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. 2025 May 26:10.1097/OLQ.0000000000002184.
doi: 10.1097/OLQ.0000000000002184. Online ahead of print.

Bacterial vaginosis incidence following a single hyperosmolal vaginal lubricant exposure: A comparison of two observational cohorts

Sarah E Brown, Xin He  1 , Laurence Magder  2 , Elizabeth D Johnston  3 , Daniel Morgan  2 , Jacques Ravel, Katrina Mark  4 , Khalil G Ghanem  5 , Rebecca M Brotman
Affiliations

Bacterial vaginosis incidence following a single hyperosmolal vaginal lubricant exposure: A comparison of two observational cohorts

Sarah E Brown et al. Sex Transm Dis. .

Abstract

Background: Hyperosmolal lubricants may negatively affect the vaginal microenvironment, increasing the risk for bacterial vaginosis (BV). We compared the incidence of Amsel-defined BV in reproductive-age women exposed to hyperosmolal lubricant during transvaginal ultrasound to those without recent lubricant exposure.

Methods: We analyzed two observational cohorts over 10 weeks: 58 lubricant-exposed women from the Gynecology and Lubricants Effects study and 59 lubricant-unexposed women from a University of Alabama Birmingham cohort linked to the University of Maryland Human Microbiome Project. BV was diagnosed using Amsel criteria at baseline, mid-study (lubricant-exposed: week 2, lubricant-unexposed: week 5), and final visit (week 10), and categorized by symptomatology. Risks for incident BV and Amsel criteria were assessed using modified Poisson regression with robust standard errors. An additional outcome of new-onset/newly-symptomatic BV included those with baseline asymptomatic BV. A secondary analysis focused on Black participants (N = 73) due to an observed higher BV incidence.

Results: Baseline demographics and behaviors were similar between the cohorts. Among all participants, lubricant was not associated with new-onset BV (adjusted relative risk (aRR):1.32, 95% CI:0.58-3.01). 88% (23/26) of all new-onset/newly-symptomatic BV cases occurred in Black participants. Among Black participants, exposure to lubricant doubled the risk of developing new-onset BV (aRR:2.18, 95% CI:1.16-4.11) and new-onset/newly-symptomatic BV (aRR:1.91, 95% CI: 1.04-3.51), and increased the risk for new-onset clue cells (aRR:2.18, 95% CI:1.17 - 4.06) versus no lubricant exposure.

Conclusion: Hyperosmolal lubricants was associated with BV incidence in Black women. Factors contributing to this elevated risk require further research.

Keywords: Amsel criteria; lubricants; osmolality; transvaginal ultrasound; vaginitis.

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Conflict of interest statement

Conflicts of interest / Disclosures: J.R. is co-founder of LUCA Biologics, a biotechnology company focusing on translating microbiome research into live biotherapeutics drugs for women's health. R.B.’s research is supported by in-kind donation of test kits from Hologic.

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