Ignite Creation Date:
2024-05-06 @ 4:59 PM
Last Modification Date:
2024-10-26 @ 2:19 PM
Study NCT ID:
NCT05151380
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-06-22
First Post:
2021-11-26
Brief Title:
Clinical and Cyto-histological Evaluation of Fractional CO2 Laser Treatment on Genito-Urinary Syndromes of Menopause Related to Vaginal Atrophy
Sponsor:
Hopital Nord Franche-Comte
Organization:
Hopital Nord Franche-Comte
Study Overview
Official Title:
Evaluation Clinique et Cyto-histologique du Traitement Laser CO2 fractionné Sur Les Syndromes Génito-Urinaires de la Ménopause liés à lAtrophie Vaginale
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-06
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:
ATROVENANS
Brief Summary:
Estrogen deficiency can occur naturally during menopause or as a secondary effect of various treatments for breast or pelvic cancer and can lead to very disabling vulvovaginal symptoms since it is associated with an anatomical and functional cellular modification of the urogenital sphere These changes result in urogenital atrophy responsible for vaginal dryness painful intercourse dyspareunia discomfort itching and burning sensations dysuria urgency and incontinence These symptoms which significantly affect quality of life are found in more than 40 of menopausal women and are grouped under the term Genitourinary Syndrome of Menopause GSM General or local estrogen-based treatments improve patients symptoms but remain contraindicated in women who have had breast cancer Non-estrogenic local treatments are less effective remain restrictive and are therefore often abandoned
The CO2 laser is currently part of the therapeutic arsenal for the management of patients with GSM This device prevents and eliminates the effects of low estrogen levels on vaginal tissue by restoring the characteristic conditions of the vaginal mucosa of a woman of childbearing age This simple treatment which lasts only a few minutes is safe and painless and has no serious side effects It restores the tone and elasticity of the tissues with positive effects on the quality of life and the couples relationship The investigators wish to evaluate the possible changes of the genital sphere in a longitudinal way before during and after the treatment including the induced cytohistological changes in patients with GSM who can benefit of this therapy
The CO2 laser is currently part of the therapeutic arsenal for the management of patients with GSM This device prevents and eliminates the effects of low estrogen levels on vaginal tissue by restoring the characteristic conditions of the vaginal mucosa of a woman of childbearing age This simple treatment which lasts only a few minutes is safe and painless and has no serious side effects It restores the tone and elasticity of the tissues with positive effects on the quality of life and the couples relationship The investigators wish to evaluate the possible changes of the genital sphere in a longitudinal way before during and after the treatment including the induced cytohistological changes in patients with GSM who can benefit of this therapy
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?:
None
Is an FDA AA801 Violation?:
None