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Urology
Protocol
Methenamine hippurate for the management and prophylaxis of recurrent urinary tract infections: a scoping review protocol
  1. Abhisekh Chatterjee1,
  2. Iihan Ali1,
  3. Franklyn Wong1,
  4. Andrea M Allen-Tejerina2,
  5. Nikolaos Chatzikrachtis3,
  6. Katie McComb3,
  7. Samuel Bishara3,
  8. Diane De Caluwe4,
  9. Nikolaos Zavras5,
  10. Joseph M Norris6,
  11. Panagiotis Nikolinakos3,5
  1. 1Imperial College School of Medicine, Imperial College London, London, UK
  2. 2Lister Hospital, East and North Hertfordshire NHS Trust, Stevenage, UK
  3. 3Department of Urology, West Middlesex University Hospital, Chelsea and Westminster Hospital NHS Foundation Trust, London, UK
  4. 4Department of Paediatric Surgery and Urology, Chelsea and Westminster Hospital NHS Foundation Trust, London, UK
  5. 5Department of Pediatric Surgery, National and Kapodistrian University of Athens, Athens, Greece
  6. 6UCL Division of Surgery & Interventional Science, University College London, London, UK
  1. Correspondence to Abhisekh Chatterjee; abhisekh.chatterjee20{at}imperial.ac.uk

Abstract

Introduction Recurrent urinary tract infections (rUTIs) are typically treated using antibiotics. Given the growing issue of antimicrobial resistance, non-antibiotic management options for rUTIs have faced a recent resurgence in popularity. Methenamine hippurate is a urinary antiseptic used as a non-antibiotic prophylactic measure in those with rUTIs. The results of a recent randomised controlled trial showed methenamine hippurate to perform on par with antibiotic prophylaxis in adult women with rUTIs. However, little is known about the efficacy of methenamine hippurate in vulnerable patient populations, such as children, the elderly, patients with indwelling catheters and those with renal tract abnormalities. Moreover, an up-to-date, comprehensive evaluation of the entirety of the literature surrounding methenamine hippurate has yet to be carried out. As such, key trends within the literature, such as common side effects and specific avenues for future research, are difficult to determine. Therefore, we developed the methodology for a scoping review to map the entirety of the existing evidence base for methenamine hippurate.

Methods and analysis The protocol for this scoping review was developed in accordance with the framework set out by Arksey and O’Malley. We will search MEDLINE, Embase, Scopus, the Cochrane Central Register of Controlled Trials and ProQuest Dissertation and Theses from inception until August 2024, with no language restrictions applied. Studies including patients of any age and sex receiving methenamine hippurate treatment, either as a primary or adjunct treatment for rUTIs, will be eligible for inclusion. Interventional studies, such as randomised controlled trials and their protocols, non-randomised clinical trials, cohort studies, case-control studies and observational studies of any design, will be included. Grey literature, systematic reviews and qualitative studies will also be included. Two independent reviewers blinded to each other’s decisions will assess the eligibility of articles at each stage using the Covidence review platform. After the relevant data from each study has been extracted, we will report the results of our scoping review using descriptive summary statistics and a narrative thematic analysis.

Ethics and dissemination Due to the nature of the present study, ethical approval was not required for this scoping review. The final manuscript of this scoping review will be published in an international, peer-reviewed journal and the findings of the review presented in relevant national and international conferences.

  • UROLOGY
  • THERAPEUTICS
  • Urinary tract infections
  • STATISTICS & RESEARCH METHODS
http://creativecommons.org/licenses/by-nc/4.0/

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

https://doi.org/10.1136/bmjopen-2025-100458

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    STRENGTHS AND LIMITATIONS OF THIS STUDY

    • The methodology for this scoping review was developed in accordance with the frameworks set out by Arksey and O’Malley in 2005 and further expanded on by Levac et al in 2010 and the Joanna Briggs Institute in 2021.

    • In order to capture the full breadth of the evidence base, we developed database-specific search strategies and did not restrict our searches to any particular language or time period.

    • We will not assess the weight (by conducting a meta-analysis, for example) of the identified evidence, as this falls outside of the purview of a scoping review.

    Introduction

    Urinary tract infections (UTIs) are one of the most common forms of bacterial infection worldwide.1 UTIs can be classified as affecting the upper or lower urinary tract.2 Lower UTIs in female patients can be classified as uncomplicated, provided they occur in the absence of comorbidities or renal tract abnormalities.2 Lower UTIs in every other patient population, irrespective of existing comorbidities, are considered to be complicated.3 Upper UTIs, regardless of the population in which they occur, are always considered to be complicated.2 Approximately 50%–60% of all women will experience a UTI in their lifetime.4 A recurrent UTI (rUTI) is defined as two or more UTIs in a 6-month period or three or more UTIs within 1 year.5 Whilst the true prevalence is difficult to determine, it is thought that 20%–30% of women with a UTI will experience a recurrence.6 In addition to impairments in quality of life for an individual, rUTIs also exert a significant psychological burden on a patient as well as an economic burden on the broader healthcare system.6 The role of antibiotics in rUTI management is prominent; acute treatment of each recurrence with antibiotics and prophylactic low-dose daily antibiotic suppression are both common mainstays of treatment.1 However, given the ever-developing issue of antimicrobial resistance,7 there is a growing interest in non-antibiotic management options for rUTIs.

