Abstract
BackgroundCondom use can reduce the risk of infection by human papillomavirus (HPV). Furthermore, it has been suggested that condom use can increase the regression rate of cervical lesions. In Denmark, women with cervical intraepithelial neoplasia grade 2 (CIN2) and a future wish to conceive are not treated immediately but are followed up by a gynecologist about 6 months later. The aim of this project was to determine if advising women to have their male partners to use a condom during sexual intercourse in the follow-up period can increase the regression rate of CIN2.Methods/designThis is a randomized clinical trial of women with CIN2. The intervention group was advised to use condoms between the date of diagnosis and the date of their follow-up visit. The control group received standard care. Cervical samples were tested for HPV. The primary endpoint will be the intention-to-treat analysis with the relative rate of CIN2 regression between the intervention group and the control group. Regression is defined as <CIN2 at the follow-up visit. In addition, a per-protocol analysis of the regression rate in women adhering to condom use compared with the control group will be performed. The secondary endpoint will be the HPV-clearance rate in the condom group.DiscussionIf condom use for 6 months can enhance the regression of cervical lesions, then more women can be spared conization. This is an efficient treatment of cervical lesions but is associated with an increased risk of preterm delivery.Trial registrationClinicalTrials.gov, NCT02907333. Registered on 14 September 2016.
Highlights
Condom use can reduce the risk of infection by human papillomavirus (HPV)
If condom use for 6 months can enhance the regression of cervical lesions, more women can be spared conization
If the woman is diagnosed with cervical intraepithelial neoplasia grade 2 (CIN2) and has a wish to conceive in the future, the recommendation is a follow-up visit to a gynecologist for a biopsy after 6 months
Summary
The use of self-care is increasing as an element of patient empowerment. Patients want to take part in decisions regarding their treatment and to contribute actively in optimizing the effect of treatment. According to the present guidelines from the Danish Society of Gynecology and Obstetrics [6], the decision on whether to follow up or to treat CIN2 immediately is made together with the woman. If the short-term use of condoms as tested here works as intended, women will have a choice for self-care and be able to do something active to enhance the regression rate of their cervical lesions. Expect to find an approximately 2.5 times increased regression rate in the condom group compared with the control group [16, 17] If this new larger study supports the observations from Hogewoning et al and Munk et al, we will suggest temporary condom use to be included in guidelines to enhance regression of cervical lesions
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