A Prospective, Open-Label Pilot Study of Concurrent Male Partner Treatment for Bacterial Vaginosis

Area of Science:

• Microbiology
• Genitourinary Medicine
• Sexual Health

Background:

• Bacterial vaginosis (BV) frequently recurs in women after standard antibiotic treatment, with reinfection from sexual partners implicated.
• High recurrence rates of BV cause significant distress for women and place a burden on healthcare systems due to repeated treatments and potential complications.

Purpose of the Study:

• To investigate the impact of concurrent antibiotic treatment of male partners on the genital microbiota composition in heterosexual couples.
• To assess the acceptability, tolerability, and preliminary efficacy of combined oral and topical therapy for male partners of women with BV.
• To inform the design of a future randomized controlled trial (RCT) for concurrent partner treatment of BV.

Main Methods:

• A pilot study involving 34 heterosexual couples where women received standard BV antibiotic treatment and male partners received oral metronidazole plus topical clindamycin cream.
• Genital microbiota analysis using 16S rRNA gene sequencing at three sites: vaginal (women), penile skin (men), and first-pass urine (men, representing the urethra).
• Microbiota composition and BV-associated bacteria abundance were assessed immediately posttreatment and over a 12-week follow-up period.

Main Results:

• Concurrent partner treatment significantly reduced BV-associated bacteria and altered the overall genital microbiota composition in both women and men immediately posttreatment.
• Suppression of BV-associated bacteria was sustained in 81% of women over 12 weeks, despite some reemergence in male partners.
• The recurrence rate in women was 17% (95% CI, 6 to 34%), and male partners tolerated and adhered to the combination therapy.

Conclusions:

• Concurrent partner treatment demonstrates potential for improving BV treatment outcomes by altering genital microbiota composition.
• The findings support the feasibility and tolerability of combined oral and topical therapy for male partners.
• This pilot study provides a strong rationale for conducting a randomized controlled trial to evaluate the efficacy of concurrent partner treatment for reducing BV recurrence.