Menstrual Tampons Research Articles

Menstrual Tampons Are Reliable and Acceptable Tools to Self-Collect Vaginal Microbiome Samples.

Many women report embarrassment as the cause for their avoidance of routine gynaecological screening appointments. Methods of self-collection of bio samples would perhaps encourage women to participate in routine screening programs. The vaginal microbiome plays a key role in women's health and reproductive function. Microbial disturbances can result in the loss of lactobacillus dominance, also known as dysbiosis, associated with an increased risk of contracting sexually transmitted infections (STIs), pregnancy complications and infertility. Our primary aim was to determine if vaginal microbiome screening results are comparable between two methods for self-collected sample acquisition: tampons and lower vaginal swabs (LVSs). Secondary aims included the assessment of the effect of pre-analytic storage on the data (to streamline processing), the prevalence of dysbiosis and the acceptability of the tampons to the participants. Statistical analysis revealed no significant difference in the microbiome data, from tampons versus LVSs or fresh versus frozen samples. The prevalence of dysbiosis in this population of healthy volunteers was 42.9%. The questionnaire data revealed that 52.4% of volunteers use tampons every period, and the majority of volunteers rated the tampons as 5 on a 1-5 Likert scale regarding their perceived comfort using tampons. All (100%) of volunteers were happy to provide a tampon as a sample for testing. The findings from this study show that tampons and LVSs were comparable when analysing the vaginal microbiome, with potential superiority of the tampon with regard to patient acceptability. Self-collection of vaginal secretions for gynaecological screening using tampons warrants further research as this could change the screening landscape, ensuring wider participation and increasing efficacy.

P-545 Efficacy, safety and acceptability of a vaginal tampon for the collection of biospecimen samples: a systematic review and meta-analysis

Abstract Study question Are self-collected vaginal tampons, as a biospecimen collection tool, comparable to current gold-standard methods in their efficacy, safety and acceptability? Summary answer Tampon efficacy for detection of gynaecological abnormalities was comparable to that of gold-standard methods in addition to being widely accepted with minimal reported adverse effects. What is known already Women’s services have poor attendance. Fear and embarrassment surrounding gynaecological health remain prevalent. Numerous long term sequalae can result from lack of gynaecological care include pelvic inflammatory disease, infertility and malignancy. Self-collection vaginal tampon samples have the potential to increase screening and diagnosis rates for multiple gynaecological conditions. Although the menstrual tampon as a biospecimen collection device has been demonstrated to be able to identify various gynaecological abnormalities, currently, possibly due to its novelty and lack of information on validity, they are not routinely used. Study design, size, duration Systematic review was conducted following PRISMA guidelines and prospectively registered with PROSPERO (CRD42022374857). A primary search through online databases was conducted, identifying 151 studies. Following this, title and abstract screening, full-text review and forward and backward citation searching were conducted in respective order, leading to a total of 92 studies for analysis. Participants/materials, setting, methods PubMed, MEDLINE, Cochrane Library, Scopus, and Web of Science were searched for eligible studies. All primary studies reporting the acceptability, efficacy or safety of vaginal tampons as a biospecimen collection device in comparison to other conventional methods of collection were included. Data was stratified based on which quantitative and/or qualitative variables were reported, baseline characteristics, and the abnormality being screened for. The Modified Newcastle Ottawa scale was used to assess risk of bias. Main results and the role of chance This systematic search identified 92 eligible studies, exploring HIV, HPV, HSV, Chlamydia trachomatis, Neisseria gonorrhoeae, cervical cancer, endometrial cancer, bacterial vaginosis, Candida albicans, Actinomyces israelii, Gardnerella vaginalis, Atopobium vaginae, and Trichomonas vaginalis. Menstrual tampons were compared to both clinician and self-collected samples including an endocervical swab, cervical brushing, cervicovaginal lavage, various tissue biopsies and urine samples. Detection of most gynaecological abnormalities did not profoundly vary between tampon collection versus gold-standard method. Self- collected tampon specimens were widely accepted with factors including lower pain scores, a greater willingness to use, convenient accessibility (especially in developing areas), and avoidance of embarrassment being reported. Very few papers reported adverse side effects and in those that did, vaginal tampon collection methods were regarded as less traumatic with a decreased likelihood of bleeding as compared to other methods including cervical swabs. Limitations, reasons for caution The effect of tampon sampling prior to other specimen collection methods could contribute to results that favoured tampon collection. A biopsy was not performed in some studies, leading to an unknown true disease status. Wider implications of the findings The use of menstrual tampons in clinical practice may help overcome barriers to accessing healthcare and participation in screening, necessary for preventing avoidable gynaecological conditions and their associated long-term complications. Further research is required to explore the optimisation of tampon specimen collection, including transportation and storage requirements. Trial registration number Not applicable

