• Sexual Dysfunction Clinical Trials
• Breast Cancer

• Sexual Dysfunction
• Obstetrics & Gynecology Clinical Trials
• Obstetrics & Gynecology
• Breast Cancer

For breast cancer survivors who experience moderate or severe penetrative dyspareunia associated with vulvovaginal atrophy, application of a topical liquid lidocaine to the vulvar vestibule prior to penetration can prevent pain and offer these women comfortable intercourse.

Martha F. Goetsch, MD, MPH, of Oregon Health and Science University, Portland, Oregon, USA, reported outcomes of the Therapy to Prevent Sexual Pain in Breast Cancer Survivors trial (NCT01539317). This was a randomized, controlled, double-blind trial that was conducted to examine whether the use of an analgesic liquid to the vulvar vestibule in estrogen-deficient breast cancer survivors with moderate to severe dyspareunia could prevent pain from penetrative intercourse.

Forty-six estrogen-deficient breast cancer survivors were randomized to 4 weeks of either 4% liquid lidocaine or saline to be applied to the vulvar vestibule for 3 minutes prior to vaginal penetration. Study participants used a diary to document twice-weekly vaginal penetration by either intercourse or tampon insertion. This intervention phase of the study was followed by an 8-week open-label trial in which all patients received lidocaine.

The primary outcomes of the study were penetration pain (from either intercourse or tampon use) measured on a scale from 0 to 10, sexual distress as assessed by the Female Sexual Distress Scale (abnormal >11), and resumption of intercourse.

All women in the study had moderate to severe penetrative dyspareunia for more than 6 months. Women with significant pelvic muscle or organ pain, and those with vulvar dystrophy, were excluded from the study.

The study showed that during the 1-month intervention phase, women who used lidocaine had significantly less pain during intercourse compared with those who used saline (median score, 1.0 vs 5.3; p=0.015).

After the 8-week open-label part of the study, completed by 41 of the 46 women, 90% (37 of 41) reported comfortable penetration as indicated by median scores of 0 and 1, and a significant decrease in the sexual distress score from a median of 30.5 at baseline to 14 (interquartile range, 3 to 20; p<0.001). Of the 20 women who abstained from sex prior to the study, 17 (85%) resumed intercourse after the study.

Prof. Goetsch emphasized that these results suggest that dyspareunia is more of a pain condition than one of atrophy, because the atrophy remained unchanged in these women. She also emphasized that successfully managing penetrative pain was achieved by targeting analgesic treatment to the vulvar vestibule, suggesting that the treatment target should be the vestibule, not the vagina.

In conclusion, the study shows that women can prevent their own pain from intercourse by using the lidocaine solution.

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