By Stan Deresinski, MD, FACP, FIDSA
Synopsis: In a randomized trial, treatment of the regular male partner with oral and topical agents was strongly associated with a reduced risk of recurrence of bacterial vaginosis in the female partner.
Souce: Vodstrcil LA, Plummer EL, Fairley CK, et al; StepUp Team. Male-partner treatment to prevent recurrence of bacterial vaginosis. N Engl J Med. 2025;392(10):947-957.
Vodstrcil and colleagues conducted an open-label, randomized clinical trial to determine whether treatment of male partners is associated with a reduced rate of recurrence of bacterial vaginosis in the female partners.
The investigators screened premenopausal women and identified those with symptoms of bacterial vaginosis as determined using the Amsel criteria and the Nugent score. The Amsel criteria include a homogenous vaginal discharge, vaginal pH > 4.5, positive amine test (fishy odor), and the presence of clue cells. The Nugent score assesses the vaginal microbiota. The women must have had a regular male partner for ≥ 8 weeks and have been able to receive first-line treatment: oral metronidazole or intravaginal clindamycin cream or metronidazole gel. Those deemed eligible were asked to refer their regular partner within the next week. Among the exclusion criteria were having other current sexual partners, being a sex worker, and having known human immunodeficiency virus (HIV) infection.
Male partners randomized to the partner-treatment group received metronidazole 400 mg twice daily for seven days and were to apply 2% clindamycin cream to the glans penis and upper shaft twice daily for seven days. Placebo was not used in the non-treatment group. Of the 164 couples, 83 were assigned to the control group and 81 were assigned to the partner-treatment group.
The data safety and monitoring board stopped the trial after completion of 12 weeks of follow-up by 150 patients because of apparent inferiority of the group without male treatment.
Recurrence of vaginosis, the primary efficacy outcome, occurred 23/69 (35%) in the partner treatment group for a recurrence rate of 1.6 per person-year (95% confidence interval [CI], 1.1 to 2.4), while in the control group the rate was 4.2 per person-year (95% CI, 3.2 to 5.7). These results corresponded to an absolute risk difference of -2.6 recurrences per person-year (95% CI, -4.0 to -1.2; P < 0.001). The treatment was well tolerated, although nausea, headache, and dysgeusia (metallic taste) were reported.
Commentary
Bacterial vaginosis is associated with vaginal dysbiosis with decreased Lactobacillus concentrations along with an increase in anaerobic bacteria. It is the most common cause of vaginal discharge in women of reproductive age. Furthermore, more than 50% of women have recurrent illness after treatment of bacterial vaginosis.
There has been an ongoing argument about whether it should be considered a sexually transmitted disease, and the results of this trial by Vodstrcil and colleagues strongly support this position. Treatment of regular male partners now should be part of the routine management of bacterial vaginosis.
Stan Deresinski, MD, FACP, FIDSA, is Clinical Professor of Medicine, Stanford University.
In a randomized trial, treatment of the regular male partner with oral and topical agents was strongly associated with a reduced risk of recurrence of bacterial vaginosis in the female partner.
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