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

Phase 2

Recruiting

• Conditions: stress urinary incontinence in women; stress urinary incontinence; high intensity Tesla magnetic stimulation

• Registration Number: TCTR20230828004
• Lead Sponsor: Division of Dermatology, Department of Internal Medicine, Faculty of Medicine, Ramathibodi Hospital, Mahidol University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-08-28
• Study Completion: 2023-09-01
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 63

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)