A Randomized Clinical Trial Comparing Vaginal Laser Therapy to Vaginal Estrogen Therapy in Women With Genitourinary Syndrome of Menopause
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- The Cleveland Clinic
- Enrollment
- 69
- Locations
- 6
- Primary Endpoint
- Vaginal Dryness
Study Overview
Brief 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.
Detailed Description
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.
Subject Recruitment and Screening Study subjects will be recruited from patients who present to the clinical sites at the Women's Health Institute at the Cleveland Clinic, Christ Hospital, Stanford University Hospital, MedStar Washington Hospital Center, Women's and Infants' Hospital of Rhode Island and Wake Forest Baptist Medical Center for treatment of GSM. Cleveland Clinic will serve as the central Data Coordinating Center
Study Identification and Recruitment Potential subjects will be identified by members of the sections of Urogynecology and Reconstructive Pelvic Surgery and Benign Gynecology at the respective institutions. Eligible patients who agree to participate will be provided written informed consent administered by the collaborators listed on this IRB.
Randomization The participants will then be randomized to either fractional CO2 vaginal laser therapy or vaginal estrogen cream according to a computer-generated randomization schedule with random block sizes with the use of the SAS statistical software package (SAS Institute, Cary, NC). All patients will be unblinded to their assignment.
Diagnostic and Therapeutic Interventions In addition to a standardized evaluation including the history and physical examination, patients will be asked to complete the Female Sexual Function Inventory (FSFI) questionnaire, the Day-to-day Impact of Vaginal Aging (DIVA) questionnaire, and the Urogenital Distress Inventory (UDI-6), at baseline, 3 months, and 6 months after baseline and visual analog scales (VAS) for GSM symptoms. The Patient Global Index (PGI) will also be administered at 6 months. Completion of these questionnaires should take no more than 15-20 minutes. A vaginal maturation index will be obtained at the baseline visit on a regular Pap Smear side and fixed with cytofixative and air dried. This will be repeated during the last follow up visit at 6 months.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
CO2 fractionated vaginal laser
Postmenopausal women will undergo treatment intravaginally with the fractional microablative CO2 laser system MonaLisa Touch vaginal laser protocol x 3 time points at baseline, 6 weeks and 3 months.
Intervention: CO2 fractionated vaginal laser (Device)
Estrogens, Conjugated (USP)
The women in the vaginal estrogen group will be prescribed and asked to administer the conjugated estrogen cream 0.5 g of cream equivalent to 0.625 mg of conjugated estrogen.
Intervention: Estrogens, Conjugated (USP) (Drug)
Outcomes
Primary Outcomes
Vaginal Dryness
Time Frame: 6 months
Vaginal dryness was assessed using a score of 0 (minimum) and 10 (maximum) on a Visual Analog Scale (VAS). Data presented is the mean difference before and after treatment. A higher mean difference signifies that the vaginal dryness score decreased to a greater measure hence resulting in a better outcome.
Secondary Outcomes
- Objective Evaluation of Vaginal Atrophy/Estrogenization(6 months)
- Effect of GMS Symptoms on Quality of Life(6 months)
- Effect of Treatment on Female Sexual Function(6 months)
- Effect of Treatment on Vaginal Maturation Index(6 months)
- Vaginal Wall Elasticity Assessed by Number of Participants Able to Tolerate a Larger Vaginal Dilator Size(6 months)
- Effect of Treatment on Urinary Symptoms(6 months)
- Rate of Satisfaction of Patients With Treatment(6 months)