P-375 Optimising vaginal biospecimen collection

Abstract Study question Are menstrual tampons an acceptable and comparable method to lower vaginal swabs (LVS) for analysing the vaginal microbiome in non-pregnant women? Summary answer Tampons capture a higher bacterial load, volunteers are familiar with them, thus are well-accepted, and can be efficiently frozen at -20 °C prior to analysis. What is known already The vaginal microbiome plays a key role in women’s reproductive health. The application of investigating this niche allows a greater understanding of the impact of the vaginal microbiota in diverse reproductive disorders including infertility, recurrent miscarriage, spontaneous preterm birth and sexually transmitted infections. Fear and embarrassment related to physicians taking a traditional vaginal swab using a speculum results in many female genitourinary health appointments to be missed in the UK and recruitment challenges into vaginal microbiota research studies. Growing evidence suggests a menstrual tampon to be a superior alternative biospecimen collection device to a vaginal swab. Study design, size, duration This was a prospective, cross-sectional observational study. Twenty-one healthy volunteers (average age 30 years) were recruited over a period of 6 weeks at the Centre for Women's Health Research, University of Liverpool, an academic, tertiary referral centre. Participants/materials, setting, methods The volunteers consented to wearing a tampon for 20 minutes, taking 2 LVS and completing an acceptability questionnaire. Samples were halved for immediate processing and freezing at -20 °C for 2-4 weeks. Real-time PCR using Femoflor-16 was carried out to identify microorganisms present in vaginal microbiota. Microbiota was classified by total bacterial mass and relative abundance of lactobacillus species. Statistical analysis was carried out using GraphPad PRISM 5, Microsoft Excel 2019 and IBM SPSS Statistics 27. Main results and the role of chance Of the 84 samples, four had insufficient material for the purpose of analysis. Three of these were LVS samples and the fourth was a frozen tampon sample. Mean tampon total bacterial mass was higher for fresh and frozen samples versus the mean LVS total bacterial mass. The Femoflor algorithm gave identical vaginal microbiota characterisation between the fresh tampon and fresh LVS in 68.4% (13/19) of cases. 92% (12/13) samples with over 80% relative abundance of lactobacillus in the LVS also had over 80% relative abundance in the tampon. More discrepancy was seen between samples within the 20-80% and <20% relative abundance groups of lactobacillus in the LVS with 50% and 75% different classifications respectively. Importantly, only one case showed an LVS with lactobacillus >80% (normal) and a tampon with non-dominance of lactobacillus (<80%, dysbiosis). The questionnaires revealed that 90.5% of the volunteers highly rated using tampons (3 or more out of 5 on a Likert scale), with 52.4% rating tampon-use at 5/5. All participants (100%) stated that they would be happy to provide a tampon sample for clinical/research testing purposes in the future. Limitations, reasons for caution This study included 21 healthy volunteers; this is not necessarily representative of the entire UK population, but the tampon and LVS from the same volunteer were consistently comparable before and after freezing. We used a multiplex PCR assay to target common vaginal bacteria, inevitably some bacteria have not been characterised. Wider implications of the findings Self-collected tampons are suitable, well accepted biospecimen collection devices that may reduce barriers posed due to embarrassment, improve attendance in genitourinary medicine clinics and encourage participation in vaginal microbiota research. Freezing before processing reduces time and costs. A large study is necessary to ensure reproducibility and acceptability to patient population. Trial registration number Not Applicable

