Female stress urinary Incontinence HIFEM, High Intensity Focused Electro-Magnetic, pelvic floor muscle training , stress urinary incontinent
Conditions
Interventions
High Intensity Focused Electro-Magnetic (HIFEM), EMSELLA, is an electromagnetic field produced by a flat spiral-shape coil which reaches intensity up to 2.5 Tesla, similar strength to MRI. The coil is
Experimental Device,Active Comparator Device
HIFEM group,Mobile application based PFMT group
Sponsors
Faculty if Medicine Ramathibodi, Hospital Mahidol University
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Female who diagnosed of SUI predominate (mild to moderate severity) by ICIQ-UI SF score plus 1-hour pad test > 1 g but less than 50 g 2. Willing to follow the research protocol follow up 3. Willing to sign informed consent 4. Age more than 18 years old 5. Able to communicate in Thai and use the mobile application
Exclusion criteria
Exclusion criteria: 1. Previous treatment for SUI 2. Suspected urethral or vesical fistula 3. Urinary tract infection or hematuria 4. Pregnancy or lactation 5. Cardiac pacemaker or implanted metallic devices 6. VTE or blood coagulation disorder 7. Severe uncontrolled disease e.g., malignancy 8. Unwilling to follow the research protocol follow up 9. Withdraw from study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| SUI symptoms Before treatment, after treatment, 3 months after treatment 1 hour pad test, perineometry | — |
Secondary
| Measure | Time frame |
|---|---|
| Quality of life Before treatment, after treatment, 3 months after treatment ICIQ-UI SF score, IIQ-7 score | — |
Countries
Thailand
Contacts
Public ContactNichanan Archanan
Faculty of Medicine Ramathibodi Hospital, Mahidol University
Outcome results
None listed