Clinical trial NCT06485167: Effect of HIFEM® Treatment of Urinary Incontinence in Women in Primary Care. A Randomized Controlled Trial
Official title: 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.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Urinary Incontinence
Quality of Life
Menopause
Mental Health Issue
Primary Health Care
Keywords: urinary incontinence
mental health
menopause
sexual health
womens health
primary health care
quality of ife
Lead sponsor: Vastra Gotaland Region
Sponsor class: OTHER_GOV
First posted: 2024-07-03
Enrollment: 100
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The intervention treatment consists pelvic floor training with high-intensity electromagnetic energy treatment (HIFEM®). HIFEM® is approval and permission of Food and Drug Administration (FDA) and CE of European Union (EU) to treat UI. One HIFEM® treatment includes 12 000 "Kegel exercises" over 28 minutes on an "intervention-chair". The intervention includes six HIFEM® treatments of 28 minutes with one session per week for six weeks. The woman sits fully clothed on the intervention BLT Emsella 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.

Group 1: Active group (AG): Pelvic floor training with electromagnetic energy HIFEM®. Active treatment group (AG): Includes six HIFEM® treatments of 28 minutes at a frequency of one session/week for six consecutive weeks at program level 1 of 2.
Primary purpose: TREATMENT

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 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.

The 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.

The intervention included six 30 minutes HIFEM® sessions once a week over six weeks compared with control group.

The 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.

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 participation in social and physical activities and is associated with large health care charge. Non-invasive 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.

Objective:

he 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.

Method:

The study is a randomized controlled trial evaluating the effect of high-intensity electromagnetic energy (HIFEM®) on pelvic floor muscles in women with urinary leakage. The participants are randomized into two groups: a treatment group receiving active HIFEM treatment and a control group receiving non-active treatment (below therapeutic level). The intervention includes six 30-minute HIFEM® sessions, conducted once a week over six weeks, compared to the control group. The study is blinded to the participants.

Expected result:

Implementation of high-intensity electromagnetic energy (HIFEM®) is expected to improve health for women seeking primary care. The results are expected to increase the knowledge of how women's health is affected by short-term care in primary care through increased quality of life, pelvic floor muscle, sexual function and reduce urinary leakage.

The result may improve existing primary care routines for women with urinary incontinence. The results are also 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.

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

Primary outcomes:
measure: Short time effect of change in health-related quality of life
timeFrame: Change from baseline to one week, three and six months after completed intervention
measure: Short time effect of high-intensity electromagnetic energy on pelvic floor muscles and urinary leakage.
timeFrame: Change from baseline to one week, three and six months after completed intervention
measure: Short time effect of high-intensity electromagnetic energy on pelvic floor muscles and sexual funktion.
timeFrame: Change from baseline to one week, three and six months after completed intervention
Secondary outcomes:
measure: Short time effect of high-intensity electromagnetic energy on pelvic floor muscles and social participation
timeFrame: Change from baseline to one week, three and six months after completed intervention
measure: Short time effect of high-intensity electromagnetic energy on physical activity and incontinence
timeFrame: Change from baseline to six months after completed intervention
measure: Does mental health improve when treating urinary incontinence with high-intensity electromagnetic energy compared to non-active treatment?
timeFrame: Change from baseline to one week, three and six months after completed intervention
measure: Short tile effect on high-intensity electromagnetic energy improve urogenital health and urinary incontinence
timeFrame: Change from baseline to one week, three and six months after completed intervention
measure: Short time effect on difference regarding incontinence aids after high-intensity electromagnetic energy compared to non-active treatment?
timeFrame: Change from baseline to one week, three and six months after completed intervention
Other outcomes:
Locations:
Study officials:
affiliation: Vastra Gotaland Region
name: Lena Rindner, PhD
role: PRINCIPAL_INVESTIGATOR
References: