Ignite Creation Date:
2024-05-06 @ 1:37 PM
Last Modification Date:
2024-10-26 @ 1:17 PM
Study NCT ID:
NCT04077580
Status:
COMPLETED
Last Update Posted:
2023-06-29
First Post:
2019-08-12
Brief Title:
The Effect of Methenamine Hippurate to Reduce Antibiotic Prescribing in Elderly Women With Recurrent UTI
Sponsor:
University of Oslo
Organization:
University of Oslo
Study Overview
Official Title:
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
Status:
COMPLETED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ImpresUWP3
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 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
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 usage for women with recurrent UTIs Methenamine hippurate has been on the market for a long time but has never been tested to prevent recurrent UTIs in larger RCTs with long time follow-up Hence this must be proven in a large randomised trial before recommending large scale use of this drug
The primary objective of this study is to investigate if taking methenamine hippurate reduce the need for antibiotic usage due to recurrent UTI measured as number of antibiotic courses Pyelonephritis hospitalization and death will be registered as safety endpoints in the study
Study design Triple- blinded randomised controlled phase IV trial where patients are randomised to active intervention methenamine hippurate or controls placebo We will include women aged 70 years with recurrent UTIs defined as 3 episodes of antibiotic treated acute cystitis acute symptoms specificrelated to the urinary tract during the last twelve months or 2 episodes during the last six months
Setting and study population
Women aged 70 years with recurrent UTIs in primary care A total of 400 patients will be randomized in this trial with approximately 100 patients in each of the participating countries Norway Sweden Poland and the Netherlands The patients will be treated for 6 months
Patients will be enrolled August-December 2019 including screening for eligibility and getting informed consent
Start of study with drugs is from October 1st 2019
Primary outcome Number of UTI antibiotic treatments during the six months of treatment If the participant receives 1 antibiotic courses for UTI without symptom relief it is regarded as one episode and counted as one antibiotic treatment If there has been an asymptomatic period of at least 14 days in-between two UTI antibiotic courses this is regarded as a new antibiotic treatment Outcomes will be assessed after 6 and 12 months
In the analysis standard linear regression will be used where number of UTI antibiotic treatments will be the dependent variable Group allocation together with the confounding variables above will be independent variables The dependent variable will be transformed using a rank transformation in case it is not normally distributed A p-value will be delivered but no useful effect size if a rank transformation is used
Existing knowledge suggests that methenamine hippurate is a safe drug with few and mild side effects and with the potential to significantly reduce antibiotic usage for women with recurrent UTIs Methenamine hippurate has been on the market for a long time but has never been tested to prevent recurrent UTIs in larger RCTs with long time follow-up Hence this must be proven in a large randomised trial before recommending large scale use of this drug
The primary objective of this study is to investigate if taking methenamine hippurate reduce the need for antibiotic usage due to recurrent UTI measured as number of antibiotic courses Pyelonephritis hospitalization and death will be registered as safety endpoints in the study
Study design Triple- blinded randomised controlled phase IV trial where patients are randomised to active intervention methenamine hippurate or controls placebo We will include women aged 70 years with recurrent UTIs defined as 3 episodes of antibiotic treated acute cystitis acute symptoms specificrelated to the urinary tract during the last twelve months or 2 episodes during the last six months
Setting and study population
Women aged 70 years with recurrent UTIs in primary care A total of 400 patients will be randomized in this trial with approximately 100 patients in each of the participating countries Norway Sweden Poland and the Netherlands The patients will be treated for 6 months
Patients will be enrolled August-December 2019 including screening for eligibility and getting informed consent
Start of study with drugs is from October 1st 2019
Primary outcome Number of UTI antibiotic treatments during the six months of treatment If the participant receives 1 antibiotic courses for UTI without symptom relief it is regarded as one episode and counted as one antibiotic treatment If there has been an asymptomatic period of at least 14 days in-between two UTI antibiotic courses this is regarded as a new antibiotic treatment Outcomes will be assessed after 6 and 12 months
In the analysis standard linear regression will be used where number of UTI antibiotic treatments will be the dependent variable Group allocation together with the confounding variables above will be independent variables The dependent variable will be transformed using a rank transformation in case it is not normally distributed A p-value will be delivered but no useful effect size if a rank transformation is used
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None