Increased risk of fungal infection detection in women using menstrual cups vs. tampons: a cross-sectional study

Objective To determine if the use of menstrual cups rather than tampons is associated with more or less health risk. Design Analysing biological, demographic, and behavioural data in a cohort of women who reported using mostly tampons ( n = 81) or menstrual cups ( n = 22). Setting A cross-sectional analysis using the inclusion data of a single centre longitudinal study. Population 149 women from 18 to 25 years old living in the area of Montpellier (France) who reported having at least one new sexual partner over the last year. Methods Statistical modelling (mainly binomial regression models and factor analyses of mixed data). Main Outcome Measures Self-reported data from questionnaires (fungal infection, urinary tract infection, stress level) and biological data (HPV screening, vaginal microbiota profiling, circulating antibodies titration, and local cytokine concentrations). Results We identify an increased risk of reporting fungal infections for women using menstrual cups over tampons. We do not detect significant differences in terms of vaginal microbiota composition or local cytokines expression profile but find that women fall into two different clusters in a factor analysis of mixed data depending on the type of menstrual product they use more (cups or tampons). Conclusions These results point to potential health risks in the use of menstrual cups and differences in local vaginal environments. In-depth studies are needed to better understand potential associations between menstrual product use and women’s health. Funding European Research Council (EVOLPROOF, grant 648963) Ethics The PAPCLEAR study [ClinicalTrials.gov][1] identifier is [NCT02946346][2]. Tweetable abstract A cross-sectional study finds a significant association between menstrual cup use and fungal infection risk. ### Competing Interest Statement The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: TW serves on advisory boards for MSD (Merck) Sharp & Dohme. ### Funding Statement This work was supported by the European Research Council (ERC) under the European Union's Horizon 2020 research and innovation programme [grant agreement No 648963 to SA]. NT is an ANRS-MIE fellow. IBU is funded by the FHU INCH. TK is funded by the Fondation pour la Recherche Médicale. The sponsors had no role in the study design; in the collection, analysis, and interpretation of data; in the writing of the report; and in the decision to submit the article for publication. ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: The PAPCLEAR trial is promoted by the Centre Hospitalier Universitaire de Montpellier and has been approved by the Comité de Protection des Personnes (CPP) Sud Méditerranée I on 11 May 2016 (CPP number 16 42, reference number ID RCB 2016-A00712-49); by the Comité Consultatif sur le Traitement de l’Information en matière de Recherche dans le domaine de la Santé on 12 July 2016 (reference number 16.504); and by the Commission Nationale Informatique et Libertés on 16 December 2016 (reference number MMS/ABD/AR1612278, decision number DR-2016-488). This trial was authorised by the Agence Nationale de Sécurité du Médicament et des Produits de Santé on 20 July 2016 (reference 20160072000007). The ClinicalTrials.gov identifier is [NCT02946346][2]. All participants provided written informed consent. I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as [ClinicalTrials.gov][1]. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines and uploaded the relevant EQUATOR Network research reporting checklist(s) and other pertinent material as supplementary files, if applicable. Yes Table 1, 2 and Figure 1, as well as Extended Data Tables S1, S3, S4, S5 and Figure S2 have associated raw data. The data that support the findings of this study are available from the corresponding author upon request, and data are available in the Zenodo public repository (XXXXX). [1]: http://ClinicalTrials.gov [2]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT02946346&atom=%2Fmedrxiv%2Fearly%2F2022%2F01%2F07%2F2021.12.10.21267584.atom