Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Alexandra Hospital, Athens, Greece | OTHER |
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fractional Microablative CO2-laser | Active Comparator |
| |
| Photothermal Non-ablative Erbium:YAG-laser | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Photothermal Non-ablative Erbium:YAG-laser | Device | Laser treatment of the vagina for GSM |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dryness - 10cm visual analogue scale | 1 year | |
| Dyspareunia- 10cm visual analogue scale | 1 year | |
| Itching- 10cm visual analogue scale | 1 year | |
| Burning- 10cm visual analogue scale | 1 year | |
| Dysuria- 10cm visual analogue scale | 1 year | |
| Frequency- 10cm visual analogue scale, | 1 year | |
| Urgency-10cm visual analogue scale | 1 year | |
| Urinary incontinence- 10cm visual analogue scale | 1 year | |
| Overall sexual satisfaction- Female sexual function index | 1 year | |
| Frequency- 3 day voiding diary | 1 year | |
| Urgency- 3 day voiding diary, | 1 year | |
| Urinary incontinence- 3 day voiding diary |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life- patients global impression of improvement questionnaire | 1 year | |
| Quality of life- day to day impact of vaginal ageing questionnaire | 1 year | |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Urogynaecology Department, King's College Hospital | London | SE5 9RS | United Kingdom |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Fractional Microablative CO2-laser | Device | Laser treatment of the vagina for GSM |
|
| 1 year |
| Overall sexual satisfaction- 10cm visual analogue scale | 1 year |
| Overall sexual satisfaction- frequency of sexual intercourse, | 1 year |
| Quality of life- kings health questionnaire |
| 1 year |
| Global impression of improvement- day to day impact of vaginal ageing questionnaire | 1 year |
| Global impression of improvement- patients global impression of improvement questionnaire | 1 year |
| Global impression of improvement- kings health questionnaire | 1 year |
| Vaginal health index score- 5 components, elasticity, epithelial integrity, pH, moisture and fluid volume | 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)) | 1 year |