Article Text
Abstract
Objective To assess the short-term acceptability, aspects of use and user satisfaction with the Oves® cap.
Design, setting and subjects A multicentre observational study, commissioned by Veos Ltd, manufacturers of the Oves® cap, was carried out by the UK Family Planning and Reproductive Health Research Network in collaboration with the Institute of Population Studies, University of Exeter, Exeter, UK. Women from ten Network centres and one collaborating centre were invited to participate. Following an assessment by vaginal examination women were fitted with the cap and taught self-fitting by a doctor. The women were asked to use the cap six times in 8 weeks. Participants were asked to complete four questionnaires on various aspects of cap use including Likert-type measures and open-ended questions on experiences with the cap. Doctors were asked to complete a first visit and follow-up questionnaires. Women were self-selected clients in the participating centres. Women aged 18 years and over, gynaecologically healthy, using hormonal contraception or sterilised were eligible for the study. Thirty-five women were enrolled and fitted with the cap; 20 chose to participate in the study.
Main outcome measures Ease of fitting and removal of the cap expressed in structured and open-ended questions by both cap users and doctors; satisfaction of women and partners with the cap, measured by desire to use the cap in the future and by premature withdrawal from the trial.
Results Twenty women used the cap on a total of 84 occasions. Four women completed the trial of six uses. While most doctors did not have difficulty with fittings or removals, 10/20 Oves® cap users reported some difficulty in fitting it over the cervix and 12 reported some difficulty removing it in the first three uses. Fewer women had difficulty in fitting in uses 4-6 but nearly half continued to have some difficulty with removals.
Conclusions Few women indicated that they would use the cap in the future. However, most women were satisfied with their current method of contraception. The study raises the question whether women using non-barrier methods of contraception and satisfied with their current method of contraception are the appropriate target recruits for a trial such as this, even in the absence of robust efficacy data.