The effect of methenamine hippurate to reduce antibiotic prescribing due to new episodes of urinary tract infections (UTI) in elderly women with recurrent UTI- a triple-blinded, randomized placebo-controlled phase IV study

Phase 4

Completed

• Conditions: cystitis; urinary tract infection; 10004018; 10046590

• Registration Number: NL-OMON54960
• Lead Sponsor: niversity of Oslo

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 100

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 GP* 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 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 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.
• lactose intolerance

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Number of UTI courses during day 2-180 for which antibiotics were prescribed </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Number of UTI courses in the period up to 6 months after discontinuation of<br /><br>methenamine<br /><br>Number of UTI during methenamine<br /><br>Severity of UTI symptoms<br /><br>Duration of UTI episodes<br /><br>Number of complications such as pyelonephritis and hospital admission for UTI</p><br>