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Recruiting
Trial ID: NCT02085980
Clinical Investigation to Assess the Safety and Efficacy of the Laser for the Treatment of Vulvovaginal Atrophy
Associate Professor of Obstetrics and Gynecology (Gynecology-Urogynecology) and, by courtesy, of Urology
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
device: Laser treatment
Recruiting
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Tine Bjornlund
650-724-7826