Background: Uncomplicated cystitis is the most common reason for women to visit a general practitioner. First choice treatment is 5 days of nitrofurantoin. The second choice is a single dose of fosfomycin-trometamol (FMT). FMT is increasingly prescribed because it is more patient friendly. Previous studies did not show a difference in efficacy between nitrofurantoin and FMT. However, a recent study suggests that a single dose of FMT is inferior to 5 days of nitrofurantoin. It is unclear whether this finding is also applicable to the Dutch situation. Pharmacological studies suggest that a single dose of FMT might be insufficient. An extra dose of FMT could provide a solution.
Research question: Does extended dosing of FMT results in a prompter resolution of symptoms in non-pregnant women with uncomplicated cystitis in comparison to the current 1st and 2nd choice treatment, without an increase in relapses and complications?
Design: Open-label randomized non-inferiority trial with 3 arms. Total of 777 patients. 259 patients per arm.
Intervention: A)FMT in a single dose of 3000mg; B)FMT 3000mg on day 1 and 3; C)5 days of nitrofurantoin 100mg bid or 50mg qid.
Outcome measurements: Duration of symptoms (primary), secondary: Clinical failure on day 28, adverse events, adherence.
Relevance: This trial will give an answer to which treatment regimen gives the quickest resolution of symptoms with equal efficacy, potentially leading to improved treatment of a common problem in primary care.