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

NCT ID: NCT06485167

Last Updated: 2024-07-03

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-01
• Study Completion Date: 2025-12-15

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.

Conditions

Urinary Incontinence; Quality of Life; Menopause; Mental Health Issue; Primary Health Care

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Experimental: Group 1 Active Treatment Group (AG)

Group 1 Active treatment group (AG)

● The AG group consists six HIFEM® treatments of 28 minutes at a frequency of one session/week 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.

Group Type: ACTIVE_COMPARATOR

HIFEM- chair

Intervention Type: DEVICE

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.

Experimental: Group 2 Sham-treatment Control Group (CG)

Group 2 Sham-treatment Control Group (CG)

● The CG group consists six non-active HIFEM® treatments (sham-treatment) of 28 minutes at a frecquency of one session/week 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 (<10% 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.

Group Type: SHAM_COMPARATOR

HIFEM- chair

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Vastra Gotaland Region

OTHER_GOV

Sponsor Role: lead

Responsible Party

Lena Rindner

PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lena Rindner, PhD

Role: PRINCIPAL_INVESTIGATOR

Vastra Gotaland Region

Central Contacts

Lena Rindner, PhD

Role: CONTACT

lena.rindner@vgregion.se

+46730620700

Lena Nordeman, PhD, Docent

Role: CONTACT

lena.nordeman@vgregion.se

Other Identifiers

FOU2023

Identifier Type: -

Identifier Source: org_study_id