Background The clinical role of LASER for vulvar and vaginal treatments in gynecology and female urology is controversial. Aims In this best practice document, we propose recommendations for the use of LASER for gynecologic and urologic conditions such as vulvovaginal atrophy, urinary incontinence, vulvodynia, and lichen sclerosus based on a thorough literature review. Materials & methods This project was developed between January and September 2018. The development of this document followed the ICS White Paper Standard Operating Procedures. Results Most of the available studies are limited by their design; for example they lack a control group, patients are not randomized, follow up is short term, series are small, LASER is not compared with standard treatments, and studies are industry sponsored. Due to these limitations, the level of evidence for the use of LASER in the treatment of these conditions remains low and does not allow for definitive recommendations for its use in routine clinical practice. Histological evidence is commonly reported as proof of tissue regeneration following LASER treatment. However, the histological changes noted can also be consistent with reparative changes after a thermal injury rather than necessarily representing regeneration or restoration of function. The use of LASER in women with vulvodynia or lichen sclerosus should not be recommended in routine clinical practice. There is no biological plausibility or safety data on its use on this population of women. Discussion The available clinical studies do not present convincing data regarding the efficacy of LASER for the treatment of vaginal atrophy or urinary incontinence. Also, while short-term complications seem to be uncommon, data concerning long-term outcomes are lacking. Conclusion At this point, LASER is not recommended for routine treatment of the aforementioned conditions unless part of well-designed clinical trials or with special arrangements for clinical governance, consent, and audit.

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The clinical role of LASER for vulvar and vaginal treatments in gynecology and female urology: An ICS/ISSVD best practice consensus document.

Treatment to External Labia and Vaginal Canal With CO2 Laser for Symptoms of Vulvovaginal Atrophy in Postmenopausal Women.

Nonsurgical Vulvovaginal Rejuvenation With Radiofrequency and Laser Devices: A Literature Review and Comprehensive Update for Aesthetic Surgeons.

Objective:The treatment of genitourinary syndrome of menopause (GSM) includes prescription hormone therapy, nonhormonal over-the-counter products, and most recently, laser treatment. Although the Food and Drug Administration has cleared fractional carbon dioxide (CO2) laser for a variety of

Rethinking the techno vagina: a case series of patient complications following vaginal laser treatment for atrophy.

Introduction The use of energy-based devices for the treatment of vaginal laxity, orgasmic dysfunction, and stress incontinence, such as minimally ablative fractional laser and radiofrequency, is gaining momentum. This review aims to answer clinical questions on the application of energy-based devices for feminine genital rejuvenation. Methods The target group includes physicians involved in esthetic medicine and feminine genital rejuvenation. A literature review was conducted on technologies in use for feminine rejuvenation to explore their safety, efficacy, tolerability, patient satisfaction, and clinical usability. A panel of physicians with clinical experience conducting these types of treatment reviewed and discussed the results of the literature search and gave clinical evidence-based recommendations. Results Energy-based devices may induce wound healing, stimulating new collagen, and elastin fiber formation. Radiofrequency treatment may also increase small nerve fiber density in the papillary dermis, improving nerve sensitivity, sexual function, including arousal and orgasmic dysfunction. Both minimally ablative fractional laser and radiofrequency has been shown to be effective when treating mild to moderate primary or secondary vulvovaginal laxity and associated secondary conditions. These treatments are reported to be safe, effective, and well tolerated with a rapid return to activities of daily living. Conclusions As this is an evolving medical field, clinical evidence often lacks robustness. Studies and clinical experience suggest that feminine genital rejuvenation using energy-based devices seems an attractive option for patients with mild-to-moderate medical conditions. The treatment can be safely and effectively delivered by trained staff as part of the comprehensive care, that is, currently available to women.

Review and clinical experience exploring evidence, clinical efficacy, and safety regarding nonsurgical treatment of feminine rejuvenation.

Effect of Single-Treatment, Surface-Cooled Radiofrequency Therapy on Vaginal Laxity and Female Sexual Function: The VIVEVE I Randomized Controlled Trial.

Objective: This subanalysis of the VIVEVE I trial aimed to evaluate the impact of cryogen-cooled monopolar radiofrequency (CMRF) therapy, for the treatment of vaginal laxity, on the domains of sexual function included in the Female Sexual Function Index (FSFI). Materials and Methods: The VIVEVE I clinical trial was prospective, randomized, single-blind, and Sham-controlled. Nine clinical study centers in Canada, Italy, Spain, and Japan were included. This subanalysis included premenopausal women with self-reported vaginal laxity who had ≥1 term vaginal delivery and a baseline FSFI total score ≤26.5, indicating sexual dysfunction. Enrolled subjects were randomized (2:1) to receive CMRF therapy [Active (90 J/cm2) vs. Sham (≤1 J/cm2)] delivered to the vaginal tissue. Independent analyses were conducted for each FSFI domain to evaluate both the mean change, as well as the clinically important change for Active- versus Sham-treated subjects at 6 months post-intervention. Results: Subjects randomized t...

Christopher G. Rowan

Papers

Effect of Single-Treatment, Surface-Cooled Radiofrequency Therapy on Vaginal Laxity and Female Sexual Function: The VIVEVE I Randomized Controlled Trial.

Effect of Single-Session, Cryogen-Cooled Monopolar Radiofrequency Therapy on Sexual Function in Women with Vaginal Laxity: The VIVEVE I Trial.