title: The clinical acceptability of a non-medicated vaginal ring.
abstract: In an open study the acceptability of a newly designed vaginal ring was evaluated. The ring, being developed for contraceptive purposes, was made of Silastic and did not contain any medication. Three groups of 10 healthy female volunteers were selected after informed consent. The 6 nulliparous and 24 parous women were equally distributed over the 3 groups. The volunteers were instructed to insert the ring as high in the vagina as possible. In each group a ring of a different stiffness was used for 3 cycles. The first cycle started with the insertion of the ring on day 5 of the menstrual cycle or on the day oral contraception was started. Each cycle consisted of 21 days of vaginal ring use, followed by a 7-day ring-free interval. Expulsions, reasons for removal and complaints were recorded. Vaginal cultures were obtained before insertion and after the third cycle. The vaginal ring was well accepted. There were no differences between the three groups of women using rings of different stiffness. Twenty-two women completed all 3 cycles. Four women (3 nulliparous) stopped after one day. One of the nulliparous women who stopped after one day complained of expulsions, the only one in the study. The 4 women who stopped after a longer period were all parous. In the first cycle several women complained of vaginal discharge, coital problems or foreign body feeling. The complaints decreased in the second cycle and almost disappeared in the third. The rings had no influence on the vaginal flora.
authors.affiliation: Department of Obstetrics and Gynecology, St. Elisabeth Clinic, Heerlen, The Netherlands.
authors.forename: F
authors.initials: F
authors.lastname: Roumen
authors.forename: T
authors.initials: T
authors.lastname: Dieben
authors.forename: R
authors.initials: R
authors.lastname: Assendorp
authors.forename: P
authors.initials: P
authors.lastname: Bouckaert
mesh_terms: D000328:Adult; D003273:Contraceptive Devices; D005260:Female; D006801:Humans; D010342:Patient Acceptance of Health Care; D010352:Patient Dropouts; D014623:Vaginal Diseases / Q000209:etiology