Clinical Trial: Comparison of Vaginal Laser Therapy to Vaginal Estrogen Therapy

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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 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.

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 sympto
Sponsor: The Cleveland Clinic

Current Primary Outcome: Vaginal dryness [ Time Frame: 6 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Objective evaluation of vaginal atrophy/estrogenization [ Time Frame: 6 months ]
  Vaginal health index (VHI) score
• Effect of GMS symptoms on quality of life [ Time Frame: 6 months ]
  DIVA questionnaire
• Effect of Treatment on vaginal maturation index [ Time Frame: 6 months ]
  VMI
• Effect of treatment on vaginal wall elasticity [ Time Frame: 6 months ]
  vaginal dilator to determine vaginal caliber
• Effect of treatment on female sexual function [ Time Frame: 6 months ]
  FSFI
• Calculation of percentage of patients who are sexually active or resume intercourse [ Time Frame: 6 months ]
  FSFI
• Effect of treatment on urinary symptoms [ Time Frame: 6 months ]
  Urogenital distress inventory (UDI-6)
• The degree of difficulty encountered by physician in performing MonaLisa laser treatment [ Time Frame: 6 months ]
  5-point Likert scale
• Rate of satisfaction of patients with treatment [ Time Frame: 6 months ]
  Patient global impression of improvement (PGI) using 5-point Likert scale

Original Secondary Outcome: Same as current

Information By: The Cleveland Clinic

Dates:
Date Received: February 22, 2016
Date Started: March 2016
Date Completion: December 2018
Last Updated: April 18, 2017
Last Verified: April 2017