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
NCT ID: NCT02747641
Last Updated: 2017-11-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
15 participants
INTERVENTIONAL
2016-05-31
2017-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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treatment
only one arm
Pixel CO2 Laser System
Interventions
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Pixel CO2 Laser System
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
35 Years
70 Years
FEMALE
Yes
Sponsors
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The Cleveland Clinic
OTHER
Alma Lasers Inc.
INDUSTRY
Responsible Party
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Locations
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The Cleveland Clinic
Weston, Florida, United States
Countries
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Other Identifiers
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FLA 15-110
Identifier Type: -
Identifier Source: org_study_id