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
| Status: | Completed |
|---|---|
| Conditions: | Women's Studies |
| Therapuetic Areas: | Reproductive |
| Healthy: | No |
| Age Range: | 35 - 70 |
| Updated: | 11/23/2017 |
| Start Date: | May 2016 |
| End Date: | August 2017 |
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.
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.
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
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