[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100595632":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":37,"responsibleParty":55,"collaborators":60,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":26,"eligibilityCriteria":68,"healthyVolunteers":64,"sex":69,"minAge":70,"maxAge":71,"enrollmentInfo":72,"targetDuration":26,"studyType":75,"phases":76,"briefSummary":78,"conditions":79,"keywords":82,"overallStatus":40,"whyStopped":26,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},{"fullName":5,"class":6},"Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Active Non-ablative Radiofrequency + Pelvic-Floor Muscle Training","EXPERIMENTAL","Participants in this group will receive non-ablative monopolar capacitive radiofrequency therapy combined with pelvic-floor muscle training guided by biofeedback.",[13],"Device: Active Radiofrequency (Capenergy C500 UpGradeC200)",{"label":15,"type":16,"description":17,"interventionNames":18},"Sham Radiofrequency + Pelvic-Floor Muscle Training","SHAM_COMPARATOR","Participants in this group will receive sham radiofrequency treatment combined with pelvic-floor muscle training guided by biofeedback.",[19],"Device: Sham Radiofrequency (Capenergy C500 UpGrade C200 - Placebo Mode)",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","Active Radiofrequency (Capenergy C500 UpGradeC200)","Non-ablative radiofrequency is applied using a Capenergy C500 device at a target tissue temperature of ≤ 45 °C, once a week for 6 consecutive weeks. Treatment is delivered through two channels simultaneously: a capacitive plate placed on the suprapubic area and an intracavitary vaginal probe. Each session lasts 20 minutes and is followed by 20 minutes of pelvic-floor muscle training guided by biofeedback. Participants will also follow a progressive home exercise programme and record adherence and events.\n\nIn addition, all participants will receive education on pelvic-floor anatomy and function, underlying mechanisms of pain after breast cancer, bladder and bowel retraining, respiratory pattern re-education, and-if interested-information on sexual health.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Sham Radiofrequency (Capenergy C500 UpGrade C200 - Placebo Mode)","Participants will receive one session per week for 6 weeks of sham (placebo) radiofrequency using the Capenergy C500 in Placebo Mode (no temperature increase), designed to simulate active treatment. The screen will display a simulated \"delivered energy\" value; temperature and energy readings will be hidden; LED indicators will activate sequentially; and a suprapubic capacitive plate and intracavitary probe will be used with the same protocol as in the intervention group. This will be followed by 20 minutes of pelvic-floor muscle training guided by biofeedback, identical to the intervention group. Participants will also follow a progressive home exercise programme and record adherence and events. All participants will receive education on pelvic-floor function, pain mechanisms after breast cancer, bladder\u002Fbowel retraining, breathing pattern correction, and-if interested-sexual health.",[15],[32],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"Irene Lázaro Navas, PhD, MSc, PT","CONTACT","+34 91 336 83 22","ilazaro@salud.madrid.org",[38],{"facility":39,"status":40,"city":41,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"Hospital Universitario Ramón y Cajal","RECRUITING","Madrid","28034","Spain","ES",{"type":46,"coordinates":47},"Point",[48,49],-3.70256,40.4165,{"lat":49,"lon":48},[52],{"name":33,"role":34,"phone":53,"phoneExt":26,"email":54},"+34 913368000","irenelazarofisioterapia@gmail.com",{"type":56,"investigatorFullName":57,"investigatorTitle":58,"investigatorAffiliation":59,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Irene Lázaro Navas","PhD Physiotherapist, Department of Rehabilitation Medicine, Hospital Universitario Ramón y Cajal","Hospital Universitario Ramon y Cajal",[61],{"name":59,"class":6},"100595632","efficacy-of-non-ablative-radiofrequency-combined-with-pelvic-floor-muscle-training-for-genitourinary-syndrome-of-menopause-in-breast-cancer-survivors-rf-sgm-100595632",false,"NCT07034976","Efficacy of Non-ablative Radiofrequency Combined With Pelvic Floor Muscle Training for Genitourinary Syndrome of Menopause in Breast Cancer Survivors (RF-SGM)","Randomized, Controlled Trial to Evaluate the Efficacy of Non-ablative Radiofrequency Combined With Pelvic Floor Muscle Training on Symptoms of Genitourinary Syndrome of Menopause in Breast Cancer Survivors","Inclusion Criteria:\n\n* Women who are breast cancer survivors and clinically confirmed to be disease-free by their physician.\n* Amenorrhea for more than 12 months and vaginal pH ≥ 5, with symptoms related to genitourinary syndrome of menopause (GSM), as diagnosed by a physician. Symptoms must be bothersome and not better explained by another clinical condition.\n* Negative urine culture at baseline.\n* Moderate to severe vaginal dryness, defined as a score \\> 4 on the Numeric Rating Scale (NRS 0-10)\n\nExclusion Criteria:\n\n* Age over 75 years.\n* Current or past diagnosis of any cancer other than breast cancer.\n* Pelvic surgery, chemotherapy, or radiotherapy in the past 3 months.\n* Use of local estrogen therapy within the past month.\n* Active genital infections.\n* Diagnosis of HIV infection or severe immunosuppression.\n* Presence of pacemakers, metallic implants, or electromagnetic devices.\n* Coagulation disorders or current use of anticoagulants.\n* Pelvic organ prolapse stage \\> III (POP-Q classification).\n* Unexplained abnormal vaginal bleeding.\n* History of pelvic anti-incontinence surgery, with or without mesh.\n* Inflammatory dermatoses of the vulva.\n* Pelvic-floor muscle strength score of 0\u002F5 on the Modified Oxford Scale.\n* Nickel allergy.\n* Previous treatment with radiofrequency in the pelvic or genital area.","FEMALE","18 Years","75 Years",{"count":73,"type":74},50,"ESTIMATED","INTERVENTIONAL",[77],"NA","The goal of this clinical trial is to find out whether non-ablative radiofrequency (RF) applied together with pelvic-floor muscle exercises can ease vaginal dryness and other symptoms of genitourinary syndrome of menopause (GSM) in women aged 18-75 years who have survived breast cancer and currently experience those symptoms.\n\nThe main questions it aims to answer are:\n\nDoes the combination of RF + exercise lower the 0-to-10 vaginal-dryness score more than sham (inactive) RF + exercise at 6 weeks (end of treatment) and 3 months?\n\nWhat other changes (pain during intercourse, Vaginal Health Index, urinary and sexual function, pelvic-floor strength, overall satisfaction) are seen in each group?\n\nResearchers will compare six sessions of active RF with six sessions of sham (inactive) RF to see whether the active treatment works better.\n\nParticipants will:\n\nVisit the hospital once a week for 6 weeks. Each visit includes about 20 minutes of intra-\u002Fextra-vaginal RF (or sham) and 20 minutes of guided pelvic-floor training whose content is adapted and progressed throughout the study.\n\nCarry out a structured, progressive home-exercise programme, recording any discomfort in a diary.\n\nComplete questionnaires and tests at baseline, after session 6, and 3 months later.",[80,81],"Genitourinary Syndrome of Menopause (GSM)","Breast Cancer",[83,84,85,86,87,88,89],"genitourinary syndrome of menopause","vaginal atrophy","vaginal dryness","breast cancer survivors","non-ablative radiofrequency","pelvic floor muscle training","physiotherapy","2025-09-09",{"date":92,"type":93},"2025-09-15","ACTUAL",{"date":95,"type":93},"2025-09-01",{"date":97,"type":74},"2027-12-31",{"name":5,"class":6},1]