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Trial record 1 of 9 for:    monalisa
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MonaLisa Touch Randomized Double-Blind Placebo Controlled Study

This study is currently recruiting participants.
Verified October 2017 by Salil Khandwala MD, Michigan Institution of Women's Health PC
Sponsor:
ClinicalTrials.gov Identifier:
NCT03331328
First Posted: November 6, 2017
Last Update Posted: November 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Salil Khandwala MD, Michigan Institution of Women's Health PC
  Purpose
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.

Condition Intervention
Genitourinary Syndrome of Menopause Device: MonaLisa Touch

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
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.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: MonaLisa Touch Randomized Double-Blind Placebo Controlled Study

Resource links provided by NLM:


Further study details as provided by Salil Khandwala MD, Michigan Institution of Women's Health PC:

Primary Outcome Measures:
  • Improvement of dyspareunia as rated by a severity score of dyspareunia [ Time Frame: 1 year ]
    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).


Secondary Outcome Measures:
  • Assess improvement of vaginal dryness as rated by a severity score [ Time Frame: 1 year ]
    Improvement in the most bothersome symptom (MBS) of vulvovaginal atrophy as defined by improvement in vaginal dryness. 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).

  • Assess improvement in irritative bladder symptoms (urgency, frequency, or urination) as rated by a severity score [ Time Frame: 1 year ]
    Improvement in irritative bladder symptoms. Patients are required to rate the severity irritative bladder symptoms of as none, mild, moderate or severe. The severity score is given a numerical value (none 0, mild 1, moderate 2 and severe 3).

  • Assess improvement in vaginal burning as rated by a severity score [ Time Frame: 1 year ]
    Improvement in the vulvovaginal atrophy symptom of burning 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).


Estimated Enrollment: 34
Actual Study Start Date: September 13, 2017
Estimated Study Completion Date: October 31, 2018
Estimated Primary Completion Date: October 31, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Sham Comparator: 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.
Device: 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.
Active Comparator: 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.
Device: 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.

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03331328


Contacts
Contact: Dr. Salil Khandwala, M.D. 3139820200 salil@augm.org

Locations
United States, Michigan
Advanced Urogynecology of Michigan, P.C. Recruiting
Dearborn, Michigan, United States, 48124
Contact: Salil Khandwala, MD    313-982-0200    admin@augm.org   
Sponsors and Collaborators
Michigan Institution of Women's Health PC
  More Information

Responsible Party: Salil Khandwala MD, Dr. Salil Khandwala, MD, FACOG, FPMRS, Michigan Institution of Women's Health PC
ClinicalTrials.gov Identifier: NCT03331328     History of Changes
Other Study ID Numbers: 1176303
First Submitted: August 31, 2017
First Posted: November 6, 2017
Last Update Posted: November 6, 2017
Last Verified: October 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No

Keywords provided by Salil Khandwala MD, Michigan Institution of Women's Health PC:
MonaLisa
Genitourinary syndrome of menopause (GSM)