Menstrual hygiene products: A practice evaluation

ObjectiveThe choice and use of a type of hygienic protection depends on many factors. Due to growing media interest, the field of hygienic protection is evolving, however, to date no study has been carried out on this subject in France. The objective of this study was to evaluate women's practices regarding the use of hygienic protection. Material and methodsFrom 2 June 2019 to 4 January 2020, 1,153 patients responding to a self-report questionnaire were included in a prospective, cross-sectional, observational, single-center study. The aim of the study was to describe women's practices with regard to menstrual hygiene products and the factors determining their choices, as well as their knowledge of the potential risks associated with these protections and their sources of information. ResultsDisposable sanitary pads were preferred by 930/1148 (81%) of patients, and menstrual tampons were used half as much (525/1150 (45.6%) of women surveyed)). The new menstrual hygiene products (washable sanitary pads, menstrual panties, and menstrual cups) were used by only 51/1150 (4.4%); 20/1149 (1.7%); 108/1150 (9.4%) of the patients; however, among the 92/1136 (8.1%) of the patients who had recently changed the type of protection, these new protections were the most popular because they were considered more ecological and less harmful to health. Menstrual hygiene products were perceived as a health risk for 924/1129 (81.8%) of patients. Menstrual toxic shock syndrome was knowledeg in only 473/1133 (41.7%) of patients. This lack of knowledge could lead to risky behavior. The majority of patients said they were not informed about hygiene protection, with only 151//1108 (13.6%) having discussed the subject with a health professional, yet 973/1067 (91.2%) wanted more information. ConclusionThis is the first French study on menstrual hygiene products. It showed that traditional sanitary protection was still the most widely used, but there was a growing awareness among patients about the products they used and their potential health risks as well as the consequences for the environment. Patients wanted to receive information on the subject from health professionals as well as manufacturers in order to be able to choose the product deemed the most suitable and in which they have confidence.

Association of Characteristics of Tampon Use with Menstrual Toxic Shock Syndrome in France

Background: Menstrual tampons are widely used in western countries. Indirect evidence suggests that tampon misuse could be associated with an increased risk of menstrual toxic shock syndrome (MTSS). The aim of the study was to determine tampon use associated with increased risk of menstrual toxic shock syndrome (MTSS). Methods: A nationwide, case-control study in France, was conducted with women that use tampon with MTSS diagnoses according to the CDC diagnostic criteria (n=55, from January 2011, to December 2017) and controls women with no MTSS history (n=126, from February to December 2017). Information regarding tampon use during a 6-month period was collected. Associations between tampon use and MTSS were assessed using logistic regression models stratified by residential area. Findings: Compared to controls, cases more frequently reported maximum tampon wear of >6 hours (62% vs. 41%; P=0.02), overnight tampon use (77% vs. 54%; P=0.006), and not having read and followed tampon instructions (65% vs. 42%; P=0.006). In univariate analysis, MTSS risk was two-fold higher with tampon use for >6 consecutive hours (odds ratio, 2.3 [95% CI, 1.2–4.5]), and three-fold higher with tampon use during sleep for >8 hours (odds ratio, 3.2 [95% CI, 1.4–7.7]). In multivariate logistic regression analysis, only maximum tampon use for >6 hours (odds ratio, 2.03 [95% CI, 1.04–3.98]), and not reading and following the tampon instructions (odds ratio, 2.25 [95% CI, 1.15–4.39]) were independent associated with MTSS. Interpretation: Our study indicates suggests that risk of MTSS was associated with women who used tampons for more than 6 hours, overnight tampon during sleep, and who reported not reading and following tampon insertion instructions. Funding Statement: This work was supported by the LABEX ECOFECT (ANR-11-LABX-0048) of Universite de Lyon within the programme Investissements d'Avenir (ANR-11-IDEX-0007) operated by the French National Research Agency (ANR). Declaration of Interests: The authors declare no competing interest. Ethics Approval Statement: This study was reviewed and accepted by the Ethics Committee (CPP Sud Est IV, Centre Leon Berard, Lyon, France, N° L16-176). Written consent was obtained from all participants, or from the parents/guardians of participants under 18 years of age.

