Comparison of Vaginal Laser Therapy to Vaginal Estrogen Therapy

Recruiting

I'm Interested

Trial ID: NCT02691936

Purpose

This is a multi-centered, randomized prospective single blinded clinical trial comparing CO2 fractionated vaginal laser therapy and vaginal estrogen cream therapy in the treatment of vulvovaginal atrophy/GSM.

Official Title

A Randomized Clinical Trial Comparing Vaginal Laser Therapy to Vaginal Estrogen Therapy in Women With Genitourinary Syndrome of Menopause

Stanford Investigator(s)

Eric R. Sokol, MD
Eric R. Sokol, MD

Professor of Obstetrics and Gynecology (Gynecology-Urogynecology) and, by courtesy, of Urology

Eligibility


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

Intervention(s):

device: CO2 fractionated vaginal laser

drug: Estrogens, Conjugated (USP)

Recruiting

I'm Interested

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Eric Sokol, M.D.