Table 1.
Study visits and procedures
| Time point | Study period | ||||||||
| Enrolment | Allocation | Treatment period | Follow-up period | ||||||
| Screening | Baseline | At time of UTI Days 2–180 |
Follow-up UTI* Days 2–180 |
Monthly follow-up Days 2–180 |
End of IMP Day 180 |
At time of UTI Days 180–360 |
Follow-up UTI* Days 180–360 |
End of study Day 360 |
|
| Enrolment | |||||||||
| Eligibility screen | X | X | |||||||
| Informed consent | X | ||||||||
| Demography | X | ||||||||
| Medical history | X | ||||||||
| Physical examination | X† | ||||||||
| Concomitant medication | X‡ | ||||||||
| Randomisation | X | ||||||||
| CRF completion | X | X | X | X | X | X | X | X | |
| Dispensing of trial drugs | X | ||||||||
| Interventions | |||||||||
| Methenamine hippurate |
|
||||||||
| Placebo |
|
||||||||
| Compliance | X | X | X | ||||||
| Midstream urine dipstick/culture | X | X§ | X§ | X§ | |||||
| Assessments | |||||||||
| UTI record | X | X | X | X | |||||
| Patient-reported outcome | X | X | X | X | X | X | X | ||
| Adverse event assessment | X | X | X | X | X | X | X¶ | ||
Standard Protocol Items: Recommendations for Interventional Trials figure for the ImpresU clinical trial.
*Every episode of acute UTI both in intervention period and follow-up period will be followed with registrations every 7 days until the patient is restored.
†If needed to determine eligibility or complete baseline data.
‡After baseline visit, concomitant medication will only be registered in case of serious adverse event (SAE).
§If taken by the GP.
¶In case of SAE present and not resolved by day 360, this will be followed until resolution.
CRF, case report form; GP, general practitioner; IMP, investigational medicinal product; UTI, urinary tract infection.