Clinical Trial Details
— Status: Recruiting
Administrative data
NCT number |
NCT06000202 |
Other study ID # |
689852 |
Secondary ID |
|
Status |
Recruiting |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
August 21, 2023 |
Est. completion date |
December 2024 |
Study information
Verified date |
March 2024 |
Source |
Istanbul University - Cerrahpasa (IUC) |
Contact |
Cemal Tamer Erel, Prof. |
Phone |
+905322946022 |
Email |
ctamererel[@]gmail.com |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
This study is a randomized controlled sham applied study. Its aim is to evaluate the efficacy
of Er:YAG laser for the treatment of atrophic vaginitis in postmenopausal women.
In this study, demonstration of the efficacy of Er:YAG 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
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 seen.These signs and symptoms
were recognized in 2014 by the International Society for the Study of Women's 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 Er:YAG 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 Er:YAG 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.