Evaluation of the effects of a female condom on the female lower genital tract.

The purposes of this study were to determine if use of the female condom (Reality) was traumatic to the vaginal mucosa and/or vulvar skin and to determine its effect on resident vaginal bacterial flora. Thirty subjects were randomly assigned to utilize the female condom or diaphragm during the study period. Initially and during 3 follow-up visits, each subject underwent colposcopic examination of the vagina, cervix, and vulva with photographic record, and qualitative fungal, aerobic and anaerobic cultures of the vagina. The two groups were compared with respect to the frequency of abnormal physical findings determined by both macroscopic and colposcopic examination. Visits were compared within each contraceptive group with respect to changes in resident vaginal flora. There was no evidence of significant trauma associated with the use of either contraceptive device during the study period. The resident vaginal flora did not significantly change during the three follow-up visits in patients using the female condom. In diaphragm users, lactobacilli were less frequently isolated at the third (14/15 vs 6/15, P = 0.008) and fourth (14/15 vs 7/15, P = 0.039) follow-up visits when compared to the initial visit. In addition, aerobic gram-negative rods were more frequently isolated during the fourth visit (1/15 vs 9/15, P = 0.021) when compared to the first visit. We conclude that neither the female condom (Reality) nor the diaphragm is associated with trauma to the lower genital tract. Subjects using the diaphragm undergo a significant change in vaginal bacterial flora, becoming more likely to be colonized with coliform microorganisms and less likely to maintain lactobacilli colonization.

RCT Entities:   Population Interventions Outcomes