- Female patients of childbearing potential (defined as < 2 years after last menstruation or not surgically sterile) must use a highly effective contraceptive method (allowed methods of birth control [i.e. with a failure rate of < 1% per year] are implants, injectables, combined oral contraceptives, intrauterine device (IUD) [only hormonal], sexual abstinence or vasectomized partner) during the trial and for a period of > 2 months following the last trial intervention. Female patients with an intact uterus (unless amenorrhea for the last 24 months) must have a negative serum pregnancy test within 48 hours prior to LITT operation per standard of care.