Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06503003
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-05
Brief Title:
Non-ablative Diode Laser Therapy for Genitourinary Syndrome of Menopause A Prospective Study on Efficacy Safety and Quality of Life and Sexuality Impact
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Non-ablative Diode Laser Therapy for Genitourinary Syndrome of Menopause A Prospective Study on Efficacy Safety and Quality of Life and Sexuality Impact
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GSMLASER
Brief Summary:
The goal of this observational study is to evaluate the efficacy safety and impact on quality of life and sexuality of non-ablative dual-wavelength diode laser treatments in managing Genitourinary Syndrome of Menopause GSM in sexually active post-menopausal women who cannot use or have not benefited from local estrogen-based therapies The main questions it aims to answer are
Does non-ablative dual-wavelength diode laser therapy improve vaginal dryness burning sensation and dyspareunia in post-menopausal women What is the impact of this therapy on the vaginal health index and sexual function Researchers will compare the laser-treated group to their baseline measurements to see if non-ablative dual-wavelength diode laser therapy effectively treats GSM
Participants will
Undergo three monthly sessions of dual-wavelength diode laser therapy Participate in follow-up evaluations at three and six months post-treatment Complete self-assessments of GSM symptoms and questionnaires evaluating sexual function and quality of life at each follow-up
This study aims to provide preliminary evidence that non-ablative dual-wavelength diode laser therapy is a safe and effective non-hormonal treatment for GSM addressing a gap in existing treatments for women who cannot use or have not benefited from hormonal therapies
Does non-ablative dual-wavelength diode laser therapy improve vaginal dryness burning sensation and dyspareunia in post-menopausal women What is the impact of this therapy on the vaginal health index and sexual function Researchers will compare the laser-treated group to their baseline measurements to see if non-ablative dual-wavelength diode laser therapy effectively treats GSM
Participants will
Undergo three monthly sessions of dual-wavelength diode laser therapy Participate in follow-up evaluations at three and six months post-treatment Complete self-assessments of GSM symptoms and questionnaires evaluating sexual function and quality of life at each follow-up
This study aims to provide preliminary evidence that non-ablative dual-wavelength diode laser therapy is a safe and effective non-hormonal treatment for GSM addressing a gap in existing treatments for women who cannot use or have not benefited from hormonal therapies
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None