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The effectiveness of High Intensity Tesla Magnetic Stimulation technology for treatment of stress urinary incontinence in women: a randomized, sham-controlled trial

The effectiveness of High Intensity Tesla Magnetic Stimulation technology for treatment of stress urinary incontinence in women: a randomized, sham-controlled trial

Status
Unknown
Phases
Phase 2
Study type
Interventional
Source
TCTR
Registry ID
TCTR20230828004
Enrollment
63
Registered
2023-08-28
Start date
2022-02-15
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

stress urinary incontinence in women stress urinary incontinence high intensity Tesla magnetic stimulation

Interventions

The subjects were treated using the StarFormer Intimawave device (Fotona, Slovenia), which incorporates a magnetic field generator positioned within a chair to stimulate pelvic floor and back muscles
Standard group,Sham group

Sponsors

Division of Dermatology, Department of Internal Medicine, Faculty of Medicine, Ramathibodi Hospital, Mahidol University
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1. participants diagnosed stress Urinary Incontinence or mixed Urinary Incontinence with a predominant stress component 2. International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) score not exceeding 12 (indicating slight to moderate severity) 3. a positive result of more than 1 gram in the 1-hour pad test

Exclusion criteria

Exclusion criteria: 1. prior surgery for urinary incontinence 2. concurrent treatment for incontinence or taking medications known to impact incontinence such as adrenergic antagonists and diuretics 3. history of previous magnetic stimulation treatment 4. Pelvic Organ Prolapse Quantification System stage III or IV pelvic organ prolapse 5. postvoid residual volume greater than 200 ml 6. record of pelvic irradiation 7. urethral and/or vesical fistula 8. urinary tract infection or hematuria 9. pregnancy 10. lactation 11. cardiac pacemaker or implanted metallic devices 12. severe uncontrolled diseases including malignancy

Design outcomes

Primary

MeasureTime frame
Severity of SUI Baseline, the last treatment session, 1 and 3 months after the last treatment session Thai version of the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF),Quality of life Baseline, the last treatment session, 1 and 3 months after the last treatment session Thai version of the Incontinence Impact Questionnaires, short form (IIQ-7)

Secondary

MeasureTime frame
Pelvic floor muscles strength Baseline, 1 and 3 months after the last treatment session Perineometer and Brink score,Reduction in SUI symptoms Baseline, 1 and 3 months after the last treatment session 1-hr pad test,Patients' satisfaction Baseline, the last treatment session, 1 and 3 months after the last treatment session Patient global impression of improvement (PGI-I)

Countries

Thailand

Contacts

Public ContactPenpun Wattanakrai

Division of Dermatology, Department of Internal Medicine, Faculty of Medicine, Ramathibodi Hospital, Mahidol University

maypenpun@gmail.com0818181103

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026