Clinical trial NCT02747641: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrophy
Vaginal Atrophy
Genital Diseases, Female
Lead sponsor: Alma Lasers Inc.
Sponsor class: INDUSTRY
Collaborators: name: The Cleveland Clinic
First posted: 2016-04-22
Enrollment: 15
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Vulvovaginal Atrophy (VVA)
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Weston
country: United States
facility: The Cleveland Clinic
state: Florida
Study officials:
References: