Histologic and Clinical Changes in Vulvovaginal Tissue After Treatment With a Transcutaneous Temperature-Controlled Radiofrequency Device

Wilson, Monique J. Vanaman; Bolton, Joanna; Jones, Isabela T; Wu, Douglas C.; Calame, Antoanella; Goldman, Mitchel P.

doi:10.1097/dss.0000000000001453

Cited by 35 publications

(32 citation statements)

References 9 publications

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“…The term VLS and therefore its therapy, vaginal rejuvenation, is not endorsed or formally defined by the leading gynecological societies . However, management of the symptoms have evolved from techniques involving sutures and the adaptation of traditional urogynecological procedures to the use of LASER and radiofrequency procedures …”

Section: Vaginal Laxity Syndromementioning

confidence: 99%

“…11 However, management of the symptoms have evolved from techniques involving sutures and the adaptation of traditional urogynecological procedures to the use of LASER 61,90 and radiofrequency procedures. [91][92][93][94][95][96][97][98][99] In 2011, there was an attempt to restore the rugae of the vagina in postmenopausal women ("vaginal rugation rejuvenation"), by vaporization of the vaginal wall in order to create parallel grooves. The procedure was performed in women with a sensation of a loose or smooth vagina.…”

Section: Grade Of Recommendationmentioning

confidence: 99%

See 1 more Smart Citation

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

Preti¹,

Vieira‐Baptista

Digesu³

et al. 2019

Neurourology and Urodynamics

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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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Section: Vaginal Laxity Syndromementioning

confidence: 99%

Section: Grade Of Recommendationmentioning

confidence: 99%

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

Preti¹,

Vieira‐Baptista

Digesu³

et al. 2019

Neurourology and Urodynamics

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“…Several studies using radiofrequency devices for GSM have demonstrated evidence of benefit; however, these are small observational studies. As with laser treatment, there appears to be a greater improvement in GSM than in SUI or sexual dysfunction …”

Section: Indications and Evidence For Usementioning

confidence: 99%

“…As with laser treatment, there appears to be a greater improvement in GSM than in SUI or sexual dysfunction. 29…”

Section: Radiofrequency Devicesmentioning

confidence: 99%

Energy devices in vaginal therapy

Hillard

2019

The Obstetric & Gynaecologis

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“…The term VLS, and therefore its therapy, vaginal rejuvenation, is not endorsed or formally defined by the leading gynecological societies 11 . However, management of the symptoms have evolved from techniques involving sutures and the adaptation of traditional urogynecological procedures to the use of LASER 61,89 and radiofrequency procedures [90][91][92][93][94][95][96][97][98] .…”

Section: Impact On the Vaginal Microbiomementioning

confidence: 99%

The Clinical Role of LASER for Vulvar and Vaginal Treatments in Gynecology and Female Urology: An ICS/ISSVD Best Practice Consensus Document

Preti

Vieira‐Baptista

Digesu

et al. 2019

J Low Genit Tract Dis

View full text Add to dashboard Cite

In this best practice document, we propose recommendations for the use of LASER for gynaecologic and urologic conditions such as vulvovaginal atrophy, urinary incontinence, vulvodynia and lichen sclerosus based on a thorough literature review. 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 most 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. 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. Therefore, 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.

show abstract

Histologic and Clinical Changes in Vulvovaginal Tissue After Treatment With a Transcutaneous Temperature-Controlled Radiofrequency Device

Cited by 35 publications

References 9 publications

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

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

Energy devices in vaginal therapy

The Clinical Role of LASER for Vulvar and Vaginal Treatments in Gynecology and Female Urology: An ICS/ISSVD Best Practice Consensus Document

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