TY - JOUR
T1 - Methenamine hippurate to prevent recurrent urinary tract infections in older women
T2 - protocol for a randomised, placebo-controlled trial (ImpresU)
AU - Heltveit-Olsen, Silje Rebekka
AU - Sundvall, Pär-Daniel
AU - Gunnarsson, Ronny
AU - Snaebjörnsson Arnljots, Egill
AU - Kowalczyk, Anna
AU - Godycki-Cwirko, Maciek
AU - Platteel, Tamara N
AU - Koning, Hilde A M
AU - Groen, Wim G
AU - Åhrén, Christina
AU - Grude, Nils
AU - Verheij, Theo J M
AU - Hertogh, Cees M P M
AU - Lindbaek, Morten
AU - Hoye, Sigurd
N1 - Funding Information: This work was supported by JPIAMR (JPIAMR_2017_P007), through national funding agencies: Norwegian Research Council (284253), the Healthcare Committee, Region Vastra Gotaland, Sweden (VGFOUREG-855661 and VGFOUREG-940739), ZonMw, the Netherlands (549003002) and National Science Centre Poland (UMO-2017/25/Z/NZ7/03024). The sponsor has received additional funding from the Norwegian Surveillance System for Antimicrobial Drug Resistance (NORM), Gidske and Peter Jacob Sørensens Research Trust and from the Department of General Practice, Institute of Health and Society at the University of Oslo Funding Information: This work was supported by JPIAMR (JPIAMR_2017_P007), through national funding agencies: Norwegian Research Council (284253), the Healthcare Committee, Region Västra Götaland, Sweden (VGFOUREG-855661 and VGFOUREG-940739), ZonMw, the Netherlands (549003002) and National Science Centre Poland (UMO-2017/25/Z/NZ7/03024). The sponsor has received additional funding from the Norwegian Surveillance System for Antimicrobial Drug Resistance (NORM), Gidske and Peter Jacob Sørensens Research Trust and from the Department of General Practice, Institute of Health and Society at the University of Oslo. Publisher Copyright: ©
PY - 2022/11/1
Y1 - 2022/11/1
N2 - INTRODUCTION: Methenamine hippurate is a urinary antiseptic used as preventive treatment for recurrent urinary tract infections (UTIs) in some Scandinavian countries. However, the scientific evidence for the preventive effect and safety for longer-term use is limited. The aim of this study is to assess whether methenamine hippurate can reduce the incidence of UTIs in older women with recurrent UTIs.METHODS AND ANALYSIS: The ImpresU consortium is a collaboration between Norway, Sweden, Poland and the Netherlands. The study is a randomised, controlled, triple-blind phase IV clinical trial. Women ≥70 years with recurrent UTIs are screened for eligibility in a general practice setting. We aim to include 400 women in total, with 100 recruited from each collaborating country. The participants are randomised to treatment with methenamine hippurate 1 g or placebo tablets two times per day for a treatment period of 6 months, followed by a drug-free follow-up period of 6 months. The primary outcome is number of antibiotic treatments for UTIs during the treatment period. The secondary outcomes include number of antibiotic treatments for UTIs during the follow-up period and self-reported symptom of severity and duration of UTI episodes. Differences in complications between the treatment groups are measured as safety outcomes. We also aim to investigate whether strain characteristics or phylogenetic subgroups of Escherichia coli present in the urine culture at inclusion have a modifying effect on the outcomes.ETHICS AND DISSEMINATION: Ethical approvals are obtained in all participating countries. The results will be communicated in peer-reviewed journals and at scientific conferences.TRIAL REGISTRATION NUMBER: ClinicalTrials.gov Registry (NCT04077580); EudraCT: 2018-002235-15.
AB - INTRODUCTION: Methenamine hippurate is a urinary antiseptic used as preventive treatment for recurrent urinary tract infections (UTIs) in some Scandinavian countries. However, the scientific evidence for the preventive effect and safety for longer-term use is limited. The aim of this study is to assess whether methenamine hippurate can reduce the incidence of UTIs in older women with recurrent UTIs.METHODS AND ANALYSIS: The ImpresU consortium is a collaboration between Norway, Sweden, Poland and the Netherlands. The study is a randomised, controlled, triple-blind phase IV clinical trial. Women ≥70 years with recurrent UTIs are screened for eligibility in a general practice setting. We aim to include 400 women in total, with 100 recruited from each collaborating country. The participants are randomised to treatment with methenamine hippurate 1 g or placebo tablets two times per day for a treatment period of 6 months, followed by a drug-free follow-up period of 6 months. The primary outcome is number of antibiotic treatments for UTIs during the treatment period. The secondary outcomes include number of antibiotic treatments for UTIs during the follow-up period and self-reported symptom of severity and duration of UTI episodes. Differences in complications between the treatment groups are measured as safety outcomes. We also aim to investigate whether strain characteristics or phylogenetic subgroups of Escherichia coli present in the urine culture at inclusion have a modifying effect on the outcomes.ETHICS AND DISSEMINATION: Ethical approvals are obtained in all participating countries. The results will be communicated in peer-reviewed journals and at scientific conferences.TRIAL REGISTRATION NUMBER: ClinicalTrials.gov Registry (NCT04077580); EudraCT: 2018-002235-15.
KW - Clinical trials
KW - INFECTIOUS DISEASES
KW - PREVENTIVE MEDICINE
KW - PRIMARY CARE
KW - Urinary tract infections
UR - http://www.scopus.com/inward/record.url?scp=85141137621&partnerID=8YFLogxK
U2 - https://doi.org/10.1136/bmjopen-2022-065217
DO - https://doi.org/10.1136/bmjopen-2022-065217
M3 - Article
C2 - 36319057
SN - 2044-6055
VL - 12
SP - e065217
JO - BMJ Open
JF - BMJ Open
IS - 11
M1 - e065217
ER -