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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age40-70
SponsorVastra Gotaland Region

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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

Trial design

Treatments tested in this trial

  • HIFEM- chair

Treatment groups

100 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators