Elastographic Improvement of Vaginal Atrophy Treated by Erbium Yag Laser
Primary Purpose
Vaginal Atrophy, Dyspareunia, Laser
Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Fotona Dynamis Er:YAG Laser System
Sham
Sponsored by
About this trial
This is an interventional treatment trial for Vaginal Atrophy
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
Sites / Locations
- Istanbul University-CerrahpaşaRecruiting
- Istanbul University-CerrahpasaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Laser Arm
Sham Arm
Arm Description
Non-ablative thermal-only Er:YAG laser (Fotona Dynamis) treatment using R11 and PS03 handpieces
The same procedure is applied but with a sham handpiece.
Outcomes
Primary Outcome Measures
Efficacy: Rate of improvement in vaginal atrophy
Evaluation of the efficacy and safety of vaginal atrophy by using ultrasonographic Elastography
Efficacy:Rate of improvement in sexual function
Evaluation of dyspareunia by Female Sexual Function Index
Efficacy: Rate of improvement in vaginal atrophy
Evaluation of Maturation Index
Efficacy: Rate of improvement in vaginal atrophy
Evaluation of Vaginal Health Index
Efficacy: Rate of improvement in pain
Evaluated by Visual Analogue Scale
Secondary Outcome Measures
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)
Full Information
NCT ID
NCT06000202
First Posted
August 12, 2023
Last Updated
August 12, 2023
Sponsor
Istanbul University - Cerrahpasa (IUC)
1. Study Identification
Unique Protocol Identification Number
NCT06000202
Brief Title
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
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 11, 2023 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul University - Cerrahpasa (IUC)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vaginal Atrophy, Dyspareunia, Laser, Genitourinary Syndrome of Menopause (GSM), Er:YAG Laser
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
The participant doesn't know if she receives the sham or laser therapy.
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Laser Arm
Arm Type
Experimental
Arm Description
Non-ablative thermal-only Er:YAG laser (Fotona Dynamis) treatment using R11 and PS03 handpieces
Arm Title
Sham Arm
Arm Type
Sham Comparator
Arm Description
The same procedure is applied but with a sham handpiece.
Intervention Type
Device
Intervention Name(s)
Fotona Dynamis Er:YAG Laser System
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Sham
Other Intervention Name(s)
Placebo
Intervention Description
Er:YAG laser is applied with sham handpiece.
Primary Outcome Measure Information:
Title
Efficacy: Rate of improvement in vaginal atrophy
Description
Evaluation of the efficacy and safety of vaginal atrophy by using ultrasonographic Elastography
Time Frame
6 months
Title
Efficacy:Rate of improvement in sexual function
Description
Evaluation of dyspareunia by Female Sexual Function Index
Time Frame
6 months
Title
Efficacy: Rate of improvement in vaginal atrophy
Description
Evaluation of Maturation Index
Time Frame
6 months
Title
Efficacy: Rate of improvement in vaginal atrophy
Description
Evaluation of Vaginal Health Index
Time Frame
6 months
Title
Efficacy: Rate of improvement in pain
Description
Evaluated by Visual Analogue Scale
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Safety:Incidence and severity of device related Adverse Events
Description
Incidence and severity of device related Adverse Events (i.e., infections, edema, superficial burns, wound dehiscence)
Time Frame
6 months
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
18 years and older postmenopausal women
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cemal Tamer Erel, Prof.
Phone
+905322946022
Email
ctamererel@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cemal Tamer Erel, Prof.
Organizational Affiliation
Istanbul University - Cerrahpasa (IUC)
Official's Role
Study Director
Facility Information:
Facility Name
Istanbul University-Cerrahpaşa
City
Istanbul
ZIP/Postal Code
34098
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cemal Tamer Erel, Prof.
Phone
+905322946022
Email
ctamererel@gmail.com
First Name & Middle Initial & Last Name & Degree
Elif Bayraktar, MD
Phone
+905426863492
Email
elibayraktar@hotmail.com
Facility Name
Istanbul University-Cerrahpasa
City
Istanbul
ZIP/Postal Code
34450
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cemal Tamer Erel, Prof.
Phone
+905322946022
Email
ctamererel@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
The results will be available after the completion of the study for a year.
IPD Sharing Time Frame
It will be available after the completion of the study for a year.
Learn more about this trial
Elastographic Improvement of Vaginal Atrophy Treated by Erbium Yag Laser
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