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Recruiting
I'm InterestedTrial ID: NCT02691936
A Randomized Clinical Trial Comparing Vaginal Laser Therapy to Vaginal Estrogen Therapy in Women With Genitourinary Syndrome of Menopause
Associate Professor of Obstetrics and Gynecology (Gynecology-Urogynecology) and, by courtesy, of Urology
Inclusion Criteria:
- Menopausal with absence of menstruation for at least 12 months
- Presence of vaginal atrophy symptoms [subjective assessment of vaginal dryness >7cm on
VAS)
- Prolapse stage < II, according to the pelvic organ prolapse quantification (POP-Q)
system[31]
- No pelvic surgery within 6 months prior to treatment (vulva biopsy may be included
after 2 weeks)
- Understanding and acceptance of the obligation to return for all scheduled follow-up
visits
Exclusion Criteria:
- Personal history of vulvovaginal condyloma,,vaginal intraepithelial neoplasia (VAIN),
vaginal carcinoma, lichen sclerosis, lichen planus, history of vaginal radiation,
history of cervical cancer, other gynecologic cancer, or pelvic radiation
- Acute or recurrent urinary tract infection (UTI), or genital infection (e.g.
bacterial; vaginosis, herpes genitalis, candida).
- Personal history of Scleroderma
- Any serious disease, or chronic condition, that could interfere with the study
compliance
- Previously undergone reconstructive pelvic surgery within the past 6 months
- Previously undergone reconstructive pelvic surgery with transvaginal mesh kits and
sacrocolpopexy with synthetic mesh for prolapse, excluding synthetic slings (unless
current untreated exposure or extrusion)
- Have used vaginal estrogen cream, ring or tablet within 1 month prior to entering the
study
- Vaginal moisturizers, lubricants or homeopathic preparations within 2 weeks of therapy
- Personal history of thrombophlebitis
- Personal history of heart failure or myocardial infarction within 12 months of
procedure
- Use or anticipated use of antiplatelet therapy, anticoagulants, thrombolytics, vitamin
E or nonsteroidal anti-inflammatory drugs within 2 weeks pre-treatment
- Taking medications that are photosensitive
- Contraindication to Vaginal Estrogen Therapy
- Unwilling to Take Vaginal Estrogen
- Inability to give informed consent
device: CO2 fractionated vaginal laser
drug: Estrogens, Conjugated (USP)
Recruiting
I'm Interested
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Eric Sokol, M.D.