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Lubrication of the Vaginal Introitus and Speculum Does Not Affect Papanicolaou Smears

From the Department of Obstetrics and Gynecology, Arrowhead Regional Medical Center, Colton, California.

Address reprint requests to: W. Benson Harer, Jr, MD, Riverside Regional Medical Center, Department Women’s Health Care, 26520 Cactus Avenue, Moreno Valley, CA 92555; E-mail: bharer{at}co.riverside.ca.us.

	ABSTRACT

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OBJECTIVE: To test the hypothesis that lubrication of the vaginal introitus and external speculum does not adversely affect Papanicolaou interpretation.

METHOD: One hundred eighty-two patients presenting for Papanicolaou smears as part of their visit were randomly assigned to have either only warm water or a water soluble lubricant to assist speculum insertion. Cytotechnicians and pathologists were blind to the cohort from which smears were obtained.

RESULTS: Two unsatisfactory smears were found among 93 patients with the lubricant and two were found among 89 using only warm water. No significant difference was found using the t test for continuous variables and ² for categoric variables.

CONCLUSION: Use of a water soluble lubricant on the vaginal introitus and external speculum facilitates examination with no adverse effect on Papanicolaou smear interpretation.

Most textbooks on gynecology written in the past 30 years dogmatically state that no vaginal lubrication should be used before speculum insertion to avoid adversely affecting Papanicolaou smears. We found none that recommended it. We conducted searches on MEDLINE (1966–2001) for any previous study regarding the use of lubrication before obtaining cervical cytology using the key words "lubrication and cervical cytology" and "vagina and examination." We found none. We reviewed multiple textbooks in our own libraries as well as the Resource Center of The American College of Obstetricians and Gynecologists (ACOG), and found none stating that prior lubrication was acceptable. This study tested the null hypothesis that such lubrication does not adversely affect Papanicolaou smear interpretation.

	MATERIALS AND METHODS

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The Arrowhead Regional Medical Center Institutional Review Board approved this study. Women presenting to the Arrowhead Regional Medical Center Women’s Health Clinic who would have Papanicolaou smears as part of their visits were invited to participate. Patients with known untreated cervical cancer or active bleeding were excluded. The study was carried out between July and October 1999. All patients gave informed consent and were seen by the regularly assigned residents and faculty. A computer-generated random number was generated by Statmate (Graphpad Software, San Diego, CA), the numbers giving an assignment to either control or lubricant. The selections were placed in opaque sequentially numbered envelopes from which patients’ assignments were obtained. One had the traditional examination with no lubricant other than water on the speculum. The second group had the vaginal introitus examined with 2 to 3 cc of Surgilube (Fougera, Melville, NY) on the gloved fingers before insertion of an externally lubricated speculum. Specimens were taken using both an Ayres spatula and an endocervical brush. These were promptly smeared on glass slides and placed in fixative. All slides were recorded in a log, batched with other slides from the hospital, and sent for routine processing and reading by cytotechnicians and pathologists who were blind to the cohort and to whether or not they were part of the study. No monolayer techniques were employed. We decided that a 5% or more increase of unsatisfactory Papanicolaou smears would be an unacceptably high level of smears that would need to be repeated. To calculate the adequate number of patients for the study, we utilized Statmate to generate the number of patients necessary in each arm. For a significance of P > 0.05, the total number of patients should be 300.

Comparisons were performed by t tests for continuous variables and ² for categoric variables (Instat; Graphpad Software). Significance was defined to be P < 0.05.

	RESULTS

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After we finished studying the first 182 patients of 200 attending our clinic (91.5% participation), we reviewed our data because we realized that we rarely got an unsatisfactory reading. Therefore, we would need 10,000 patients to demonstrate some statistical but clinically meaningless difference. Demographic data regarding age, gravidity, parity, and ethnicity are shown in Table 1. No gross lubricant was seen on the slides. The low numbers of unsatisfactory slides were similar in both groups (2.1% versus 2.2%, P = .528) (Table 2). The presence of lubricant was not implicated in any slide. Because the incidence of unsatisfactory slides was so low, it was impossible to correlate results with the level of the providers’ training and experience. Therefore, we decided to close the study and report the results.

	DISCUSSION

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The move to evidence-based practice supports challenging dogma such as the avoidance of lubricant before performing a Papanicolaou smear. The ACOG technical bulletin Cervical Cytology: Evaluation and Management of Abnormalities¹ falls short of condoning use of lubricant, stating that "care should be taken to avoid contaminating the slide with lubricant." Lubrication of the introitus and speculum facilitates speculum insertion without impairing smear quality.

Patient comfort and satisfaction are important contributors to compliance in women’s health care. Use of a water soluble lubricant to examine the introitus and use of an externally lubricated speculum facilitate this procedure. The traditional unfounded belief that lubricant cannot be used should be abandoned in light of this evidence.

	Footnotes

 
PII S0029-7844(02)02168-3

Received October 11, 2001. Received in revised form April 8, 2002. Accepted April 25, 2002.

	REFERENCE

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1. American College of Obstetricians and Gynecologists. Cervical cytology: Evaluation and management of abnormalities. ACOG technical bulletin no. 183. Washington, DC: American College of Obstetricians and Gynecologists, 1993.

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