Methenamine hippurate as prophylaxis for recurrent urinary tract infections in older women - a triple-blind, randomised, placebo-controlled, phase IV trial (ImpresU)
Abstract
OBJECTIVE
To investigate the preventive effect of the antiseptic methenamine hippurate on recurrent urinary tract infections (rUTIs) in older women.
METHODS
Triple-blind, randomised, placebo-controlled phase IV trial with a six-month treatment period and a six-month follow-up. Women ≥ 70 years with rUTIs were recruited from general practice in Norway, Sweden, Poland, and The Netherlands. Recruitment started December 2019, with follow-up completed at the end of June 2023. Participants were randomised to methenamine hippurate 1g x 2 or placebo 1 tablet x 2 for six months. The primary outcome was number of antibiotic treatments for UTIs during the treatment period. Secondary outcomes included number of antibiotic treatments for UTIs during the follow-up period, UTI symptom severity and episode duration. Differences in complications were measured as safety outcomes.
RESULTS
Of 289 recruited women, 281 (97%) were included in the main analysis (140 in the methenamine hippurate group, 141 in the placebo group). During the treatment period, the methenamine hippurate group had a lower incidence of antibiotic treatments for UTIs than the placebo group, with an incidence rate ratio of 0.75 (95% CI 0.57-1.0, p= 0.049). In the follow-up period, the ratio was reversed: The methenamine hippurate group had a higher incidence of antibiotic treatments for UTIs than the placebo group, with an incidence rate ratio of 1.7 (95% CI 1.3-2.3, p<0.001). There were no important differences in UTI…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 289 participants or records.
Read the paper
Related studies
- Association of lower urinary tract symptoms and OAB severity with quality of life and mental health in China, Taiwan and South Korea: results from a cross-sectional, population-based study
- Ten-Day Quadruple Therapy Comprising Low-Dose Rabeprazole, Bismuth, Amoxicillin, and Tetracycline Is an Effective and Safe First-Line Treatment for Helicobacter pylori Infection in a Population with High Antibiotic Resistance: a Prospective, Multicenter, Randomized, Parallel-Controlled Clinical Trial in China
- The Role of the NLR and PLR in Urinary Tract Infection
- Threat of Antimicrobial Resistance among Pilgrims with Infectious Diseases during Hajj: Lessons Learnt from COVID-19 Pandemic
- Leclercia adecarboxylata urinary tract infection in a patient with bladder cancer and recurrent hematuria
- A Case Series of Staphylococcus lugdunensis Infection in Cancer Patients at an Academic Cancer Institute in the United States
Go deeper in Evidence Hub
Evidence Hub adds a study data sheet (design, sample size, evidence level, key numbers), an AI summary and a chat grounded in the paper's text.