How does gardnerella affect men

Certain diseases are often thought of by most as women-only ailments. Here's a look at seven conditions that are also known to affect men. Like women, men have hormonal shifts and changes. But do cis men have periods? We gathered the best blogs….

Some research has shown that regular bidet use could increase your exposure to certain pathogens. Learn more. Yeast infections are common. Here are seven of the best over-the-counter products to help manage a yeast infection. The Bartholin glands are a pair of glands, near the opening of the vagina. If a duct from one of the gland gets blocked, fluids can build up….

A cyst may form if…. If you have vaginal atrophy, you may wonder if it can be reversed. With treatment, some women find that their symptoms improve. Sex with both males and females can increase the risk of BV to spread. But males can carry the bacteria that cause BV. The bacteria can accumulate on the penis or in the urethra of males. This means that people carrying the bacteria can transmit it to females by having sex with them.

The closest condition to BV in males is urethritis. This is where the urethra becomes inflamed. The urethra is a tube connecting to the bladder that helps to remove urine from the body.

Both males and females have a urethra. Urethritis is a common condition that affects roughly 2. Researchers are now exploring associations between BV and urethritis, where there is no clear cause. Bacterial vaginitis does not cause many symptoms, and those that do develop are typically mild. Some people may not notice any symptoms at all. Having BV also increases the chances of getting sexually transmitted diseases STDs , such as chlamydia. Pregnant women can also get BV.

When this happens, women are more likely to give birth early or to a baby with low birth weight. Pregnant women should make sure they get treatment for BV to avoid these complications. The infection that causes BV is the result of an overgrowth of certain bacteria coming into contact with the vagina. The randomisation allocation button will only be visible once all the required information has been entered and the couple are deemed eligible.

If a protocol violation occurs after randomisation defined above , reasons will be collected and the participant will be deemed either lost to follow up or withdrawal if this is formally what they decide to do. As this is an open-label RCT, both the research nurse performing randomisation and the participants will know which group they are in.

However, the microscopists performing Nugent scoring, clue cell reporting and amine testing will be blinded to randomisation group. The study constitutes enrolment, day 8 post-antibiotic follow up and then three other follow-up time points.

A summary of the study schedule and procedures for couples at each study time point is provided in Table 1 and Fig. Once eligibility has been assessed and consent forms signed, participants will be instructed on self-collection of high-vaginal swabs and vaginal secretions on a slide for NS, penile swabs, and urine samples Table 1 , Fig.

A clinician and pharmacist will instruct participants about antibiotic use and AEs. Couples will be asked to avoid alcohol and to abstain from sex during treatment. Female participants will collect samples and complete questionnaires on four occasions after baseline including the day after completing antibiotics day 8 , and at weeks 4, 8 and 12 Table 1 , Fig.

At scheduled clinic visits weeks 4 and 12 females will be assessed for BV by Amsel and Nugent criteria, and will complete a questionnaire.

At day 8 and week 8, swabs, slides for Nugent scoring, and questionnaires completed at home will be returned by replied paid post to MSHC. Slides with morphotypes unable to be easily scored will be read by a second independent microscopist and consensus reached.

Male participants will self-sample and complete questionnaires at enrolment and, for those in the Intervention group , the day after completing treatment day 8 , or if in the Control group , the day after their partner has finished her treatment Fig.

Men will be instructed to complete their follow up specimens and questionnaires at the same time as their partner. All male questionnaires and specimens will be collected at home and returned by replied paid post to MSHC. Validated questionnaires at each time point will collect data detailing sexual practices e. Adherence and AEs will be recorded on day 8 questionnaires and participants instructed to call the dedicated study phone if they have any enquiries or are concerned about any AEs experienced.

A reminder SMS will be sent to participants 1—2 business days prior to any clinic-based appointment. At the week 12 visit, the research nurse or treating clinician will assess the women for clinical signs of BV using Amsel criteria and take a swab for future molecular studies and slide for Nugent scoring Table 1 and the participant will be asked to complete the week 12 questionnaire.

All women experiencing BV recurrence during the study or at its conclusion will be given an appointment with a clinician and offered treatment accordingly. Couples randomised to the Control group will be offered the opportunity for male partner treatment if the female experiences BV recurrence during the study.

These data will not be included in the trial but will contribute to a subsequent sub study. Genital specimens will be collected at every time point for future molecular analysis Table 1. All specimens will be collected in clinic or sent via post to the Central Co-ordinating site, processed and then stored at C for future analysis. A detailed Statistical Analysis Plan will be written close to final data lock, but before any analyses are performed, that will define all analyses in detail.

