Status:
NOT_YET_RECRUITING
Effect of HIFEM® Treatment of Urinary Incontinence in Women in Primary Care. A Randomized Controlled Trial
Lead Sponsor:
Vastra Gotaland Region
Conditions:
Urinary Incontinence
Quality of Life
Eligibility:
FEMALE
40-70 years
Phase:
NA
Brief Summary
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 participati...
Detailed Description
Background 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 ...
Eligibility Criteria
Inclusion
- Woman
- Age 40-70 years
- Any form of UI - stress incontinence (AI), urge incontinence (TI) or mixed urinary incontinence (MUI) according to QUID
- No major language difficulties that prevent understanding and speaking the Swedish language and filling in questionnaires.
Exclusion
- 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
- Implanted pacemaker or larger metal implant in the body: metal plates, screws, defibrillator and metal implants in the pelvic area or copper coil
- The patient has a piercing between the waist and knees and is not willing to remove it before each treatment
- Pregnant, or planning to become pregnant, at screening or at any time during the study period
- Painful urges
- Bladder emptying difficulties
- Previous malignancy in the abdomen or urinary tract
- Pelvic floor physical therapy, including muscle training and/or electrical stimulation, in a clinical setting within 30 days prior to screening
- Severely overweight (defined as weight \> 135 kg)
- Pulmonary insufficiency, defined as difficulty breathing and fatigue, especially during exercise
- Any condition that causes a lack of normal skin sensation in the pelvis, buttocks and lower extremities
- Currently recovering from surgical procedures where muscle contraction may interfere with the healing process
- Currently receiving treatment for a malignant tumor that would interfere with study participation.
- Used the BTL EMSELLA unit before
- The person has urinary incontinence of neurogenic etiology, such as multiple sclerosis, spina bifida, Parkinson's, spinal cord injury, diabetic neuropathy, etc.
- Vaginal prolapse
- Vaginal rejuvenation treatment, including laser treatments and radiofrequency therapy, within 6 months prior to the screening visit
Key Trial Info
Start Date :
August 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 15 2025
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06485167
Start Date
August 1 2024
End Date
December 15 2025
Last Update
July 3 2024
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