Clinical trial NCT03331328: MonaLisa Touch Randomized Double-Blind Placebo Controlled Study
Official title: MonaLisa Touch Randomized Double-Blind Placebo Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Genitourinary Syndrome of Menopause
Keywords: MonaLisa
Genitourinary syndrome of menopause (GSM)
Lead sponsor: Michigan Institution of Women's Health PC
Sponsor class: OTHER
First posted: 2017-11-06
Enrollment: 34
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Improvement of dyspareunia as rated by a severity score of dyspareunia
timeFrame: 1 year
Secondary outcomes:
measure: Assess improvement of vaginal dryness as rated by a severity score
timeFrame: 1 year
measure: Assess improvement in irritative bladder symptoms (urgency, frequency, or urination) as rated by a severity score
timeFrame: 1 year
measure: Assess improvement in vaginal burning as rated by a severity score
timeFrame: 1 year
Other outcomes:
Locations:
city: Dearborn
country: United States
facility: Advanced Urogynecology of Michigan, P.C.
state: Michigan
Study officials:
References: