Effectiveness of the non-spermicidal fit-free diaphragm.

Standard instructions for diaphragm use call for an individually sized latex diaphragm, used in conjunction with spermicide jelly. However, some investigators have reported that the diaphragm can be effective without a spermicide. A non-randomized trial designed to measure the contraceptive effectiveness of the diaphragm used without spermicide was conducted. A total of 110 self-selected women were enrolled to use a non-spermicide fit-free (60mm) diaphragm for a period of one year. They were advised to wear the diaphragm continuously, removing it once each day for washing but not within six hours after intercourse. Product-related problems related to insertion, retention and removal were few at both the 6- and 12-month follow-up visits, most commonly odor. The 12-month life table accidental pregnancy rate during typical use was 24.1 per 100 women (29.5 per 100 women without female barrier experience and 17.9 per 100 women with barrier experience). Over 85% of the women who returned for follow-up visits reported using the diaphragm during every act of intercourse. Until better data refute the traditional recommendations, users should be advised to add spermicide to fitted latex diaphragms.