RCT of Laser therapy for GSM
Research type
Research Study
Full title
Fractional Microablative CO2-laser versus Photothermal Non-ablative Erbium:YAG-laser for the management of Genitourinary Syndrome of Menopause: A non-inferiority, single-blind randomised controlled trial
IRAS ID
227344
Contact name
Richard Flint
Contact email
Sponsor organisation
King’s College Hospital NHS Foundation Trust
Clinicaltrials.gov Identifier
Duration of Study in the UK
4 years, 0 months, 0 days
Research summary
GGenitourinary Syndrome of Menopause (GSM) is the new terminology for “vulvovaginal”. Although women may present with some or all of the clinical signs and symptoms, the most common symptom of GSM is vaginal dryness. Vaginal dryness appears early at menopause with a subsequent increase as postmenopausal years’ progresses and is associated with rising occurrence of lower urinary tract symptoms (LUTS).
The therapeutic management of GSM includes lubricants and moisturizers as a first line therapy and low-dose vaginal oestrogens (locally applied hormone replacement therapy) as a second one, especially for women with a history of estrogen dependent cancer. However, lubricants and moisturizers can only be used for symptomatic relief during sexual intercourse. They do not restore the local architecture of the vagina and they are ineffective when LUTS are present. However, the quality of evidence is low or very-low when oestrogens efficacy is compared to placebo, while the risk to the endometrial thickness with sustained vaginal estrogen use is not clear.
Recently, intravaginal laser therapy has been proposed for the management of GSM. There are currently two lasers available. All available studies consistently suggest that both lasers (CO2-laser and Er:YAG-laser) are safe and are effective in alleviating vaginal dryness and pain on sexual intercourse, as well as restoring the local architecture of the vagina. Additionally, data regarding CO2-laser indicate LUTS improvement, as well as sexual function-satisfaction and quality of women’s life. Relevant published data are not available for the Er:YAG-laser. Moreover, there is lack of studies comparing the 2 laser-technologies for the management of postmenopausal women with GSM.
The aim of the current study is to assess whether the CO2-laser results in superior alleviation of GSM symptoms compare to Er:YAG-laser. Specifically, we will compare objective and subjective measurements of symptoms and clinical signs of GSM, between groups of postmenopausal women with GSM receiving treatment with CO2-laser or Er:YAG-laser.
REC name
London - Central Research Ethics Committee
REC reference
17/LO/1958
Date of REC Opinion
21 Dec 2017
REC opinion
Further Information Favourable Opinion