A pilot study of vaginal flora changes with randomization to cessation of douching.

OBJECTIVES: The objectives of this study were to determine whether women who douche regularly would enter a randomized trial of douching cessation or continuation, whether they would adhere to the assigned behavior, and whether there was a dramatic impact on vaginal flora. GOAL: The goal of this study was to determine the feasibility of a large, definitive trial of douching cessation. STUDY
DESIGN: Women who douched at least weekly and who had either bacterial vaginosis or normal flora by Gram stain were assigned at random either to continue douching or to stop for 8 weeks. Vaginal Gram stains were obtained every 7 days from each woman.
RESULTS: Forty-eight women were randomized. Those assigned to continue reported douching during 77% of study weeks; those assigned to stop denied douching in 94% of weeks. No dramatic differences in flora were observed between women in the continue versus stop groups.
CONCLUSION: A large randomized trial of douching cessation is feasible.

RCT Entities:   Population Interventions Outcomes