[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100553367":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":26,"centralContacts":30,"locations":25,"responsibleParty":38,"collaborators":25,"id":41,"slug":42,"hasResults":43,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":25,"eligibilityCriteria":47,"healthyVolunteers":48,"sex":49,"minAge":50,"maxAge":51,"enrollmentInfo":52,"targetDuration":25,"studyType":55,"phases":56,"briefSummary":58,"conditions":59,"keywords":65,"overallStatus":73,"whyStopped":25,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":25},{"fullName":5,"class":6},"Vastra Gotaland Region","OTHER_GOV",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Experimental: Group 1 Active Treatment Group (AG)","ACTIVE_COMPARATOR","Group 1 Active treatment group (AG)\n\n● The AG group consists six HIFEM® treatments of 28 minutes at a frequency of one session\u002Fweek for six consecutive weeks at program level 1 of 2. The woman will be sitting fully clothed on the HIFEM-chair. Before the first treatment, the woman answers questions about the degree of urinary leakage and records the frequency of urinary leakage before treatment and to next treatment.",[13],"Device: HIFEM- chair",{"label":15,"type":16,"description":17,"interventionNames":18},"Experimental: Group 2 Sham-treatment Control Group (CG)","SHAM_COMPARATOR","Group 2 Sham-treatment Control Group (CG)\n\n● The CG group consists six non-active HIFEM® treatments (sham-treatment) of 28 minutes at a frecquency of one session\u002Fweek for six consecutive weeks. The sham-treatment will provide some sensation but without active HIFEM technology. The programming for the sham treatment will be amplitude limited, with the setting below the therapeutic level (\\\u003C10% effect).The participants will be placed on the HIFEM-chair in the same way as the AG group. Before the first treatment, the woman answers questions about the degree of urinary leakage and records the frequency of urinary leakage.",[13],[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","HIFEM- chair","The intervention consists of pelvic floor training combined with high-intensity electromagnetic energy treatment (HIFEM®). This includes six HIFEM® treatments (each lasting 28 minutes) with one session per week over six weeks. The woman completes a voiding diary before treatment and one week (±7 days) after treatment. She sits fully clothed on the HIFEM chair.",[9,15],null,[27],{"name":28,"affiliation":5,"role":29},"Lena Rindner, PhD","PRINCIPAL_INVESTIGATOR",[31,35],{"name":28,"role":32,"phone":33,"phoneExt":25,"email":34},"CONTACT","+46730620700","lena.rindner@vgregion.se",{"name":36,"role":32,"phone":25,"phoneExt":25,"email":37},"Lena Nordeman, PhD, Docent","lena.nordeman@vgregion.se",{"type":29,"investigatorFullName":39,"investigatorTitle":40,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Lena Rindner","PhD","100553367","effect-of-hifem-treatment-of-urinary-incontinence-in-women-in-primary-care-a-randomized-controlled-trial-100553367",false,"NCT06485167","Effect of HIFEM® Treatment of Urinary Incontinence in Women in Primary Care. A Randomized Controlled Trial","Effect of High-intensity Electromagnetic Energy (HIFEM®), a Non-invasive Treatment of Urinary Incontinence and Pelvic Floor Dysfunction in Women in Primary Care. A Randomized Controlled Study.","Inclusion Criteria:\n\n* Woman\n* Age 40-70 years\n* Any form of UI - stress incontinence (AI), urge incontinence (TI) or mixed urinary incontinence (MUI) according to QUID\n* No major language difficulties that prevent understanding and speaking the Swedish language and filling in questionnaires.\n\nExclusion Criteria:\n\n* Woman with a serious illness such as psychosis, pulmonary insufficiency, epilepsy, severe depression, dementia, is being treated in palliative care, has ongoing drug or alcohol abuse\n* Implanted pacemaker or larger metal implant in the body: metal plates, screws, defibrillator and metal implants in the pelvic area or copper coil\n* The patient has a piercing between the waist and knees and is not willing to remove it before each treatment\n* Pregnant, or planning to become pregnant, at screening or at any time during the study period\n* Painful urges\n* Bladder emptying difficulties\n* Previous malignancy in the abdomen or urinary tract\n* Pelvic floor physical therapy, including muscle training and\u002For electrical stimulation, in a clinical setting within 30 days prior to screening\n* Severely overweight (defined as weight \\> 135 kg)\n* Pulmonary insufficiency, defined as difficulty breathing and fatigue, especially during exercise\n* Any condition that causes a lack of normal skin sensation in the pelvis, buttocks and lower extremities\n* Currently recovering from surgical procedures where muscle contraction may interfere with the healing process\n* Currently receiving treatment for a malignant tumor that would interfere with study participation.\n* Used the BTL EMSELLA unit before\n* The person has urinary incontinence of neurogenic etiology, such as multiple sclerosis, spina bifida, Parkinson's, spinal cord injury, diabetic neuropathy, etc.\n* Vaginal prolapse\n* Vaginal rejuvenation treatment, including laser treatments and radiofrequency therapy, within 6 months prior to the screening visit",true,"FEMALE","40 Years","70 Years",{"count":53,"type":54},100,"ESTIMATED","INTERVENTIONAL",[57],"NA","Urinary incontinence (UI) is a condition with involuntary leakage of urine. UI has a significant impact on health related quality of life, poorer sleep quality and sexual function, reduced participation in social and physical activities and is associated with large health care charge. Non-surgical method is always recommended as first action with a step-by-step care starting from non-invasive to more invasive interventions. Systematic overview shows that available non-surgical treatment options in primary care indicated low results in improving effect. HIFEM® technology is a non-invasive method and studies showed significant result on women with UI. For Swedish healthcare HIFEM® is a new medical technology product to treat UI. However, there is a lack of knowledge about the HIFEM® effect in women seeking primary care.\n\nThe aim is to evaluate the effect of high-intensity electromagnetic energy (HIFEM®) on pelvic floor muscles, urinary leakage, sexual function, and health-related quality of life in women with urinary leakage in Swedish primary care, as well as to evaluate cost-effectiveness.\n\nThe intervention included six 30 minutes HIFEM® sessions once a week over six weeks compared with control group.\n\nThe results are expected to lead to effective non-surgical treatment options that can reach many patients, contribute to improving existing routines and can be a new potential way to support health promotion care in primary care and be a cost-effective investment.",[60,61,62,63,64],"Urinary Incontinence","Quality of Life","Menopause","Mental Health Issue","Primary Health Care",[66,67,68,69,70,71,72],"urinary incontinence","mental health","menopause","sexual health","womens health","primary health care","quality of ife","NOT_YET_RECRUITING","2024-06-26",{"date":76,"type":77},"2024-07-03","ACTUAL",{"date":79,"type":54},"2024-08-01",{"date":81,"type":54},"2025-12-15",{"name":5,"class":6}]