MonaLisa Touch Randomized Double-Blind Placebo Controlled Study

NCT ID: NCT03331328

Last Updated: 2019-08-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-13
• Study Completion Date: 2019-07-10

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.

Detailed Description

Study design: Randomly assigning the intervention can eliminate the influence of unknown or immeasurable confounding variables that may otherwise lead to biased and incorrect estimate of treatment effect. Also, randomization eliminates confounding by baseline variables and blinding eliminates confounding by co-interventions, thus eliminating the possibility that the observed effects of intervention are due to differential use of other treatments. The best comparison is placebo control that allows participants, investigators and study staff to be blinded. The advantage of trial over an observational study is the ability to demonstrate causality.

Background: Genitourinary syndrome of Menopause is a condition of postmenopausal women due to estrogen deprivation which results in progressive worsening of the vaginal and vulvar anatomy with symptoms of vulvar itching or pain during intercourse, vaginal dryness, urinary urgency and frequency and frequent bladder infections. It could ultimately lead to vaginal bleeding, petechial hemorrhages, vaginal narrowing or stenosis and hypertonicity of the pelvic muscles due to anticipation of coital pain. The hypertonicity by itself can cause pelvic pressure or pain.

Thus, GSM is a chronic progressive disease state that if left untreated could have dire vaginal and urogynecological consequences.

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.

Initial trials on MonaLisa Touch have shown promising results with significant improvement in vaginal exams and patient satisfaction scores.

Conditions

Genitourinary Syndrome of Menopause

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Control/sham

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.

Group Type: SHAM_COMPARATOR

MonaLisa Touch

Intervention Type: 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.

Treated

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.

Group Type: ACTIVE_COMPARATOR

MonaLisa Touch

Intervention Type: 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.

Interventions

MonaLisa Touch

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Michigan Institution of Women's Health PC

OTHER

Sponsor Role: lead

Responsible Party

Salil Khandwala

Dr. Salil Khandwala, MD, FACOG, FPMRS

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Advanced Urogynecology of Michigan, P.C.

Dearborn, Michigan, United States

Countries

United States

Other Identifiers

1176303

Identifier Type: -

Identifier Source: org_study_id