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HIFEM for Incontinence After Menopause High-Intensity Focused Electromagnetic (HIFEM) (HIM2025) 100 Randomizzato

Non ancora in arruolamento
I dettagli dello studio clinico sono disponibili principalmente in inglese. Tuttavia, Trial Radar IA può essere d'aiuto! Basta cliccare su 'Spiega lo studio' per visualizzare e discutere le informazioni sullo studio nella lingua selezionata.
La sperimentazione clinica NCT07260604 (HIM2025) è uno studio interventistico per Urinary Incontinence (UI), attualmente non ancora in arruolamento. L'arruolamento dovrebbe iniziare il 15 ottobre 2026, con l'obiettivo di raggiungere 100 partecipanti. Sotto la guida di l'Università di Göteborg, dovrebbe concludersi entro il 30 giugno 2028. I dati più recenti da ClinicalTrials.gov sono stati aggiornati l'ultima volta il 3 dicembre 2025.
Sommario breve
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 h...Mostra di più
Titolo ufficiale

Randomized Trial on Pelvic Floor Training With and Without HIFEM for Stress Urinary Incontinence

Patologie
Urinary Incontinence (UI)
Altri ID dello studio
  • HIM2025
  • FoU in Sweden 284879
Numero NCT
NCT07260604
Data di inizio (effettiva)
2026-10-15
Ultimo aggiornamento pubblicato
2025-12-03
Data di completamento (stimata)
2028-06-30
Arruolamento (previsto)
100
Tipo di studio
Interventistico
FASE
N.D.
Stato
Non ancora in arruolamento
Parole chiave
urinary incontinence
pelvic floor training
HIFEM-treatment
Scopo principale
Trattamento
Allocazione
Randomizzato
Modello di intervento
In parallelo
Mascheramento
Singolo
Bracci / Interventi
Gruppo/Braccio di partecipantiIntervento/Trattamento
Comparatore attivoArm 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.
Esercizi del pavimento pelvico
Pelvic floor training according to national guidelines
SperimentaleArm 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.
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.
Esito primario
Misure di esitoDescrizione della misuraArco temporale
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
Esito secondario
Misure di esitoDescrizione della misuraArco temporale
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
Assistente alla partecipazione
Criteri di eleggibilità

Età idonea
Adulto anziano
Età minima
65 Years
Sessi idonei
Femmina
  • 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

  • -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
Göteborg University logoUniversità di Göteborg
Contatti principali dello studio
Contatto: Monika Fagevik Olsén, Professor, +46 766-185713, [email protected]
1 Centri dello studio in 1 paesi
Gothenburg university, Gothenburg, 405 30, Sweden
MOnika Fagevik Olsén, Professor, Contatto, +46 766185713, [email protected]