Background: Discomfort during sexual activity is common after breast cancer and may be exacerbated by endocrine therapy. Vaginal estrogens are effective but commonly avoided due to systemic absorption. No randomized studies have compared lubricant products, despite a large commercial market. We aimed to compare efficacy and acceptability of two major types of lubricant, water-based and silicone-based, for discomfort during sexual activity in postmenopausal breast cancer patients.
Methods: In a single-center, randomized, double-blind, AB/BA crossover design, sexually active postmenopausal breast cancer patients used each lubricant for four weeks. The primary patient-reported efficacy outcome was total discomfort related to sexual activity (Fallowfield Sexual Activity Questionnaire Discomfort subscale SAQ-D, range 0-6, higher scores correspond to worse discomfort). Acceptability was measured by patient preference and reported intention to continue using the products. Participants also completed sexual activity diaries.
Results: Over 90% of participants experienced clinically significant sexually-related distress at baseline. Water- and silicone-based lubricants did not differ statistically in efficacy based on total sexual discomfort (difference 0.7, 95% confidence interval (CI) 0-1.4, p=0.06). In a post hoc analysis, pain/discomfort during penetration improved more during silicone-based lubricant use than during water-based (odds ratio 5.4, 95% CI 1.3-22.1, p=0.02). All aspects of sexual discomfort measured with diaries were reported more commonly with water- than silicone-based lubricant. Almost twice as many women preferred silicone-based to water-based lubricant than the converse (n=20, 65%, v. n=11, 35%). After the trial, all but one respondent (n=33, 86.9%) reported continuing symptoms of sexual discomfort. One participant volunteered that she was no longer sexually active due to ongoing discomfort. 88% continued to experience clinically significant sexually-related distress despite use of either lubricant.
Conclusions: Total sexual discomfort was lower after use of silicone-based lubricant than water-based, but many women continue to experience sexual discomfort and sexually-related distress.