Fractionated Carbon Dioxide Laser for the Treatment of Vulvar Lichen Sclerosus: A Randomized Controlled Trial.

OBJECTIVE: To estimate the efficacy of fractionated carbon dioxide (CO2) laser therapy for vulvar lichen sclerosus. METHODS: We conducted a prospective, double-blind, randomized, sham-controlled, trial conducted in a clinic specializing in vulvar disorders. The study participants were 40 women with active vulvar lichen sclerosus confirmed with biopsy who were abstaining from topical and systemic treatments for at least 4 weeks before enrollment. Women were randomized in a 1:1 ratio to receive either five sham laser treatments or five fractionated CO2 treatments in a 24-week period. Study participants, treating clinicians, and the evaluating pathologist were blinded. The primary endpoint was the change in the histopathology scale score between pretreatment and posttreatment biopsies. We estimated 20 per group for 80% power to detect a 40% reduction in the histopathology scale score with up to 10% attrition. A secondary endpoint was the change in the validated CSS (Clinical Scoring System for Vulvar Lichen Sclerosus). RESULTS: From November 2018 to June 2020, 40 women were randomized to participate in the trial, and 37 women (19 fractionated CO2, 18 sham) were included in an intention-to-treat (ITT) analysis. Three women were excluded from the ITT analysis because they did not have posttreatment biopsies and, therefore, a posttreatment histopathology scale score could not be obtained. There was a 0.20 reduction (improvement) in histopathology scale score from baseline in the active treatment group (95% CI -1.1, 0.80, P=.74) and a 0.1 increase from baseline in the sham treatment group (95% CI -0.90, 1.0, P=.91). The change in histopathology scale score between the active and sham arm was not statistically significant (95% CI -1.14, 1.06, P=.76). CONCLUSION: Fractionated CO2 is not an effective monotherapy treatment for vulvar lichen sclerosus. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT03665584. FUNDING SOURCE: Additional funding for this study was supplied by El.En Group, Florence, Italy, the manufacturer of the laser used in this study. In addition, El.En Group supplied the laser used in the study.

Exploring Pain-Related Anxiety and Depression in Female Patients With Provoked Vulvodynia With Associated Overactive Pelvic Floor Muscle Dysfunction.

INTRODUCTION: Vulvodynia is a chronic pain condition with potential associated factors, including musculoskeletal and psychosocial components. AIM: This study explores the prevalence of pain-related anxiety and depression in women with provoked vestibulodynia with associated overactive pelvic floor muscle dysfunction (PVD-PFD). METHODS: A retrospective chart review of 352 women presenting to 2 urban vulvovaginal specialty clinics over the course of a year was conducted. Women presenting for initial evaluation completed validated questionnaires for pain-related anxiety and depression. Women who completed these questionnaires with a diagnosis of PVD-PFD independently confirmed by a women's health physical therapist were included in analysis. Information on previously attempted treatments was gathered. MAIN OUTCOME MEASURES: Pain-related anxiety was measured with the Pain Anxiety Symptoms Scale-20 and depression with the Patient Health Questionnaire 8. RESULTS: Of 79 women with confirmed PVD-PFD, 22% met criteria for pain-related anxiety alone, 4% for depression alone, and 27% for both pain-related anxiety and depression, with a significant association between anxiety and depression (χ2 (1) = 21.44, P < .0005, phi = 0.521). There was also a significant association between anxiety and/or depression and whether prior treatment was attempted (χ2 (2) = 6.81, P = .03, phi = 0.294). CONCLUSION: The study found that 49% of women with PVD-PFD experienced pain-related anxiety, with or without depression. In addition, there was a statistically significant association between attempts at prior treatment and greater pain-related anxiety and depression. This is the first study to report a rate of pain-related anxiety specifically in women with PVD-PFD. These findings are consistent with studies showing elevated pain-related anxiety in other chronic musculoskeletal conditions, including lower back pain and fibromyalgia. Govind V, Krapf JM, Mitchell L, et al. Exploring Pain-Related Anxiety and Depression in Female Patients With Provoked Vulvodynia With Associated Overactive Pelvic Floor Muscle Dysfunction. J Sex Med 2020;8:517-524.

Injury to Perineal Branch of Pudendal Nerve in Women: Outcome from Resection of the Perineal Branches.

Background This study describes outcomes from a new surgical approach to treat "anterior" pudendal nerve symptoms in women by resecting the perineal branches of the pudendal nerve (PBPN). Methods Sixteen consecutive female patients with pain in the labia, vestibule, and perineum, who had positive diagnostic pudendal nerve blocks from 2012 through 2015, are included. The PBPN were resected and implanted into the obturator internus muscle through a paralabial incision. The mean age at surgery was 49.5 years (standard deviation [SD] = 11.6 years) and the mean body mass index was 25.7 (SD = 5.8). Out of the 16 patients, mechanisms of injury were episiotomy in 5 (31%), athletic injury in 4 (25%), vulvar vestibulectomy in 5 (31%), and falls in 2 (13%). Of these 16 patients, 4 (25%) experienced urethral symptoms. Outcome measures included Female Sexual Function Index (FSFI), Vulvar Pain Functional Questionnaire (VQ), and Numeric Pain Rating Scale (NPRS). Results Fourteen patients reported their condition pre- and postoperatively. Mean postoperative follow-up was 15 months. The overall FSFI, and arousal, lubrication, orgasm, satisfaction, and pain domains significantly improved (p < 0.05). The VQ also significantly improved (p < 0.001) in 13 (93%) of 14 patients. The NPRS score decreased on average from 8 to 3 (p < 0.0001). All four patients with urethral symptoms were relieved of these symptoms. Conclusion Resection of the PBPN with implantation of the nerve into the obturator internus muscle significantly reduced pain and improved sexual function in women who sustained injury to the PBPN.