Ignite Creation Date:
2025-12-25 @ 3:39 AM
Ignite Modification Date:
2026-01-09 @ 11:05 PM
Study NCT ID:
NCT06000202
Status:
COMPLETED
Last Update Posted:
2025-04-30
First Post:
2023-08-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Elastographic Improvement of Vaginal Atrophy Treated by Erbium Yag Laser
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004414', 'term': 'Dyspareunia'}], 'ancestors': [{'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D012735', 'term': 'Sexual Dysfunction, Physiological'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D020018', 'term': 'Sexual Dysfunctions, Psychological'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': "The participant doesn't know if she receives the sham or laser therapy."}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-08-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2024-02-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-29', 'studyFirstSubmitDate': '2023-08-12', 'studyFirstSubmitQcDate': '2023-08-12', 'lastUpdatePostDateStruct': {'date': '2025-04-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy: Rate of improvement in vaginal atrophy', 'timeFrame': '6 months', 'description': 'Evaluation of the efficacy and safety of vaginal atrophy by using ultrasonographic Elastography'}, {'measure': 'Efficacy:Rate of improvement in sexual function', 'timeFrame': '6 months', 'description': 'Evaluation of dyspareunia by Female Sexual Function Index'}, {'measure': 'Efficacy: Rate of improvement in vaginal atrophy', 'timeFrame': '6 months', 'description': 'Evaluation of Maturation Index'}, {'measure': 'Efficacy: Rate of improvement in vaginal atrophy', 'timeFrame': '6 months', 'description': 'Evaluation of Vaginal Health Index'}, {'measure': 'Efficacy: Rate of improvement in pain', 'timeFrame': '6 months', 'description': 'Evaluated by Visual Analogue Scale'}], 'secondaryOutcomes': [{'measure': 'Safety:Incidence and severity of device related Adverse Events', 'timeFrame': '6 months', 'description': 'Incidence and severity of device related Adverse Events (i.e., infections, edema, superficial burns, wound dehiscence)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Vaginal Atrophy', 'Dyspareunia', 'Laser', 'Genitourinary Syndrome of Menopause (GSM)']}, 'referencesModule': {'references': [{'pmid': '38860935', 'type': 'DERIVED', 'citation': 'Bayraktar E, Erel CT, Akturk H, Erkan IBO, Hamid R, Alper E, Adaletli I, Urfalioglu M. A novel objective evaluation method, shear wave elastography, in the treatment of atrophic vaginitis by nonablative intravaginal Er:YAG laser, a randomized-sham controlled pilot study. Menopause. 2024 Aug 1;31(8):716-723. doi: 10.1097/GME.0000000000002380. Epub 2024 Jun 11.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nIn 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', 'detailedDescription': '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.\n\nLaser 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.\n\nThe 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.\n\nIn 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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': '18 years and older postmenopausal women', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Postmenopausal women with vaginal atrophy symptoms\n* Adult Female, 18 years of age or older\n\nExclusion Criteria:\n\n* Patients with a history of previous vaginal operation,\n* Patients with pelvic organ prolapse'}, 'identificationModule': {'nctId': 'NCT06000202', 'briefTitle': 'Elastographic Improvement of Vaginal Atrophy Treated by Erbium Yag Laser', 'organization': {'class': 'OTHER', 'fullName': 'Istanbul University - Cerrahpasa'}, 'officialTitle': 'Elastographic Improvement of Vaginal Atrophy Treated by Er:YAG Laser', 'orgStudyIdInfo': {'id': '689852'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Laser Arm', 'description': 'Non-ablative thermal-only Er:YAG laser (Fotona Dynamis) treatment using R11 and PS03 handpieces', 'interventionNames': ['Device: Fotona Dynamis Er:YAG Laser System']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham Arm', 'description': 'The same procedure is applied but with a sham handpiece.', 'interventionNames': ['Device: Sham']}], 'interventions': [{'name': 'Fotona Dynamis Er:YAG Laser System', 'type': 'DEVICE', '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.', 'armGroupLabels': ['Laser Arm']}, {'name': 'Sham', 'type': 'DEVICE', 'otherNames': ['Placebo'], 'description': 'Er:YAG laser is applied with sham handpiece.', 'armGroupLabels': ['Sham Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34098', 'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Istanbul University-Cerrahpaşa', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}, {'zip': '34450', 'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Istanbul University-Cerrahpasa', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'overallOfficials': [{'name': 'Cemal Tamer Erel, Prof.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Istanbul University - Cerrahpasa'}]}, 'ipdSharingStatementModule': {'infoTypes': ['CSR'], 'timeFrame': 'It will be available after the completion of the study for a year.', 'ipdSharing': 'YES', 'description': 'The results will be available after the completion of the study for a year.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istanbul University - Cerrahpasa', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. Principal investigator', 'investigatorFullName': 'Cemal Tamer Erel', 'investigatorAffiliation': 'Istanbul University - Cerrahpasa'}}}}