The effect of vaginal speculum lubrication on the rate of unsatisfactory cervical cytology diagnosis

doi:10.1016/S0029-7844(02)02348-7

Obstetrics & Gynecology

Volume 100, Issue 5, Part 1, November 2002, Pages 889-892

https://doi.org/10.1016/S0029-7844(02)02348-7 Get rights and content

Abstract

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.

Section snippets

Materials and methods

Approval for the study was granted by the institutional review board of the University of Washington. The study was conducted from July 1998 through December 1999 at five Public Health Seattle King County family planning clinics. The clinics were randomized by drawing names from an envelope labeled for assignment to either water-soluble gel lubricant or no lubricant except tap water for all speculum examinations for cervical cytology specimen collection during the intervention period. The sites

Results

Results of a review of MEDLINE during January 1998 back to 1966 using the key words “gel,” “speculum,” “lubrication,” “Pap smear,” “cervical cytology,” and “pelvic exam” revealed only one study12 assessing the effect of gel lubrication on Papanicolaou smear interpretation. A total of 8534 Papanicolaou smears were collected from all five clinics during the entire study period. From July 1, 1998 to December 31, 1998 and from July 1, 1999 to December 31, 1999, 5628 Papanicolaou smears were

Discussion

The Bethesda system requires that Papanicolaou preparations must include enough cells to cover 10% of a slide.13 If 75% of the epithelial cells are obscured by blood, inflammation, or artifact, the slide is considered unsatisfactory. Multiple variables have been studied and have been shown to affect the rate of unsatisfactory smears, including: presence of menses, hormonal contraceptive use,14 genital atrophy,15 use of the cytobrush,16 experience of the provider,17, 18, 19, 20 individual

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To provide guidelines for the pelvic clinical exam in gynecology and obstetrics.
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Does lubrication of the vaginal speculum reduce pain during a gynecologic oncology examination?
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Citation Excerpt :
Previously published obstetrics and gynecological textbooks often discourage the use of gel lubricant or recommend only warm water lubrication during SE, due to concerns that lubricant gel may interfere with cytologic interpretation of the Pap test and cervical microbiology [10,11]. In contrast, most studies support the view that lubrication of the speculum does not alter the cytological interpretation of cervical specimens [9,12–16]. Moreover, based on the current commentary published in 2010, speculum lubrication is a conscientious step in female health care and is safe for cytologic evaluation of the cervix [17].
To evaluate the effectiveness of lubricant gel for reducing pain during a vaginal speculum examination (SE) in patients with gynecologic cancers.
This non blind randomized controlled trial included 200 women who underwent SE for post-treatment surveillance. One-hundred patients each were allocated to the water and lubricant gel groups. All patients were asked to score their pain during speculum insertion, dilatation, and extraction using a visual analog scale (VAS). Pain intensity during speculum insertion was the primary outcome measure.
There were no statistically significant differences in demographic characteristics between the water (n = 97) and lubricant gel (n = 98) groups. The VAS pain scores obtained during all phases of the SE were significantly lower in the lubricant gel group compared with the water group during the insertion (3.95 ± 1.57 vs. 5.28 ± 1.71, P < 0.001), dilatation (5.96 ± 1.48 vs. 6.74 ± 1.69, P < 0.001) and extraction phases (2.60 ± 1.17 vs. 3.50 ± 1.25 P < 0.001). When a separate analysis was performed for the patients who underwent radiation therapy, the mean VAS pain scores were significantly lower in the lubricant gel group during the insertion (4.46 ± 1.45 vs. 6.22 ± 1.79, P < 0.001), dilatation (6.31 ± 1.66 vs. 7.52 ± 1.61, P = 0.002) and extraction phases (2.68 ± 1.31 vs. 3.66 ± 1.06, P = 0.001).
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The unsatisfactory rate on conventional cervical cytology smears in the present study was 4.9%. This is comparable to that reported from studies carried out in Taiwan (4.5%) and Italy (4.1%), but is higher than that reported from United States (1.02–1.4%) and The Netherlands (1.11%) [11–14]. The unsatisfactory rates have been reported to be significantly lower in LBC as compared to the conventional cytology, primarily because of elimination of obscuring blood and inflammation and better fixation of smears in LBC [6,7].
To investigate clinical and cytomorphological determinants of unsatisfactory conventional Papanicolaou (Pap) smears.
Records of 82,108 conventional cervicovaginal smears received over a ten-year period were retrieved. The significance of clinical determinants, viz. age (<45 or ≥45) and history of hysterectomy, radiotherapy (RT) and chemotherapy (CT), with respect to unsatisfactory outcomes was evaluated using univariate and multivariate analysis by logistic regression. Reasons for unsatisfactory results, i.e. cellularity, obscuration by blood or inflammation and drying artifact, were compared in the women managed by hysterectomy/RT/CT with those without these histories, using Chi square/Fischer's exact test.
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^☆: LK and S-KL received funding support from the National Institutes of Health (grants CA34493 and AI38383).

¹: The authors thank the Public Health Seattle King County Family Planning Program for its invaluable assistance.

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Original researchThe effect of vaginal speculum lubrication on the rate of unsatisfactory cervical cytology diagnosis1 ☆,

Abstract

Section snippets

Materials and methods

Results

Discussion

J Urol

J Urol

Obstet Gynecol

Lancet

Screening for cervical cancer

Ann Intern Med

The screening histories of women with invasive cervical cancer, Connecticut

Am J Public Health

Beliefs about Papanicolaou smear and compliance with Papanicolaou smear follow-up in adolescents

Arch Pediatr Adolesc Med

Gynecologic history, examination, and diagnostic procedures

History, physical examination, and preventive health care

Original research
The effect of vaginal speculum lubrication on the rate of unsatisfactory cervical cytology diagnosis¹ ☆,