Nonspermicide fit-free diaphragm trial reported.
The standard technique of diaphragm fitting and the use of spermicide with diaphragms have been challenged by Edward Stim, a physician who developed and tested a nonspermicide fitfree disphragm (NFFD) method.  He suggested that the main cause of diaphragm failure was erratic use, and that occasional nonuse was a result of the irritations caused by overly large diaphragms, the messiness of spermicides, and the need to anticipate intercourse in order to place the diaphragm in advance.  From 1974-79, Stim prescribed the Koroflex diaphragm with a rim diameter of 60 mm for all his patients requesting diaphragm contraception.  He believed the 1 size produced "an efficient sperm-blocking obstruction in virtually all women."  Stim deemphasized spermicide use while carefully instructing the women on correctdiaphragm placement and advising continual use of the device.  He reported a high rate of effectiveness for a barrier method, with 1.1 pregnancies/100 woman-years of use.  Failure rates ranging from 2-19% have been reported for users of conventional diaphragms with spermicide.  In 1981, the Marie Stopes House in London undertook a study to determine the failure rate for the NFFD as compared to that reported for the conventional diaphragm, to ascertain acceptability of NFFD to women and their partners, and to determine whether NFFD offered significant practical advantages for service delivery.  Family Health International assisted in the analysis of data.  The incidence of pregnancy in the Marie Stopes study was much higher than had been previously reported.  A total of 39 (35.5%) of the women remained in the study discontinued use of the NFFD within a 12-month period, 20 (18.2%) because they become pregnant.  Of 110 women enrolled in the trial, 22 (20%) were lost to follow-up.  The 2nd most common reason for termination of NFFD use was "personal reasons," including lack of confidence in the method.  In spite of the reported pregnancy rate of 24.1/100 women at 12 months, a high level of acceptability of the NFFD was demonstrated among the women who had used it successfully.  In fact, 48 (43.6%) women refused to discontinue use of the method even after being told of the high risk of pregnancy.  Although the diaphragm is a proven contraceptive method, research remains to be done in this area.  The NFFD study was not able to distinguish whether lack of fit or nonuse of spermicides caused the failures.  A next step may be a small  controlled trial of fitted diaphragms with and without spermicides.
D001723:Birth Rate; D003267:Contraception; D003268:Contraception Behavior; D003270:Contraceptive Agents; D003271:Contraceptive Agents, Female; D003274:Contraceptive Devices, Female; D003933:Diagnosis; D005069:Evaluation Studies as Topic; D005193:Family Planning Services; D010342:Patient Acceptance of Health Care; D018873:Pregnancy Rate; D013089:Spermatocidal Agents; D013812:Therapeutics
D003270:Contraceptive Agents; D003271:Contraceptive Agents, Female; D013089:Spermatocidal Agents
Barrier Methods; Contraception; Contraception Failure; Contraception Termination; Contraceptive Agents; Contraceptive Agents, Female; Contraceptive Effectiveness; Contraceptive Methods; Contraceptive Usage; Examinations And Diagnoses; Family Planning; Fertility Measurements; Fitting; Method Acceptability; Pregnancy Rate; Spermicidal Contraceptive Agents; Treatment; Use-effectiveness; Vaginal Barrier Methods; Vaginal Diaphragm