    One such non-antibiotic management option for rUTIs is methenamine hippurate. Preparations of methenamine, a cyclic hydrocarbon, have been utilised as a urinary antiseptic for decades.8 9 In the environment of acidic urine, a salt preparation of methenamine degrades to form ammonia and formaldehyde; the latter is thought to act as a bacteriostatic agent by inhibiting bacterial cell division.10 Methenamine hippurate is often thought to have gone overlooked by most clinicians,11 with most guidelines providing no strong recommendation regarding the use of methenamine hippurate for long-term rUTI prevention in women.12 Nonetheless, methenamine hippurate is widely prescribed in some Scandinavian countries,13 particularly in Norway.14 Following the resolution of a 4-month drug shortage of methenamine hippurate in Norway, the number of prescriptions for methenamine hippurate rose as prescriptions for UTI antibiotics fell sharply.15

    Recently, methenamine hippurate has faced a resurgence in popularity. The ALTAR non-inferiority randomised controlled trial (RCT) found methenamine hippurate to be equivalent to antibiotic therapy at reducing the incidence of rUTIs in a large cohort of adult women.13 Two recent systematic reviews of the literature, similarly focused on adult women with uncomplicated rUTIs, identified that methenamine hippurate performed on par with antibiotic prophylaxis.16 17 Recent reviews, both systematic reviews and those looking broadly at non-antibiotic treatments for rUTIS,8 9 have not investigated the efficacy of methenamine hippurate in vulnerable patient populations. rUTIs are a common problem in the elderly, and diagnosis and management can prove to be challenging in the presence of multiple comorbidities, contraindications to antibiotic treatment and the increased risk of Clostridium difficile infections due to prolonged antibiotic use.18–20 Indeed, elderly women are particularly vulnerable to UTIs, with the prevalence of UTIs being almost threefold higher in this population.5 In children, long-term infection of the urinary tract can have, although rare, negative consequences on kidney function in later life,21 and long-term prophylactic antibiotic regimens are typically not recommended.22 Moreover, patients with indwelling catheters are at greater risk for developing catheter-related UTIs.23 24 It is unclear to what extent the literature has evaluated methenamine hippurate’s viability in these vulnerable patient subgroups.

    In the existing literature, a Cochrane review of RCTs last updated in 2012 did identify a number of studies that evaluated methenamine hippurate’s effectiveness in diverse populations of patients with both complicated and uncomplicated UTIs.25 Given methenamine hippurate’s recent resurgence in popularity, an updated review of the literature is warranted. Moreover, non-randomised studies, cohort studies and institutional experiences have likely gone overlooked by systematic reviews of RCTs16 17 and reviews of only the most recent evidence.26 27 As a result, there is difficulty in ascertaining the necessity of systematic reviews focusing on methenamine hippurate’s efficacy in the aforementioned subgroups; indeed, it is unclear whether the recent evidence base has evaluated methenamine hippurate’s effectiveness in these patients at all. These knowledge gaps are the primary focuses of our scoping review.

    Scoping reviews are conducted to identify a breadth of studies within a field of research.28 29 Scoping reviews can be applicable to any domain, including the implementation of healthcare practices,30 surgical procedures31 or the effects of a particular medication,32 33 and employ a systematic methodology but forego subsequent meta-analyses in favour of characterising the breadth of and trends within the extant literature.28 29 Scoping reviews are commonly used to identify whether systematic reviews, which typically focus on a specific patient population, are warranted.34 As such, scoping reviews are perfectly suited to both characterise a broad evidence base and, as a result, to identify gaps that exist. Thus, we identified that a scoping review framework provided a methodologically sound, systematic method to characterise and summarise the evidence surrounding methenamine hippurate. To date, a rigorous, inclusive assessment of methenamine hippurate’s evidence base has yet to be undertaken.

