Ignite Creation Date:
2024-05-06 @ 8:19 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06336564
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-28
First Post:
2024-03-22
Brief Title:
Microablative Radiofrequency in the Treatment of Urinary Symptoms Associated With Genitourinary Syndrome of Menopause
Sponsor:
Centro de Atenção ao Assoalho Pélvico
Organization:
Centro de Atenção ao Assoalho Pélvico
Study Overview
Official Title:
Microablative Radiofrequency in the Treatment of Urinary Symptoms Associated With Genitourinary Syndrome of Menopause Randomized Clinical Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
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:
Genitourinary Syndrome fo Menopause GSM is made up of a set of changes in the region of the vulva vagina and lower urinary tract associated with a decrease in estrogen levels in the urogenital tissue which leads to a reduction in blood supply disorders in collagen metabolism and skin elasticity The standard treatment for urinary incontinence during menopause is pelvic floor muscle training associated or not with local hormone replacement therapy Although low cost and easy to access it is associated with low patients adherence Physical methods such as laser and radiofrequency in non-ablative ablative and microablative forms are technologies that have recently been used in the vaginal mucosa to promote neoelastogenesis and neocollagenesis It is hypothesized that menopausal women who present symptoms of GSM may benefit from this new minimally invasive resource microablative radiofrequency This is a randomized clinical trial in which women aged between 40 and 65 years old will be included with clinical complaints of urinary symptoms associated with GSM A basic anamnestic questionnaire will be used as the study instrument to collect sociodemographic clinical data and symptoms following the routine and standard of the service To evaluate the treatment the following will be used voiding diary pad test vaginal cytology histopathology Female Sexual Function Index FSFI Short-Form Health Survey - SF-36 Questionnaire Kings Health Questionnaire evolution of symptoms dryness pain during sexual activity vaginal laxity itching burning sensation and pain in the vaginal introitus and level of patients satisfaction Patients will be randomized into group 1 or control group which will perform pelvic floor muscle training PFMT with supervision three times and at home twice a day and group 2 or test group which will perform the same PFMT protocol associated with vaginal microablative radiofrequency 10 lidocaine spray will be applied three minutes before the procedure and three applications will be made to the vaginavaginal introitus with an interval of 30 to 40 days The purpose of this study is to test the efficacy and duration of effect of microablative radiofrequency in the treatment of urinary symptoms associated with GSM
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None