Estimating leakage of vaginal products

Introduction Leakage is a common complaint associated with vaginal contraceptives. As part of a study of a new vaginal product called cellulose sulfate (CS), we used KY Jelly™ (KY) and Conceptrol® (Con) as controls. Subjective reports of leakage were compared with the sanitary pad weight change (PWC) after product application. This was done to determine whether this improved the clinical assessment of leakage. Methods An unused weighed pad and ziplock bag were given to the participant with the dispensed study drug. The pad was placed in the panty after product application at bed-time, worn for 10 hours, and then returned to clinic in the ziplock bag that day. Population Forty-eight healthy women volunteers in a protocol approved by the Institutional Review Board of Eastern Virginia Medical School were randomized to receive 2.5ml of KY, Con, or CS or 5ml of CS. 47 women completed the study. All participants were to abstain from intercourse during the study. Participants' mean age was 33 (range: 19-47) years. Results PWC ranged from 0.1gm to 6.2gm. The PWC showed differences between products (Table 1) using an exact test of linear by linear association. Most participants (82-92%) reported 'slight' or 'very slight' leakage similar for each group. (Table 1)TABLE 1There was little agreement between subjective leakage and pad weight change (Table 2). 3 participants with high PWC (over 2.5gm) reported no leakage and one of four reporting moderate leakage had very low PWC (0.4gm).TABLE 2Conclusions: Sanitary pad weight in this trial distinguished between different products while subject reports did not. There was little agreement between subjective reports of vaginal leakage and PWC. These results may not predict product acceptability by a consumer.