippurate (oral dose of 1 g BID for 12 months) N=120 antibiotic prophylaxis (oral dose of nitrofurantoin, TMP, or cefalexin taken daily for 12 months) Primary outcome Symptomatic antibiotic treated urinary tract infections at 12 months 1.4/py 1.38 1.0/py 0.89 0.7/py Difference not exceeding nonferiority margin 0.3/py 0.0/py https://web.pathway.md/studies/recM3avSQu6OrrqC1 1/2 6/28/23, 12:07 AM 0.0/py ALTAR Pathway Methenamine hippurate Antibiotic prophylaxis Difference not exceeding nonferiority margin in symptomatic antibiotic treated UTIs at 12 months (1.38 episodes / p-y vs. 0.89 episodes / p-y; AD 0.49 episodes / p-y, 95% CI 0.08 to 0.9) Secondary outcomes No significant difference in symptomatic antibiotic treated UTIs at 6 months (1.72 episodes / p-y vs. 1.19 episodes / p-y; AD 0.53 episodes / p-y, 95% CI -0.03 to 1.09) No significant difference in microbiologically confirmed UTIs at 12 months (0.53 episodes / p-y vs. 0.41 episodes / p-y; AD 0.11 episodes / p-y, 95% CI -0.12 to 0.35) Significant increase in microbiologically confirmed UTIs at 6 months (0.86 episodes / p-y vs. 0.48 episodes / p-y; AD 0.38 episodes / p-y, 95% CI 0.04 to 0.72) Safety outcomes No significant difference in adverse events. Conclusion In adult women with recurrent UTIs requiring prophylactic treatment, methenamine hippurate was noninferior to antibiotic prophylaxis with respect to symptomatic antibiotic treated UTIs at 12 months. Reference Chris Harding, Helen Mossop, Tara Homer et al. Alternative to prophylactic antibiotics for the treatment of recurrent urinary tract infections in women: multicentre, open label, randomised, non- inferiority trial. BMJ. 2022 Mar 9;376:e068229. Open reference URL https://web.pathway.md/studies/recM3avSQu6OrrqC1 2/2