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Research & Clinical Trials > Study Search Tool > MonaLisa Touch Study - Michigan

MonaLisa Touch Study - Michigan

This study is open to:

This study is open to women who have: 

  • Postmenopausal pain during intercourse or vaginal dryness that is moderate to severe
  • Undergone surgical removal of both ovaries or menopause for at least 12 months
  • Presence of vaginal atrophy symptoms based upon a vaginal health index
  • Prolapse stage < III, according to the pelvic organ prolapse quantification (POP-Q) system
This study is not open to:

This study is not open to women who:

  • Have a history of vaginal cancer or dysplasia
  • Have a history of vaginal or pelvic radiation
  • Have a genital infection (e.g. bacterial; vaginosis, herpes genitalis, candida)
  • Have any serious disease, or chronic condition such as uncontrolled diabetes, that could interfere with the study compliance
  • Have had 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
  • Are not willing to stop use of any vaginal lubricants or estrogen of any form including phytoestrogens such as Estroven
MonaLisa Touch Study - Michigan

MonaLisa Touch Study - Michigan

Clinicaltrials.gov identifier:
NCT03331328

Quality of Life:
Breast Cancer Survivor
High Risk But No Cancer

Study Contact Information

Contacts

Contact: Dr. Salil Khandwala, M.D. by phone: 313-982-0200 or by email.

About the Study

This is a clinical trial designed to test the effectiveness of MonaLisa Touch laser procedure for treating vaginal symptoms associated with menopause.

Study Background

Women can have vaginal changes after menopause that can cause vaginal and sexual symptoms. Genitourinary Syndrome of Menopause (GSM) is a condition of postmenopausal women due to estrogen deprivation. GSM can lead to these symptoms: 

  • vulvar itching
  • pain during intercourse
  • vaginal dryness
  • urinary urgency and frequency
  • frequent bladder infections
  • vaginal bleeding
  • pelvic pain or pressure

MonaLisa Touch is a type of treatment that uses a carbon dioxide laser to stimulate and treat vaginal tissue. It can improve vaginal pH (acidity) and moisturize of the vaginal tissue.Initial trials on MonaLisa Touch have shown promising results with significant improvement in vaginal exams and patient satisfaction scores.

Type of Study

This is a two arm, randomized, double-blind, placebo-controlled study.

  • The study has two arms. This means that participants in the study will be placed into one of two groups. One group will received MonaLisa Touch laser treatments. The other group will receive "treatments" with an inactivated laser. The group that receives the inactivated laser will serve as a "control" or "placebo" group. 
  • This is a randomized study, which means that participants will be placed into one of the two treatment groups by chance. Neither patients nor the research doctor will choose the group participants are placed in. 
  • The study is double-blinded. This means that neither the participants nor their doctors will know whether they are receiving the active or the inactive laser treatments. 
  • The study is  placebo-controlled. Placebos are harmless, but inactive treatments. Placebos are only used in research in situations where there is no standard treatment. Participants in the placebo group will receive "sham" treatment using an inactive laser. All other care in the placebo group will be similar to the active group.

What the Study Entails

  • Participants receive three treatments, six weeks apart.
  • Participants return for the follow up visits at:
    • one month after third treatment
    • three months
    • six months
    • twelve months

Study Site

This study is open at one site:

Dearborn, Michigan
Advanced Urogynecology of Michigan

Study Principal Investigator

Salil Khandwala, MD
Phone: 313-982-0200
Email: salil@augm.org

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