Effect of HIFEM® Treatment of Urinary Incontinence in Women in Primary Care. A Randomized Controlled Trial

Launched by VASTRA GOTALAND REGION · Jun 26, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new non-invasive treatment called HIFEM® (high-intensity electromagnetic energy) to help women with urinary incontinence (UI), which is the involuntary leakage of urine. The trial aims to see if this treatment can improve urinary leakage, pelvic floor muscle strength, sexual function, and overall quality of life for women aged 40 to 70 who experience any form of UI. It will also look at whether this treatment is cost-effective compared to traditional care options.

To participate, women need to be between 40 and 70 years old and have any type of urinary incontinence. They should be able to understand and communicate in Swedish. However, certain health conditions or treatments may exclude them from joining the trial, such as serious illnesses, having a pacemaker, or recent pelvic treatments. Participants will undergo six sessions of HIFEM® treatment, each lasting 30 minutes, over six weeks. This trial is not yet recruiting participants, but the results could lead to better treatment options for many women dealing with urinary incontinence in primary care settings.

Gender

FEMALE

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