[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100417106":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":42,"responsibleParty":64,"collaborators":26,"id":66,"slug":67,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":70,"acronym":71,"eligibilityCriteria":72,"healthyVolunteers":68,"sex":73,"minAge":74,"maxAge":75,"enrollmentInfo":76,"targetDuration":26,"studyType":79,"phases":80,"briefSummary":82,"conditions":83,"keywords":85,"overallStatus":45,"whyStopped":26,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},{"fullName":5,"class":6},"Medical University of Graz","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention group (laser therapy)","ACTIVE_COMPARATOR","Participants allocated to the laser-therapy group will receive 2 laser treatments over a period of 3 months. Laser therapy will be performed according to a standardized protocol.",[13],"Device: Erbium:Yag laser",{"label":15,"type":16,"description":17,"interventionNames":18},"Control group (sham laser therapy)","SHAM_COMPARATOR","Participants allocated to the control group will receive 2 sham laser treatments over a period of 3 months. Laser therapy will be performed according to a standardized protocol.",[19],"Device: Sham Erbium:Yag laser",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","Erbium:Yag laser","Vulvovaginal laser therapies will be performed with the non-ablative 2940 nm Er:YAG laser (Smooth XS, Fotona, Slovenia) in the Renova mode according to the manufacturer's guidelines and recommendations. The spot size (diameter of the laser beam) is 7 mm, with a pulse at a frequency of 1.6 Hz, and a fluence (laser energy delivered per unit area) of 5.0 to 10.0 J\u002Fcm2.\n\nAll sensitive\u002Fpainful areas of the introitus will be treated, using 1-3 repetitions.\n\nIn postmenopausal women with signs of atrophy, additional irradiation of the vaginal wall will be performed.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Sham Erbium:Yag laser","Clinical examination and preparations will be identical to the intervention group. Sham laser treatments will be performed with the same laser and the same procedures. However, a specially devised placebo probe with a steel shutter, which blocks the emission of radiation, will be used. Women will therefore receive no therapeutic irradiation. Before treatment, a study assistant, who is aware of the study allocation, will prepare the laser with the placebo probe, which looks identically to the \"normal\" probe. The treating physician will not be aware of the study allocation and the type of probe in use.",[15],[32,38],{"name":33,"role":34,"phone":35,"phoneExt":36,"email":37},"Gerda Trutnovsky, MD","CONTACT","+43 316 385","81081","gerda.trutnovsky@medunigraz.at",{"name":39,"role":34,"phone":35,"phoneExt":40,"email":41},"Karl Tamussino, MD","81068","karl.tamussino@medunigraz.at",[43],{"facility":44,"status":45,"city":46,"state":26,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"Department of Obstetrics and Gynecology\u002F Medical University of Graz","RECRUITING","Graz","8036","Austria","AT",{"type":51,"coordinates":52},"Point",[53,54],15.44197,47.06733,{"lat":54,"lon":53},[57,58,62],{"name":33,"role":34,"phone":35,"phoneExt":36,"email":37},{"name":59,"role":34,"phone":35,"phoneExt":60,"email":61},"Daniela Gold, MD","81437","daniela.gold@medunigraz.at",{"name":33,"role":63,"phone":26,"phoneExt":26,"email":26},"PRINCIPAL_INVESTIGATOR",{"type":65,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100417106","lasertherapy-for-vulvodynia-100417106",false,"NCT04711369","Lasertherapy for Vulvodynia","Lydia","Inclusion Criteria:\n\n* Women with vulvodynia (diagnosed according to the 2015 Consensus Terminology)\n* multidisciplinary treatment for at least 3 months\n* Informed consent\n\nExclusion Criteria:\n\n* Current genital infection (i.e. candidiasis, herpes )\n* Inflammatory vulvar disease\u002F dermatosis (i.e. lichen sclerosus, lichen planus)\n* Neoplastic vulvar disease (e.g. HSIL Vulva, Paget disease)\n* Recent vulvar trauma (i.e. bleeding, erosion or ulceration)\n* Pudendal neuralgia\n* Pregnancy, delivery \\\u003C6 months\n* Epilepsy or major neurologic or psychiatric morbidity\n* Active systemic infection\n* Previous treatment with ionizing radiation in the area to be treated\n* History of wound healing disorders (i.e. hyperpigmentation, abnormal scarring)\n* Fever\n* Systemic or local autoimmune disorders\n* History of photosensitivity disorder","FEMALE","18 Years","80 Years",{"count":77,"type":78},92,"ESTIMATED","INTERVENTIONAL",[81],"NA","The study aims to assess the efficacy, acceptance and safety profile of vulvovaginal laser therapy in women with vulvodynia.",[84],"Vulvodynia",[23],"2025-03-03",{"date":88,"type":89},"2025-03-04","ACTUAL",{"date":91,"type":89},"2021-01-15",{"date":93,"type":78},"2026-07-30",{"name":5,"class":6},1]