Assessing menstrual tampon irritation using the “Behind-The-Knee” test

Colposcopic inspection of the vagina is a routine component of the safety assessment of intravaginal products. However, colposcopic findings occur frequently in healthy women, raising questions about their relevance to intravaginal product safety. Practical disadvantages limit the utility of colposcopy for evaluating menstrual tampons, among them the presence of background microtrauma, the inability to assess effects during menstruation, and, importantly, the question of whether post hoc assessments are sufficiently sensitive to detect small inflammatory changes. The Behind-The-Knee (BTK) test is an alternative for evaluating inflammatory and tissue dryness effects of physical articles by their repeated application to the popliteal fossa under an elastic bandage. It enables concurrent parallel comparisons of experimental and control articles over time and substantially increases the sensitivity of detecting small changes in tissue inflammation. With the protocol, uncompressed experimental and control tampons yielded comparable relative and absolute erythema scores (after overnight recovery) as did colposcopic assessment of the lower genital tract 3-48 h after menstrual use. Scoring erythema in the BTK test immediately after product removal increased the level of visually discernible inflammation sixfold. In a study of commercial menstrual pads, subclinical inflammation visualized with cross-polarized light correlated with the frequency of subjective reports of discomfort during the test and discriminated the relative tolerability of the two products determined by market surveillance, providing added confidence in the predictive value of the test. We believe the BTK test can be a valuable alternative to colposcopy for assessing inflammation and dryness associated with menstrual tampons.

The “behind-the-knee” test for menstrual tampon irritation

Colposcopic inspection of the vagina is a routine component of the safety assessment of intravaginal products. However, colposcopic findings occur frequently in healthy women, raising questions about their relevance to intravaginal product safety. Practical disadvantages limit the utility of colposcopy for evaluating menstrual tampons, among them the presence of background microtrauma, the inability to assess effects during menstruation, and, importantly, the question of whether post-hoc assessments are sufficiently sensitive to detect small inflammatory changes. The Behind-the-knee (BTK) test is an alternative for evaluating inflammatory and tissue dryness effects of physical articles by their repeated application to the popliteal fossa under an elastic bandage. It enables concurrent parallel comparisons of experimental and control articles over time and substantially increases the sensitivity of detecting small changes in tissue inflammation. With this protocol, uncompressed experimental and control tampons yielded comparable relative and absolute erythema scores (after overnight recovery) as did colposcopic assessment of the lower genital tract 3 to 48 hours after menstrual use. Scoring erythema in the BTK test immediately after product removal increased the level of visually discernible inflammation 6-fold. In a study of commercial menstrual pads, subclinical inflammation visualized with cross-polarized light correlated with the frequency of subjective reports of discomfort during the test and discriminated the relative tolerability of the two products determined by market surveillance, providing added confidence in the predictive value of the test. We believe the BTK test to be a valuable alternative to colposcopy for assessing inflammation and dryness associated with menstrual tampons.

Clinical Safety Assessment of an Ultra Absorbency Menstrual Tampon

Menstrual tampons are available in a range of absorbencies to allow women to use the product most appropriate to their needs. This study assessed the safety of an ultra absorbency (15 g to 18 g) tampon compared with a currently marketed super-plus absorbency (12 g to 15 g) tampon as a control. Healthy women age 18-45 years (n = 95) were enrolled in this single-blind, crossover study. Subjects used, in random order, the experimental tampon during one menstrual cycle and the control tampon during the other. Subjects were also randomly assigned to receive either vaginal microbial assessments for determination of the presence and density of Staphylococcus aureus (n = 35) or colposcopic examinations for assessment of changes in the vaginal mucosa (n = 60). Data on comfort and acceptability of the tampons were collected by using diaries and questionnaires completed by the subjects in both groups. Twenty-eight women in the microbial assessment group and 43 in the colposcopic examination group completed the study; these subjects made up the primary analysis population. No differences in isolation frequency or cell density of S. aureus or in vaginal mucosal changes were observed with the experimental tampon in comparison with the control tampon. No reported adverse events were attributed to the experimental tampon. Both tampons received positive comfort ratings. Based upon microbial assessments, colposcopic examinations, adverse events, and subject reporting of comfort, the ultra absorbency tampon is similar in safety profile to the currently marketed super plus absorbency tampon.

