Fractional CO2 Laser Therapy Versus 4% Topical Lidocaine Gel for Dyspareunia in Breast Cancer Survivors

This is a randomized trial to determine the comparative effectiveness of the CO2RE laser
device relative to topical lidocaine in treating dyspareunia among breast cancer survivors.
The large and growing population of breast cancer survivors experience a significant burden
of urogenital symptoms including dyspareunia. Several studies have evaluated the feasibility
and effectiveness of CO2 lasers for the treatment of symptomatic vulvovaginal atrophy in
postmenopausal women suggesting improvements in atrophy symptoms with favorable histological
and microscopic changes. There is little know about the effectiveness of CO2 laser therapy in
breast cancer survivors.

Patients who are breast cancer survivors experiencing dyspareunia and desiring intervention
will be randomized to two cohorts: (1) Treatment with the CO2RE laser or (2) application of
4% aqueous lidocaine applied to the vulvar vestibule for 3 minutes before vaginal
penetration. The primary outcome will be the overall as well as lubrication, satisfaction,
and pain domain scores on the Female Sexual Function Index instrument. Secondary outcomes
will be according to other validated pain and pelvic floor symptom instruments.

Following initiation of treatment, both groups will follow up at one-week, 1-month, 3-months,
and 6-months. At the 3-month assessment, subjects in the lidocaine arm will be given the
option to undergo CO2RE laser therapy. A combination of validated and non-validated physical
exam and survey instruments will be utilized at each visit in order to assess pelvic floor
function, bowel and bladder function, and sexual function before and after treatment.

Inclusion Criteria:

- Subjects included must be female breast cancer survivors over the age of 18, sexually
active (at least 4 episodes of sexual intercourse per month), and find intercourse
painful. Subjects must also be English speaking and able to give informed consent.

Exclusion Criteria:

- Subjects will be excluded if pregnant, has not had breast cancer, does not have
painful intercourse secondary to treatment received for their breast cancer, is not
English speaking, or lacks the ability to sign informed consent.