Ignite Creation Date:
2024-05-06 @ 7:24 PM
Last Modification Date:
2024-10-26 @ 3:06 PM
Study NCT ID:
NCT06000202
Status:
RECRUITING
Last Update Posted:
2024-03-18
First Post:
2023-08-12
Brief Title:
Elastographic Improvement of Vaginal Atrophy Treated by Erbium Yag Laser
Sponsor:
Istanbul University - Cerrahpasa IUC
Organization:
Istanbul University - Cerrahpasa IUC
Study Overview
Official Title:
Elastographic Improvement of Vaginal Atrophy Treated by ErYAG Laser
Status:
RECRUITING
Status Verified Date:
2024-03
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:
This study is a randomized controlled sham applied study Its aim is to evaluate the efficacy of ErYAG laser for the treatment of atrophic vaginitis in postmenopausal women
In this study demonstration of the efficacy of ErYAG laser for the treatment of atrophic vaginitis in postmenopausal women is intended with Maturation Index MI vaginal pH measurement Female Sexual Function Index FSFI Vaginal Health Index VaHI Visual Analogue Scale VAS and ultrasonographic elastography
In this study demonstration of the efficacy of ErYAG laser for the treatment of atrophic vaginitis in postmenopausal women is intended with Maturation Index MI vaginal pH measurement Female Sexual Function Index FSFI Vaginal Health Index VaHI Visual Analogue Scale VAS and ultrasonographic elastography
Detailed Description:
In the postmenopausal period especially due to estrogen deficiency vaginal atrophy occurs in the vulvo-vagina lower urinary tract pelvic floor muscles and endopelvic fascia Vaginal dryness secondary to atrophy in genital organs pain and tenderness especially during sexual intercourse and decreased genital elasticity are the most common symptoms and signs during the postmenopausal period With regard to the urinary system frequent urination feeling of urgency recurrent urinary tract infections organ prolapses-urethrocele cystocele urethral prolapse and stress or urge type urinary incontinence could be seenThese signs and symptoms were recognized in 2014 by the International Society for the Study of Womens Sexual Health ISSWSH and the North American Menopause Society NAMS under the main title OF genito-urinary syndrome of menopause GSM During the postmenopausal period a detailed history should be taken a complete physical examination should be performed and various tests should be performed for the evaluation of GSM
Laser is a treatment option for the genitourinary symptoms that could occur at the postmenopausal period Laser can be applied to vulva by giving an external beam or it can be applied intravaginally or directly to the urethra using vaginal and urethral cannula
The smooth mode application of the ErYAG laser ensures that the laser beam retains the heat it gives without ablation and penetrates deeper into the tissue After laser application thermomechanical and thermochemical effects occur in the tissue respectively It provides controlled thermal energy and causes shrinkage of the collagen fibrils in the vaginal epithelium and lamina propria It also induces neocollagenesis elastogenesis and neoangiogenesis by temperature change With minimum damage to the peripheral tissue the viable cells in the target tissue reacts to this temperature change by expressing heat shock proteins HSP Then HSP increases the levels of transforming growth factor-beta fibroblast growth factor epidermal growth factor platelet-derived growth factor vascular epithelial growth factor which induce neocollagenesis and neoangiogenesis Therefore the thermal energy stored in the vaginal wall induces proliferation of the epithelium which is rich in glycogen neovascularization and collagen production in the lamina propria
In this study evaluation and demonstration of the efficacy of ErYAG laser for the treatment of atrophic vaginitis in postmenopausal women is intended with Maturation Index MI vaginal pH measurement Female Sexual Function Index FSFI Vaginal Health Index VaHI Visual Analogue Scale VAS and ultrasonographic elastography
Laser is a treatment option for the genitourinary symptoms that could occur at the postmenopausal period Laser can be applied to vulva by giving an external beam or it can be applied intravaginally or directly to the urethra using vaginal and urethral cannula
The smooth mode application of the ErYAG laser ensures that the laser beam retains the heat it gives without ablation and penetrates deeper into the tissue After laser application thermomechanical and thermochemical effects occur in the tissue respectively It provides controlled thermal energy and causes shrinkage of the collagen fibrils in the vaginal epithelium and lamina propria It also induces neocollagenesis elastogenesis and neoangiogenesis by temperature change With minimum damage to the peripheral tissue the viable cells in the target tissue reacts to this temperature change by expressing heat shock proteins HSP Then HSP increases the levels of transforming growth factor-beta fibroblast growth factor epidermal growth factor platelet-derived growth factor vascular epithelial growth factor which induce neocollagenesis and neoangiogenesis Therefore the thermal energy stored in the vaginal wall induces proliferation of the epithelium which is rich in glycogen neovascularization and collagen production in the lamina propria
In this study evaluation and demonstration of the efficacy of ErYAG laser for the treatment of atrophic vaginitis in postmenopausal women is intended with Maturation Index MI vaginal pH measurement Female Sexual Function Index FSFI Vaginal Health Index VaHI Visual Analogue Scale VAS and ultrasonographic elastography
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