Intravaginal and in vitro temperature changes with tampons of differing composition and absorbency

Vaginal tampons are Class II medical devices used by women to manage menstruation. The purpose of this study was to investigate intravaginal temperature changes with simulated and actual menstrual tampon use. Tampons (with varying absorbent compositions) embedded with a thermocouple sensor were used to study temperature effects in vitro in a model of the vagina (condom placed in a hollow glass tube, jacketed in a 37 degrees C water bath, and dosed with human menses to fluid saturation) and clinically during menstrual tampon wear under controlled conditions (up to 8 h in a stationary, supine position). Elevations in the temperature of the tampon core occurred upon menses fluid acquisition both in vitro and clinically. Temperature profile characteristics varied from a transient spike with commercial cotton-rayon blend tampons of two different absorbencies to a small but sustained rise (> or =6 h) with a carboxymethyl cellulose (CMC)-containing prototype. On the basis of the results from this study, fluid absorption by tampons generates an exothermic event whose characteristics vary with tampon design and composition. We speculate the small, sustained increased in tampon temperature noted during this study may enhance the production of a bacterial exotoxin associated with tampons composed of CMC.

Reemergence of Staphylococcal Toxic Shock Syndrome in the United States since 2000

Schlievert et al. recently reported that the increased number of cases of toxic shock syndrome (TSS) observed by their surveillance group over the last 4 years in the Minneapolis-St. Paul metropolitan area is consistent with Centers for Disease Control and Prevention findings of an 18% increase in the incidence of TSS from 2002 to 2003 (3). He wisely cautioned medical practitioners and women using tampons (especially teenagers and young women) to be aware that the TSS incidence is rising. Further, Schlievert et al. suggested that while the reason for this increased incidence is unclear, the possible role of changed tampon usage patterns might offer an explanation (3). I would like to support that contention with two additional observations. First, in 1999 the Food and Drug Administration proposed an amendment to tampon labeling regulation 21CFR 801.430(e)(1) which provided an absorbency term for tampons that absorb 15 to 18 g of fluid, namely, ultra. Soon thereafter tampons with this increase in absorbency became widely available on the marketplace, thereby making five categories of extant tampons, namely, light (6 g), regular (6 to 9 g), super (9 to 12 g), super-plus (12 to 15 g), and ultra (15 to 18 g). Clearly, this permitted increase in absorbency is of concern because the statistical association of highly absorbent tampons with development of TSS has been unequivocally established (1, 2, 4). Thusly, this absorbency increase might also be a reason for the observed increased incidence of TSS. In the past, increases in absorbency were achieved by using more absorbent synthetic fibers. Although tampon composition has not recently changed, the increases in tampon absorbency can be accounted for by increased weight of the current component fibers. Second, the Food and Drug Administration’s position on “8-h/overnight” usage of menstrual tampons may have also inadvertently contributed to the observed increased incidence of TSS by allowing manufacturers to use the word “overnight” on their packaging (even though they explain that by that word they mea n8ho rless). Simply put, women may not be able to precisely control their sleeping cycles and therefore may sleep considerably longer than 8 h with a more absorbent tampon in place, thus increasing their risk for TSS development. Implicit with the pattern of tampon usage is its absorbency, which in turn is related to length of use. In conclusion, it seems prudent, in light of accumulating data, to suggest that if tampons are to be used at bedtime the timeframe of their use must be controlled or they should not be used. Additionally, tampon absorbency should be reduced to the pre-2000 absorbency levels with capacity limits of no more than 15 g of fluid as an extra measure of safety.

