Table 1

SPIRIT flow chart: schedule of enrolment, interventions and assessments

TimepointStudy period
EnrolmentAllocationPostallocationClose-outFollow-up
Day 0Day 0Day 1Day2Day3Day4Day 5Day 7Day 90
Enrolment:
Eligibility screenX        
Informed consentX        
Assessment of inclusion/exclusion criteriaX        
Allocation, randomisation X       
Interventions:
Pharmacotherapy Embedded Image 
Assessments:
ACSS scoreX      X 
Patient diaries       X 
Urine cultureX      X 
Follow-up interview        X

  • ACSS, Acute Cystitis Symptom Score; SPIRIT, Standard Protocol Items: Recommendations for Interventional Trials.