Enrolment and longitudinal specimen and questionnaire data will be entered into two separate password-protected online databases within REDCap and then imported into a statistical package Stata for analysis. Women who attend at week 4 but not week 12, are still eligible for the primary outcome analysis. Primary analyses will be simple unadjusted two-group comparisons of the randomised arms using Cox regression.

If there are important imbalances in baseline characteristics, further adjusted analyses will be performed. Cox regression analyses will be also used to assess co-variates associated with recurrence including demographics, sexual practices, contraception use, smoking and other factors previously shown to be associated with BV recurrence. Any AEs leading to cessation of treatment, and all reported clinical AEs will be summarised descriptively. Analyses will be performed for the primary outcome i.

Differences between the randomisation arms within subgroups will only be considered robust if there is statistically significant evidence of an interaction between randomised arm and subgroup. Females receive first line recommended antibiotic therapies, which have been used extensively for decades with an excellent safety profile for the treatment of BV. Metronidazole is also used in a broad range of non-genital anaerobic infections. All female and male participants are assessed for contraindications and drug interactions prior to enrolment.

Safety assessments post-treatment will be focused on AEs and symptom-directed assessments. An interim analysis will be undertaken by an independent researcher not running the trial when the first couples 75 in each arm have reached the week study endpoint and will include the stated primary and secondary outcome measures of interest.

The TMC will conduct the day-to-day management of the trial, review of protocol deviations, and are responsible for project milestones. The TSC will provide trial oversight and advise on scientific design and rigour. The DSMB, in agreement with the TSC, may suggest changes in the conduct of the study should concerns surrounding the safety of patients arise from review of the interim results or aspects of study conduct that warrant modification e.

The HREC may audit the trial at any time. Any identifying or confidential data will be kept in locked cabinets or password protected computer databases, accessible only by named investigators. All specimens will be de-identified prior to processing. All data will be de-identified and aggregated prior to dissemination in conference abstracts, presentations or publications. Plain language summaries of the findings will be available on the trial site hosted by MSHC at the conclusion of the trial.

The post-treatment recurrence rates for the common vaginal condition, BV, remain unacceptably high. A considerable body of evidence now shows that men carry BV-organisms and may be a reservoir for re-infection. This open-label multicentre pragmatic RCT is designed to assess the impact of concurrent male partner treatment with combined oral metronidazole and topical clindamycin with the current standard of care - female treatment only. If effective, concurrent partner treatment will provide an adjunctive therapy for women with a regular partner and may provide the first opportunity for high level sustained BV cure.

Additionally, if effective, this approach would also result in improved antibiotic stewardship as women would not require repeated courses of antibiotics for recurrence. This clinical research will be able to be translated to changes to treatment guidelines for BV. The first participant was recruited on 8 April and recruitment is expected to continue to 31 December High global burden and costs of bacterial vaginosis: a systematic review and meta-analysis. Sex Transm Dis. A public health approach to adverse outcomes of pregnancy associated with bacterial vaginosis.

Int J Gynaecol Obstet. PubMed Article Google Scholar. Bacterial vaginosis assessed by gram stain and diminished colonization resistance to incident gonococcal, chlamydial, and trichomonal genital infection. J Infect Dis. Bacterial vaginosis associated with increased risk of female-to-male HIV-1 transmission: a prospective cohort analysis among African couples. PLoS Med. Genital inflammation and the risk of HIV acquisition in women. Clin Infect Dis. Sexually Transmitted Disease Treatment Guidelines, Google Scholar.

The effects of antimicrobial therapy on bacterial vaginosis in non-pregnant women. Whilst women provide accounts from their perspective of how BV affects their relationships and the responses of their partners, this is the first study we are aware of to speak directly to men about their views and experiences of BV and associated partner treatment. Women in other studies have reported receiving similar reassurances from their partners [ 13 , 44 ], yet this study is the first to demonstrate that this is actually a lived experience of men.

Different health conditions can be imbued with varied meanings in cultural and social contexts, affecting the way in which they are viewed and experienced [ 33 ]. Stigma is strongly associated with STIs which have been historically constructed as symbols of immoral or irresponsible behaviour [ 49 , 50 ].

Such beliefs have been demonstrated to influence sexual health seeking behaviours, psychosocial well-being and self-concept in adjustment to diagnosis, and disruption of intimate relationship dynamics [ 47 , 51 , 54 , 56 , 57 ]. However, several participants themselves demonstrated that the impact of STI stigma can be somewhat attenuated by the current ambiguity of the classification of BV.

Men who discussed how they perceived of people who may have STIs and how they may feel with an STI diagnosis did not demonstrate the same response to partner treatment for BV. This finding will be important when considering how clinicians may communicate MPT for BV if it is found to be successful in reducing BV recurrence in women.

