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 blinded placebo-controlled study

Phase 1

• Conditions: recurrent urinary tract infection in women; Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]

• Registration Number: EUCTR2018-002235-15-NL
• Lead Sponsor: niversity of Oslo

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-03-04
• Last Update Posted: 17 August 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: 400

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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100

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 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 (i.e. single kidney, persistent urinary tract stone disease, severe vesicoureteral reflux) or neuropathic bladder disorders
•the patient has lactose intolerance.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To investigate if taking methenamine hippurate reduce the need for antibiotic usage due to recurrent UTI (meassured as the number of courses of antibiotics);Secondary Objective: -To investigate if methenamine hippurate will have a prolonged effect on antibiotic usage even after discontinuation.<br>-To investigate if taking methenamine Hippurate reduces the incidence of UTI<br>-To investigate if methenamine hippurate can reduce severity of UTI symptoms.<br>-To investigate if methenamine hippurate can reduce duration of UTI episodes.<br>-To investigate if number of complications such as pyelonephritis and hospital admission for UTI differ between methenamine hippurate and placebo.<br>- To investigate if phylogenetic subgroups of E. coli found at inclusion is an effect modifier in the above outcomes<br><br>;Primary end point(s): Number of antibiotic courses during the first half year of treatment;Timepoint(s) of evaluation of this end point: After six months of treatment.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 2a. Number of UTI antibiotic treatments during the six months following completion of the trial.<br>2b. Number of UTIs (acute symptoms specific/related to the urinary tract) during the six months of treatment;Timepoint(s) of evaluation of this end point: 2a. Six months after completion (12 months after commencing treatment)<br>2b. After six months of treatment.