Comparison of Vaginal Laser Therapy to Vaginal Estrogen Therapy

Trial ID or NCT#

NCT02691936

Status

recruiting iconRECRUITING

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

Eligibility Criteria

Sexes Eligible for Study: Female
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. - 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:
  1. - 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
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Investigator(s)

Eric R. Sokol, MD
Eric R. Sokol, MD
Urogynecologist, Pelvic surgeon, Minimally invasive gynecologic surgeon, Pelvic reconstructive surgeon, Obstetrician and Gynecologist (OB-GYN)
Associate Professor of Obstetrics and Gynecology (Gynecology-Urogynecology) and, by courtesy, of Urology

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Contact

Eric Sokol, M.D.

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View on ClinicalTrials.gov