Clinical Investigation to Assess the Safety and Efficacy of the Laser for the Treatment of Vulvovaginal Atrophy

Study Overview
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Brief Summary
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The purpose of this study is to assess the safety and the efficacy of a laser in the treatment of vulvovaginal atrophy (VVA), that is to assess the change in the severity of the vaginal dryness symptom, by means of a visual analogic scale (10 cm VAS).

Detailed Description
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The laser handpiece (probe) will be deposited in the vaginal canal and the laser energy will be delivered through the handpiece. Subjects will receive a total of three (3) treatments every six (6) weeks (+/-1 week). Subjects will return one week (+/- 3 days) post the first treatment, as well as three (3) months (+/- 2 weeks) and twelve (12) months (+/- 2 weeks) post the third treatment.

Official Title
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Clinical Investigation to Assess the Safety and Efficacy of the Laser for the Treatment of Vulvovaginal Atrophy

Conditions
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Vulvovaginal Atrophy

Intervention / Treatment
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* Device: Laser treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy non-smoking post menopausal women with absence of menstruation of at least 12 months Exhibiting VVA symptoms Prolapse staged < II, according to the pelvic organ prolapse quantification (ICS-POP-Q) system Have not had procedures in the anatomical area through 6 months prior to treatment Understand and accept the obligation and is logistically able to present for all scheduled follow-up visits Exclusion Criteria: • Acute or recurrent urinary tract infection (UTI), or genital infection (e.g. herpes candida). Prolapse staged ≥ II, according to the pelvic organ prolapse quantification (ICS-POP-Q) system Any serious disease, or chronic condition, that could interfere with the study compliance Previously undergone reconstructive pelvic surgery Have used vaginal creams, moisturizers, lubricants or homeopathic preparations for at least 3 months A history of thrombophlebitis A history of acute infections A history of heart failure Received or is anticipated to receive antiplatelets, anticoagulants, thrombolytics, vitamin E or anti inflammatories within 2 weeks pre treatment Any medical condition, that, in the investigator's opinion would interfere with the patient's participation in the study Taking medications that are photosensitive A history of keloid formation

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 60 Years

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Laser Treatment<br>Laser Treatment | Device: Laser treatment<br>* The laser handpiece (probe) will be deposited in the vaginal canal and the laser energy will be delivered through the handpiece<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Main Outcome of the Study is the Efficacy of the Laser Procedure, Intended as the Amelioration of 50% of the Severity of the Vaginal Dryness at 12 Months, Compared With Baseline | The main outcome of the study is the efficacy of the laser procedure, intended as the amelioration of 50% of the severity of the vaginal dryness at 12 months, compared with baseline. The change in the vaginal dryness symptom has been assessed by means of a visual analogic scale (10 cm VAS). | Baseline and at follow up visit at 12 months post last treatment |