MonaLisa Touch Randomized Double-Blind Placebo Controlled Study

NCT03331328 | Completed FDA Device

• 1 other identifier: 1176303
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

Aim of the study: To assess the efficacy of MonaLisa Touch procedure for the management of genitourinary syndrome of menopause (GSM) in a randomized double-blind placebo controlled study.

Conditions

Genitourinary Syndrome of Menopause

Keywords

MonaLisa; Genitourinary syndrome of menopause (GSM)

Outcome Measures

Primary Outcomes (1)

• Improvement of dyspareunia as rated by a severity score of dyspareunia

  Improvement in the most bothersome symptom (MBS) of vulvovaginal atrophy as defined by improvement in dyspareunia. Patients are required to rate the severity of dyspareunia/dryness as none, mild, moderate or severe. The severity score is given a numerical value (none 0, mild 1, moderate 2 and severe 3).

  1 year

Secondary Outcomes (3)

• Assess improvement of vaginal dryness as rated by a severity score

  1 year

• Assess improvement in irritative bladder symptoms (urgency, frequency, or urination) as rated by a severity score

  1 year

• Assess improvement in vaginal burning as rated by a severity score

  1 year

Study Arms (2)

Control/sham

SHAM COMPARATOR

The CO2 laser will not be activated but the same procedure of moving the probe inside the vagina in a systematic manner including depressing the foot pedal at similar frequency will be performed. The smoke evacuator will also be activated, laser eye glasses and masks worn by the laser team and the subject. However, the laser will remain in the standby mode.

Device: MonaLisa Touch

Treated

ACTIVE COMPARATOR

Active arm subjects will be treated intravaginally with the fractional microablative CO2 laser system (SmartXide 2 V 2 LR, MonaLisa Touch, DEKA, Florence, Italy), using the following setting: dot power 30 watt, dwell time 1000 μs, dot spacing 1000 μm and the smart stack parameter from 1 to 3. For the vulva, the dot power will be reduced to 26 watts, dwell time 800 μs, dot spacing 800 μm and the smart stack parameter of 1.

Device: MonaLisa Touch

Interventions

MonaLisa Touch DEVICE

MonaLisa Touch is a fractional CO2 laser that has been specially designed with the DEKA pulse to stimulate vaginal tissue. It is delivered in a very precise manner and results in the synthesis of collagen and stratification of the vaginal epithelium with improvement of the vaginal pH and moisturization of the vaginal tissue due to increased blood flow and turgidity of the ground substance from the synthesis of the proteoglycans, hyaluronic acid and collagen.

Control/sham; Treated

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Postmenopausal dyspareunia or vaginal dryness rated from moderate to severe
• Desirous of sexual function
• Menopausal women with absence of menstruation for at least 12 months or those who have had bilateral oophorectomy
• Presence of vaginal atrophy symptoms based upon the vaginal health index assessment \< 15 and vagina pH \>5
• Prolapse stage \< III, according to the pelvic organ prolapse quantification (POP-Q) system
• No pelvic reconstructive surgery within 6 months prior to treatment
• Understanding and acceptance of the obligation to return for all scheduled follow-up visits

You may not qualify if:

• History of vaginal carcinoma or dysplasia, history of vaginal or pelvic radiation
• Acute or recurrent genital infection (e.g. bacterial; vaginosis, herpes genitalis, candida)
• Any serious disease, or chronic condition such as uncontrolled diabetes, that could interfere with the study compliance
• Reconstructive pelvic surgery within the past 6 months
• Have used vaginal estrogen cream, ring or tablet within 3 months prior to entering the study
• Have used vaginal moisturizers, lubricants or homeopathic preparations within 30 14 days of therapy
• Not willing to stop use of any vaginal lubricants or estrogen of any form including phytoestrogens such as Estroven

Sponsors & Collaborators

• Michigan Institution of Women's Health PC: lead

Study Sites (1)

Advanced Urogynecology of Michigan, P.C.

Dearborn, Michigan, 48124, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Salil Khandwala, MD, FACOG, FPMRS

Model Details: All subjects will be consented for the study prior to the procedure. They will be made aware of the meaning of case control study. Subjects will be randomized to a treatment or a non-treatment group.

Study Record Dates

• First Submitted: August 31, 2017
• First Posted: November 6, 2017
• Study Start: September 13, 2017
• Primary Completion: July 10, 2019
• Study Completion: July 10, 2019
• Last Updated: August 14, 2019

Record last verified: 2019-08

Locations

US (1)