Randomized data on CO2 laser vs Kegels for sexual dysfunction
Lou W, Chen F, Xu T, et al. A randomized controlled study of vaginal fractional CO2 laser therapy for female sexual dysfunction. Lasers Med Sci. March 15, 2021. doi: 10.1007/s10103-021-03260-x.
In a small randomized controlled trial (RCT) conducted in China, Lou and colleagues identified premenopausal women at “high risk” for sexual dysfunction as determined by the Chinese version of the Female Sexual Function Index (CFSFI).
Details of the study
A total of 84 women (mean age, 36.5 years) were included in the study. All the participants were heterosexual and married or with a long-term partner. The domain of sexual dysfunction was not considered. Women were excluded if they had no current heterosexual partner; had genital malformation, urinary incontinence, or prolapse stage 2 or higher; a history of pelvic floor mesh treatment; current gynecologic malignancy; abnormal cervical cytology; or were currently pregnant or postpartum. In addition, women were excluded if they had been treated previously for sexual dysfunction or mental “disease.” The cohort was randomized to receive fractional CO2 laser treatments (three 15-minute treatments 1 month apart at 60W, 1,000 microseconds) or coached Kegel exercises (10 exercises repeated twice daily at least 3 times/week and monitored by physical therapists at biweekly clinic visits). Sexual distress was evaluated by using the Female Sexual Distress Scale-Revised (FSDSR). Outcomes measured were pelvic floor muscle strength and scores on the CFSFI and FSDSR. Data were obtained at 3, 6, 9, and 12 months after initiation of therapy.
Both groups showed improvement
The laser cohort showed slightly more improvement in scale scores at 6 and 12 months. Specifically, the laser group had better scores on lubrication and overall satisfaction, with moderate effect size; neither group had improvements in arousal, desire, or orgasm. The Kegel group showed a significant improvement in pelvic floor strength and orgasm at 12 months, an improvement not seen in the laser cohort. Both groups showed gradual improvement in the FSDSR, with the laser group reporting a lower score (10.0) at 12 months posttreatment relative to the Kegel group (11.1). Again, these were modest effects as baseline scores for both cohorts were around 12.5. There were minimal safety signals in the laser group, with 22.5% of women reporting scant bloody discharge posttreatment and 72.5% describing mild discomfort (1 on a 1–10 VAS scale) during the procedure.
This study is problematic in several areas. Although it was a prospective, randomized trial, it was not blinded, and the therapeutic interventions were markedly different in nature and requirement for individual patient motivation. The experiences of sexual dysfunction among the participants were not stratified by type—arousal, desire, lubrication, orgasm, or pain. All patients had regular cyclic menses; however, the authors do not report on contraceptive methods, hormonal therapy, or other comorbid conditions that could impact sexual health. The cohorts may or may not have been similar in baseline types of sexual dissatisfaction.
CO2 laser for lichen sclerosus: Is it effective?
Pagano T, Conforti A, Buonfantino C, et al. Effect of rescue fractional microablative CO2 laser on symptoms and sexual dysfunction in women affected by vulvar lichen sclerosus resistant to long-term use of topic corticosteroid: a prospective longitudinal study. Menopause. 2020;27:418-422. doi: 10.1097 /GME.0000000000001482.
Burkett LS, Siddique M, Zeymo A, et al. Clobetasol compared with fractionated carbon dioxide laser for lichen sclerosus: a randomized controlled trial. Obstet Gynecol. 2021;137:968-978. doi: 10.1097 /AOG.0000000000004332.
Mitchell L, Goldstein AT, Heller D, et al. Fractionated carbon dioxide laser for the treatment of vulvar lichen sclerosus: a randomized controlled trial. Obstet Gynecol. 2021;137:979-987. doi: 10.1097 /AOG.0000000000004409.
High potency corticosteroid ointment is the current standard treatment for lichen sclerosus. Alternative options for disease that is refractory to steroids are limited. Three studies published in the past year explored the CO2 laser’s ability to treat lichen sclerosus symptoms and resultant sexual dysfunction—Pagano and colleagues conducted a small prospective study and Burkett and colleagues and Mitchell et al conducted small RCTs.
Details of the Pagano study
Three premenopausal and 37 postmenopausal women with refractory lichen sclerosus (defined as no improvement after 4 cycles of ultra-high potency steroids) were included in the study. Lichen sclerosus was uniformly biopsy confirmed. Women using topical or systemic hormones were excluded. VAS was administered prior to initial treatment and after each of 2 fractional CO2 treatments (25–30 W; 1,000 microseconds) 30 to 40 days apart to determine severity of vulvar itching, dyspareunia with penetration, vulvar dryness, sexual dysfunction, and procedure discomfort. Follow-up was conducted at 1 month after the final treatment. VAS score for the primary outcome of vulvar itching declined from 8 pretreatment to 6 after the first treatment and to 3 after the second. There was no significant treatment-related pain reported.
The authors acknowledged the limitations of their study; it was a relatively small sample size, nonrandomized and had short-term follow-up of a mixed patient population and no sham or control group. The short-term improvements reported in the study patients may not be sustained without ongoing treatment for a lifelong chronic disease, and the long-term potential for development of squamous cell carcinoma may or may not be ameliorated.
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