06 Mar NEJM: Treating Male Partners Reduces Recurrence Rate of Bacterial Vaginosis
MedicalResearch.com Interview with:
Dr. Vodstrcil
Lenka Vodstrcil PhD
Senior Research Fellow
Deputy Head, Genital Microbiota and Mycoplasma Group
President, Sexual Health Society of Victoria
Associate Editor, Sexually Transmitted Infections
School of Translational Medicine, FMNHS, Monash University
Melbourne Sexual Health Centre, The Alfred Hospital
Melbourne School of Population & Global Health, University of Melbourne
Dr. Bradshaw
Catriona Bradshaw MMBS(Hons), PhD, FAChSHM, FAHMS
Professor (Research), Head of Research Translation and Mentorship
and of The Genital Microbiota and Mycoplasma Group Melbourne
School of Translational Medicine, Monash University and Alfred Hospital
Principal Research Fellow at the Burnet Institute
MedicalResearch.com: What is the background for this study?
Response: One in three women globally have bacterial vaginosis (BV), a condition that causes a malodourous discharge, and associated with serious gynaecologic and obstetric sequelae (including miscarriage and preterm birth) and increases the risk sexually transmitted infections (STIs) and HIV. Women with symptoms are treated with broad-spectrum antibiotics, however, over 50% of women experience BV recurrence within 3-6 months. The recurrence rate is even higher at 60-80% among women with an ongoing regular partner. Current practice is to simply retreat women experiencing BV recurrence with the same antibiotics, which leaves them (and clinicians) frustrated and distressed.
We and others have accumulated a body of evidence to show that BV has the profile of an STI. BV-associated bacteria are detected in men in the distal urethra and on penile-skin, and couples share these organisms. However, to date, has not been recommended for BV as it is for other STIs. This is largely because men do not usually have any symptoms, and past partner-treatment trials in the 1980s and 1990s, which only used oral antibiotics for men, failed to prevent BV recurrence, which was taken as conclusive evidence against sexual transmission. Reviews of these trials have since identified their limitations.
Given the evidence of male carriage of BV-associated bacteria at two genital sites, we hypothesised that both sites needed to be targeted with antimicrobial therapy to prevent re-infection post-treatment. The aim of our study was to assess if male partner-treatment concurrently with female treatment using a combination of oral and topical antibiotics for the first time, would decrease BV recurrence over 12 weeks compared to the current standard practice of treating women only.
MedicalResearch.com: What are the main findings?
Response: In our randomized, multicentre, open-label trial, 164 couples were randomized to receive female and male-partner treatment (intervention) or female-treatment only (control group). The trial was stopped early by the data safety and monitoring board because the control group was statistically inferior to male-partner treatment over 12 weeks.
In the male-partner treatment group, 35% of women experienced BV recurrence over 12 weeks compared to 63% in the control group (recurrence rates 1.6 per person-year, 95% confidence interval 1.1-2.4 versus 4.2 per person-year, 95%CI 3.2-5.7, respectively). This corresponds to a ~60% reduction in the risk of BV recurrence in the male partner-treatment group compared to the female-only treatment group (Hazard ratio=0.37, 95%CI: 0.22-0.61). Importantly, men reported adverse events at a similar rate to women, and most were attributable to metronidazole.
MedicalResearch.com: Were the men treated with antibacterial meds? Did the treatments work better if the male was circumcised?
Response: The men in this trial were treated with two antibacterial agents that are commonly used first-line treatments for BV in women. Men were instructed to take oral metronidazole and apply topical 2% clindamycin cream to their penile skin twice a day for seven days.
We know that male circumcision status is a risk factor for BV, with secondary analyses of large circumcision trials showing that the female partners of circumcised men were less likely to have BV. In our trial we didn’t have enough circumcised men (~20%) to definitively see differences between uncircumcised and circumcised men, but the key takeaway is that partner-treatment was still effective for the partners of uncircumcised men.
MedicalResearch.com: What should readers take away from your report?
Response: Our trial found that re-infection from an ongoing sexual partner is a significant driver of BV recurrence, and by adding male partner-treatment to the treatment of women, we now have a simple strategy to reduce BV recurrence.
It is important to highlight that when enrolling couples, we emphasised that this trial would benefit couples in a monogamous relationship where both partners are treated. We also asked couples to synchronise treatment where possible and avoid sexual contact until both had completed treatment.
Additionally – couples should be counselled to take all of the prescribed medication – the female partners of men who reported taking all of the doses of both treatments had the lowest rate of recurrence, indicating that adherence is important.
In a group of women with a high burden of risk factors for BV recurrence (all had an ongoing partner, >80% had prior episodes of BV, 30% had an IUD and >80% of male partners were uncircumcised), treating the male partner at the same time as the female received treatment significantly reduced the rate of recurrence.
MedicalResearch.com: What recommendations do you have for future research as a results of this study?
Response: This study creates a genuine opportunity to reduce the burden of BV and opens up exciting opportunities for BV prevention strategies, including a test for BV-bacteria in men.
We know that reinfection is responsible for a significant proportion of BV recurrence but it is not the whole story. Some women appear to experience persistence of BV immediately after treatment in the absence of resuming sex. We believe this group may fail to clear BV. Some have clear risk factors like an intrauterine device (IUD) in place and others may just have a very dense BV-biofilm. This group of women may benefit other strategies such as longer courses of antibiotics or additional agents or IUD removal and retreatment. Our group is continuing to research this.
MedicalResearch.com: Is there anything else you would like to add? Any disclosures?
Response: We have developed resources available at https://www.mshc.org.au/Bacterial-vaginosis-in-focus for consumers and health professionals, to support them with this treatment strategy.
It’s important to recognise that this is a paradigmshift in how BV is discussed between patients and their treating clinicians. When recruiting for the trial, we used language like “couples share bacteria during sex that can be both good and bad” and that “partner-treatment is a strategy that can reduce BV recurrence for the female partner”. We recognise that for men without symptoms, taking medication can be confusing, but through this study we have shown that treating BV can be seen as a shared responsibility.
No disclosures
Citation:
Male-Partner Treatment to Prevent Recurrence of Bacterial Vaginosis
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Last Updated on March 6, 2025 by Marie Benz MD FAAD