Clinical trial NCT06000202: Elastographic Improvement of Vaginal Atrophy Treated by Erbium Yag Laser
Official title: Elastographic Improvement of Vaginal Atrophy Treated by Er:YAG Laser
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vaginal Atrophy
Dyspareunia
Laser
Genitourinary Syndrome of Menopause (GSM)
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
First posted: 2023-08-21
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

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 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.

Eligibility criteria: Inclusion Criteria:

* Postmenopausal women with vaginal atrophy symptoms
* Adult Female, 18 years of age or older

Exclusion Criteria:

* Patients with a history of previous vaginal operation,
* Patients with pelvic organ prolapse

Primary outcomes:
measure: Efficacy: Rate of improvement in vaginal atrophy
timeFrame: 6 months
measure: Efficacy:Rate of improvement in sexual function
timeFrame: 6 months
measure: Efficacy: Rate of improvement in vaginal atrophy
timeFrame: 6 months
measure: Efficacy: Rate of improvement in vaginal atrophy
timeFrame: 6 months
measure: Efficacy: Rate of improvement in pain
timeFrame: 6 months
Secondary outcomes:
measure: Safety:Incidence and severity of device related Adverse Events
timeFrame: 6 months
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University-Cerrahpaşa
city: Istanbul
country: Turkey
facility: Istanbul University-Cerrahpasa
Study officials:
affiliation: Istanbul University - Cerrahpasa
name: Cemal Tamer Erel, Prof.
role: STUDY_DIRECTOR
References: