Lea's Shield (R) contraceptive device: pilot study of its short-term patient acceptability and aspects of use

Objective: To assess the short term patient acceptability and aspects of us e of the Lea's Shield(R). Design: Observational study. Ten women were each invited to use the Lea's S hield on 10 occasions and to report their observations and experiences on s tructured questionnaires after each use. Thus, data on a maximum of 100 use s would become available for analysis. Answers were recorded on numerical s cales and in descriptive terms. On conclusion of their study participation, patients and their partners were required to document their overall experi ence with the product. Setting and subjects: Women aged 18 to 40 years, self-selected from clients attending the Margaret Pyke Family Planning Centre. They had to be in a st able monogamous relationship, gynaecologically healthy and willing to conti nue their use of oral contraceptives, IUD, or injectable. Main outcome measure: Ability to use the method without formal teaching, as sessed after vaginal examination by the investigator at end of first visit User satisfaction as expressed in structured questionnaires and by prematur e withdrawal from trial. Results: Ten women used Lea's Shield on a total of 70 occasions, of which 4 6(66 per cent) were associated with sexual intercourse. Five subjects withd rew from the trial prematurely on account of discomfort to either or both p artners (four), and recurrent cystitis (one). At the enrolment visit, all b ut one woman inserted the device correctly without formal teaching, but the re was considerable inter-patient variation in their responses concerning e ase of insertion/removal, and comfort during subsequent uses. Conclusions: These preliminary observations suggest that the Lea's Shield m ay be acceptable to a highly select minority of women. However much more re search is required to permit a reliable assessment of its acceptability to the wirier public. The product's potential for causing pain and discomfort also needs further exploration.