Methenamine hippurate to prevent recurrent urinary tract infections in older women: protocol for a randomised, placebo-controlled trial (ImpresU)
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 asse...
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| Format: | Article |
| Language: | English |
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BMJ Publishing Group
2022-11-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/12/11/e065217.full |
| _version_ | 1828156373385347072 |
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| author | Cees M P M Hertogh Anna Kowalczyk Maciek Godycki-Cwirko Morten Lindbaek Ronny Gunnarsson Pär-Daniel Sundvall Theo J M Verheij Nils Grude Wim G Groen Silje Rebekka Heltveit-Olsen Sigurd Hoye Egill Snaebjörnsson Arnljots Tamara N Platteel Hilde A M Koning Christina Åhrén |
| author_facet | Cees M P M Hertogh Anna Kowalczyk Maciek Godycki-Cwirko Morten Lindbaek Ronny Gunnarsson Pär-Daniel Sundvall Theo J M Verheij Nils Grude Wim G Groen Silje Rebekka Heltveit-Olsen Sigurd Hoye Egill Snaebjörnsson Arnljots Tamara N Platteel Hilde A M Koning Christina Åhrén |
| author_sort | Cees M P M Hertogh |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-04-11T23:09:51Z |
| format | Article |
| id | doaj.art-634b33881650425a867b14d3a7c851dd |
| institution | Directory Open Access Journal |
| issn | 2044-6055 |
| language | English |
| last_indexed | 2024-04-11T23:09:51Z |
| publishDate | 2022-11-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj.art-634b33881650425a867b14d3a7c851dd2022-12-22T03:57:53ZengBMJ Publishing GroupBMJ Open2044-60552022-11-01121110.1136/bmjopen-2022-065217Methenamine hippurate to prevent recurrent urinary tract infections in older women: protocol for a randomised, placebo-controlled trial (ImpresU)Cees M P M Hertogh0Anna Kowalczyk1Maciek Godycki-Cwirko2Morten Lindbaek3Ronny Gunnarsson4Pär-Daniel Sundvall5Theo J M Verheij6Nils Grude7Wim G Groen8Silje Rebekka Heltveit-Olsen9Sigurd Hoye10Egill Snaebjörnsson Arnljots11Tamara N Platteel12Hilde A M Koning13Christina Åhrén14Department of Medicine for Older People, Amsterdam Public Health Research Institute, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, The NetherlandsCentre for Family and Community Medicine, Faculty of Health Sciences, Medical University of Lodz, Lodz, PolandCentre for Family and Community Medicine, Faculty of Health Sciences, Medical University of Lodz, Lodz, PolandAntibiotic Centre for Primary Care, Department of General Practice, Institute of Health and Society, University of Oslo, Oslo, NorwayGeneral Practice/Family Medicine, School of Public Health and Community Medicine, Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, SwedenGeneral Practice/Family Medicine, School of Public Health and Community Medicine, Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, SwedenJulius Center for Health Sciences and Primary Care, UMC Utrecht, Utrecht, The NetherlandsAntibiotic Centre for Primary Care, Department of General Practice, Institute of Health and Society, University of Oslo, Oslo, NorwayDepartment of Medicine for Older People, Amsterdam Public Health Research Institute, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, The NetherlandsAntibiotic Centre for Primary Care, Department of General Practice, Institute of Health and Society, University of Oslo, Oslo, NorwayAntibiotic Centre for Primary Care, Department of General Practice, Institute of Health and Society, University of Oslo, Oslo, NorwayGeneral Practice/Family Medicine, School of Public Health and Community Medicine, Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, SwedenJulius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, The NetherlandsJulius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, The NetherlandsInstitute of Biomedicine, Department of Infectious Diseases and Centrum for Antibiotic Resistance Research (CARe), University of Gothenburg, Gothenburg, SwedenIntroduction 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.https://bmjopen.bmj.com/content/12/11/e065217.full |
| spellingShingle | Cees M P M Hertogh Anna Kowalczyk Maciek Godycki-Cwirko Morten Lindbaek Ronny Gunnarsson Pär-Daniel Sundvall Theo J M Verheij Nils Grude Wim G Groen Silje Rebekka Heltveit-Olsen Sigurd Hoye Egill Snaebjörnsson Arnljots Tamara N Platteel Hilde A M Koning Christina Åhrén Methenamine hippurate to prevent recurrent urinary tract infections in older women: protocol for a randomised, placebo-controlled trial (ImpresU) BMJ Open |
| title | Methenamine hippurate to prevent recurrent urinary tract infections in older women: protocol for a randomised, placebo-controlled trial (ImpresU) |
| title_full | Methenamine hippurate to prevent recurrent urinary tract infections in older women: protocol for a randomised, placebo-controlled trial (ImpresU) |
| title_fullStr | Methenamine hippurate to prevent recurrent urinary tract infections in older women: protocol for a randomised, placebo-controlled trial (ImpresU) |
| title_full_unstemmed | Methenamine hippurate to prevent recurrent urinary tract infections in older women: protocol for a randomised, placebo-controlled trial (ImpresU) |
| title_short | Methenamine hippurate to prevent recurrent urinary tract infections in older women: protocol for a randomised, placebo-controlled trial (ImpresU) |
| title_sort | methenamine hippurate to prevent recurrent urinary tract infections in older women protocol for a randomised placebo controlled trial impresu |
| url | https://bmjopen.bmj.com/content/12/11/e065217.full |
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