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

NCT06485167 | Not Yet Recruiting DMC

• 1 other identifier: FOU2023
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

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

Outcome Measures

Primary Outcomes (3)

• Short time effect of change in health-related quality of life

  Change in health-related quality of life using The Menopause Rating Scale (MRS) and The Short-Form Health Survey (SF-36). Validated questionnaires are used measured quality of life: MRS: measures occurrence of menopausal symptoms and health-related quality of life. The questionnaire, which consists of 11 questions and brings together menopausal symptoms in total and in three main groups, somatic symptoms, urogenital symptoms and psychological symptoms. The questionnaire indicates severity of symptoms on a 5-point scale. Low prevalence of symptoms indicates 0 points and high prevalence of symptoms 4 points. The total, individual questions and three subgroups are reported. SF-36: examines physical and mental health and changes over time. The questionnaire consists of 36 multiple-choice questions that are divided into eight subscales. Points on the subscales are between 0 - 100, higher values indicate better perceived health.

  Change from baseline to one week, three and six months after completed intervention

• Short time effect of high-intensity electromagnetic energy on pelvic floor muscles and urinary leakage.

  What is the effect of high-intensity electromagnetic energy on pelvic floor musculature and urinary leakage measured by change in score in ICIQ-UI from baseline to one week, three and six months after completed intervention. •International Consultation on Incontinence Questionnaire-Urinary Incontinence-Short Form (ICIQ-UI):The ICIQ-UI is a validated form for use to assess female urinary incontinence. The form consists of four questions and calculates a total score from 0 to 21 from three of the four questions. Recommended cut-offs for severity of urinary leakage: mild (1-5), moderate (6-12), severe (13-18) and very severe (19-21). Higher value indicates worse perceived health.

  Change from baseline to one week, three and six months after completed intervention

• Short time effect of high-intensity electromagnetic energy on pelvic floor muscles and sexual funktion.

  What is the effect of high-intensity electromagnetic energy on pelvic floor musculature and sexual funktion measured by change in score in ICIQ-UI and MRS urogenital symptoms from baseline to one week, three and six months after completed intervention. •International Consultation on Incontinence Questionnaire-Urinary Incontinence-Short Form (ICIQ-UI):The ICIQ-UI is a validated form for use to assess female urinary incontinence. The form consists of four questions and calculates a total score from 0 to 21 from three of the four questions. Recommended cut-offs for severity of urinary leakage: mild (1-5), moderate (6-12), severe (13-18) and very severe (19-21). Higher value indicates worse perceived health. The ICIQ-UI form is a validated form to assess female patients with urinary incontinence. The MRS assessed urogenital symptoms such as sexual funktion. With this measures, we hope to be able to assess for overall improvement in symptoms after treatment.

  Change from baseline to one week, three and six months after completed intervention

Secondary Outcomes (5)

• Short time effect of high-intensity electromagnetic energy on pelvic floor muscles and social participation

  Change from baseline to one week, three and six months after completed intervention

• Short time effect of high-intensity electromagnetic energy on physical activity and incontinence

  Change from baseline to six months after completed intervention

• Does mental health improve when treating urinary incontinence with high-intensity electromagnetic energy compared to non-active treatment?

  Change from baseline to one week, three and six months after completed intervention

• Short tile effect on high-intensity electromagnetic energy improve urogenital health and urinary incontinence

  Change from baseline to one week, three and six months after completed intervention

• Short time effect on difference regarding incontinence aids after high-intensity electromagnetic energy compared to non-active treatment?

  Change from baseline to one week, three and six months after completed intervention

Study Arms (2)

Experimental: Group 1 Active Treatment Group (AG)

ACTIVE COMPARATOR

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.

Device: HIFEM- chair

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

SHAM COMPARATOR

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.

Device: HIFEM- chair

Interventions

HIFEM- chair 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 1 Active Treatment Group (AG); Experimental: Group 2 Sham-treatment Control Group (CG)

Eligibility Criteria

• Age: 40 Years - 70 Years
• Gender Eligibility Details: If the woman identifies herself as a woman, she fulfills one of the inclusion criteria for participating in the study
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vastra Gotaland Region: lead

MeSH Terms

Conditions

Urinary Incontinence; Psychological Well-Being

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Personal Satisfaction; Behavior

Study Officials

• Lena Rindner, PhD

  Vastra Gotaland Region

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lena Rindner, PhD

CONTACT

+46730620700; lena.rindner@vgregion.se

Lena Nordeman, PhD, Docent

CONTACT

lena.nordeman@vgregion.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Group 2: Control group (CG): Non-active HIFEM® (sham-treatment) includes six 28-minute treatments with non-active HIFEM®, one treatment/week for a six-week continuous period with setting below therapeutic level (\<10% effect). The control group will be placed on the intervention chair in the same way as the active treatment group. 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).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Model Details: 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.

Study Record Dates

• First Submitted: June 19, 2024
• First Posted: July 3, 2024
• Study Start: August 1, 2024
• Primary Completion: December 1, 2025
• Study Completion: December 15, 2025
• Last Updated: July 3, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share