Recruitment methods in a clinical trial of provoked vulvodynia: Predictors of enrollment.

BACKGROUND: Successful recruitment in clinical trials for chronic pain conditions is challenging, especially in women with provoked vulvodynia due to reluctance in discussing pain associated with sexual intercourse. The most successful recruitment methods and the characteristics of women reached with these methods are unknown. OBJECTIVE: To compare the effectiveness and efficiency of four recruitment methods and to determine socioeconomic predictors for successful enrollment in a National Institutes of Health-sponsored multicenter clinical trial evaluating a gabapentin intervention in women with provoked vulvodynia. METHODS: Recruitment methods utilized mass mailing, media, clinician referrals and community outreach. Effectiveness (number of participants enrolled) and efficiency (proportion screened who enrolled) were determined. Socioeconomic variables including race, educational level, annual household income, relationship status, age, menopausal status and employment status were also evaluated regarding which recruitment strategies were best at targeting specific cohorts. RESULTS: Of 868 potential study participants, 219 were enrolled. The most effective recruitment method in enrolling participants was mass mailing ( p < 0.001). There were no statistically significant differences in efficiency between recruitment methods ( p = 0.11). Relative to clinician referral, black women were 13 times as likely to be enrolled through mass mailing (adjusted odds ratio 12.5, 95% confidence interval, 3.6-43.1) as white women. There were no differences in enrollment according to educational level, annual income, relationship status, age, menopausal status, or employment status and recruitment method. CONCLUSION: In this clinical trial, mass mailing was the most effective recruitment method. Race of participants enrolled in a provoked vulvodynia trial was related to the recruitment method.

Relationship between nongenital tender point tenderness and intravaginal muscle pain intensity: ratings in women with provoked vestibulodynia and implications for treatment.

BACKGROUND: Vulvodynia is a chronic vulvar pain disorder and fibromyalgia is a chronic widespread musculoskeletal pain disorder, both of unknown etiology. Association of these conditions is well documented. Intravaginal algometer measurement of tenderness to pressure applied to the pelvic floor muscles helps define vulvodynia associated with musculoskeletal factors. Women with both vulvodynia and fibromyalgia might have increased pelvic muscle pain compared to women with vulvodynia alone, defining the possible link of these 2 conditions. OBJECTIVE: We sought to: (1) correlate pain intensity during the nongenital tender point tenderness examination to pain intensity with the vaginal algometer in women with provoked vestibulodynia, and (2) determine whether subjects with provoked vestibulodynia and fibromyalgia had higher pain intensity scores with the vaginal algometer than those without fibromyalgia. STUDY DESIGN: In all, 92 subjects referred for vulvar pain were confirmed to have provoked vestibulodynia using the cotton swab test. A diagnosis of fibromyalgia was made if pain was present (numeric rating scale >1) in at least 11 sites of the 18-point nongenital tender point tenderness exam. Vaginal pain sensitivity was measured using an intravaginal pressure algometer, where 0.1, 0.3, and 0.5 kg/cm2 forces were applied digitally in random assignment by force and location to the right and left iliococcygeus muscle regions and the posterior vaginal wall. Both tender point tenderness and algometer pain intensity were reported on a 0 (no pain) to 10 (worse pain) numeric rating scale. Correlations were computed between the composite pain intensity (total of rating scale from each pressure threshold at specified site) of nongenital and those of iliococcygeus regions and the posterior vaginal wall. Independent t tests were used to determine differences in iliococcygeus regions and the posterior vaginal algometer pain ratings and presence or absence of fibromyalgia. The significance level was at P < .05. The data were expressed as mean ± SD. RESULTS: A significant correlation was found between numeric rating scale pain scores on the nongenital tender point tenderness exam and algometer testing on the iliococcygeus region (r = 0.44, P < .0001) and the posterior vaginal wall (r = 0.45, P < .0001). Subjects with fibromyalgia by tender point tenderness had significantly higher iliococcygeal pain (6.14 ± 2.07 vs 3.74 ± 2.22, P = .0001) and posterior vaginal wall pain (5.67 ± 2.10 vs 3.07 ± 2.16, P < .0001) than women without fibromyalgia by tender point tenderness. CONCLUSION: Women with provoked vestibulodynia who experience more severe pain with nongenital tender point palpation also experience more deep vaginal pain on pelvic exam. Those who fulfill the diagnosis of fibromyalgia show significantly more intense deep vaginal pain to palpation of iliococcygeus muscles and posterior vaginal wall. Further research using a more precise definition of fibromyalgia is necessary to confirm this relationship, but findings suggest that women with provoked vestibulodynia coexisting with fibromyalgia have greater risk of superimposed vaginal muscle pain and may be candidates for early adjunctive pelvic floor physical therapy. These findings need to be explored in women with generalized, nonprovoked vulvodynia.