Comparison of the effects of different menstrual tampons on the vaginal epithelium: a randomised clinical trial

The effects of the vaginal epithelium of three different menstrual tampons in normal conditions of use were studied in 41 women during the menstrual period. The vaginal epithelium was studied in a total of 123 cycles at a structural and ultra-structural level with colposcopy, vaginal smear and biopsy on TEM and SEM. One of the three tampons studied showed a lower level of abnormalities on colposcopy (36.6% vs. 56.1% vs. 68.3%), with an inverse correlation between the severity of the dryness and the quantity of blood absorbed by the tampon (4.2 g when the colposcopy was normal vs. 1.8 g in case of severe dryness). Cytology is not a good test for assessing the effects of tampons because of the high rate of accellular and uninterpretable samplings. The biopsy effects were defined according to their depth in the epithelium. The same tampon showed the lowest level in biopsy abnormalities. No correlation was found between severity of the colposcopy and biopsy results. Colposcopy can demonstrate the degree of severity of dryness or any other effect, but biopsy only confirms the effect and does not correlate the degree of severity. Materials and designs of tampons can play a role in reducing the drying effects to the vaginal epithelium.

The Gynaeseal diaphragm tampon

Medical Journal of AustraliaVolume 152, Issue 1 p. 52-53 Letter to the Editor The Gynaeseal diaphragm tampon John F. Cattanach DObstRCOG, John F. Cattanach DObstRCOG 68 Manningtree Road, Hawthorn, VIC, 3122Search for more papers by this author John F. Cattanach DObstRCOG, John F. Cattanach DObstRCOG 68 Manningtree Road, Hawthorn, VIC, 3122Search for more papers by this author First published: 01 January 1990 https://doi.org/10.5694/j.1326-5377.1990.tb124442.xCitations: 2AboutPDF ToolsRequest permissionExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL Share a linkShare onFacebookTwitterLinkedInRedditWechat No abstract is available for this article.Citing Literature Volume152, Issue1January 1990Pages 52-53 RelatedInformation

On quantifying menstrual blood loss

The measurement of menstrual blood loss by the alkaline hematin method of Hallberg and Nillson requires that menstrual blood hemoglobin in sanitary materials be simultaneously extracted in and converted by 5% aqueous sodium hydroxide to alkaline hematin. The alkaline hematin is then measured photometrically. The procedure is straightforward and equipment needs are minimal. Whatman No. 4 paper can be used to clear any turbidity that may occur. There are 2 major drawbacks to this method: 1) the unpleasant odor produced when sodium hydroxide solution and soiled menstrual tampons are mixed; and 2) the necessity of manually pummeling agitating or massaging these materials until their contained hemoglobin is eluted and converted to brown hematin. This may require considerable time and labor. The Stomacher Lab-Blender can be used to automatically extract sanitary materials inside sealed plastic bags. The extraction and conversion has been found to be nearly complete within 5 minutes and complete in 15 minutes. Results were satisfactorily accurate enough to recommend its use in laboratories measuring many samples.

Clinical note on the use of intravaginal tampons during menstruation

The “normal” woman, whose hormone balance is adequate to maintain a vaginal pH of 3.5 to 5.0 and abundant Döderlein bacillus vaginal flora, need only use a vinegar douche during menstruation to overcome the undesired alkalinizing effect of the menstrual flow.When a cervical or vaginal infection is present, use of a vinegar douche in the morning during the menses actually tends to prevent a flare-up of the infection, and is, therefore, a valuable prophylactic, as well as therapeutic, adjunct to treatment.Those girls and women who prefer to use vaginal tampons during menstruation, but who have been unable to do so because of a profuse amount of flow, have been advised to douche in the morning and use the tampon. By washing out the overnight accumulation of menstrual flow, there is much less apparent flow and the tampon is adequate protection. Two tampons can be inserted if desired.No ill effects on menstruation or pelvic organs have yet been complained of, or noted on examination, by girls and women who have used a vinegar douche daily while menstruating. In my opinion, it is impossible to speculate upon what ill effects could possibly follow such a procedure.The intravaginal menstrual tampon is safe to use whether or not cervical or vaginal infection is present.Every woman who has accepted the suggestion to use the warm vinegar water douche solution and vaginal tampons while menstruating has been delighted with results.Physicians can confidently recommend the use of intravaginal menstrual tampons because they are confortable, adequate, and safe to use. Also because they eliminate the inexpedient contact between anus and vulva which the external pads afford, use of menstrual tampons should be actively urged.