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

NCT07260604 | Not Yet Recruiting DMC

• 1 other identifier: FoU in Sweden 284879
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Urinary Incontinence (UI)

Keywords

urinary incontinence; pelvic floor training; HIFEM-treatment

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• Number of leakage/day

  From enrollment to the end of treatment at 5 weeks. Follow up at 6 months and at 1 year.

• Need of continence aids

  From enrollment to the end of treatment at 5 weeks. Follow up at 6 months and at 1 year.

• Pelvic floor muscle strength

  Before and after the intervention

• Impact of urinary incontinence on sexual health

  At baseline, post-treatment, 6 months, and 12 months.

• Health-related quality of life

  At baseline, post-treatment, 6 months, and 12 months.

Study Arms (2)

Arm A - Standard Pelvic Floor Training

ACTIVE COMPARATOR

* 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

Arm B - Pelvic Floor Training + HIFEM

EXPERIMENTAL

* 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.

Interventions

Pelvic floor training as described in point a above, with the addition of HIFEM. DEVICE

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.

Arm B - Pelvic Floor Training + HIFEM

Pelvic Floor exercises OTHER

Pelvic floor training according to national guidelines

Arm A - Standard Pelvic Floor Training

Eligibility Criteria

• Age: 65 Years - 85 Years
• Gender Eligibility Details: Women, aged 65-85 years.
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Göteborg University: lead

Study Sites (1)

Gothenburg university

Gothenburg, 405 30, Sweden

Location

MeSH Terms

Conditions

Urinary Incontinence

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Monika Fagevik Olsén, Professor

CONTACT

+46 766-185713; monika.fagevik-olsen@gu.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Single Blind (Outcomes Assessor) - physiotherapist performing muscle strength assessment blinded to allocation
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Before the RCT, a case study will be performed. In addition, a qualitative study part is included in the RCT

Study Record Dates

• First Submitted: November 21, 2025
• First Posted: December 3, 2025
• Study Start (Estimated): October 15, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): June 30, 2028
• Last Updated: December 3, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)