What is clear from the results of this study is the central importance of the relationship in influencing not only the impact of BV on men, but their acceptance of treatment. This overrepresentation of committed couples seems to potentially corroborate the central role of the relationship in determining MPT acceptance for BV. In this way, MPT can be understood as tool to demonstrate a certain type of masculine identity.

Gender relational theory [ 34 ] proposes that the responses of men and women to health are based on the gender scripts that determine what is considered to be appropriate behaviour within the specific social structure or culture in which they live [ 34 , 58 ].

This demonstrates the numerous versions of masculinity that can be enacted and revered in different contexts. The central importance of the relationship is also reflected in the STI literature relating to partner notification.

While we were unable to identify any studies that explore partner treatment acceptance, the literature demonstrates that men are more likely to notify partners of an STI diagnosis if they are in committed relationships, with stronger emotional ties [ 29 , 45 , 52 , 68 , 69 ]. Indeed, a US-based study found that people were three-times more likely to inform partners with whom they were in a long-term relationship of an STI diagnosis [ 70 ].

This demonstrates that the role of the relationship is an important determinant of sexual health related behaviours and intentions. Many participants identified that men, including themselves, may refuse MPT for BV due to the belief that treatment would be of no personal benefit. These findings support the finding that the lack of BV symptoms in men may represent a serious barrier to the success of MPT. However, an unexpected finding of great interest in this study was the prolonged symptoms one participant experienced which he attributed to BV and his resulting belief that BV was sexually transmitted.

Current knowledge suggests that men do not generally experience BV symptoms. However, 30 year old case reports describe three men experiencing Gardnerella vaginalis -associated balanoposthitis malodourous balanitis [ 73 ] and there is very recent interest in whether BVABs may cause urethral symptoms in men [ 74 ].

This indicates a growing consideration of how the presence of and exposure to BVABs may physically affect men. Though assessment of urethral symptoms is part of routine sexual health history taking in men, questions of genital malodour are generally only asked of women [ 75 ].

This raises questions of how many men may actually be experiencing BV-like symptoms and whether further consideration of this is required in future research. This study has some very important limitations. Men who had not participated in the StepUp studies may have very different views from the men interviewed in this study. Despite attempting to recruit men who declined MPT through the StepUp studies, none of these men expressed interest in participating.

Accordingly, all study participants had accepted MPT. Thus, the reasons identified for MPT decline are largely hypothetical, with the exception of one participant who had previously declined a similar study. The lack of cultural diversity among the men interviewed means this study may not have captured the diversity of attitudes or experiences among different populations of men.

Male experience of symptoms was an unexpected theme that did not reach saturation and will be the subject of another study. Considering the significant health and personal costs of BV on women, and economic costs of repeated infection, evidence of successful sustained cure in women through partner treatment would be a welcome management approach that could radically change the way the infection is managed.

However, uptake of treatment by male partners may be heavily influenced by contextual factors that may improve or diminish their willingness to accept treatment. Encouragingly, it seems that strong caring relationships may mitigate some of these issues, as does the fact BV is not currently classified an STI. Interestingly, this research suggests there may indeed be men suffering from BV like symptoms which may alter their understandings of the personal health benefit of seeking and accepting treatment.

We would like to acknowledge the broader StepUp studies research team, and all of the staff at MSHC who facilitated recruitment of couples into the StepUp studies. We would also like to thank the men who kindly participated in this study.

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We notice that your manuscript contains offensive terms in some of the quotes. We would like you to reduce the number of offensive terms in this manuscript and don't think that these verbatim examples have to be printed to make the points made in your manuscript.

Please remove the offensive words on page 16 and 32 and generally make sure that there is only a minimal number of offensive terms in your manuscript and only where absolutely scientifically necessary.

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Please use the space provided to explain your answers to the questions above. You may also include additional comments for the author, including concerns about dual publication, research ethics, or publication ethics. Please upload your review as an attachment if it exceeds 20, characters. How was confidentiality ensured? Was verbal consent taken when setting up an interview time or just before the interview began?

Why was this important? If you agree about potentially biased selection of respondents, include in limitations. If you disagree, explain a bit why this was a good approach for the current setting. All I know is that a hospital in Victoria gave the ethical approval, but where was the study conducted?

Later I read about phone interviews, but it needs to be clear in the methods where they were conducted. And ethnicities? How did you ensure maximum variation in the respondents when you purposely selected them? Were your respondents varied enough to conclude saturation? Why was this person an appropriate person to conclude data saturation?

You do it a bit in your discussion but these concepts can be defined in the methods and theory section. This should come earlier when or before JB was first introduced. Were there only 20 who contacted you with interest in being in a study? When you stopped at 11, did you contact the remaining 9 to inform them why they were not contacted further? Reviewer 2: This is a really well written article about men's experiences of BV and their views on male partner treatment.

