Effect of HIFEM® Treatment of Urinary Incontinence in Women in Primary Care. A Randomized Controlled Trial
NCT Number: NCT06485167
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Urinary Incontinence|Quality of Life|Menopause|Mental Health Issue|Primary Health Care
Interventions: DEVICE: HIFEM- chair
Sponsor: Vastra Gotaland Region
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2024-08-01
Completion Date: 2025-12-15

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.

Primary Outcome Measures: 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 Outcome Measures: Short time effect of high-intensity electromagnetic energy on pelvic floor muscles and social participation, Change in health-related quality of life using the social participation measured by:

* The Menopause Rating Scale (MRS): measures occurrence of health-related quality of life. The questionnaire, which consists of 11 questions divided 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 Short-Form Health Survey (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.
* The Hospital Anxiety and Depression Scale (HADS): examines degree of anxiety (HAD-A) and depressive symptoms (HAD-D). The form consists of 14 graded on a 4-point scale. Higher scores indicate higher prevalence of symptoms., 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 in health-related quality of life using the physical activity measured by change in score in two forms the MFI-20 and GSLPAQ from baseline to one week, three and six months after completed intervention. With this measures, we hope to be able to assess for overall improvement in symptoms after treatment.

* Multidimensional Fatigue Inventory-20 (MFI-20). Measures general and mental fatigue (fatigue) with five dimensions of fatigue; general fatigue, physical fatigue, mental fatigue, reduced motivation and reduced activity. The form contains 20 statements on a five-point scale (25).
* The Godin-Shephard Leisure-Time Physical Activity Questionnaire (GSLPAQ): The patient estimates how many times on average they do strenuous/moderate/light exercise for more than 15 minutes, during a typical 7-day period. The total score is calculated (26).

With this measures, we hope to be able to assess for overall improvement in symptoms after treatment., 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 in mental health will be measured with:

The Stress and Crisis Inventory (SCI-93). Assesses clinical signs of stress both physical and psychological. Assesses symptoms consistent with autonomic dysfunction. Reference values of \<25 no dysfunction. Stress level \> 25 - autonomic dysfunction - means limitation to varying degrees of ability and resources for normal psychosocial functioning and vocational rehabilitation. At a stress level \> 105, the patient has obvious clinical problems as an obstacle to rehabilitation.

* The Montgomery-Asberg Depression Rating Scale (MADRS-S): examines the degree of depressed mood and depressive symptoms. The questionnaire consists of 9 questions and higher scores indicate higher prevalence of symptoms.
* The Hospital Anxiety and Depression Scale (HADS): examines degree of anxiety (HAD-A) and depressive symptoms (HAD-D). The form consists of 14 graded on a 4-point scale. Higher scores indicate higher prevalence of symptoms., 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, What is the effect of high-intensity electromagnetic energy on urogenital health measured by change in scores in MRS urogential and ICIQ-UI from baseline to one week, three and six months after completed intervention. These questionnaires MRS and ICIQ-UI, provide an overview of symptoms and the severity of discomfort on urogential health and incontinence. 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|Short time effect on difference regarding incontinence aids after high-intensity electromagnetic energy compared to non-active treatment?, What is the effect of high-intensity electromagnetic energy on incontinence aids and incontinence from baseline to one week, three and six months after completed intervention. Questionnaire and diary for the assessment of frequency and consumption of incontinence aids., Change from baseline to one week, three and six months after completed intervention