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

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: Not yet recruiting
• Conditions: Urinary Incontinence (UI)
• Intervention / Treatment: Other: Pelvic Floor exercises; Device: Pelvic floor training as described in point a above, with the addition of HIFEM.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Monika Fagevik Olsén, Professor; Phone Number: +46 766-185713; Email: monika.fagevik-olsen@gu.se

Study Locations

• Sweden
  • Gothenburg, Sweden, 405 30
    • Gothenburg University
    • Contact: MOnika Fagevik Olsén, Professor; Phone Number: +46 766185713; Email: monika.fagevik-olsen@gu.se

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Leakage volume	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	International Consultation on Incontinence Questionnaire-short form ICIQ-SF.	Baseline, post-treatment, 6 months, 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of leakage/day	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	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	Modified Oxford Scale, pre- and post-treatment, blinded assessor	Before and after the intervention
Impact of urinary incontinence on sexual health	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	Questionnaire: Pelvic Floor Impact Questionnaire - Short Form 7 (PFIQ-7) som	At baseline, post-treatment, 6 months, and 12 months.
Rated physical function	Patient-Specific Functional Scale (PSFS)	At baseline, post-treatment, 6 months, and 12 months

Collaborators and Investigators

• Sponsor: Göteborg University

Study record dates

Study Major Dates

• Study Start (Estimated): October 15, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): June 30, 2028

Study Registration Dates

• First Submitted: November 21, 2025
• First Submitted That Met QC Criteria: November 21, 2025
• First Posted (Estimated): December 3, 2025

Study Record Updates

• Last Update Posted (Estimated): December 3, 2025
• Last Update Submitted That Met QC Criteria: November 21, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: urinary incontinence; pelvic floor training; HIFEM-treatment
• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urination Disorders; Lower Urinary Tract Symptoms; Urological Manifestations; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Urinary Incontinence
• Other Study ID 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