It is a qualitative study conducted alongside a RCT where women with confirmed BV were enrolled, as well as male partners. It would be interesting to know a bit more about what the Step Up Trial consisted of for the male partners, beyond the eligibility requirements. Was it treatment only or were there other aspects of the study e. A bit more detail on the consent process in the text would be helpful. Recruitment: In the analysis, the authors state that they reached data saturation after 11 participants had been interviewed but, in the results section, it seems that the others who were not interviewed the remaining 9 of the 20 contacted were not interested in participating.

Had data saturation not been reached, what would have happened? Methods: minute interviews seem quite short for lived experience research, what was the average length? Results: What was the sexual identification of the 1 participant who did not identify as heterosexual?

Is there a better way to format the case scenarios? It was difficult to read side by side over several pages. Discussion: Regarding your point about local categories of illnesses and its impact on the disease and treatment experiences and acceptance , I wonder if there is any literature about the perceptions of men regarding vaccination for HPV and about stigma related to HPV care seeking. This literature, if it exists, might be interesting to explore. I also think that the finding about BV not being classified as a STI is important to think about when working out how to communicate with the public about treatment and decision making as well as the case of the man who had symptoms.

Additionally, I do think that further research is needed into reasons men decline MPT beyond the hypothetical reasons listed by those who had already accepted it. The group interviewed were a very specific population as they were enrolled in studies about the topic with partners who were also enrolled in studies. Their views might be wildly different than those who refused participation and within the community more broadly but the finding from this study could be used to inform data collection in other studies.

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Please note that Supporting Information files do not need this step. Thank you to both reviewers for their review of our manuscript. The authors are grateful for their comprehensive and thoughtful review and comments, and for outlining the grammatical inconsistencies in the initial document.

Please see below our responses to all raised queries, referenced line numbers refer to the tracked changes document. We trust that you will find all queries satisfactorily addressed and hope you now consider this manuscript suitable for publication. We agree and have removed all words that we believe may have been identified as offensive from the quotes in the manuscript. Please see the detailed response to this concern in responses to reviewer one 2a, 2b and 2h.

We have provided the final iteration of the interview guide as supporting information. You mention that BV being sexually transmitted is a controversial and debated idea and then you elaborate more on the possibility of it being sexually transmitted. I would like to see a short sentence summarising what the other lines of thought are if BV is not sexually transmitted, e. Thank you for your comment. The following line has been inserted into the introduction lines 37 to 42 to address this point.

These factors include racial variants in vaginal microbiota, altered host immunity, an endogenous source, environmental factors such as nutrition and intravaginal practices such as douching 2.

Ethics statements needs more elaboration on confidentiality and verbal consent. Thank you for this comment. We have now elaborated on confidentiality and verbal consent in the Methods, under the recruitment and data collection sections. The following lines have been inserted or revised in blue.

The reviewer raises a valid point that the requirement for audio recording could potentially bias the group, however, this is our usual process in studies conducted through Melbourne Sexual Health Centre, particularly where sensitive topics exploring lived experiences are concerned. It is important that in interviews such as these, the interviewer is able to pay full attention to participants accounts and pursue relevant lines of questioning without distraction and enable an easy and comfortable flow of conversation.

Men were informed when first contacted of the need to audio record the interview for these purposes, and no participants declined upon learning of this requirement. Study setting is missing from methods. Participants were able to be interviewed in person at MSHC, or via phone line All participants elected to be interviewed over the phone line The aforementioned lines were in the submitted manuscript, and we have also added the following line to clarify study location:.

What was the age distribution of the respondents? Only men with a lived experience of accepting or declining MPT within the StepUp study were eligible to participate as this was central to the research question.

As maximum variation sampling is utilised to capture the available diversity of experiences relevant to the research question [1], contacting all eligible men provides the maximum variation possible within this very limited pool of eligible men.

Men had to be eligible for participation in the StepUp studies and provide consent to be contacted about a qualitative research study. All men who were eligible to participate were contacted for interview, thereby providing insights from all available angles.

As noted in the paper, participants ranged in age from 23 to 60 line , with a median age of 28 Table 3. This was not an ethnically diverse sample, as only one participant was born outside of Australia Table 3 and most identified as Australian with European ancestry.

The limited cultural diversity of the sample has been highlighted in the limitations in the previously submitted manuscript. The following lines have also been amended in blue and added to the manuscript to improve clarity and address the questions about participants:.

In addition to our response to Comment 2d above, saturation was reached within the available sample we were able to recruit. As noted in our earlier response, maximum diversity was limited but achieved among the eligible men who were offered MPT for BV and expressed interest in the qualitative study. Male experience of symptoms was an unexpected theme that did not reach saturation, and will be the subject of another study.