Prospective, Open-Label, Single-Center, Non-Comparative Study to Assess the Use of Pixel CO2 Laser System (FemiLift) in the Treatment of Vulvovaginal Atrophy (VVA) in Postmenopausal Female Subjects

Alma Lasers

Status

Completed

Conditions

Atrophy

Vaginal Atrophy

Genital Diseases, Female

Treatments

Procedure: Pixel CO2 Laser System

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT02747641

FLA 15-110

Details and patient eligibility

About

The purpose of this study is to assess the use of the Alma CO2 Pixel FemiLift™ in the treatment of VulvoVaginal Atrophy (VVA) in postmenopausal female subjects. The primary endpoint is to assess the change in the vaginal dryness by means of a Visual Analogic Scale (10 cm VAS) and/or Bachmann Index in VVA. The clinical improvement will be assessed by patient filled Vulvovaginal Atrophy.

Enrollment

15 patients

Sex

Female

Ages

35 to 70 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Healthy, non-smoking
Woman, age 35 to 70 yrs, menopausal
Provided written Informed Consent
Exhibiting VVA and/or SUI symptoms (mild or moderate SUI, according to severity index developed by Sandvik.)
Prolapse staged < II, according to the pelvic organ prolapse quantification (ICS-POP-Q) system
Normal PAP smear (up to 1 year prior to baseline)
Vaginal canal, introitus and vestibule free of injuries and bleeding
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

Severe prolapse (POP>= grade 3)
Use of photosensitive drugs
Acute or recurrent urinary tract infection (UTI), or genital infection (e.g. herpes candida).
Any serious disease, or chronic condition, that could interfere with the study compliance
Acute or actively present within the last 2 months HPV/HSV
Undiagnosed vaginal bleeding
Urge or overflow incontinence
Patients who are on antidepressants, or α-adrenergic and anticholinergic medications
Patients with immune system diseases.
Patients with allergic reaction to laser.
Obese women (BMI >30)
Patient unable to follow post-treatment instructions
History of keloid formation
Received or is anticipated to receive antiplatelets, anticoagulants, thrombolytics, vitamin E or anti inflammatories within 2 weeks pre treatment
A history of thrombophlebitis
A history of acute infections
A history of heart failure
Previously undergone reconstructive pelvic surgery
Have used vaginal creams, moisturizers, lubricants or homeopathic preparations for at least 3 months
Any medical condition that in the investigators opinion would interfere with the patients participation in the study