The Effect of Methenamine Hippurate to Reduce Antibiotic Prescribing in Elderly Women With Recurrent UTI

• Status: Enrolling by invitation
• Trial end date: 2022-11-30
• Target enrollment: 0
• Participant gender: Female

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 field. Methenamine hippurate is frequently prescribed in Norway and Sweden as prophylaxis for recurrent UTI. Methenamine hippurate acts via the production of formaldehyde from hexamine, which in turn acts as a bacteriostatic agent, therefore methenamine hippurate is not defined as an antibiotic. According to a Cochrane review 2012 the rates of adverse events for preventing UTI was low. Although this review showed methenamine hippurate might be effective in preventing UTI in the short term, there is a need for large well-conducted randomised controlled trial (RCT) to clarify both the safety and effectivity of preventive methenamine hippurate for longer term use. This is particularly important for longer term use for people without neuropathic bladder disorders. A Norwegian longitudinal observational study including women aged 50-80 years with recurrent UTI indicated a significant and large reduction of more than 50% in antibiotic prescriptions for UTI after start of prophylactic methenamine hippurate. This further strengthens the need for an RCT of methenamine hippurate as prophylaxis for recurrent UTI.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Oslo
• Collaborators: Göteborg University; Medical University of Lodz; Medical Universtity of Lodz; UMC Utrecht; VU University Medical Center
• Treatments: Anti-Bacterial Agents; Methenamine; Methenamine hippurate; Methenamine mandelate

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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