Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 12:44 AM
Ignite Modification Date:
2025-12-25 @ 12:44 AM
NCT ID:
NCT06485167
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.
Study:
NCT06485167
Study Brief:
Protocol Section:
NCT06485167