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Vulvar Vestibulitis Syndrome: Reliability of Diagnosis and Evaluation of Current Diagnostic Criteria

From the Departments of Psychology and Obstetrics and Gynecology, McGill University, Royal Victoria Hospital, Montreal, Quebec, Canada; and Departments of Obstetrics and Gynecology and Psychiatry, Cornell University Medical College and New York Hospital, New York, New York.

Address reprint requests to: Sophie Bergeron, PhD, Département de sexologie, Université du Québec à Montréal, C.P. 8888, succursale Centre-Ville, Montréal, Québec H3C 3P8, Canada; E-mail: bergeron.sophie{at}uqam.ca

	ABSTRACT

TOP ABSTRACT MATERIALS AND METHODS RESULTS DISCUSSION REFERENCES

 
OBJECTIVE: To assess the reliability of the diagnosis of vulvar vestibulitis as defined by Friedrich and to evaluate the usefulness of Friedrich’s criteria in the diagnostic process.

METHODS: In a university hospital, 146 women with dyspareunia had two sets of gynecologic examinations involving vulvar pain ratings, took part in structured interviews, and completed the McGill-Melzack Pain Questionnaire.

RESULTS: Kappa values for the vulvar vestibulitis diagnosis ranged from 0.66 to 0.68 for inter-rater agreement and from 0.49 to 0.54 for test-retest reliability. Mean vestibular pain ratings ranged from 2.45 at the 12 o’clock site to 7.58 at the 9–12 o’clock site; ratings for all sites correlated significantly between gynecologists. Pain in the labia majora and labia minora was minimal for both sets of examinations, with mean participant pain ratings ranging from 0 to 1.49. Gynecologists’ erythema ratings did not correlate significantly with respect to either inter-rater agreement or test-retest reliability. Of Friedrich’s three diagnostic criteria, only tenderness to pressure within the vulvar vestibule differentiated dyspareunia patients with and without vulvar vestibulitis. In reference to their coital pain, 88.1% of women with vulvar vestibulitis chose adjectives from the McGill-Melzack Pain Questionnaire describing a thermal quality, and 86.6% chose adjectives describing an incisive pressure sensation.

CONCLUSION: Vulvar vestibulitis can be reliably diagnosed in women with dyspareunia. Pain is limited to the vulvar vestibule and can be rated and described in a consistent fashion by these women. Erythema does not appear to be a useful diagnostic criterion.

Since Friedrich proposed the terminology in 1987,¹ the diagnostic criteria for vulvar vestibulitis syndrome have been: 1) severe pain on vestibular touch or attempted vaginal entry, 2) tenderness to pressure localized within the vulvar vestibule, and 3) physical findings confined to vestibular erythema of various degrees. Despite the absence of studies regarding the diagnostic reliability and validity of these criteria, many researchers and clinicians implicitly or explicitly use them because they constitute the first attempt at formulating an operational diagnosis. However, Friedrich’s definition has been subject to varying interpretations, leading to potentially heterogeneous samples in studies purporting to investigate vulvar vestibulitis.² In addition, some researchers and clinicians have been using other diagnostic criteria, such as erythematous vestibular lesions on colposcopy and nonspecific inflammation on histopathology, without evidence that these increase diagnostic reliability.³ Another implicit criterion not currently included in Friedrich’s definition is a minimum of 6 months’ duration of the symptoms.⁴

Friedrich’s criteria may not be sufficient to differentiate vulvar vestibulitis from other vulvar and coital pain syndromes. For example, vestibular erythema is a common symptom of many types of vulvar inflammation, and there is no empirical evidence that it distinguishes vulvar vestibulitis from other vulvovaginal conditions. The term "tenderness to pressure" does not seem to accurately reflect the thermal sensation or the severe pain that many women with vulvar vestibulitis report during the cotton-swab test. In addition, the first criterion lacks clarity because it fails to differentiate between vestibular touch and attempted vaginal entry. These constitute distinct activities that usually correspond to two different measures of pain, one being the cotton-swab test and the other, a self-report of pain intensity during attempted intercourse. In fact, the extent to which these two reports of pain correlate is unknown. The purposes of this study were to assess the reliability of the vulvar vestibulitis diagnosis as defined by Friedrich and to evaluate the usefulness of Friedrich’s criteria in the diagnostic process.

