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ORIGINAL RESEARCH |
From the Department of Obstetrics and Gynecology, University of Washington School of Medicine; and Department of Epidemiology and Biostatistics, University of Washington, Seattle, Washington.
Address reprint requests to: Anne-Marie Amies, MD, University of Washington Medical Center, Department of Obstetrics and Gynecology, Box 356460, 1959 NE Pacific Street, Seattle, WA 98195; E-mail: aamies{at}u.washington.edu.
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ABSTRACT |
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 ABSTRACT MATERIALS AND METHODSRESULTSDISCUSSIONREFERENCES |
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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.
Cervical cancer screening has dramatically decreased the rate of invasive cervical cancer. In patients screened every year from age 20 to age 64, the incidence of cervical cancer is 93% lower than in the unscreened population.1 A review of the histories of women who have died from cervical cancer revealed that 57% had not had a Papanicolaou smear in the 5 years before diagnosis, if ever.2 Investigation into why women do not present for screening cervical cytology or for colposcopic examination showed that fear of pain was a reason cited by 87% of young, reproductive-age women.3 Water-soluble gel lubrication of instruments to ease insertion has been shown to decrease pain with cystoscopy.4,5 Little has been published on the topic of vaginal speculum discomfort. One study used the subjects’ rating of pain with speculum insertion as a baseline measure for the subsequent reported pain with surgical termination of pregnancy.6 In that study, women reported pain of speculum insertion averaged 17 on a scale of 1–100, half the pain of cervical dilation. This suggests that speculum discomfort may be clinically important. The use of gel lubrication versus water only to decrease pain during speculum examination has not been studied.
Gynecology textbooks either have no mention of speculum lubrication or discourage the use of lubrication besides tap water during speculum examination. The reason for this admonition is often not cited, although some voice concern about possible interference with cytologic interpretation of the Papanicolaou smear. 7–11 A single retrospective review of 205 Papanicolaou smears, of which 96.5% were collected using gel lubricant, reported that even with a thin gel overlay adequate cytology interpretation was possible.12 To evaluate the use of lubricant gel, we proposed randomizing our clinics to evaluate the effect on cytology results.
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MATERIALS AND METHODS |
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ABSTRACTMATERIALS AND METHODSRESULTSDISCUSSIONREFERENCES |
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The two clinics randomized to lubricant use were provided with HR Lubricating Jelly (Carter Wallace Inc., New York, NY). The lubricant ingredients include water, propylene glycol, hydroxpropyl methylcellulose, carbomer 934P, methylparaben, propylparaben, and sodium hydroxide. Clinicians were instructed to apply a dime-sized amount of gel lubricant on the distal end of the outer surface of the inferior blade of the plastic speculum to lubricate the introitus from January 1, 1999 to June 30, 1999. The clinics randomized to nonlubricant use were asked to use only tap water if lubricant was needed during the same period.
Cervical cytology samples were collected from the ectocervix using the Ayers spatula, followed by a cytobrush. The cells were then applied to a single glass slide, fixed with alcohol, and allowed to air dry. The laboratory vendor and cytology supplies were the same for the entire study period. The laboratory and cytopathologists were not alerted regarding lubricant use for specimen collection. The cumulative 6-month totals of normal and abnormal cervical cytology diagnoses were collected by site for the 6 months preceding intervention (July through December 1998), the 6 months during intervention (January through June 1999), and the 6 months after intervention (July through December 1999). The percentages of normal, abnormal, and unsatisfactory cytology rates were compared within clinics and between clinics for each 6-month period. Data were collected from the clinic charts of the patients with unsatisfactory cytology diagnoses to evaluate the etiologies for the unsatisfactory smears. Specific questions asked included pathology diagnosis, age, day of menstrual cycle, type of contraceptive used, presence of sexually transmitted disease, and cytology history. Multivariate logistic regression (SPSS for Windows 8.0; SPSS Inc., Chicago, IL) was used to examine associations between lubricant use and cytology diagnosis 1) during the gel intervention period for all clinics, which were divided into two categories (clinics that used lubricant and clinics that did not) (Table 1
), and 2) before and after the gel intervention period versus during the intervention period for the two clinics where gel was used. This model was adjusted by clinic (Table 2). We calculated that 1150 Papanicolaou smears in each arm were necessary to detect an odds ratio of 2.0 or doubling of the unsatisfactory diagnosis with a power of 80% and an 
error of .05.
