Lara C. Pullen, PhD

May 01, 2014

CHICAGO — The application of topical liquid lidocaine to the vulvar vestibule allows for comfortable intercourse in breast cancer survivors with severe menopausal dyspareunia, new research shows.

"Women can prevent their own pain," said investigator Martha Goetsch, MD, MPH, from Oregon Health and Science University in Portland.

Breast cancer survivors are often searching for an alternative to hormonal therapy. The fact that this approach can be used by women prior to penetration is likely to be particularly useful.

Conventional wisdom holds that dyspareunia, a common complaint of postmenopausal women, is related to vaginal atrophy. Consequently, hormones are often prescribed as a first-line therapy.

Dr. Goetsch's team took a different approach, looking at dyspareunia as a pain condition rather than an atrophy condition.

The randomized controlled trial was awarded first prize here at the American Congress of Obstetricians and Gynecologists Annual Clinical Meeting 2014, where it was presented by Dr. Goetsch.

The double-blind trial involved 46 breast cancer survivors with dyspareunia. Women with pelvic muscle and organ pain were excluded.

The average age of the cohort was 55.63 years, the average postmenopausal duration was 8 years, the average time from the diagnosis of breast cancer was 4.5 years, and the average time with the spouse was 24.9 years.

All of the women had severe vulvovaginal atrophy. Median score on the 10-point dyspareunia pain scale was 8, and median score on the Female Sexual Distress Scale was 30.5 (a score higher than 11.0 indicates abnormal functioning).

The women were randomized to the precoital application of 4% aqueous lidocaine or saline for 4 weeks. They recorded pain associated with intercourse and twice-weekly tampon insertion in a diary.

Dr. Goetsch examined all the women and located individual sites of tenderness. She then showed them the vulvar vestibule, where the pain was localized, and taught them how to apply the 3-minute treatment prior to penetration.

The blinded trial was followed by a 2-month open-label trial of lidocaine. After the open-label trial, 90% of women reported comfortable penetration. Median sexual distress score decreased to 14 (P < .001).

After the 4-week double-blind phase, median score on a 10-point pain scale was lower in the lidocaine group than in the placebo group (1.0 vs 5.3; P = .015). After the 2-month open-label phase, pain scores remained at 0 or 1.

At the beginning of the study, 20 women had chosen to abstain from sex. At the end of the open-label trial, 85% of these women had resumed penetrative intimacy.

"The partners complained of nothing. They were very happy," reported Dr. Goetsch. In particular, none of them complained of numbness.

"The issue of treating symptoms was based on fear of hormonal therapy," said Edward Lichten, MD, from Birmingham, Michigan, immediately after the presentation.

Dr. Goetsch explained that she believes that "atrophy is not the problem. I think it will be found to be a form of vestibulodynia." This could mean a paradigm shift in the treatment to dyspareunia, she suggested.

"Everybody agrees that these women are in pain and aren't being well served by the current medical community," said Caela Miller, MD, assistant professor and gynecologic oncologist at the San Antonio Military Medical Center.

"We thought this was the best paper of the 600 abstracts that were submitted, and we support the research," said Dr. Miller, who was a member of the Committee on Scientific Program.

Dr. Goetsch and Dr. Miller have disclosed no relevant financial relationships. Dr. Lichten is the author of the Textbook of Bio-Identical Hormones.

American Congress of Obstetricians and Gynecologists (ACOG) Annual Clinical Meeting 2014: Abstract 1S. Presented April 28, 2014.

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