    We will conduct a scoping review to systematically map the existing evidence base surrounding methenamine hippurate as a treatment for or prophylactic measure against rUTIs. Assessing the literature in this holistic manner will allow for the identification of patient populations that have and have not been evaluated in the literature thus far. Our work will identify avenues for future research into methenamine hippurate’s efficacy in these patient subgroups, including focused systematic reviews and novel RCTs. Moreover, we will characterise how methenamine hippurate has been evaluated up until now, including whether it is more commonly used as a standalone medication for prophylaxis, alongside antibiotics or alongside other non-antibiotic treatments for rUTIs. Moreover, no review to date has yet covered in detail whether methenamine hippurate can be used to prevent UTIs postoperatively or to prevent catheter-associated UTIs. By characterising the literature in this rigorous, detailed manner, we seek to provide specific suggestions to guide future research. In this study, we outline the methodological approach of our scoping review in keeping with the guidance originally set out by Arksey and O’Malley28 and further expanded on by Levac et al35 and the Joanna Briggs Institute.29 The framework for this protocol outlines our approach to the four stages of a scoping review28: identifying the research questions, identifying relevant studies, study selection and reporting the data. This scoping review protocol was prospectively registered on the Open Science Framework (OSF) (https://doi.org/10.17605/OSF.IO/NWMB8).

    Methods

    This protocol was written in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews checklist (PRISMA-ScR)36 (online supplemental file 1).

    Research questions

    As outlined by Arksey and O’Malley,28 the first stage of conducting a scoping review involves identifying the pertinent research questions. Based on our understanding of the current evidence surrounding methenamine hippurate as a management option for rUTIs, we developed the following research questions that our scoping review seeks to address:

    1. In what patient populations has the efficacy of methenamine hippurate already been investigated, and, conversely, in what patient demographics is there a lack of research into the efficacy of methenamine hippurate for the management of rUTIs?

    2. How effective is methenamine hippurate in managing rUTIs in these patients (as defined by each study’s endpoints), and does its efficacy vary between different patient populations?

    3. In what manner is methenamine hippurate evaluated? That is, as a standalone prophylactic measure, an adjunct to antibiotic treatment or alongside other non-antibiotic treatments for rUTIs?

    4. What dosage of and over what time course is methenamine hippurate commonly given in the extant literature, and does this vary between studies?

    5. What are the commonly reported side effects of methenamine hippurate?

    6. What are the geographical and temporal trends in research investigating the efficacy of methenamine hippurate? In other words, is methenamine hippurate evidently more popular in certain countries, and is there a reason for this?

    Search strategy

    In order to identify potentially eligible studies for inclusion in our scoping review, we will conduct a systematic search of five databases: MEDLINE, Embase, Scopus, the Cochrane Central Register of Controlled Trials (CENTRAL) and ProQuest Dissertation and Theses Global. A thorough search strategy for each database was developed using key terms identified from our research questions and Medical Subject Heading (MeSH) terms and was adapted to suit each database accordingly using the appropriate Boolean operators, database-specific MeSH terms and database-specific syntax (online supplemental file 2, table S1). Key terms included but were not limited to ‘methenamine hippurate’, ‘recurrent urinary tract infections’, ‘rUTIs’ and ‘urinary tract infections’. The polyglot search translator was used to aid the process of constructing the search strategy. Databases will be searched from inception up until 10 August 2024, and no language filters will be applied. Prior to the final analysis, the searches will be re-run up until the present day, and any additional studies meeting the eligibility criteria will be included. In addition to database searching, citations of relevant articles will be manually exported and included within the screening process. For studies not given in the English language, a suitable translated version will be sought, either from the authors themselves or using Google’s inbuilt translation software.

    Identification of eligible studies

    Identified studies will be assessed for eligibility using the Population, Concept and Context framework set out by Arksey and O’Malley28 and the Joanna Briggs Institute.29 With respect to the population, we will include studies investigating patients with rUTIs, with the strict definition of rUTI being defined by each study individually. Owing to the broad nature of our scoping review, we will include studies investigating both adult (>16 years old) and paediatric (<16 years old) patients with both complicated and uncomplicated rUTIs receiving methenamine hippurate for UTI prophylaxis (ie, long term). We will also include studies where methenamine hippurate is used as an adjunct (eg, alongside conventional antibiotics) or as a control arm. As methodology is likely to be heterogeneous between studies, we have no specific exclusion criteria relating to a comparator; this may be a placebo, conventional antibiotic suppression or no treatment at all. Studies investigating methenamine hippurate for UTI prophylaxis, for example, following surgery or in those with long-term catheters (irrespective of whether these patients have a history of rUTIs or not) will also be included. We will exclude studies conducted exclusively in vitro and in non-human participants. Studies in which patients are given methenamine hippurate for any indication other than rUTI management or UTI prophylaxis will be similarly excluded.

    With regard to the context, we will include studies conducted in any healthcare or community setting. We will also include grey literature (in the form of conference abstracts) and systematic reviews of the literature (irrespective of whether a subsequent meta-analysis was undertaken). In order to capture the full breadth of the evidence base, qualitative studies investigating patient or clinician perspectives on methenamine hippurate will also be included. Narrative literature reviews, case reports and case series with fewer than five patients and research letters containing no novel research will be excluded. The full details of the inclusion and exclusion criteria are provided in table 1.

