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

To assess the short term patient acceptability and aspects of use of the Lea's Shield(R).

Observational study. Ten women were each invited to use the Lea's Shield on 10 occasions and to report their observations and experiences on structured questionnaires after each use. Thus, data on a maximum of 100 uses would become available for analysis. Answers were recorded on numerical scales and in descriptive terms. On conclusion of their study participation, patients and their partners were required to document their overall experience with the product.

Women aged 18 to 40 years, self-selected from clients attending the Margaret Pyke Family Planning Centre. They had to be in a stable monogamous relationship, gynaecologically healthy, and willing to continue their use of oral contraceptives, IUD, or injectable.

Ability to use the method without formal teaching, assessed after vaginal examination by the investigator at end of first visit. User satisfaction, as expressed in structured questionnaires and by premature withdrawal from trial.

Ten women used Lea's Shield on a total of 70 occasions, of which 46(66 per cent) were associated with sexual intercourse. Five subjects withdrew from the trial prematurely on account of discomfort to either or both partners (four), and recurrent cystitis (one). At the enrolment visit, all but one woman inserted the device correctly without formal teaching, but there was considerable inter-patient variation in their responses concerning ease of insertion/removal, and comfort during subsequent uses.

These preliminary observations suggest that the Lea's Shield may be acceptable to a highly select minority of women. However, much more research is required to permit a reliable assessment of its acceptability to the wider public. The product's potential for causing pain and discomfort also needs further exploration.