RCT of Laser Therapy for GSM

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Genitourinary Syndrome of Menopause

Intervention / Treatment
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* Device: Photothermal Non-ablative Erbium:YAG-laser
* Device: Fractional Microablative CO2-laser


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Dryness and dyspareunia with moderate to severe intensity Vaginal Health Index <15 Absence of menstruation for at least 12 months Recent Negative Pap-smear test (For women over 65 years old a negative pap smear test up to the age of 65). Exclusion Criteria: Not willing to abstain from vaginal intercourse for one week following the laser-therapy Use of hormonal therapy within 6 months prior to study inclusion (systemic or local) Acute urinary tract infections (UTIs) History of a genital fistula, a thin recto-vaginal septum as determined by the investigator or history of a fourth-degree laceration during screening physical exam (e.g., perineal body) Active sexually transmitted disease upon vaginal exam (as determined by the investigator) that precludes treatment or any other vaginal infection Active or history of genital herpes Prolapse stages > II (according to the POP-Q system) History of radiotherapy for cervical or uterine cancer Medical condition that may interfere with participants' compliance to the protocol
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Fractional Microablative CO2-laser<br> | Device: Fractional Microablative CO2-laser<br>* Laser treatment of the vagina for GSM<br>|
| Active Comparator: Photothermal Non-ablative Erbium:YAG-laser<br> | Device: Photothermal Non-ablative Erbium:YAG-laser<br>* Laser treatment of the vagina for GSM<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 |  | 1 year | 
| Overall sexual satisfaction- 10cm visual analogue scale |  | 1 year | 
| Overall sexual satisfaction- frequency of sexual intercourse, |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 |