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Effect of Replens Gel Used with a Diaphragm on Tests for Human Papillomavirus and Other Lower Genital Tract Infections

Smith-McCune, Karen K. MD, PhD1; Tuveson, Jennifer L. BS1; Rubin, Mary M. RN, PhD1; Da Costa, Maria M. BS2; Darragh, Teresa M. MD3; Shiboski, Stephen C. PhD4; Van Der Pol, Barbara BS. MPH5; Moscicki, Anna-Barbara MD6; Palefsky, Joel M. MD2; Sawaya, George F. MD1,4

Journal of Lower Genital Tract Disease:
doi: 10.1097/01.lgt.0000225889.13916.c6
Original Articles
Abstract

Objective. Little is known about effects of vaginal lubricants with barrier contraceptives on detection of sexually transmissible infections. We hypothesized that Replens gel used with a diaphragm would neither inhibit human papillomavirus (HPV) detection in cervical samples and chlamydia (CT) and gonorrhea (GC) detection in urine samples, nor affect cervical cytology quality.

Materials and Methods. After a clinician-collected cervical sample and a self-collected vaginal sample for HPV detection ("pregel" specimens), women placed a diaphragm containing Replens gel into the vagina. Participants (n = 77) removed the diaphragm after 6 hours and performed vaginal HPV self-sampling at several time points thereafter. Clinicians performed cervical cytology sampling and HPV testing ("postgel" specimens) 24 hours after diaphragm removal. Pregel and postgel specimens were analyzed with and without added SiHa cells (source of defined numbers of HPV16 genomes). HPV was detected by polymerase chain reaction using MY09/11 primers. Urine samples were obtained for CT and GC testing. Proportions of samples testing positive were compared using relative risk (RR) regression models.

Results. Proportions with detectable HPV in the clinician-collected cervical pregel and postgel samples were not statistically different for samples with added SiHa cells (88.3% vs 93.2%, RR = 1.06, 95% confidence interval = 0.96-1.14) or for native HPV infection (32.9% vs 28.2%, RR = 0.87, 95% confidence interval = 0.71-1.06). In self-collected vaginal postgel samples, there was no trend for decreased HPV detection after gel exposure. Gel affected neither urine tests for CT and GC nor cytological quality.

Conclusions. Recent Replens gel use with a diaphragm does not inhibit cervical HPV testing, urine testing for CT and GC, or cervical cytology quality.

In Brief

Recent Replens gel use with a diaphragm does not appear to inhibit human papillomavirus testing or urine testing for chlamydia and gonorrhea.

Author Information

1Department of Obstetrics, Gynecology and Reproductive Sciences, University of California San Francisco, San Francisco, CA, 2Department of Medicine, University of California San Francisco, San Francisco, CA, 3Department of Pathology, University of California San Francisco, San Francisco, CA, and 4Department of Epidemiology and Biostatistics, University of California San Francisco, San Francisco, CA, 5Division of Infectious Diseases, Indiana University School of Medicine, Indianapolis, IN, and 6Department of Pediatrics, University of California San Francisco, San Francisco, CA

Reprint requests to: Karen K. Smith-McCune MD, PhD, 2340 Sutter Street, Room S331, University of California San Francisco, San Francisco, CA 94143-0128 (zip for FedEx 94115). E-mail:kmccune@cc.ucsf.edu

Supported by The Bill and Melinda Gates Foundation and the General Clinical Research Center at UCSF through the National Center for Research Resources grant M01-RR-00079.

©2006The American Society for Colposcopy and Cervical Pathology