    View this table:
    Table 1

    Inclusion and exclusion criteria for assessing eligibility of studies

    Retrieved articles from each database will be exported and uploaded to Covidence, a digital platform built to facilitate and streamline the process of carrying out systematic reviews.37 First, duplicate articles will be removed. Remaining articles will undergo title and abstract screening as per the eligibility criteria (table 1). This will be undertaken by two independent reviewers (AC, IA, FW, PN) who will be blinded to each other’s decisions. A disagreement between reviewers will be resolved either via a third independent reviewer or by discussion among researchers. Included articles will then undergo full-text screening by two independent reviewers, again blinded to each other’s decisions, with conflicts resolved by discussion among reviewers or, if this is unsuccessful, by a third reviewer. At the full-text review stage, the specific reason for exclusion will be recorded. The details of the screening process will be reported using a PRISMA flowchart.29

    Charting the data

    Data will be extracted from each included study using a data extraction form. This data extraction form contains key information regarding each study and was developed in line with our PCC framework. This includes but is not limited to information regarding the nature of the study design, the year of publication, whether patients were randomly assigned to a treatment or not, the characteristics of the included patients, the dosage and time course of methenamine hippurate treatment, UTI frequency pre- and post-intervention, outcome measures used and reported side effects (table 2). Data from included qualitative studies and systematic reviews will be extracted using separate data extraction forms (online supplemental file 2, table S2, S3 respectively) owing to their distinct methodology.

    View this table:
    Table 2

    Data extraction fields

    This data extraction tool will be implemented into Covidence and initially piloted by two authors (AC, PN) on five included studies to internally assess its validity prior to the commencement of data extraction, in line with recommendations from Levac et al in 2010.35 If needed, the data extraction fields will be expanded on or edited by the senior authors. Once this is complete, data extraction will be undertaken by one reviewer for each study (AC, IA, FW, PN) with a second independent author checking the extracted data against the original study. The data extraction process will be iterative and collaborative,35 with any disagreements or difficulty in extracting heterogeneous data being resolved through discussion and consideration between the authors. In addition to extracting data from each study, we will also assess the quality of included trials and observational studies. This will be conducted in duplicate for each study (AC, IA, FW, PN), with any disagreements being resolved by consensus among reviewers. For RCTs, the Cochrane Risk of Bias 2 tool will be used.38 For non-randomised trials, the Risk of Bias in non-randomised studies – of interventions (ROBINS-I) tool will be utilised.39

    Collating, summarising and reporting the results

    After charting the data, reporting the results of a scoping review is separated into three phases:35 1) descriptive numerical summary analysis and qualitative thematic analysis, 2) reporting the results in line with the research questions and 3) Discussion of the future implications of the findings of the scoping review.

    First, the extracted data will be exported as a CSV file to undergo further analysis. Data analysis will be undertaken using a combination of R40 and Microsoft Excel. Initially, study characteristics will be grouped together (eg, methodological approach, patient characteristics, methenamine hippurate regimen, reported outcomes), tabularised and presented in the final manuscript. Where possible, we will calculate and present simple descriptive summary statistics (eg, the proportion of patients reporting side effects of methenamine hippurate across studies). We will use the extracted data to construct evidence maps and simple descriptive figures that will holistically outline the key trends and patterns within the extant literature surrounding methenamine hippurate. Depending on the nature and intrinsic heterogeneity of the extracted evidence, we may construct bar charts, line graphs, word clouds, network diagrams and conceptual frameworks, all popular methods of data visualisation within scoping reviews.41 Qualitative thematic analysis will also be undertaken. Key themes between studies will be identified by discussion among the reviewers, and these will be grouped in accordance with the research questions of our scoping review. These themes will be addressed in a narrative manner in the final manuscript, and their implications for future research will be addressed accordingly.

    Ethics and dissemination

    Due to the nature of the present study, ethical approval was not required for this scoping review. The final manuscript of this scoping review will be published in an international, peer-reviewed journal, and the findings of the review presented in relevant national and international conferences.

    Ethics statements

    Patient consent for publication

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    Footnotes

    • Contributors AC, JMN and PN were responsible for conceptualisation of the protocol. AC was responsible for the initial draft of the manuscript. IA, AAT, NC, KM, SB, DDC, NZ and PN provided feedback on the manuscript. All authors read and approved the final version of the manuscript. AC is the guarantor of the review.

    • Funding Funding for the Open Access publication charge for this article was provided by the Imperial Open Access Fund. JMN has received funding from the MRC (UK) and RCSEng.

    • Competing interests None declared.

    • Patient and public involvement Patients and/or the public were not involved in the design, conduct, reporting or dissemination plans of this research.

    • Provenance and peer review Not commissioned; externally peer-reviewed.

    • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.