An interventional study of Photothermal Non-ablative Erbium:YAG-laser and Fractional Microablative CO2-laser in Genitourinary Syndrome of Menopause, sponsored by King's College Hospital NHS Trust. Completed at 1 site in United Kingdom. Open to female participants, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-02-12.
Sponsored by King's College Hospital NHS Trust · Not applicable, Interventional, and Treatment
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.
Genitourinary Syndrome of Menopause (GSM) is the new terminology for "vulvovaginal (VVA)". Although women may present with some or all of the clinical signs and symptoms, the most common symptom of VVA/GSM is vaginal dryness. Vaginal dryness appears early at menopause with a subsequent increase of prevalence 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 estrogens as a second one, especially for women with a history of estrogen dependent cancer. However, lubricants and moisturizers can only be used for symptoms relief during sexual intercourse. They do not restore the local pathophysiology and they are inefficacious when LUTS are present. However, the quality of evidence is low or very-low when estrogens 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 have a high efficacy on alleviating vaginal dryness and dyspareunia, as well as restoring the local pathophysiology. 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.
Exclusion Criteria:
Device: Fractional Microablative CO2-laser
Device: Photothermal Non-ablative Erbium:YAG-laser
Laser treatment of the vagina for GSM
Laser treatment of the vagina for GSM
Dryness - 10cm visual analogue scale
Time frame: 1 year
Dyspareunia- 10cm visual analogue scale
Time frame: 1 year
Itching- 10cm visual analogue scale
Time frame: 1 year
Burning- 10cm visual analogue scale
Time frame: 1 year
Dysuria- 10cm visual analogue scale
Time frame: 1 year
Frequency- 10cm visual analogue scale,
Time frame: 1 year
Urgency-10cm visual analogue scale
Time frame: 1 year
Urinary incontinence- 10cm visual analogue scale
Time frame: 1 year
Overall sexual satisfaction- Female sexual function index
Time frame: 1 year
Frequency- 3 day voiding diary
Time frame: 1 year
Urgency- 3 day voiding diary,
Time frame: 1 year
Urinary incontinence- 3 day voiding diary
Time frame: 1 year
Overall sexual satisfaction- 10cm visual analogue scale
Time frame: 1 year
Overall sexual satisfaction- frequency of sexual intercourse,
Time frame: 1 year
Quality of life- patients global impression of improvement questionnaire
Time frame: 1 year
Quality of life- day to day impact of vaginal ageing questionnaire
Time frame: 1 year
Quality of life- kings health questionnaire
Time frame: 1 year
Global impression of improvement- day to day impact of vaginal ageing questionnaire
Time frame: 1 year
Global impression of improvement- patients global impression of improvement questionnaire
Time frame: 1 year
Global impression of improvement- kings health questionnaire
Time frame: 1 year
Vaginal health index score- 5 components, elasticity, epithelial integrity, pH, moisture and fluid volume
Time frame: 1 year
Vaginal maturation value- vaginal smear stained with papanicolaou technique and VMI value is evaluated by defining the percentage of superficial, intermediate and paranasal epithelial cells on smear.
VMV = ((1x%superficial)+(0.5x%intermediate)+0xparabasal))
Time frame: 1 year
Plan to share: No
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King's College Hospital NHS Trust