Urinary Incontinence (UI)HIM2025NCT07260604
HIFEM for Incontinence After Menopause High-Intensity Focused Electromagnetic (HIFEM)
A study testing Pelvic floor training as described in point a above, with the addition of HIFEM. and Pelvic Floor exercises in people with Urinary Incontinence (UI), run by Göteborg University at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 to 85 years, women only
- Conditions the study is for
- Urinary Incontinence (UI)
- What is being tested?
- Pelvic floor training as described in point a above, with the addition of HIFEM. and Pelvic Floor exercises
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSweden
- Study dates
- 15 Oct 2026to 30 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 85 years
- Women only
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- -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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site
Gothenburg university
Gothenburg, 405 30
MOnika Fagevik Olsén, Professor, +46 766185713, monika.fagevik-olsen@gu.se
About this study
Official title: 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.
Read more
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:
- Standard treatment, i.e. physiotherapy-led pelvic floor training
- 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.
- Conditions
- Urinary Incontinence (UI)
- Being tested
- Pelvic floor training as described in point a above, with the addition of HIFEM., Pelvic Floor exercises
- Keywords
- urinary incontinence, pelvic floor training, HIFEM-treatment
- Medical subject headings
- Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Pelvic Floor exercisesOther
Pelvic floor training according to national guidelines
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Pelvic floor training as described in point a above, with the addition of HIFEM. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Leakage volume
Weight of leakage
Measured: 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). Scale from 0 (no symptoms) to 21 (maximal symptoms).
Measured: Baseline, post-treatment, 6 months, 12 months
Secondary outcomes (6)
Number of leakage/day
Number/ day
Measured: 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
Measured: 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, by a blinded assessor. Scale from 0 (no contraction) to 5 (very strong muscle contraction).
Measured: Before and after the intervention
Impact of urinary incontinence on sexual health
The questionnaire "Impact of urinary incontinence on sexual health (ICIQ-FLUTSsex). Total score from 0 (no reported symtoms) to 14 (severe symtoms).
Measured: At baseline, post-treatment, 6 months, and 12 months.
Health-related quality of life
Questionnaire: Pelvic Floor Impact Questionnaire - Short Form 7 (PFIQ-7). Score from 0 (none effect on quality of life) to 300 (maximal effect on quality of life).
Measured: At baseline, post-treatment, 6 months, and 12 months.
Rated physical function
Patient-Specific Functional Scale (PSFS). Ability to perform acitivities is rated on a scale from 0 (no ability to perform the activity) to 10 (total ability to perform the acitivty).
Measured: At baseline, post-treatment, 6 months, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2025
- Study start15 Oct 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Incontinence (UI)Studies of the same condition, open and under way.
- More trials run by Göteborg UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Before the RCT, a case study will be performed. In addition, a qualitative study part is included in the RCT
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Göteborg University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07260604
- Sponsor's protocol ID
- FoU in Sweden 284879
- Acronym
- HIM2025
- Status last verified
- Sep 2025
- First submitted
- 21 Nov 2025
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial on Pelvic Floor Training With and Without HIFEM for Stress Urinary Incontinence
- ClinicalTrials.gov ID
- NCT07260604
- Acronym / sponsor ID
- HIM2025 / FoU in Sweden 284879
- Conditions
- Urinary Incontinence (UI)
- Keywords
- urinary incontinence, pelvic floor training, HIFEM-treatment
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Göteborg UniversityUniversity, hospital or other
- Study start
- 15 Oct 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 3 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Standard treatment, i.e. physiotherapy-led pelvic floor training
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Before the RCT, a case study will be performed. In addition, a qualitative study part is included in the RCT
| Arm | Type | Receives |
|---|---|---|
| Arm A - Standard Pelvic Floor Training | Active comparator | Other: Pelvic Floor exercises* Active pelvic floor muscle training led by a physiotherapist, following standard practice. * Includes individualized advice and daily Kegel exercises to increase endurance and strength. |
| Arm B - Pelvic Floor Training + HIFEM | Experimental | Device: Pelvic floor training as described in point a above, with the addition of 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. |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (12 listed)
- -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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Arm B - Pelvic Floor Training + HIFEM |
| Pelvic Floor exercisesPelvic floor training according to national guidelines | Other | Arm A - Standard Pelvic Floor Training |
Primary outcome
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
Urinary incontinence severity
Time frame: Baseline, post-treatment, 6 months, 12 months
International Consultation on Incontinence Questionnaire-short form (ICIQ-SF). Scale from 0 (no symptoms) to 21 (maximal symptoms).
6 secondary outcomes
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.
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.
Pelvic floor muscle strength
Time frame: Before and after the intervention
Impact of urinary incontinence on sexual health
Time frame: 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.
Rated physical function
Time frame: At baseline, post-treatment, 6 months, and 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pelvic floor training as described in point a above, with the addition of HIFEM. and Pelvic Floor exercises in people with Urinary Incontinence (UI), run by Göteborg University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Monika Fagevik Olsén, Professor (+46 766-185713, monika.fagevik-olsen@gu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Leakage volume (time frame: From enrollment to the end of treatment at 5 weeks. Follow up at 6 months and at 1 year.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026.