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Pubmed for Handhelds

PUBMED FOR HANDHELDS

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  • Title: Lea's Shield contraceptive device: pilot study of its short-term patient acceptability and aspects of use.
    Author: Bounds W, Guillebaud J.
    Journal: Br J Fam Plann; 1999 Jan; 24(4):117-20. PubMed ID: 10023094.
    Abstract:
    OBJECTIVE: To assess the short term patient acceptability and aspects of use of the Lea's Shield(R). DESIGN: 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. 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 stable monogamous relationship, gynaecologically healthy, and willing to continue their use of oral contraceptives, IUD, or injectable. MAIN OUTCOME MEASURE: 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. RESULTS: 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. CONCLUSIONS: 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. The cup-shaped, reusable, one-size Lea's Shield barrier contraceptive is commercially available in Canada and a few European countries. In advance of its introduction to the UK, a study was conducted to assess the short-term acceptability of this device. Enrolled were 10 clients 18-40 years of age from the Margaret Pyke Family Planning Center in London, England, who used the device a total of 70 times, 46 of which were associated with sexual intercourse. Nine women inserted the device correctly on the basis of reading the manufacturer's instructions. However, five women reported continued problems with insertion and seven found removal to be difficult, suggesting a need for formal instruction in use of the device. Ease of insertion, ease of removal, and female comfort scores fluctuated widely between both participants and episodes of use, with no trend of progressive improvement over time. Four women discontinued the trial because of discomfort to themselves and/or their partner and another women withdrew because of recurrent cystitis. These generally negative responses may impact on the product's use effectiveness.
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