The evidence for laser treatments to the vulvo‐vagina: Making sure we do not repeat past mistakes

Abstract

Following menopause, up to 49% of women will experience genitourinary symptoms such as vaginal itching, dryness, dyspareunia and incontinence as a result of oestrogen deficiency. Treatments such as vaginal lubricants and moisturisers only temporarily relieve symptoms, while local oestrogen treatments are often unacceptable or unsafe for many women. Recently, a novel laser treatment has been proposed as a non-invasive, long-term solution to vulvo-vaginal and urinary symptoms. While preliminary histological results have been promising, its therapeutic, clinical effect has yet to be determined. However, despite the scarcity of evidence for its safety and long-term benefit, laser treatments are widely marketed for a range of genitourinary symptoms, with high uptake by both clinicians and women alike. This review aims to examine the evidence for laser treatments to the vulvo-vagina and to evaluate its safety and efficacy. Our results include 17 studies investigating the effect of laser therapy for vulvo-vaginal symptoms, seven for its effects on urinary incontinence and four for histology. These are limited to non-randomised, observational data with small sample sizes between 15 to 175 women and follow-up duration from none to two years. As such, strong evidence for laser efficacy and safety is limited and warrants more robust, placebo-controlled, randomised trials before widespread implementation.

Energy‐based treatment for gynecologic conditions including genitourinary syndrome of menopause: Consensus, controversies, recommendations, and FDA clearance

“…The time has come to collect pertinent outcomes and adverse event data using a “global registry,” potentially on a US FDA or World Health Organization (WHO) sponsored website. This editorial supports the FDA arguments to define the proper indications for EBT in gynecology based on scientific evidence as so previously and eloquently summarized by Song et al : “ while this treatment may well be efficacious, these claims must be validated through large‐scale randomized controlled trials which can provide stronger evidence to ensure responsible representation of this new treatment to the public ”. In sum, randomized, controlled clinical trials with a comparison to the “gold standard” current FDA‐approved treatment of topical estrogens are underway and will be necessary in order to pave the way for FDA clearances of fractionated and/or radiofrequency devices for the treatment of GSM.…”

“…They are often described as mild, moderate, or severe and frequently sub‐divided by time‐frames such as immediate (minutes/hours), short (days/weeks), and long (months/years) following treatment. In a recently published review, the co‐authors searched the literature between 2012–2017 focusing on safety and efficacy of laser treatments to the vulvo‐vagina (VV) region . A total of 761 women underwent treatment for VV symptoms, and 408 for urinary incontinence.…”

“…AE reported on the US Food and Drug Administration (FDA) MAUDE database (Manufacturer and User Facility Device Experience) reveal few minor events. Personal communication with the Australian co‐authors for this review indicates over 20,000 EB vulvovaginal treatments have been undertaken in their territory with estimated hundreds of thousands of treatments worldwide. This information is relevant when patient's safety is considered, but prospective sham‐controlled studies are needed in order to clarify the exact benefits in specific medical conditions and terms.…”

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

“…LASER has been available for use and disseminated among clinicians before sufficient data regarding quality, safety, and efficacy were provided . Use of this technology prior to rigorous scientific examination may end in adversity, as has been demonstrated by previous technologies such as vaginal mesh for prolapse repair and power tissue morcellation …”

“…135 Use of this technology prior to rigorous scientific examination may end in adversity, as has been demonstrated by previous technologies such as vaginal mesh for prolapse repair and power tissue morcellation. 136 Although LASER technology seems promising for select indications, long-term efficacy and safety data are lacking. In order to elucidate its optimal clinical application, LASER therapy must be evaluated in rigorous, well-designed studies that are of appropriate time scale, randomized and sham-controlled, to evaluate safety and efficacy.…”