- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06000202
Elastographic Improvement of Vaginal Atrophy Treated by Erbium Yag Laser
Elastographic Improvement of Vaginal Atrophy Treated by Er:YAG Laser
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
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Cemal Tamer Erel, Prof.
- Phone Number: +905322946022
- Email: ctamererel@gmail.com
Study Locations
-
-
-
Istanbul, Turkey, 34098
- Recruiting
- Istanbul University-Cerrahpasa
-
Contact:
- Cemal Tamer Erel, Prof.
- Phone Number: +905322946022
- Email: ctamererel@gmail.com
-
Contact:
- Elif Bayraktar, MD
- Phone Number: +905426863492
- Email: elibayraktar@hotmail.com
-
Istanbul, Turkey, 34450
- Recruiting
- Istanbul University-Cerrahpasa
-
Contact:
- Cemal Tamer Erel, Prof.
- Phone Number: +905322946022
- Email: ctamererel@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Laser Arm
Non-ablative thermal-only Er:YAG laser (Fotona Dynamis) treatment using R11 and PS03 handpieces
|
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 Comparator: Sham Arm
The same procedure is applied but with a sham handpiece.
|
Er:YAG laser is applied with sham handpiece.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Efficacy: Rate of improvement in vaginal atrophy
Time Frame: 6 months
|
Evaluation of the efficacy and safety of vaginal atrophy by using ultrasonographic Elastography
|
6 months
|
Efficacy:Rate of improvement in sexual function
Time Frame: 6 months
|
Evaluation of dyspareunia by Female Sexual Function Index
|
6 months
|
Efficacy: Rate of improvement in vaginal atrophy
Time Frame: 6 months
|
Evaluation of Maturation Index
|
6 months
|
Efficacy: Rate of improvement in vaginal atrophy
Time Frame: 6 months
|
Evaluation of Vaginal Health Index
|
6 months
|
Efficacy: Rate of improvement in pain
Time Frame: 6 months
|
Evaluated by Visual Analogue Scale
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety:Incidence and severity of device related Adverse Events
Time Frame: 6 months
|
Incidence and severity of device related Adverse Events (i.e., infections, edema, superficial burns, wound dehiscence)
|
6 months
|
Collaborators and Investigators
Investigators
- Study Director: Cemal Tamer Erel, Prof., Istanbul University - Cerrahpasa (IUC)
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Pathological Conditions, Anatomical
- Sexual Dysfunctions, Psychological
- Sexual Dysfunction, Physiological
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Male Urogenital Diseases
- Genital Diseases, Male
- Genital Diseases
- Genital Diseases, Female
- Atrophy
- Dyspareunia
Other Study ID Numbers
- 689852
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Supporting Information Type
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Vaginal Atrophy
-
Petra LarmoTurun Gynekologikeskus Oy; Tekes - The Finnish Funding Agency for Technology...CompletedVaginal Atrophy | Vaginal Dryness | Vulvar Atrophy | Vulvar DrynessFinland
-
Rajavithi HospitalTerminatedVaginal Atrophy | Oxytocin Gel | Postmenopausal Women | Vaginal Maturation IndexThailand
-
BionovoUnknownVaginal Atrophy | Vulvar AtrophyUnited States
-
Sun Pharmaceutical Industries LimitedTerminated
-
Bitop AGCompleted
-
University of Texas Southwestern Medical CenterAmerican Society for Aesthetic Plastic SurgeryCompleted
-
Dr. August Wolff GmbH & Co. KG ArzneimittelproDERM GmbHCompleted
-
National and Kapodistrian University of AthensIRCCS San RaffaeleUnknown
-
Syneron MedicalUnknownVaginal AtrophyUnited States
-
Herbarium Laboratorio Botanico LtdaNot yet recruiting
Clinical Trials on Fotona Dynamis Er:YAG Laser System
-
Cork University HospitalFotona d.o.o.UnknownStress Urinary IncontinenceUnited Kingdom, Switzerland, Germany, Greece, Ireland, Slovenia
-
Istanbul University - Cerrahpasa (IUC)Fotona d.o.o.RecruitingVulvodynia | Episiotomy Wound | Laser | Vulva PainTurkey
-
Fotona d.o.o.UnknownStress Urinary IncontinenceCanada
-
National and Kapodistrian University of AthensUnknownCystocele | Vaginal Vault Prolapse | Rectocele | EnteroceleGreece
-
Krizaj d.o.o.Completed
-
Chulalongkorn UniversityCompletedAcne VulgarisThailand
-
Medical University of GrazRecruitingLichen Planus | Lichen Sclerosus Et AtrophicusAustria
-
Rambam Health Care CampusCompleted
-
University of MiamiWithdrawn
-
Damascus UniversityCompletedClass II Division 1 Malocclusion | Protrusion, Incisor | Maxillary PrognathismSyrian Arab Republic