Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:44 AM
Ignite Modification Date:
2025-12-25 @ 12:44 AM
NCT ID:
NCT06485167
Eligibility Criteria:
Inclusion Criteria:
* 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 Criteria:
* 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
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
40 Years
Maximum Age:
70 Years
Study:
NCT06485167
Study Brief:
Protocol Section:
NCT06485167