[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"dyspareunia-female\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:dyspareunia-female":33},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,52],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":34,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":41,"startDateStruct":44,"completionDateStruct":46,"leadSponsor":48,"locationsCount":51},"100579772","treatment-of-vulvo-vaginal-atrophy-vva-using-vaginal-dilator-in-addition-to-usual-treatment-100579772",false,"NCT06828640","Treatment of Vulvo-vaginal Atrophy (VVA) Using Vaginal Dilator in Addition to Usual Treatment","Treatment of Vulvo-vaginal Atrophy (VVA) Using Vaginal Dilator in Addition to Usual Treatment : a Randomized Control Trial","Inclusion Criteria:\n\n* Peri- or postmenopausal women suffering from vulvovaginal atrophy (VVA)\n* Breast cancer survivors with VVA symptoms\n* Understand the study, be willing to participate, and sign an informed consent form.\n* The use of estrogen\u002Fprogestogen-based products (vaginal, oral, pellets, transdermal, etc.) is permitted but must be documented (this will be considered during randomization).\n\nExclusion Criteria:\n\n* Undiagnosed abnormal genital bleeding.\n* Administration of any investigational drug within 30 days prior to the screening visit.\n* Presence of a serious medical condition, neurological disorder, or significant comorbidities.\n* Other gynecological malignancies.\n* Recent vaginal surgery.\n* Clinically significant prolapse (POP-Q ≤ 2).\n* Current urinary tract or vaginal infection, or recent sexually transmitted infection.\n* Individuals with disabilities unable to communicate.\n* Women eligible for the study but unwilling to participate.","FEMALE","18 Years","85 Years",{"count":20,"type":21},160,"ESTIMATED","INTERVENTIONAL",[24],"NA","This is a randomized, controlled trial aiming to evaluate the effectiveness of adding vaginal dilators to the treatment of vulvovaginal atrophy.\n\nStudy Population:\n\nPeri- and postmenopausal women with VVA, including breast cancer survivors.\n\nDesign: Monocentric pilot RCT evaluating SoC (MHT, lubricants, moisturizers) (control group) to SoC + vaginal dilators (test group).\n\nVaginal Dilator : A silicone medical device will be used for gradual stretching progression. The kit includes dilators of progressively larger sizes.\n\nProcedures: Assessments at baseline, at 4 \\& 12 weeks\n\nMeasures : Vulvo Vaginal Atrophy severity , dyspareunia, Vaginal Health Index Score, Female Sexual Fonction Index, and Visual Analogue Scale (for vaginal dryness, vaginal and\u002For vulvar irritation\u002Fitching, and pain during sexual intercourse).\n\nStatistical Analysis:\n\nDifferences at baseline, 4 weeks, and 12 weeks will be tested using:\n\nTwo-sample t-test Mann-Whitney test\n\nStatistical Power:\n\nAssuming a 20% improvement in Group 1 and 40% in Group 2, with:\n\np \\\u003C 0.05 (type I error) 80% power (type II error), 160 patients needed across both groups.\n\nSoC = Standard of care RCT = Randimized control trial MHT = Menopausal hormonal therapy",[27,28,29,30,31,32,33],"Vulvo Vaginal Atrophy","Genitourinary Syndrome of Menopause (GSM)","Vaginal Atrophy in Breast Cancer Patients","Vaginal Atrophy Patients With GSM","Treatment","Sexual Disfunction","Dyspareunia (Female)",[35,36,37,38],"Vulvo vaginal atrophy","vaginal dilators","Genitourinary syndrome of menopause","treatment","RECRUITING","2025-02-11",{"date":42,"type":43},"2025-02-14","ACTUAL",{"date":45,"type":43},"2024-10-16",{"date":47,"type":21},"2025-10",{"name":49,"class":50},"Centre Hospitalier Universitaire Saint Pierre","OTHER",1,{"id":53,"slug":54,"hasResults":11,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":4,"eligibilityCriteria":58,"healthyVolunteers":11,"sex":16,"minAge":59,"maxAge":60,"enrollmentInfo":61,"targetDuration":4,"studyType":22,"phases":63,"briefSummary":64,"conditions":65,"keywords":66,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":51},"100572246","effect-of-transcutaneous-electrical-acupoint-stimulation-on-dyspareunia-100572246","NCT06730776","Effect of Transcutaneous Electrical Acupoint Stimulation on Dyspareunia","Effect of Transcutaneous Electrical Acupoint Stimulation on Dyspareunia: a Randomized Controlled Trial","* Inclusion Criteria:\n\n  * Women complain of secondary dyspareunia, diagnosed and referred by the gynecologist.\n  * Multiparous women.\n  * Their ages will range from 25-35 years.\n  * Their body BMI will be less than 35 kg\u002Fm².\n  * Their pain level on the VAS will be ≥ 4.\n  * All the women were negative for vaginal infections caused by viruses, bacteria or fungi.\n* Exclusion Criteria:\n\n  * Pregnancy\n  * Malignancy.\n  * The presence of an intrauterine device, vaginal infection, or skin\u002Fmucous lesions.\n  * Diabetes mellitus.\n  * Dermatological abnormalities on the skin at acupuncture point.\n  * Severe uncontrolled cardiac patients or implanted cardiac rhythm devices.\n  * Dyspareunia with endometriosis.\n  * Fearing from electricity.","25 Years","35 Years",{"count":62,"type":21},38,[24],"Transcutaneous electrical acupoint stimulation (TEAS)was proven to stimulate the secretion of endogenous opioid peptides which are partial substitutes for the exogenous opioids stimulated by drugs in the central nervous system and can thus relieve pain. Till now there is no previous study that investigates the effect of TEAS on dyspareunia. This study will determine the effect of transcutaneous acupoint stimulation on dyspareunia.\n\nPatients will be divided randomly into two groups equal in number: The control group will receive only topical medication. The study group will receive Acu-TENS and topical medication.",[33],[67],"dyspareunia,","NOT_YET_RECRUITING","2024-12-09",{"date":71,"type":43},"2024-12-12",{"date":73,"type":21},"2024-12-15",{"date":75,"type":21},"2025-05-30",{"name":77,"class":50},"Cairo University"]