Status:
COMPLETED
The Effect of Methenamine Hippurate to Reduce Antibiotic Prescribing in Elderly Women With Recurrent UTI
Lead Sponsor:
University of Oslo
Collaborating Sponsors:
Amsterdam UMC, location VUmc
UMC Utrecht
Conditions:
Recurrent Urinary Tract Infection
Eligibility:
FEMALE
70-99 years
Phase:
PHASE4
Brief Summary
Recurrent urinary tract infection (UTI) in elderly women is a major driver of antibiotic prescription. Hence, the question of feasible and appropriate preventive measures are important issues in this ...
Detailed Description
Rationale for conducting this study: Existing knowledge suggests that methenamine hippurate is a safe drug with few and mild side effects and with the potential to significantly reduce antibiotic usa...
Eligibility Criteria
Inclusion
- woman
- age ≥ 70 years
- recurrent UTIs defined as ≥ 3 episodes of antibiotic treated acute cystitis (acute symptoms specific/related to the urinary tract) during the last twelve months or ≥ 2 episodes during the last 6 months
- able and willing to comply with all trial requirements
- able and willing to give informed consent
Exclusion
- the patient has taken methenamine hippurate within the last 12 months
- the patient is allergic to methenamine hippurate
- the patient is having current antibiotic prophylaxis for UTI
- the patient has a urinary catheter (chronic indwelling catheters as well as intermittent urinary catheterisation)
- the patient has known severe chronic renal failure or estimated creatinine glomerular filtration rate ≤ 30 ml/min (known = registered in general practice clinical records)
- the patient has a known condition or treatment associated with significant impaired immunity (e.g. long-term oral steroids, chemotherapy, or immune disorder) (known = registered in general practice (GP) clinical records)
- the patient has a known severe hepatic impairment (known = registered in GP clinical records)
- the patient is suffering from severe dehydration
- the patient has shown signs of gout
- the patient has a need for long term use of antacids such as magnesium hydroxide, magnesium carbonate, aluminium hydroxide
- the patient has a life expectancy estimated by a clinician to be less than six months
- the patient has been involved in, including completion of, follow-up procedures, in another clinical trial of an investigational medicinal product in the last 90 days
- the patient suffers from incontinence too severe to be able to provide a voided urine specimen
- the patient is participating in ImpresU Work Package 2
- the patient is suffering from significant known abnormal renal tract anatomy/physiology or neuropathic bladder disorders.
- The patient has intolerance versus lactose
Key Trial Info
Start Date :
November 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2023
Estimated Enrollment :
289 Patients enrolled
Trial Details
Trial ID
NCT04077580
Start Date
November 1 2019
End Date
June 30 2023
Last Update
September 3 2024
Active Locations (4)
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1
Universitair Medisch Centrum Utrecht
Utrecht, Netherlands, 3584CX,
2
University of Oslo
Oslo, Norway, NO 0317
3
Medical University of Lodz,
Lodz, Poland, 90-153
4
Research and Development Primary Health Care, Region Västra Götaland,
Borås, Sweden, SE-503 38