Condom use to enhance regression of cervical intraepithelial neoplasia: study protocol for a randomized controlled trial

Malene Skorstengaard, Julie Suhr, Elsebeth Lynge, Malene Skorstengaard, Julie Suhr, Elsebeth Lynge

Abstract

Background: Condom 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/design: This 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.

Discussion: If 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 registration: ClinicalTrials.gov, NCT02907333 . Registered on 14 September 2016.

Keywords: CIN2; Cervical lesions; condom use; regression rate.

Conflict of interest statement

EL is the principal investigator of another randomized controlled trial for which Roche provides HPV test kits. MS and JS have nothing to declare.

Figures

Fig. 1
Fig. 1
SPIRIT diagram of the project stages. CIN2 Cervical intraepithelial neoplasia grade 2
Fig. 2
Fig. 2
SPIRIT flowchart of the project design. CIN2 Cervical intraepithelial neoplasia grade 2

References

    1. Sundhedsstyrelsen. Screening for livmoderhalskræft - anbefalinger. Vol. 57. [In Danish] Statens Institut for Folkesundhed. 2012. Available at: . Accessed 18 July 2019.
    1. Lynge E, Skorstengaard M, Lübker CL, Thamsborg L. HPV-vaccination impact in Denmark: is the vaccine working? Expert Rev Vaccines. 2018;17(9):1–3. doi: 10.1080/14760584.2018.1509001.
    1. DKLS. Dansk Kvalitetsdatabase for Livmoderhalskræftscreening Årsrapport 2015. [In Danish] 2016;(september):1–125. Available at: . Accessed 18 July 2019.
    1. Skorstengaard M, Thamsborg LH, Lynge E. Burden of HPV-caused cancers in Denmark and the potential effect of HPV-vaccination. Vaccine. 2017;35(43):5939–5945. doi: 10.1016/j.vaccine.2017.08.062.
    1. Nøhr B, Tabor A, Frederiksen K, Kjær SK. Loop electrosurgical excision of the cervix and the subsequent risk of preterm delivery. Acta Obstet Gynecol Scand. 2007;86(5):596–603. doi: 10.1080/00016340701279145.
    1. DSOG guideline. Udredning, behandling og kontrol af cervikal dysplasi. [In Danish]. 2012;1–30. Available at: . Accessed 18 July 2019.
    1. Walboomers J, Jacobs M, Manos M, Bosch F, Kummer J, Shah K, et al. Human Papillomavirus Is a Necessary Cause of Invasive Cervical Cancer Worldwide. J Pathol. 1999;19(May):12–19. doi: 10.1002/(SICI)1096-9896(199909)189:1<12::AID-PATH431>;2-F.
    1. Tota JE, Chevarie-Davis M, Richardson LA, DeVries M, Franco EL. Epidemiology and burden of HPV infection and related diseases: Implications for prevention strategies. Prev Med (Baltim) 2011;53(SUPPL. 1):S12–S21. doi: 10.1016/j.ypmed.2011.08.017.
    1. Stanley M. Immune responses to human papillomavirus. Vaccine. 2006;24(SUPPL. 1):16–22. doi: 10.1016/j.vaccine.2005.09.002.
    1. Winer RL, Hughes JP, Feng Q, O’Reilly S, Kiviat NB, Holmes KK, et al. Condom Use and the Risk of Genital Human Papillomavirus Infection in Young Women. N Engl J Med. 2006;354(25):2645–2654. doi: 10.1056/NEJMoa053284.
    1. Manhart LE, Koutsky LA. Do Condoms Prevent Genital HPV Infection, External Genital Warts, or Cervical Neoplasia? A meta-analysis. Sex Transm Dis. 2002;29(11):725–735. doi: 10.1097/00007435-200211000-00018.
    1. Lam JUH, Rebolj M, Dugué P-A, Bonde J, von Euler-Chelpin M, Lynge E. Condom use in prevention of Human Papillomavirus infections and cervical neoplasia: systematic review of longitudinal studies. J Med Screen. 2014;21(1):38–50. doi: 10.1177/0969141314522454.
    1. Wang X, Zhuang J, Wu K, Xu R, Li M, Lu Y. Human semen: The biological basis of sexual behaviour to promote human papillomavirus infection and cervical cancer. Med Hypotheses. 2010;74(6):1015–1016. doi: 10.1016/j.mehy.2010.01.009.
