User acceptability and ease of use of the MedRing, a new personalized vaginal drug delivery and monitoring device.

BACKGROUND

The MedRing is an innovative, flexible vaginal ring that, unlike other rings, allows personalized drug administration and monitoring. This study evaluated its user acceptability and ease of use.

RESEARCH DESIGN AND

METHODS

This was an exploratory, prospective, open-label, interventional, multicenter study. Twenty-one women (25 - 75 years) used the dummy/placebo MedRing for three weeks, with insertions/removals on day 1 and after weeks 1 and 3. Participants scored design, ease of self-insertion/removal, wearing comfort, and potential future use. They also kept a daily diary, rating comfort on a 10-point scale (1 = intolerable, 10 = no problem). In addition, physicians rated ease of use and complications on a 5-point scale (1 = no problem; 5 = problematic). Safety evaluations included vaginal examinations and adverse event (AE) monitoring. Data were analyzed descriptively.

RESULTS

After three weeks, the median (min-max) overall acceptance score was 9.5 (5 - 10); insertion and removal scored 10 (8-10) and 9 (3-10), respectively. Median comfort scores ranged 8-10. The physician's ease-of-insertion/removal median score was 1 (1 - 5). Two participants discontinued due to AEs: inability to remove the ring and vaginal irritation.

CONCLUSION

The MedRing demonstrated high user acceptability and ease of use, supporting its use as a personalized, self-controlled treatment device across a wide age range.