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Clinical Investigation to Assess the Safety and Efficacy of the Laser for the Treatment of Vulvovaginal Atrophy
Recruiting
Trial ID: NCT02085980
Purpose
The purpose of this study is to assess the safety and the efficacy of a laser in the
treatment of vulvovaginal atrophy (VVA), that is to assess the change in the severity of the
vaginal dryness symptom, by means of a visual analogic scale (10 cm VAS).
Official Title
Clinical Investigation to Assess the Safety and Efficacy of the Laser for the Treatment of Vulvovaginal Atrophy
Stanford Investigator(s)
Eric R. Sokol, MD
Associate Professor of Obstetrics and Gynecology (Gynecology-Urogynecology) and, by courtesy, of Urology
Eligibility
Inclusion Criteria:
- Healthy non-smoking post menopausal women with absence of menstruation of at least 12
months
- Exhibiting VVA symptoms
- Prolapse staged < II, according to the pelvic organ prolapse quantification
(ICS-POP-Q) system
- 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:
- • Acute or recurrent urinary tract infection (UTI), or genital infection (e.g. herpes
candida).
- Prolapse staged ≥ II, according to the pelvic organ prolapse quantification
(ICS-POP-Q) system
- Any serious disease, or chronic condition, that could interfere with the study
compliance
- Previously undergone reconstructive pelvic surgery
- Have used vaginal creams, moisturizers, lubricants or homeopathic preparations
for at least 3 months
- A history of thrombophlebitis
- A history of acute infections
- A history of heart failure
- Received or is anticipated to receive antiplatelets, anticoagulants,
thrombolytics, vitamin E or anti inflammatories within 2 weeks pre treatment
- Any medical condition, that, in the investigator's opinion would interfere with
the patient's participation in the study
- Taking medications that are photosensitive
- A history of keloid formation
Intervention(s):
device: Laser treatment
Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Tine Bjornlund
650-724-7826