    1. Kelly RW. Contraception: Immunosuppressive mechanisms in semen: Implications for contraception. Hum Reprod. 1995;10(7):1686–1693. doi: 10.1093/oxfordjournals.humrep.a136156.
    1. Kelly RW. Prostaglandins in primate semen: Biasing the immune system to benefit spermatozoa and virus? Prostaglandins Leukot Essent Fat Acids. 1997;57(2):113–118. doi: 10.1016/S0952-3278(97)90000-4.
    1. Hogewoning CJA, Bleeker MCG, Van Den Brule AJC, Voorhorst FJ, Snijders PJF, Berkhof J, et al. Condom use promotes regression of cervical intraepithelial neoplasia and clearance of human papillomavirus: A randomized clinical trial. Int J Cancer. 2003;107(5):811–816. doi: 10.1002/ijc.11474.
    1. Munk AC, Gudlaugsson E, Malpica A, Fiane B, Løvslett KI, Kruse AJ, et al. Consistent Condom Use Increases the Regression Rate of Cervical Intraepithelial Neoplasia 2-3. PLoS One. 2012;7(9):5–9. doi: 10.1371/journal.pone.0045114.
    1. Chih HJ, Lee AH, Colville L, Xu D, Binns CW. Condom and oral contraceptive use and risk of cervical intraepithelial neoplasia in Australian women. J Gynecol Oncol. 2014;25(3):183–187. doi: 10.3802/jgo.2014.25.3.183.
    1. Bjerregaard B, Larsen OB. The Danish pathology register. Scand J Public Health. 2011;39(7):72–74. doi: 10.1177/1403494810393563.
    1. Van Duin M, Snijders PJF, Schrijnemakers HFJ, Voorhorst FJ, Rozendaal L, Nobbenhuis MAE, et al. Human papillomavirus 16 load in normal and abnormal cervical scrapes: An indicator of CIN II/III and viral clearance. Int J Cancer. 2002;98(4):590–595. doi: 10.1002/ijc.10232.
    1. Chan A-W, Tetzlaff J, Altman D, Laupacis A. SPIRIT 2013 Statement: Defining standard protocol items for clinical trials. Ann Intern Med. 2013;158(3):200–207. doi: 10.7326/0003-4819-158-3-201302050-00583.
    1. Chai S, Yao B, Xu L, Wang D, Sun J, Yuan N, et al. The effect of diabetes self-management education on psychological status and blood glucose in newly diagnosed patients with diabetes type 2. Patient Educ Couns. 2018;101:1427–1432. doi: 10.1016/j.pec.2018.03.020.
    1. Nelson LA, Wallston KA, Kripalani S, Greevy RA, Jr, Elasy TA, Bergner EM, et al. Mobile Phone Support for Diabetes Self-Care Among Diverse Adults: Protocol for a Three-Arm Randomized Controlled Trial. JMIR Res Protoc. 2018;7(4):e92. doi: 10.2196/resprot.9443.
    1. Price D, Keininger DL, Viswanad B, Gasser M, Walda S, Gutzwiller FS. Factors associated with appropriate inhaler use in patients with COPD – lessons from the REAL survey. Int J COPD. 2018;13:695–702. doi: 10.2147/COPD.S149404.
    1. Squires SI, Boal AJ, Lamont S, Naismith GD. Implementing a self-management strategy in inflammatory bowel disease (IBD): Patient perceptions, clinical outcomes and the impact on service. Frontline Gastroenterol. 2017;8(4):272–278. doi: 10.1136/flgastro-2017-100807.
    1. Schmidt M, Schmidt SA, Sandegaard JL, Ehrenstein V, Pedersen L, Sorensen HT. The Danish National Patient Registry: a review of content, data quality, and research potential. Clin Epidemiol. 2015;7:449–490. doi: 10.2147/CLEP.S91125.
    1. Sharp L, Day N, Marteau T, Parmar M, Patnick J, Woodman C. Biopsy and selective recall compared with immediate large loop excision in management of women with low grade abnormal cervical cytology referred for colposcopy: Multicentre randomised controlled trial. BMJ. 2009;339(7716):330.

Source: PubMed

Sponzoři a spolupracovníci

Zdravotní podmínky

Drogové intervence

3
Předplatit