Nancy A Phillips1, Candace Brown, David Foster, Candi Bachour, Leslie Rawlinson, Jim Wan, Gloria Bachmann. 1. 1Department of Obstetrics, Gynecology and Reproductive Sciences, Rutgers Robert Wood Johnson Medical School, New Brunswick, NJ 2Department of Clinical Pharmacy, University of Tennessee Health Science Center, Memphis, TN 3Department of Obstetrics and Gynecology, University of Rochester School of Medicine and Dentistry, Rochester, NY 4Department of Preventive Medicine, University of Tennessee Health Science Center, Memphis, TN.
Abstract
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 ± 8.6 y) and (54.4 ± 6.5 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 ± 1.0 vs 2.37 ± 1.4, 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 ± 1.93 vs 5.83 ± 2.15, P = 0.77), daily vulvar pain (3.20 ± 2.55 vs 3.83 ± 2.49, P = 0.38) and sexual intercourse (6.00 ± 2.53 vs 5.98 ± 2.29, 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.
RCT Entities:
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 ± 8.6 y) and (54.4 ± 6.5 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 ± 1.0 vs 2.37 ± 1.4, 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 ± 1.93 vs 5.83 ± 2.15, P = 0.77), daily vulvar pain (3.20 ± 2.55 vs 3.83 ± 2.49, P = 0.38) and sexual intercourse (6.00 ± 2.53 vs 5.98 ± 2.29, 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.