Ignite Creation Date:
2024-05-06 @ 10:43 AM
Last Modification Date:
2024-10-26 @ 12:34 PM
Study NCT ID:
NCT03331328
Status:
COMPLETED
Last Update Posted:
2019-08-14
First Post:
2017-08-31
Brief Title:
MonaLisa Touch Randomized Double-Blind Placebo Controlled Study
Sponsor:
Michigan Institution of Womens Health PC
Organization:
Michigan Institution of Womens Health PC
Study Overview
Official Title:
MonaLisa Touch Randomized Double-Blind Placebo Controlled Study
Status:
COMPLETED
Status Verified Date:
2019-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None