HIFEM for Incontinence After Menopause High-Intensity Focused Electromagnetic (HIFEM) (HIM2025)

November 21, 2025 updated by: Göteborg University

Randomized Trial on Pelvic Floor Training With and Without HIFEM for Stress Urinary Incontinence

It is not difficult to imagine that leaking urine affects life in many contexts. Unfortunately, it is everyday life for far too many people in our society. According to the National Board of Health and Welfare, incontinence primarily affects older people, and both women and men are vulnerable. In Sweden, just over 530,000 people over the age of 65 have problems and almost 80 percent of all people in special housing have such urine leakage that they need to use incontinence aids. First-line treatment for women with incontinence is local estrogen and pelvic floor training. Surgery may also be considered if this treatment does not provide sufficient effect.

A new type of treatment for stress, urge and mixed incontinence is now on the market, High-Intensity Focused Electromagnetic (HIFEM®) treatment. This involves electromagnetic stimulation that causes contractions in the pelvic floor muscles. The treatment is not painful or invasive and the patient sits clothed in the treatment chair. In Sweden, HIFEM® is mainly available outside of traditional healthcare and is very expensive. It is also often given by unauthorized actors.

We are now planning a study whose purpose is to evaluate the effect of HIFEM® on women over 65 years of age with stress incontinence. A group of 100 women will be randomized to:

  1. Standard treatment, i.e. physiotherapy-led pelvic floor training
  2. As above with the addition of 10 treatments of 30 minutes with HIFEM®.

The evaluation will be carried out regarding leakage, need for incontinence aids and pelvic floor strength immediately and six months after the intervention. The women will also rate their incontinence symptoms, physical activity level, physical function and quality of life. A group will also be interviewed about their experiences of living with incontinence and the treatment. Before the study start, a case study will be performed in which 10 women will be included. They will receive 10 treatments and measure, with the same outcomes, the effects.

Alternative treatment methods are important to meet the care needs we have today but also in the future. If treatment with HIFEM® can be effective for women over 65, it could, in addition to reducing incontinence problems and the consequences of these problems, also lead to reduced costs for society regarding care and incontinence products, as well as reduced environmental impact.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Sweden
      • Gothenburg, Sweden, 405 30

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Women aged 65-85 ears
  • Having daily stress incontinence requiring use of incontinence aids.
  • Living in ordinary housing without home (health-) care
  • Being physically active and can move independently both indoors and outdoors.
  • Being able to give independent informed consent in speech and writing
  • To understand and follow instructions in one of following languages Swedish, Arabic, French, and/or English

Exclusion Criteria:

  • -Ongoing coached pelvic floor training
  • Heart disease where treatment is contraindicated
  • Lung disease with chronic cough
  • Pacemaker, defibrillator, neurostimulator, medication pump, and implanted devices in the head or spinal cord
  • Electronic or metal implants in the abdomen, hips, or knees
  • Epilepsy
  • Ongoing cancer
  • Stoma or abdominal hernia
  • Ongoing treatment with anticoagulants such as warfarin, medicines affecting the bladder such as muscarin receptor antagonist, diuretics and local oestrogen which affect the bladder and urine production.
  • infection, fever, bleeding, or pain in the lower abdomen
  • Skin diseases or any skin sensitivity
  • BMI exceeding 30 kg/m2

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Arm A - Standard Pelvic Floor Training
  • Active pelvic floor muscle training led by a physiotherapist, following standard practice.
  • Includes individualized advice and daily Kegel exercises to increase endurance and strength.
Other: Pelvic Floor exercises
Pelvic floor training according to national guidelines
Experimental: Arm B - Pelvic Floor Training + HIFEM
  • Same physiotherapist-led training as Arm A.
  • In addition: HIFEM treatment with Emsella chair.
  • 10 sessions, 30 min each, over 5 weeks (2 sessions per week).
  • Standardized stimulation delivered while seated, fully clothed, in a nurse-led clinic in Gothenburg.
Device: Pelvic floor training as described in point a above, with the addition of HIFEM.
Pelvic floor training with the addition of HIFEM. The treatment will be administered over 8-10 sessions of 30 minutes each, over a period of 4-6 weeks, with two sessions per week. During treatment, the women will sit fully clothed in a treatment chair and receive standardized stimulation of the pelvic floor muscles.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Leakage volume
Time Frame: From enrollment to the end of treatment at 5 weeks. Follow up at 6 months and at 1 year.
Weight of leakage
From enrollment to the end of treatment at 5 weeks. Follow up at 6 months and at 1 year.
Urinary incontinence severity
Time Frame: Baseline, post-treatment, 6 months, 12 months
International Consultation on Incontinence Questionnaire-short form ICIQ-SF.
Baseline, post-treatment, 6 months, 12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of leakage/day
Time Frame: From enrollment to the end of treatment at 5 weeks. Follow up at 6 months and at 1 year.
Number/ day
From enrollment to the end of treatment at 5 weeks. Follow up at 6 months and at 1 year.
Need of continence aids
Time Frame: From enrollment to the end of treatment at 5 weeks. Follow up at 6 months and at 1 year.
Number of aids used per day
From enrollment to the end of treatment at 5 weeks. Follow up at 6 months and at 1 year.
Pelvic floor muscle strength
Time Frame: Before and after the intervention
Modified Oxford Scale, pre- and post-treatment, blinded assessor
Before and after the intervention
Impact of urinary incontinence on sexual health
Time Frame: At baseline, post-treatment, 6 months, and 12 months.
The questionnaire "Impact of urinary incontinence on sexual health (ICIQ-FLUTSsex)."
At baseline, post-treatment, 6 months, and 12 months.
Health-related quality of life
Time Frame: At baseline, post-treatment, 6 months, and 12 months.
Questionnaire: Pelvic Floor Impact Questionnaire - Short Form 7 (PFIQ-7) som
At baseline, post-treatment, 6 months, and 12 months.
Rated physical function
Time Frame: At baseline, post-treatment, 6 months, and 12 months
Patient-Specific Functional Scale (PSFS)
At baseline, post-treatment, 6 months, and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Göteborg University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 15, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 21, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 21, 2025

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 3, 2025

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 3, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 21, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • FoU in Sweden 284879

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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