Ignite Creation Date:
2024-07-17 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06485167
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-03
First Post:
2024-06-19
Brief Title:
Effect of HIFEM Treatment of Urinary Incontinence in Women in Primary Care A Randomized Controlled Trial
Sponsor:
Vastra Gotaland Region
Organization:
Vastra Gotaland Region
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 womens 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
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 womens 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None