Locating pain in breast cancer survivors experiencing dyspareunia: a randomized controlled trial.

OBJECTIVE: To locate sites of genital tenderness in breast cancer survivors not using estrogen who experience dyspareunia and to test the hypothesis that tenderness is limited to the vulvar vestibule rather than the vagina and is reversed by topical anesthetic.

METHODS: Postmenopausal survivors of breast cancer with moderate and severe dyspareunia were recruited for an examination including randomization to a double-blind intervention using topical aqueous 4% lidocaine or normal saline for 3 minutes to the areas found to be tender. Comparisons of changes in patients' reported numerical rating scale values were made with the Wilcoxon rank-sum test with significance set at P<.05.

RESULTS: Forty-nine patients aged 37-69 years (mean 55.6±8.6 years) had a median coital pain score of 8 (interquartile range 7-9, scale 0-10). On examination, all women had tenderness in the vulvar vestibule (worst site 4 o'clock median 6, 4-7). In addition, one had significant vaginal mucosal tenderness and two had pelvic floor myalgia. All had vulvovaginal atrophy with 86% having no intravaginal discharge. Aqueous lidocaine 4% reduced the vestibular tenderness of all painful sites. For example, pain at the worst site changed from a median of 5 (4-7) to 0 (0-1) as compared with saline placebo, which changed the worst site score from 6 (4-7) to 4 (3-6) (P<.001). After lidocaine application, speculum placement was nontender in the 47 without either myalgia or vaginal mucosal tenderness.

CONCLUSION: In breast cancer survivors with dyspareunia, exquisite sensitivity was vestibular and reversible with aqueous lidocaine. Vaginal tenderness was rare despite severe atrophy.

CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.clinicaltrials.gov, NCT01539317.

LEVEL OF EVIDENCE: I.