An interventional study of Pelvic floor training as described in point a above, with the addition of HIFEM. and Pelvic Floor exercises in Urinary Incontinence (UI), sponsored by Göteborg University. Not yet recruiting at 1 site in Sweden. Open to female participants aged 65 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-09-15.
Sponsored by Göteborg University · Not applicable, Interventional, and Treatment
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:
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.
Exclusion Criteria:
* 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
* 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.
Pelvic floor training according to national guidelines
Leakage volume
Weight of leakage
Time frame: 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).
Time frame: Baseline, post-treatment, 6 months, 12 months
Number of leakage/day
Number/ 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
Number of aids used per day
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
Modified Oxford Scale, pre- and post-treatment, by a blinded assessor. Scale from 0 (no contraction) to 5 (very strong muscle contraction).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: At baseline, post-treatment, 6 months, and 12 months
Plan to share: No
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Göteborg University