Presenting symptoms among premenopausal and postmenopausal women with vulvodynia: a case series.

OBJECTIVE: The aim of the study was to determine whether there are differences in the clinical presentation of symptoms and vulvar pain ratings in postmenopausal women compared with premenopausal women with provoked vestibulodynia (PVD) enrolled in a clinical trial, after correcting for estrogen deficiency. METHODS: Questionnaire data were collected from 76 premenopausal and 24 postmenopausal women enrolled in a clinical trial for PVD. The questionnaire obtained information about the presence or absence of vulvar pain, the characteristics of this pain, and information about the women's demographic characteristics and reproductive health history. Participants were clinically confirmed to have PVD by a positive cotton swab test on pelvic examination and either absence of or corrected vulvovaginal atrophy based on Ratkoff staining with less than 10% parabasal cells. Women completed a standardized questionnaire describing their vulvar symptoms and rated daily pain on a visual analog scale (0 = no pain to 10 = worse pain imaginable) from sexual intercourse, tampon insertion (as a surrogate measure of intercourse) and 24-hour vulvar pain for 2 weeks during the screening period. Pretreatment data were analyzed before pharmacologic intervention. Chi-square was used to determine differences between pre- and postmenopausal women in demographic characteristics and clinical presentation, and independent t tests were used to analyze pain ratings by (0-10) numeric rating scale (NRS). RESULTS: The average ages of premenopausal and postmenopausal women were (30.6 ±â€Š8.6 y) and (54.4 ±â€Š6.5 y), respectively. The groups significantly differed with regard to relationship status (P = 0.002) and race (P = 0.03), but did not differ in years of education (P = 0.49), income level (P = 0.29), or duration of symptoms (P = 0.09). Postmenopausal women reported significantly more vulvar burning (70.00% vs 43.42%, P = 0.03), but there were no differences in vulvar itching (20.00% vs 22.37%, P = 0.82), vulvar stinging (40.00% vs 36.84%, P = 0.79), vulvar aching (50.00% vs 63.16%, P = 0.28), and vulvar stabbing (60.00% vs 71.06% P = 0.34) or in mean number of symptoms (2.40 ±â€Š1.0 vs 2.37 ±â€Š1.4, P = 0.92). Of the 70 participants completing diaries and meeting tampon insertion pain, there were no significant differences in mean (±SD) NRS pain ratings of postmenopausal compared with premenopausal women for tampon insertion (5.66 ±â€Š1.93 vs 5.83 ±â€Š2.15, P = 0.77), daily vulvar pain (3.20 ±â€Š2.55 vs 3.83 ±â€Š2.49, P = 0.38) and sexual intercourse (6.00 ±â€Š2.53 vs 5.98 ±â€Š2.29, P = 0.98). CONCLUSIONS: Pre- and postmenopausal women with PVD have similar pain scores, and with the exception of a higher incidence of burning in postmenopausal women, similar presenting clinical symptoms. The statistical power of this conclusion is limited by the small number of postmenopausal women in the study. Further research on the vulvar pain experience of the older woman with PVD is warranted.

Presenting Symptoms Among Black and White Women with Provoked Vulvodynia.

BACKGROUND: The prevalence of vulvodynia has been reported to be lower in black compared to white and Latina women. Use of different terminology to describe vulvar pain symptoms may play a role in lower prevalence. The objectives were to compare pain descriptors used by black and white women with provoked vulvodynia (PVD) to determine the effect of race on symptom reporting. METHODS: Ninety-two women, self-identified as black (n = 55) and white (n = 37) with clinically confirmed PVD completed a questionnaire containing demographic information and vulvar pain characteristics. Variables that were significant with race retained in the logistic regression model were included in multivariate analysis to determine the effect of race on reporting of vulvar pain symptoms. RESULTS: Of statistical significance, white women more often described their pain as burning as compared with black women (84% vs. 22%, p ≤ 0.0001). White women more frequently reported their pain as stinging (51% vs. 29%, p = 0.03) and itching (32% vs. 15%, p = 0.04) as well, whereas there was a trend for black women to more often describe their pain as aching (67% vs. 49%, p = 0.07). Overall, white women were 19 times as likely to report their pain as burning (adjusted odds ratio [aOR] 18.51, 99% confidence interval [CI] 4.46-76.86). CONCLUSIONS: These data suggest that black women are less likely to self-report their vulvar pain as burning, the classic symptom of PVD. Cultural influences and different underlying pain mechanisms may contribute to differences in symptom reporting by race.