	MATERIALS AND METHODS

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Participants were 146 women with dyspareunia recruited between January and July 1996 through local media announcements and professional referrals. Potential participants were screened over the telephone by a trained clinical associate. If interested, women were interviewed at a university hospital, where study procedures were explained and informed consent was obtained. Women not meeting the selection criteria were referred appropriately. This study protocol was approved by the McGill Institutional Ethics Review Board.

The main inclusion criterion was pain during intercourse, which was subjectively distressing, occurred on most intercourse attempts, and lasted for at least 6 months. Women who stopped attempting intercourse as a result of the pain were included if the pain could be confirmed during the gynecologic examinations or through a recent attempt at intercourse. Exclusion criteria were: pelvic or vaginal pain not clearly linked to intercourse; a history of past coital pain; presence of one of the following: major medical and/or psychiatric illness, active infection, and vaginismus; ongoing treatment for coital pain; pregnancy; age less than 18 or greater than 50 years.

Participants took part in a structured interview administered by a trained clinical associate. The interview covered sociodemographic information, medical history, and a detailed description and history of coital pain and other possible vulvar/pelvic pain, including a self-report measure of painful intercourse and the McGill-Melzack Pain Questionnaire.⁵ This adjective checklist is a widely used, reliable, and valid measure of both qualitative and quantitative aspects of pain.

At the first visit, each woman had two independent gynecologic examinations carried out according to the following standardized protocol: 1) a urine sample was obtained; 2) a brief interview about past medical history, medication, and obstetric-gynecologic history, including painful intercourse, was conducted by the gynecologist performing the first examination; 3) vaginal cultures were taken for candida, gardnerella, and trichomonas, as well as a Papanicolaou smear if the women had not been tested in the past year; 4) a cotton-swab palpation of the labia majora and labia minora (right, left, and midline), and six vestibular sites (in a clockwise fashion: 12 o’clock, then 12–3, 3–6, 6, 6–9, and 9–12 o’clock); 5) the degree of vestibular erythema was evaluated by each gynecologist on a scale of 0 (none) to 3 (severe) and noted on a standardized form; 6) a standard bimanual palpation of the following areas was carried out: vagina (anterior vaginal wall, pubococcygeal muscle, uterosacral ligament, insertion of speculum, insertion of finger), uterus (cervix and corpus with and without motion), and adnexae (with and without motion). Patients rated the pain at each site on a scale of 0 (no pain) to 10 (worst pain ever); a research assistant recorded patients’ pain ratings on a standardized form for all of the above-mentioned sites. In addition, any other physical findings were noted, as were the gynecologists’ final diagnoses.

Gynecologists were instructed to use Friedrich’s criteria as best they could to diagnose vulvar vestibulitis syndrome. These criteria were stated as follows: 1) severe pain on vestibular touch or attempted vaginal entry, 2) tenderness to pressure localized within the vulvar vestibule, and 3) physical findings confined to vestibular erythema of various degrees. Participants were asked to remain untreated and to discontinue use of potential allergens (eg, perfumed soaps) for a minimum of 6 weeks, at which point they were scheduled for two additional gynecologic examinations, identical to the initial ones and done independently by the same gynecologists. The order of gynecologists carrying out the examination at time one was reversed at time two. At this second appointment, participants were informed of examination results.

Statistical analyses were conducted by investigating: 1) the relationship between sociodemographic variables (age, income, educational level, birthplace, religion, marital status, parity, language of interview) and dependent measures (pain and physical findings), using Pearson product moment correlations, Spearman rank order correlations, and ² tests; 2) the reliability of the gynecologists’ vulvar vestibulitis diagnoses using kappa statistics; 3) the difference in participants’ mean pain ratings within gynecologists (paired samples t tests) and between labia majora and labia minora (Wilcoxon signed ranks tests); 4) the usefulness of Friedrich’s three diagnostic criteria (Pearson product moment correlations, Spearman rank order correlations, kappa, descriptive statistics, and discriminant function analyses).

	RESULTS

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Of 146 participants, 102 completed all the medical and psychosocial testing; 26 dropped out of the study after the first set of gynecologic examinations, and 18 were not tested a second time by one of the gynecologists. Five of the initial 146 women did not complete the structured interview. Sociodemographic information for these groups of women is shown in Table 1. The women who dropped out of the study did not differ significantly from the others on any of the demographic or pain variables. None of the sociodemographic variables were significantly associated with our dependent measures.

