Climacteric
Conditions
Interventions
48 post-menopausal women with symptoms of genitourinary syndrome of menopause will be interviewed and after evaluation of the inclusion and exclusion criteria they will be randomized into 4 different
E07.632.490
Sponsors
Hospital da Mulher Prof. Dr. José Aristodemo Pinotti - CAISM
Hospital da Mulher Prof. Dr. José Aristodemo Pinotti - CAISM
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: Post-menopausal women; genitourinary menopausal syndrome symptoms; vaginal dryness complaint
Exclusion criteria
Exclusion criteria: Vaginal estrogen use in the last 6 months; current or past 6 months use of systemic hormone replacement therapy; presence of stage III or IV pelvic organ prolapses; use of pacemaker; decompensated heart disease; cognitive deficit; peripheral or central neurological disorders; presence of any type of cancer or cervical dysplasia; hx of active urinary or vaginal infection; decompensated metabolic diseases
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| It is expected to find that the groups using microablative and non-ablative laser and microablative and non-ablative Radiofrequency will present significant improvement of more than 80% of symptoms through visual analogue scale of symptoms of the genitourinary syndrome of menopause and of the histological parameters evaluated through the greater amount of neocollagenesis. | — |
Secondary
| Measure | Time frame |
|---|---|
| It is expected to find that women treated with non-ablative erbium-doped yttrium aluminium garnet laser, microablative dioxidy carbon laser, non-ablative radiofrequency and fractional microablative radiofrequency will show similar improvement, with no statistical difference, in symptoms of genitourinary menopausal syndrome, stress urinary incontinence, overactive bladder and sexual function assessed using the genitourinary menopausal syndrome symptoms visual analogue scale, Incontinence Questionnaire-urinary Incontinence Short Form (ICIQ-SF), International Consultation on Incontinence Overactive Bladder Questionnaire (ICIQ-OAB) and Female Sexual Function Index (FSFI), respectively.;We believe that the vaginal mucosa of women treated with different types of energy will show an increase in the thickness of the epithelium and an increase in the concentration of collagen fibers through histological evaluation, but this increase will be higher in those treated with microablative dioxidy carbon laser. ;It is expected to find that all treatments will present few adverse events, with no difference between them and that most women will feel satisfied with the treatment. | — |
Countries
Brazil
Contacts
Public ContactHelena Slongo
Hospital da Mulher Prof. Dr. José Aristodemo Pinotti - CAISM
Outcome results
None listed