Mags Beksinska1, Jenni Smit2, Ross Greener3, Gilda Piaggio4, Carol Joanis5. 1. MatCH Research (Maternal, Adolescent and Child Health Research), Department of Obstetrics and Gynaecology, Faculty of Health Sciences, University of the Witwatersrand, Durban, South Africa; Faculty of Epidemiology and Population Health, London School of Hygiene and Tropical Medicine, Keppel Street, London WC1E, UK. Electronic address: mbeksinska@matchresearch.co.za. 2. MatCH Research (Maternal, Adolescent and Child Health Research), Department of Obstetrics and Gynaecology, Faculty of Health Sciences, University of the Witwatersrand, Durban, South Africa; School of Pharmacy and Pharmacology, Faculty of Health Sciences, University of KwaZulu-Natal, Durban, South Africa. 3. MatCH Research (Maternal, Adolescent and Child Health Research), Department of Obstetrics and Gynaecology, Faculty of Health Sciences, University of the Witwatersrand, Durban, South Africa. 4. Faculty of Epidemiology and Population Health, London School of Hygiene and Tropical Medicine, Keppel Street, London WC1E, UK. 5. Joanis Consulting, 120 Chastain Road NW, Unit 1305, Kennesaw, GA 30144, USA.
Abstract
BACKGROUND:Male and female condom (FC) functional performance failure declines with user experience. With the recent availability of a wider range of FCs, it is important to know if women with experience in using one type of FC are more proficient in using another type, even if the FC design is quite different. STUDY DESIGN: A randomized, noninferiority crossover clinical trial assessed the function of four FCs (FC2, Woman's Condom, Cupid and VA w.o.w) among 300 women in Durban, South Africa. FC functional failure (breakage, slippage, invagination and misdirection) by condom type and use period was investigated in women using five FCs of each type (20 FC uses in total). RESULTS: Of the 5364 condoms used during intercourse by 272 women, 200 clinical failures occurred in 195 condoms (190 condoms had one failure, and 5 had two failures). Total clinical failure was comparable across FC types. Of the 195 condoms in which failures occurred, the number of failures in the first condom use period was 103 (7.7%), decreasing to 43 events (3.2%) in the second, 33 (2.5%) in the third and 16 (1.2%) in the fourth. Only 2 failures were reported in the 20th use of an FC compared to 29 in the first use, irrespective of condom type. CONCLUSIONS:FC failure rates decreased markedly after use of the first five condoms regardless of FC type and continued to fall across the next three use periods. IMPLICATIONS: FC failure rates decrease over 20 uses, regardless of FC condom type used. The decrease is higher at the beginning of use, indicating that improvement is greatest after the first five uses.
RCT Entities:
BACKGROUND: Male and female condom (FC) functional performance failure declines with user experience. With the recent availability of a wider range of FCs, it is important to know if women with experience in using one type of FC are more proficient in using another type, even if the FC design is quite different. STUDY DESIGN: A randomized, noninferiority crossover clinical trial assessed the function of four FCs (FC2, Woman's Condom, Cupid and VA w.o.w) among 300 women in Durban, South Africa. FC functional failure (breakage, slippage, invagination and misdirection) by condom type and use period was investigated in women using five FCs of each type (20 FC uses in total). RESULTS: Of the 5364 condoms used during intercourse by 272 women, 200 clinical failures occurred in 195 condoms (190 condoms had one failure, and 5 had two failures). Total clinical failure was comparable across FC types. Of the 195 condoms in which failures occurred, the number of failures in the first condom use period was 103 (7.7%), decreasing to 43 events (3.2%) in the second, 33 (2.5%) in the third and 16 (1.2%) in the fourth. Only 2 failures were reported in the 20th use of an FC compared to 29 in the first use, irrespective of condom type. CONCLUSIONS:FC failure rates decreased markedly after use of the first five condoms regardless of FC type and continued to fall across the next three use periods. IMPLICATIONS: FC failure rates decrease over 20 uses, regardless of FC condom type used. The decrease is higher at the beginning of use, indicating that improvement is greatest after the first five uses.
Authors: Beatrice A Chen; Diana L Blithe; Gitonga R Muraguri; Audrey A Lance; Bruce R Carr; Jeffrey T Jensen; Thomas D Kimble; Amitasrigowri S Murthy; Courtney A Schreiber; Michael A Thomas; Terri L Walsh; Carolyn Westhoff; Anne E Burke Journal: Contraception Date: 2019-03-06 Impact factor: 3.375