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Methenamine Hippurate for Recurrent UTI in Elderly Women
NCT04077580Phase 4
Key facts
- Status
- Completed
- Start
- Nov 2019
- Primary completion
- Jun 2023
- Countries
- 4
- Sponsor
- University of Oslo
- Modality
- Classical Binding Small Molecules
- Conditions
- urinary tract infection (UTI)
01
Overview
Phase 4, randomised, triple-blind trial in urinary tract infection (UTI) comparing Methenamine hippurate with Placebo (2 arms). Primary endpoint: Number of UTI antibiotic treatments at 6 months. Started Nov 2019; status: completed.
02
Design
2 arms- Study design
- RandomizedTriple-blind
Methenamine hippurate
Active intervention with methenamine hippurate tablets
Placebo
Control group receiving lactose placebo tablets
03
Who it enrols
Women aged 70 or older with recurrent UTIs (at least 3 episodes in 12 months or 2 in 6 months) who do not have severe renal/hepatic impairment, indwelling catheters, or lactose intolerance.
04
Endpoints
Primary
Number of UTI antibiotic treatments
Secondary
Prolonged effect on antibiotic usage
Incidence of UTI
Severity of UTI symptoms
Duration of UTI episodes
Complications such as pyelonephritis and hospital admission for UTI
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