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RESULTS |
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ABSTRACTMATERIALS AND METHODSRESULTSDISCUSSIONREFERENCES |
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The percentages of unsatisfactory, atypical squamous cells of undetermined significance (ASCUS), low-grade squamous intraepithelial lesion (SIL), high-grade SIL, and atypical glandular cells of undetermined significance (AGCUS) smears for the lubricant use clinics did not significantly differ from those of the control clinics during the intervention period (Table 1
). The rates of unsatisfactory, ASCUS, low-grade SIL, high-grade SIL, and AGCUS diagnoses within the lubricant use clinics for the 6 months during versus 6-month periods before and after use of lubricant did not significantly differ (Table 2). There were only three atypical endometrial cell Papanicolaou smears collected during the 6-month study period, two with lubricant (0.1%) and one without (0.1%). There were no cases of invasive cancer. The rate of absent endocervical cells was significantly less with the use of lubricant within the lubricant use clinics (8.1% versus 12.1% [odds ratio 0.6; 95% confidence interval 0.5, 0.8]). During the entire study period one lubricant clinic had persistently elevated rates of absent endocervical cells (12.72% from January 1, 1999 through June 30, 1999; 17.23% for the preceding 6 months, and 23.82% for the following 6 months). Investigation into the clinical practice at this site revealed a provider who was not using the cytobrush on any patient suspected to be pregnant. Because the unsatisfactory rate was lower during the lubricant study period, it is unlikely that the higher rate of absent endocervical cells was due to lubricant use.
Review of the unsatisfactory Papanicolaou smear descriptive sections of the cytology reports revealed no reported gel overlay or drying artifact causing difficulty with interpretation. Unsatisfactory reports revealed excess inflammation, excess blood, or scanty cells for the etiology of the unsatisfactory diagnosis. The average age of patients in the lubricant group with unsatisfactory cytology was 22.7, versus 22.5 in the control group. Oral contraceptive pill or medroxyprogesterone usages for patients with unsatisfactory diagnoses were 50.0% and 53.8% for the lubricant and control populations, respectively. During the lubricant intervention period, 25% of the lubricant patients with unsatisfactory smears reviewed had positive cultures for chlamydia, whereas no members of the nonlubricant group with unsatisfactory smears had chlamydia diagnosed.
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DISCUSSION |
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ABSTRACTMATERIALS AND METHODSRESULTSDISCUSSIONREFERENCES |
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Because fear of pain may be a reason women do not seek Papanicolaou screening, efforts should be made to try to minimize the pain associated with examination without compromising the quality of the Papanicolaou smear as a screening tool for cancer. Our results show that the use of a small amount of water-soluble lubricant on the outer inferior blade of the plastic vaginal speculum did not significantly increase the rate of unsatisfactory cervical cytology smear diagnoses in our young, reproductive-age population. This finding suggests that lubrication may be used cautiously when indicated during speculum examination when obtaining cervical cytology.
Our study did not evaluate the pain level women experienced with speculum insertion or other variables potentially important to reported or experienced pain like parity, anxiety, history of sexual abuse, or infection. We did not directly address the effect of water-soluble lubricant formulation with bacteriostatic preservatives on gonorrhea and chlamydia culture or normal saline and potassium hydroxide slide evaluation of vaginal discharge. Our population is young and not in the highest-risk group for cervical carcinoma, and we also used the standard smear cytology preparation and not the liquid cytology preparation. Our study did not assess if there is an upper limit of gel that may interfere with cytology interpretation, but our results indicate that using a dime-sized amount of water-soluble gel lubricant did not change the cytology results.
Because lubricant use did not impede the interpretation of Papanicolaou smears, it is most likely safe to conduct further studies to assess whether lubricant use can decrease pain or discomfort associated with speculum examination. Comparison of the comfort with metal and plastic speculums would be instructive. Further investigation should be done to assess the use of lubricant during the evaluation and diagnosis of vaginal and cervical infections to verify that any woman undergoing speculum exam could be offered a sterile water-soluble lubricant to ease speculum examination.
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Footnotes |
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The authors thank the Public Health Seattle King County Family Planning Program for its invaluable assistance.
Received March 14, 2002. Received in revised form July 15, 2002. Accepted August 1, 2002.
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REFERENCES |
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2. Janerich DT, Hadjimichael O, Schwartz PE, Lowell DM, Meigs JW, Merino MJ, et al. The screening histories of women with invasive cervical cancer, Connecticut. Am J Public Health 1995;85:791–4.
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21. Ciatto S, Cariaggi MP, Minuti AP, Confortini M, Palli D, Pas L, et al. Interlaboratory reproducibility in reporting inadequate cervical smears: A multicentre multinational study. Cytopathology 1996;7:386–90.[Medline]
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