NCT02747641CompletedNot Applicable
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
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Alma Lasers Inc.
- Enrollment
- 15
- Locations
- 2
- Primary Endpoint
- Vulvovaginal Atrophy (VVA)
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 35 Years to 70 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
treatment
Other
only one arm
Intervention: Pixel CO2 Laser System (Procedure)
Outcomes
Primary Outcomes
Vulvovaginal Atrophy (VVA)
Time Frame: 6 months
Utilizing Bachman Vaginal Health Index
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (2)
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