Objective: This study aimed to evaluate the effect of a vaginal probiotic suppository on the vaginal microenvironment among pessary users.
Study design: Women who used pessaries were randomized to vaginal probiotic suppository use versus without use. The intervention was a vaginal probiotic suppository and moisturizing vaginal gel. The vaginal microenvironment was assessed using Gram stain and Nugent's criteria at baseline and 3 months by a microbiologist blinded to group allocation. Symptoms and experience with use of the probiotic were assessed using questionnaires. The primary outcome was change in lactobacilli count on Nugent subscore at 3 months.
Results: A total of 147 postmenopausal women were randomized (86 to the intervention arm and 61 to the control arm), and 124 (87.9%) presented for a 3-month follow-up. There was no difference between the arms in age, race, body mass index, and Charlson Comorbidity Index. A majority of participants had the pessary managed by the health care professional (intervention arm vs control arm, 46 [76.7%] vs 55 [68.8%]; P = 0.30). Composition of the vaginal microenvironment did not differ with or without probiotic treatment at 3 months. Bother from vaginal symptoms, including discharge, itching, and discomfort, did not differ between arms. Adverse effects from the intervention were minor, resolved with discontinuation, and occurred at 39.1%.
Conclusion: Vaginal probiotic suppository use did not affect the composition of the vaginal microenvironment, patient satisfaction, or vaginal symptoms after 3 months of use in pessary users.
Elisabeth C Sappenfield,1 Colleen Mellen,1 Jennifer Wilcox,1 Deirdre Elizabeth O'Hanlon,2 David M O'Sullivan,3 Elena Tunitsky-Bitton1
- From the Division of Female Pelvic Medicine and Reconstructive Surgery, Department of Obstetrics and Gynecology, Hartford Hospital, Hartford, CT.
- Thermo Fisher Scientific, Baltimore, MD.
- Department of Research Administration, Hartford HealthCare, Hartford, CT.