NCT05670392

Laser and High Intensity Tesla Magnetic Stimulation (HITS) for Stress Urinary Incontinence (SUI)

The Advantage of Combined Non-ablative Erbium Yttrium Aluminum Garnet Laser and High Intensity Tesla Magnetic Stimulation for Treatment of Female Stress Urinary Incontinence

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Cork University Maternity Hospital · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

To investigate the efficacy of combined laser and HITS treatment for female stress urinary incontinence (SUI)

Detailed description

This study is a single-centre, two-arm randomized control trial study conducted according to Helsinki Declaration. Women with symptoms of stress urinary incontinence (SUI) (stress or mixed with stress incontinence as the predominant symptom) will be enrolled. The efficacy and safety of combined treatment with non-ablative intravaginal Er:YAG laser procedure and high intensity Tesla magnetic stimulation will be compared to the treatment of non-ablative intravaginal Er:YAG laser alone.

Conditions

• Stress Urinary Incontinence

Interventions

Type	Name	Description
DEVICE	laser and High intensity Tesla magnetic stimulation	Three (3) non-ablative Er:YAG laser treatments will be applied at monthly intervals followed by Eight (8) HITS therapies) Patients will receive two (2) HITS treatments per week for four (4) weeks(.
DEVICE	laser (without HITS treatment)	Three (3) non-ablative Er:YAG laser treatments will be applied at monthly intervals as described above.

Timeline

• Start date: 2023-02-01
• Primary completion: 2025-01-31
• Completion: 2025-01-31
• First posted: 2023-01-04
• Last updated: 2023-01-04