Study on MonaLisa Touch® Laser therapy for Genitourinary Syndrome of Menopause

We are pleased to inform you that we are now conducting a clinical research study on the investigational novel office-based MonaLisa CO2 laser therapy for Genitourinary Syndrome of Menopause (GSM).

After menopause, due to lack of estrogen, atrophic changes are seen in the female genitalia that result in symptoms such as: vaginal dryness, pain during sex, vaginal itching, urinary urgency, frequency and frequent bladder infections. If left untreated, these changes could progress into vaginal stenosis (narrowing) and pelvic floor muscle hypertonicity (spasm) that become hard to reverse back to normal.

MonaLisa Touch® is designed for postmenopausal women who are suffering from GSM. The unique DEKA Pulse of the MonaLisa Touch® delivers accurate and precise fractional CO2 laser to the vaginal tissues. It restores vaginal health by generating new collagen, elastin and vascularization.

Attached are some facts about GSM and the MonaLisa Touch® laser. To learn whether you would qualify for the study, please call our office at 313-982-0200 and press prompt # 4 to speak to Chelsea, and our MonaLisa team.

If you qualify for the study, there is no charge to you.

MonaLisa Touch: Frequently Asked Questions

What is genitourinary syndrome of menopause (GSM)? GSM is a collection of symptoms and signs due to decrease in estrogen that include genital symptoms (dryness, burning, and irritation), sexual symptoms (lack of lubrication, discomfort or pain, and impaired function), and urinary symptoms (urgency, dysuria, and recurrent urinary tract infections).

How common is GSM? The AGATA study done in 913 postmenopausal women showed that 65-84% women suffered from vulvovaginal atrophy. The CLOSER study (Clarifying Vaginal Atrophy’s Impact on Sex and Relationships) found that vaginal discomfort had a negative impact on the intimacy of both partners (women, 58%; men, 78%).

The Vaginal Health: Insights, Views, and Attitudes (VIVA) study in 3520 postmenopausal women found that 80% of women with genital atrophy considered its impact on their lives to be negative, 68% reported that it made them feel less sexual, 33% reported negative effects on their marriage or relationship, and 26% reported a negative impact on their self-esteem.

Will GSM symptoms go away with time? Unlike hot flashes and night sweats that go away with time, GSM continues to progressively worsen.

What is the main principle for treating GSM? GSM is a chronic, condition that progressively worsens and if left untreated, postmenopausal women develop the negative vicious circle of worsening sexual dysfunction and bladder symptoms such as urgency, frequency, and urinary tract infections. Over time, if left untreated, certain chronic changes such as vaginal narrowing and pelvic muscle spasm will set in that become hard to reverse. Therefore the most important principle is to institute treatment early and maintain it throughout her life.

How does the MonaLisa Touch® work? This is a special laser that delivers precise energy to the vaginal tissue. The DEKA pulse, uniquely designed for vaginal tissue, allows for precise delivery of energy that results in emergence of new healthier and more youthful tissue, similar to before menopause.

What is involved in the actual procedure? This is almost like a speculum examination. The laser probe is inserted into the vagina and the laser is activated while rotating the probe inside the vagina. Within 3-4 minutes the vaginal cavity is completely treated.

How does the vagina look under the microscope after menopause? The surface lining is very thin and the underlying tissue lacks the (deep pink) connective tissue that is important for the nutrition of the vaginal lining and maintenance of the elasticity and stretch-ability of the vagina.

What happens to the vagina after MonaLisa treatment? The vaginal epithelium becomes thick and is now formed of many cell layers (20–40). The lower part of the epithelium is indented by the underlying rich connective tissue (very pink) creating numerous projections that nourish the epithelium. This is similar to the vagina of a young well estrogenized woman.

Facts about MonaLisa Treatment:

· 3 treatments; each treatment takes < 5 minutes

· In office procedure

· No anesthesia, no prep required

· No downtime – can return to work the same day

· No post treatment limitations but for avoiding sex for 48 hours

· Indicated for ANY and ALL postmenopausal woman suffering from GSM

· Best for women who cannot take estrogen such as breast cancer, heart disease, blood clots

· 85-95% success in all domains of quality of life and all aspects of GSM (urgency, vaginal pain, dryness)

· 50,000 women treated worldwide

How much will the procedure cost? The average cost of initial treatment is $1800 (this includes all three initial treatments). Maintenance treatments (typically performed every 12-18 months) are $600.

Would I have to pay if I am part of the study? If you are part of our clinical trial on MonaLisa Touch® then you would not have to pay. However, it is important that you follow up with the stipulated timelines of the study.

Are there any risks of being part of the MonaLisa Touch® study? Your personal information will be kept confidential. There are no risks but that of the actual procedure. The risks of the MonaLisa procedure are very rare. It may only cause slight vaginal discomfort during the procedure as the vagina has to be dry for the laser to work.

Are there patients who should NOT get MonaLisa Touch® Therapy? There are no absolute contraindications for MonaLisa Touch® therapy. Nearly all women with genitourinary syndrome of menopause may be safely treated. Patients who have active vaginitis should get it treated prior to laser treatment.

What do I have to do to enroll in the study? When you call the office – 313-982-0200 and press prompt # 4 to speak to Chelsea, you will be asked to fill out a screening form online or at the office. Once you are found to be eligible then we shall go over the study parameters with you. Once this is acceptable, you will sign the informed consent and then begin the study.

Please remember that every study has pre-defined inclusion and exclusion criteria that have to be fulfilled and even if you have the symptoms that qualify you for treatment, it may not qualify you for this particular study. Also, the number of subjects needed is limited and enrollment will be on a first come first serve basis.

If you do not qualify for the study then you can still get the treatment outside the study, but this will be at the standard MonaLisa fees.