Evaluation of Friedrich’s three diagnostic criteria was conducted using the sample of 126 women diagnosed with vulvar vestibulitis by both gynecologists at time one. The first criterion—pain on attempted vaginal entry—was an inclusion criterion for this study and was documented by a one-time patient self-report of typical pain during intercourse on a scale of 0 (no pain) to 10 (worst pain ever). The median pain rating was 7.0. Aside from presenting with dyspareunia (severe pain on attempted vaginal entry), women suffering from vulvar vestibulitis reported experiencing pain associated with a number of activities, sexual and other (severe pain on vestibular touch) (see Table 2).

Also tested was the second criterion—tenderness to pressure localized within the vulvar vestibule. Patient pain ratings from each of the four gynecologic examinations were averaged for every vestibular palpation site. Mean ratings ranged from 2.45 at the 12 o’clock site to 7.58 at the 9–12 o’clock site. These mean patient pain ratings were then correlated between gynecologists’ examinations at both times one and two. Although the means from one gynecologist’s examinations (KP) tended to be lower, all pain ratings correlated significantly (see Table 3). Paired samples t tests were used to compare participants’ mean pain ratings within gynecologists; no significant differences were found between participants’ mean pain ratings at times one and two for either of the gynecologists. In terms of the pattern of the pain, the mean pain ratings were lower at 12 o’clock for all exams, and the mean 12–3 o’clock ratings were the second lowest ratings of each exam. Vestibular pain did not otherwise exhibit a specific pattern. The most painful areas encompassed the 3–6, 6, 6–9, and 9–12 o’clock areas. After averaging the participants’ six vestibular pain ratings per examination, we examined the frequency distributions of the four variables and found that they were all normally distributed, with 52.1–71.2% of cases falling between 4.5 and 7.5.

To examine the degree of association between Friedrich’s first and second criteria, we collapsed the participants’ six vestibular pain ratings for each gynecologist’s set of examinations to form two indices of vestibular pain. These indices were then correlated with the measure of self-reported pain during intercourse on a scale of 0 to 10; this yielded r = 0.28 (P < .01) for one gynecologist (SK) and r = 0.04 (not significant) for the other gynecologist (KP).

Friedrich’s third criterion—physical findings confined to vestibular erythema of various degrees—was also examined. Comparison of the two gynecologists’ erythema ratings revealed r = 0.06 (not significant) at time one and r = -0.04 (not significant) at time two. As for test-retest reliability, comparison between times one and two for each gynecologist resulted in r = 0.11 (not significant) and r = 0.23 (P < .02). To explore further the degree of inter-rater agreement, erythema ratings were recoded to form only two categories, that is, presence or absence of erythema, and kappa analyses were performed. Results show that the percentage agreement between the two gynecologists at time one was 59.8%, yielding = 0.12, and that the percentage agreement at time two was 83.3%, yielding = -0.08. The percentage agreements between times one and two for each of the gynecologists were respectively 64.2% ( = 0.10) and 33.3% ( = -0.13).

Stepwise discriminant function analyses were conducted to test the point at which Friedrich’s three diagnostic criteria were effective in discriminating participants who were suffering from vulvar vestibulitis from those who were not. Tenderness to pressure within the vulvar vestibule was assessed by averaging the six patient vestibular pain ratings to form one index of vestibular pain per examination. Erythema was recoded as present or absent. Both the vestibular pain ratings and the pain during intercourse variables were normally distributed as per examination of the frequency distributions. The discriminant function analysis for the first gynecologist’s examinations at time one resulted in one significant function (² = 50.50, P < .001) in which only the second criterion—tenderness to pressure within the vulvar vestibule—was included; 90.4% of cases were correctly classified. The discriminant function for the second gynecologist’s examinations at time one yielded one significant function (² = 58.48, P < .001) in which both the first—attempted vaginal entry—and second criteria were included, resulting in 92.5% of the cases being correctly classified. The discriminant function for the first gynecologist’s examinations at time two yielded one significant function (² = 13.23, P < .005) in which only the second criterion was included; 89.7% of cases were correctly classified. Finally, the discriminant function for the second gynecologist’s examinations at time two also yielded one significant function (² = 5.21, P < .05) in which only the second criterion was included, classifying 91.7% of cases correctly.

