Elastographic Improvement of Vaginal Atrophy Treated by Erbium Yag Laser

Vaginal Atrophy Clinical Trial

Official title:

Elastographic Improvement of Vaginal Atrophy Treated by Er:YAG Laser

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06000202
• Other study ID #: 689852
• Status: Recruiting
• Phase: N/A
• 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
• 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrophy
• Dyspareunia
• Genitourinary Syndrome of Menopause (GSM)
• Laser
• Vaginal Atrophy

Intervention

Device:
• Fotona Dynamis Er:YAG Laser System
The patient receives 2940 nm Er:YAG Laser (XS Dynamis, Fotona, Slovenia) at intervals of 21 days. She receives 3 sessions, in total. Each session consists of application of PS03 handpiece intravaginal with spot size of 7 mm, fluence of 10 j/cm2, frequency of 1.6 Hz and 4-7 pulses per point and 6 passes followed by R11 handpiece intravaginal with spot size of 7 mm, fluence of 10 j/cm2, frequency of 1.6 Hz and 4-7 pulses per point and 3 passes.
• Sham
Er:YAG laser is applied with sham handpiece.

Locations

Country	Name	City	State
Turkey	Istanbul University-Cerrahpasa	Istanbul
Turkey	Istanbul University-Cerrahpasa	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul University - Cerrahpasa (IUC)

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy: Rate of improvement in vaginal atrophy	Evaluation of the efficacy and safety of vaginal atrophy by using ultrasonographic Elastography	6 months
Primary	Efficacy:Rate of improvement in sexual function	Evaluation of dyspareunia by Female Sexual Function Index	6 months
Primary	Efficacy: Rate of improvement in vaginal atrophy	Evaluation of Maturation Index	6 months
Primary	Efficacy: Rate of improvement in vaginal atrophy	Evaluation of Vaginal Health Index	6 months
Primary	Efficacy: Rate of improvement in pain	Evaluated by Visual Analogue Scale	6 months
Secondary	Safety:Incidence and severity of device related Adverse Events	Incidence and severity of device related Adverse Events (i.e., infections, edema, superficial burns, wound dehiscence)	6 months