A Practical Solution for Dyspareunia in Breast Cancer Survivors: A Randomized Controlled Trial

Abstract

Purpose: Dyspareunia is common in breast cancer survivors because of low estrogen. This study explored whether dyspareunia is introital pain, preventable with analgesic liquid.

Patients and methods: In a randomized, controlled, double-blind trial, estrogen-deficient breast cancer survivors with severe penetrative dyspareunia applied either saline or 4% aqueous lidocaine to the vulvar vestibule for 3 minutes before vaginal penetration. After a 1-month blinded trial of patient-assessed twice-per-week tampon insertion or intercourse, all patients received lidocaine for 2 months in an open-label trial. The primary outcome was patient-related assessment of penetration pain on a scale of zero to 10. Secondary outcomes were sexual distress (Female Sexual Distress Scale), sexual function (Sexual Function Questionnaire), and resumption of intercourse. Comparisons were made with the Mann-Whitney U and Wilcoxon signed rank test with significance set at P < .05.

Results: In all, 46 patients, screened to exclude those with pelvic muscle and organ pain, uniformly had clinical evidence of severe vulvovaginal atrophy, dyspareunia (median pain score, 8 of 10; interquartile range [IQR], 7 to 9), increased sexual distress scores (median, 30.5; IQR, 23 to 37; abnormal, > 11), and abnormal sexual function. Users of lidocaine reported less pain during intercourse in the blinded phase (median score of 1.0 compared with saline score of 5.3; P = .007). After open-label lidocaine use, 37 (90%) of 41 reported comfortable penetration. Sexual distress decreased (median score, 14; IQR, 3 to 20; P < .001), and sexual function improved in all but one domain. Of 20 prior abstainers from intercourse who completed the study, 17 (85%) had resumed comfortable penetrative intimacy. No partners reported penile numbness.

Conclusion: Breast cancer survivors with menopausal dyspareunia can have comfortable intercourse after applying liquid lidocaine compresses to the vulvar vestibule before penetration.

Trial registration: ClinicalTrials.gov NCT01539317.

Fig 1.

CONSORT diagram for part 2 of study. See Data Supplement for full CONSORT diagram.

Fig 2.

Median pain scores during or after intercourse as recorded in weekly diaries using the Numeric Rating Scale. Black horizontal lines indicate medians; colored boxes indicate the values of the interquartile range (IQR) between Q1 (the 25th) and Q3 (the 75th) percentiles. Vertical black lines indicate the ranges between Q3 + 1.5 IQR and Q1 − 1.5 IQR. Black diamonds are outliers. At enrollment, patients assigned to saline versus lidocaine did not differ significantly from each other (P = .61). During the blinded weeks, the two groups differed significantly (P = .01), and later during the open-label weeks, the two groups again did not differ (P = .41). During the open-label lidocaine period, each group had a median score that was significantly lower than baseline (P < .001).

Fig 3.

Sexual Function Questionnaire domain scores after 4 weeks of blinded interventions. Black horizontal lines indicate medians; colored boxes indicate the values of the interquartile range (IQR) between Q1 (the 25th) and Q3 (the 75th) percentiles. Vertical black lines indicate the ranges between Q3 + 1.5 IQR and Q1 − 1.5 IQR. Black diamonds are outliers. Red lines represent the minimum scores considered to represent normal function. All patients were instructed to use lubricant, so the “Arousal_lub” domain score does not accurately reflect spontaneous arousal. Asterisks show domains in which the scores for placebo and lidocaine were significantly different. cog, cognitive; lub, lubrication; sen, sensation.

Fig 4.

Sexual Function Questionnaire scores after 12 weeks. Black horizontal lines indicate medians; colored boxes indicate the values of the interquartile range (IQR) between Q1 (the 25th) and Q3 (the 75th) percentiles. Vertical black lines indicate the ranges between Q3 + 1.5 IQR and Q1 − 1.5 IQR. Black diamonds are outliers. Red lines represent the minimum scores considered to represent normal function. After completion of blinded and then open-label interventions, scores were not significantly different for any domain except Arousal-cognitive (Arousal_cog), indicated by an asterisk (P = .049), which measured two questions: how much and how often the patient felt “excited, ‘turned on,’ and wanting sexual activity to continue.” Improvement was statistically significant by 12 weeks compared with baseline in all domains except Orgasm. All patients were instructed to use lubricant, so the “Arousal_lub” domain score does not accurately reflect spontaneous arousal. cog, cognitive; lub, lubrication; sen, sensation.

Fig 5.

Female Sexual Distress Score values. Scores at each interval combined randomization groups because there was not a significant difference between them at any time interval. Scores of more than 11 are considered abnormal (indicated by the red line). Black horizontal lines indicate medians; colored boxes indicate the values of the interquartile range (IQR) between Q1 (the 25th) and Q3 (the 75th) percentiles. Vertical black lines indicate the ranges between Q3 + 1.5 IQR and Q1 − 1.5 IQR.