	DISCUSSION

TOP ABSTRACT MATERIALS AND METHODS RESULTS DISCUSSION REFERENCES

 
The present study demonstrates that vulvar vestibulitis syndrome constitutes a clinical entity that can be diagnosed reliably in women with dyspareunia. This is supported by the substantial inter-rater agreement between the two gynecologists at both times and by the moderate test-retest reliability.⁶ The observed discrepancy between the percentage agreement figures and the kappa values is due to the high sensitivity of the kappa statistic to the number of categories⁷ and to the proportions of true positive and true negative cases in the sample.⁸ In the current study, the high frequency of the vulvar vestibulitis diagnosis contributed to lower the kappa values. Reliability indices obtained from samples with different base rates may not be comparable.⁸

The McGill-Melzack Pain Questionnaire results show that 88.1% of vulvar vestibulitis participants chose adjectives that described a thermal quality, and 86.6% chose adjectives that described an incisive pressure sensation. These results demonstrate that there is a remarkable consistency in the pain descriptions of women with vulvar vestibulitis. They also corroborate clinical accounts that often describe a burning pain; however, an incisive pressure sensation had never been previously documented. Furthermore, the high score on the sensory component of the pain suggests that it is the most important dimension of vulvar vestibulitis, as opposed to the affective or evaluative dimensions. The high mean pain rating index suggests that dyspareunia resulting from vulvar vestibulitis is a very intense pain, twice as intense as dysmenorrhea. Pain quality reports are important in the diagnosis and classification of pain and may be very useful in distinguishing between different genital and pelvic pain syndromes.

Although patient pain ratings from the cotton-swab test correlated significantly between gynecologists for each of the vestibular and labial palpation sites, they tended to differ depending on which gynecologist conducted the examination. The vestibular patient pain ratings based on one gynecologist’s examinations (KP) were often lower than those elicited by the other gynecologist. This difference appears to result from the differing degrees of pressure applied by each gynecologist and was the source of disagreement for the majority of cases that could not be reliably diagnosed. Use of an algesiometer⁹ or Von Frey hairs¹⁰ may solve this problem by allowing quantification of pressure application. Nonetheless, average patient vestibular pain ratings were not significantly different from time one to time two. Taken together, these results show that the cotton-swab test involving patient pain ratings is a reliable measure of pain that should be used in future outcome studies. Furthermore, results from the discriminant function analyses support the discriminant validity of this measure.

Our data confirm that pain caused by vulvar vestibulitis is limited to the vulvar vestibule and that, consequently, pain within the labia majora and labia minora is generally nonexistent. This is illustrated by the fact that 79.5% of the women did not report pain in the labia majora at any of the four gynecologic examinations. In contrast, 84.5% reported pain in the labia minora, although the mean pain rating was very low. These findings may serve to distinguish vulvar vestibulitis from chronic vulvar pain syndromes where pain may be felt in the entire vulvar area.

Despite the fact that the mean pain ratings were lowest at the 12 o’clock and 12–3 o’clock sites, vestibular pain did not otherwise exhibit a specific pattern. This is contrary to what has been mentioned in the literature,^11,12 where pain has been reported to be worse between 4 and 8 o’clock or in the region of the Bartholin glands (posterior fourchette). The fact that the 12–3 o’clock area was generally less painful than the 9–12 o’clock region may be explained by the clockwise pattern of the cotton-swab examination, which is a limitation of this study. Future studies and clinical examinations should counterbalance the order of palpation in the cotton-swab test.

The averaged vestibular patient pain ratings were normally distributed for each of the gynecologic examinations. Similarly, Goetsch¹¹ found that swab sensitivity occurred along a continuum. These findings suggest that the pain of vulvar vestibulitis is best represented as a continuum and that categorical diagnostic boundaries based solely on the cotton-swab test may be somewhat arbitrary. Future studies using the cotton-swab test for selection of participants should thus adopt an a priori cutoff point for patient pain ratings.

