Comparison of Vaginal Laser Therapy to Vaginal Estrogen Therapy

• Status: Completed
• Trial end date: 2018-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Cleveland Clinic
• Collaborator: Foundation for Female Health Awareness
• Treatments: Estrogens; Estrogens, Conjugated (USP)

Criteria

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