OBJECTIVE: Nonlubricated plastic specula can adhere to the vaginal introitus and cause discomfort with pelvic examination. We wanted to see if application of water-soluble gel lubricant to the plastic vaginal speculum would change the unsatisfactory cervical cytology diagnosis rate. METHODS:Five public health family planning clinic sites were randomized to either water-soluble gel or water only as lubricant during speculum examination for cervical cytology collection. The pathologists were unaware of the assignment of lubricant use. The cumulative rates of cervical cytology diagnoses were calculated for 6 months before, 6 months during, and 6 months after the intervention. RESULTS:From July 1998 through December 1999, 8534 Papanicolaou smears were collected, with 1440 using gel lubrication from January 1999 through June 1999. Rates of unsatisfactory smears for lubricant use clinics were 1.4% during use of lubricant and 1.4% without use (odds ratio [OR] 1.0; 95% confidence interval [CI] 0.6, 1.8). Rates of unsatisfactory smears for lubricant use versus nonlubricant use clinics during the gel intervention period were 1.4% versus 1.3% (OR 1.1; 95% CI 0.6, 2.0). There were no significant differences for the rates of atypical squamous cells of undetermined significance, low-grade squamous intraepithelial lesion, high-grade squamous intraepithelial lesion, or atypical glandular cells of undetermined significance within or between lubricant and nonlubricant clinics for each 6-month period. There were no cases of invasive cancer. CONCLUSION: The use of a small amount of water-soluble gel lubricant on the outer inferior blade of the plastic vaginal speculum does not change cervical cytology results in a young, reproductive-age population.
RCT Entities:
OBJECTIVE: Nonlubricated plastic specula can adhere to the vaginal introitus and cause discomfort with pelvic examination. We wanted to see if application of water-soluble gel lubricant to the plastic vaginal speculum would change the unsatisfactory cervical cytology diagnosis rate. METHODS: Five public health family planning clinic sites were randomized to either water-soluble gel or water only as lubricant during speculum examination for cervical cytology collection. The pathologists were unaware of the assignment of lubricant use. The cumulative rates of cervical cytology diagnoses were calculated for 6 months before, 6 months during, and 6 months after the intervention. RESULTS: From July 1998 through December 1999, 8534 Papanicolaou smears were collected, with 1440 using gel lubrication from January 1999 through June 1999. Rates of unsatisfactory smears for lubricant use clinics were 1.4% during use of lubricant and 1.4% without use (odds ratio [OR] 1.0; 95% confidence interval [CI] 0.6, 1.8). Rates of unsatisfactory smears for lubricant use versus nonlubricant use clinics during the gel intervention period were 1.4% versus 1.3% (OR 1.1; 95% CI 0.6, 2.0). There were no significant differences for the rates of atypical squamous cells of undetermined significance, low-grade squamous intraepithelial lesion, high-grade squamous intraepithelial lesion, or atypical glandular cells of undetermined significance within or between lubricant and nonlubricant clinics for each 6-month period. There were no cases of invasive cancer. CONCLUSION: The use of a small amount of water-soluble gel lubricant on the outer inferior blade of the plastic vaginal speculum does not change cervical cytology results in a young, reproductive-age population.
Authors: Jennifer Potter; Sarah M Peitzmeier; Ida Bernstein; Sari L Reisner; Natalie M Alizaga; Madina Agénor; Dana J Pardee Journal: J Gen Intern Med Date: 2015-07-10 Impact factor: 5.128