We found only a weak relationship between self-reported pain during intercourse and patient pain ratings taken during the cotton-swab test. A low correlation between laboratory and function measures of pain is common to many chronic pain syndromes.¹³ From a biopsychosocial perspective, this weak relationship can be partly explained by the fact that an intimate sexual relationship and a gynecologic examination are two very distinct situations associated with different interpersonal and emotional cues. In addition, our measure of self-reported pain during intercourse is retrospective and represents an average over time (last 6 months); perhaps the use of a daily pain-monitoring diary would provide a better estimate of the relationship between these two measures of pain. Our results also point to the importance of clarifying Friedrich’s first criterion, which includes both vestibular touch and attempted vaginal entry. Finally, the weak association between self-reported pain during intercourse and cotton-swab test pain ratings suggests the need to include both outcome measures in future clinical trials.

Inter-rater agreement and test-retest reliability for the presence or absence of erythema were poor,⁶ suggesting that despite the fact that it is one of Friedrich’s three diagnostic criteria, it may not significantly contribute to diagnostic decision making. This conclusion was further supported by the results of discriminant function analyses, which revealed that tenderness to pressure within the vulvar vestibule was the only criterion that differentiated between dyspareunic women who were diagnosed as having vulvar vestibulitis and those who were not. Additional support is also provided by Friedman,¹⁴ who found that normal controls were not significantly different from vulvar vestibulitis women in terms of the presence of erythematous lesions.

Based on the results of this research, moderate to severe pain during attempted penetration and moderate to severe pain limited to the vulvar vestibule as confirmed by a cotton-swab test appear to be the two main diagnostic criteria for vulvar vestibulitis. Additionally, pain experienced as a thermal and/or an incisive pressure sensation is described by a majority of women with vulvar vestibulitis and thus merits diagnostic consideration.

This study has a number of limitations. Our design did not include a pain-free control group, which weakens the conclusions that can be drawn from the reliability results. Furthermore, vulvar vestibulitis cases were over-represented in our sample of women with dyspareunia, which may limit generalization of the findings. Future studies including no-pain controls are needed to provide additional validation of the proposed refinements to Friedrich’s criteria and to shed more light on the complex factors that contribute to cause and maintain vulvar vestibulitis.

	Footnotes

 
Supported by a Social Sciences and Humanities Research Council of Canada Fellowship to S. Bergeron, and by Health Canada (NHRDP) and Pfizer Canada Inc. research grants to Y. M. Binik. This article stands in partial fulfillment of Ms. Bergeron’s PhD requirements.

PII S0029-7844(01)01389-8

Received October 31, 2000. Received in revised form February 5, 2001. Accepted March 8, 2001.

	REFERENCES

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1. Friedrich EG. Vulvar vestibulitis syndrome. J Reprod Med 1987;32:110–4.[Medline]

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3. Goetsch MF. Simplified surgical revision of the vulvar vestibule for vulvar vestibulitis. Am J Obstet Gynecol 1996;174:1701–7.[Medline]

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7. Hanley JA. Standard error of the kappa statistic. Psych Bull 1987;102:315–21.

8. Uebersax JS. Diversity of decision-making models and the measurement of interrater agreement. Psych Bull 1987; 101:140–6.

9. Fischer AA. Pressure algometry over normal muscles. Standard values, validity and reproducibility of pressure threshold. Pain 1987;30:115–26.[Medline]

10. Gracely RH. Studies of pain in human subjects. In: Wall PD, Melzack R, eds. Textbook of pain. 4th ed. Toronto: Churchill Livingstone, 1999:385–407.

11. Goetsch MF. Vulvar vestibulitis: Prevalence and historic features in a general gynecologic practice population. Am J Obstet Gynecol 1991;161:1609–17.

12. Peckham BM, Maki DG, Patterson JJ, Hafez G-R. Focal vulvitis: A characteristic syndrome and cause of dyspareunia. Am J Obstet Gynecol 1986;154:855–64.[Medline]

13. Rudy TE, Turk DC, Brody MC. Quantification of biomedical findings in chronic pain: Problems and solutions. In: Turk DC, Melzack R, eds. Handbook of pain assessment. New York: Guilford Press, 1992:447–69.

14. Friedman M. Understanding vaginal vestibulum dyspareunia syndrome. Cerv Lower Female Genital Tract 1995; 13:135–40.

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