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

Not Applicable

Completed

• Conditions: Genital Diseases, Female; Atrophy; Vaginal Atrophy
• Interventions: Procedure: Pixel CO2 Laser System

• Registration Number: NCT02747641
• Lead Sponsor: Alma Lasers Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-04-12
• Study First Submitted QC: 2016-04-21
• Study First Posted: 2016-04-22
• Study Start: 2016-05
• Status Verified: 2016-10
• Primary Completion: 2016-12
• Study Completion: 2017-08
• Last Update Submitted: 2017-11-17
• Last Update Posted: 2017-11-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
treatment	Pixel CO2 Laser System	only one arm

Primary Outcome Measures

Name	Time	Method
Vulvovaginal Atrophy (VVA)	6 months	Utilizing Bachman Vaginal Health Index

Trial Locations

Locations (1)

The Cleveland Clinic; 🇺🇸 Weston, Florida, United States