Urinary IncontinenceNCT06485167
Effect of HIFEM® Treatment of Urinary Incontinence in Women in Primary Care. A Randomized Controlled Trial
A study testing HIFEM- chair in people with Urinary Incontinence and Quality of Life, run by Vastra Gotaland Region.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Urinary Incontinence, Quality of Life, Menopause
- What is being tested?
- HIFEM- chair
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2024to 15 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 17Show fewer
- 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
Trial locations and contacts
No sites are listed yet.
Lena Nordeman, PhD, Docent contact
About this study
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.
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.
Read more
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.
Read the 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
- Being tested
- HIFEM- chair
- Keywords
- urinary incontinence, mental health, menopause, sexual health, womens health, primary health care, quality of ife
- Medical subject headings
- Urinary Incontinence, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HIFEM- chairDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: HIFEM- chair |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Change from baseline to one week, three and six months after completed intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2024
- Study start1 Aug 2024 (estimated)
- Primary completion1 Dec 2025 (estimated)
- Study completion15 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary IncontinenceStudies of the same condition, open and under way.
- More trials run by Vastra Gotaland RegionThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vastra Gotaland Region
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Lena Rindner, Vastra Gotaland Region
- Investigators
- Lena Rindner, PhD, Principal investigator, Vastra Gotaland Region
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06485167
- Sponsor's protocol ID
- FOU2023
- Status last verified
- Jun 2024
- First submitted
- 19 Jun 2024
- Last updated
- 3 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The descriptive data provided will be summary data for each group. The investigators will not show data from single participants.
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT06485167
- Acronym / sponsor ID
- FOU2023
- 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
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Vastra Gotaland RegionOther government
- Study start
- 1 Aug 2024 (estimated)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 15 Dec 2025 (estimated)
- First posted
- 3 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Experimental: Group 1 Active Treatment Group (AG) | Active comparator | Device: HIFEM- chairGroup 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. |
| Experimental: Group 2 Sham-treatment Control Group (CG) | Sham comparator | Device: HIFEM- chairGroup 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. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HIFEM- chairThe 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. | Device | Experimental: Group 1 Active Treatment Group (AG), Experimental: Group 2 Sham-treatment Control Group (CG) |
Primary outcome
Short time effect of change in health-related quality of life
Time frame: Change from baseline to one week, three and six months after completed intervention
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.
Short time effect of high-intensity electromagnetic energy on pelvic floor muscles and urinary leakage.
Time frame: Change from baseline to one week, three and six months after completed intervention
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.
Short time effect of high-intensity electromagnetic energy on pelvic floor muscles and sexual funktion.
Time frame: Change from baseline to one week, three and six months after completed intervention
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.
5 secondary outcomes
Short time effect of high-intensity electromagnetic energy on pelvic floor muscles and social participation
Time frame: 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
Time frame: 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?
Time frame: 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
Time frame: 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?
Time frame: Change from baseline to one week, three and six months after completed intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
- Individual participant dataSharing planned: No. The descriptive data provided will be summary data for each group. The investigators will not show data from single participants.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lena Nordeman, PhD, Docent contact
Lena Rindner, PhD principal investigator
Vastra Gotaland Region
Questions about this trial
What is this clinical trial studying?
A study testing HIFEM- chair in people with Urinary Incontinence and Quality of Life, run by Vastra Gotaland Region.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lena Rindner, PhD (+46730620700, lena.rindner@vgregion.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Short time effect of change in health-related quality of life (time frame: Change from baseline to one week, three and six months after completed intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2024.