Gothenburg university
Gothenburg, 405 30, Sweden
NCT Number: NCT07260604
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.
Trial opening soon.
Get Notified65 year–85 year
Female
Interventional
Not applicable
Gothenburg, 405 30, Sweden
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: From enrollment to the end of treatment at 5 weeks. Follow up at 6 months and at 1 year.
Weight of leakage
Time frame: Baseline, post-treatment, 6 months, 12 months
International Consultation on Incontinence Questionnaire-short form ICIQ-SF.
Time frame: From enrollment to the end of treatment at 5 weeks. Follow up at 6 months and at 1 year.
Number/ day
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
Time frame: Before and after the intervention
Modified Oxford Scale, pre- and post-treatment, blinded assessor
Time frame: At baseline, post-treatment, 6 months, and 12 months.
The questionnaire "Impact of urinary incontinence on sexual health (ICIQ-FLUTSsex)."
Time frame: At baseline, post-treatment, 6 months, and 12 months.
Questionnaire: Pelvic Floor Impact Questionnaire - Short Form 7 (PFIQ-7) som
Time frame: At baseline, post-treatment, 6 months, and 12 months
Patient-Specific Functional Scale (PSFS)
Contact information is provided by the study sponsor or research team.
Göteborg University
Other
Randomized Trial on Pelvic Floor Training With and Without HIFEM for Stress Urinary Incontinence
Acronym: HIM2025
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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