[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100554739":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":24,"locations":29,"responsibleParty":46,"collaborators":10,"id":48,"slug":49,"hasResults":50,"nctId":51,"briefTitle":52,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":50,"sex":55,"minAge":56,"maxAge":57,"enrollmentInfo":58,"targetDuration":10,"studyType":61,"phases":10,"briefSummary":62,"conditions":63,"keywords":65,"overallStatus":32,"whyStopped":10,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":79},{"fullName":5,"class":6},"University of Cagliari","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Laser Therapy Group",null,"Participants will receive non-ablative dual-wavelength diode laser therapy for Genitourinary Syndrome of Menopause (GSM). The intervention includes three monthly sessions using the Leonardo® Diode laser (Biolitec®) with wavelengths of 980 nm and 1470 nm. Each session lasts about 20 minutes and involves 8 pulses per centimeter along the vaginal canal. Local lidocaine gel is used as an anesthetic. Evaluations occur at baseline, 3 months, and 6 months post-treatment.",[13],"Device: Leonardo® Diode laser",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":10},"DEVICE","Leonardo® Diode laser","The intervention involves non-ablative dual-wavelength diode laser therapy for treating Genitourinary Syndrome of Menopause (GSM). This includes three monthly sessions of the Leonardo® Diode laser (Biolitec®), with wavelengths of 980 nm and 1470 nm, delivering 8 pulses per centimeter along the vaginal canal, using local lidocaine gel as an anesthetic. Evaluations are conducted at baseline, 3 months, and 6 months post-treatment.",[9],[21],{"name":22,"affiliation":5,"role":23},"Stefano Angioni","PRINCIPAL_INVESTIGATOR",[25],{"name":22,"role":26,"phone":27,"phoneExt":10,"email":28},"CONTACT","+3907051093399","sangioni@yahoo.it",[30],{"facility":31,"status":32,"city":33,"state":34,"zip":35,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"Division of Gynecology and Obstetrics Department of Surgical Sciences, University of Cagliari, Cagliari, Italy","RECRUITING","Cagliari","CA","09042","Italy","IT",{"type":39,"coordinates":40},"Point",[41,42],9.11917,39.23054,{"lat":42,"lon":41},[45],{"name":22,"role":26,"phone":27,"phoneExt":10,"email":28},{"type":23,"investigatorFullName":22,"investigatorTitle":47,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Professor","100554739","non-ablative-diode-laser-therapy-for-genitourinary-syndrome-of-menopause-a-prospective-study-on-efficacy-safety-and-quality-of-life-and-sexuality-impact-100554739",false,"NCT06503003","Non-ablative Diode Laser Therapy for Genitourinary Syndrome of Menopause: A Prospective Study on Efficacy, Safety, and Quality of Life and Sexuality Impact","GSMLASER","Inclusion Criteria:\n\n* Post-menopausal women aged 45-73 years.\n* Sexually active.\n* Experiencing physiological amenorrhea for more than 12 months.\n* Exhibiting at least one symptom of Genitourinary Syndrome of Menopause (GSM).\n* Not using lubricants or hormonal therapy in the previous 6 months.\n* Able to provide written informed consent.\n\nExclusion Criteria:\n\n* Untreated uterine or vulvovaginal cancers.\n* Pacemaker or other implanted electrode carriers.\n* Severe multi-organ or neurological diseases.\n* Active sexually transmitted infections.\n* Moderate to severe uterine prolapse.\n* Active urinary tract infections.\n* Acute or chronic dermatological conditions in the vulvar or vaginal area.\n* Active genital herpes.\n* Active high-risk Human Papillomavirus (HPV).\n* Ischemic tissues, unhealed wounds, sores, or undiagnosed mucosal or epithelial alterations.\n* Recent unhealed invasive or ablative surgeries.\n* Bleeding disorders or anticoagulant therapy.\n* Immunodeficiencies.\n* Uncontrolled diabetes.","FEMALE","45 Years","73 Years",{"count":59,"type":60},50,"ESTIMATED","OBSERVATIONAL","The goal of this observational study is to evaluate the efficacy, safety, and impact on quality of life and sexuality of non-ablative dual-wavelength diode laser treatments in managing Genitourinary Syndrome of Menopause (GSM) in sexually active post-menopausal women who cannot use or have not benefited from local estrogen-based therapies. The main questions it aims to answer are:\n\nDoes non-ablative dual-wavelength diode laser therapy improve vaginal dryness, burning sensation, and dyspareunia in post-menopausal women? What is the impact of this therapy on the vaginal health index and sexual function? Researchers will compare the laser-treated group to their baseline measurements to see if non-ablative dual-wavelength diode laser therapy effectively treats GSM.\n\nParticipants will:\n\nUndergo three monthly sessions of dual-wavelength diode laser therapy. Participate in follow-up evaluations at three and six months post-treatment. Complete self-assessments of GSM symptoms and questionnaires evaluating sexual function and quality of life at each follow-up.\n\nThis study aims to provide preliminary evidence that non-ablative dual-wavelength diode laser therapy is a safe and effective non-hormonal treatment for GSM, addressing a gap in existing treatments for women who cannot use or have not benefited from hormonal therapies.",[64],"Genitourinary Syndrome of Menopause",[64,66,67,68,69],"Diode laser","Vaginal Atrophy","Menopause","Sexual Function","2024-07-13",{"date":72,"type":73},"2024-07-16","ACTUAL",{"date":75,"type":73},"2023-09-01",{"date":77,"type":60},"2025-01-01",{"name":5,"class":6},1]