NCT05097456

Carbon Dioxide Acupulse Laser Treatment Versus Sham Treatment and Stress Urinary Incontinence Symptoms

Randomized, Double-blind, Sham-controlled Clinical Trial for Evaluating the Efficacy of Fractional Carbon Dioxide Laser in the Treatment of Stress Urinary Incontinence

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 125 (actual)
• Sponsor: Rambam Health Care Campus · Academic / Other
• Sex: Female
• Age: 30 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The study is intended to assess the safety and efficacy of Carbon dioxide AcuPulse laser treatment in patients with stress urinary incontinence. Eligible subjects will be randomized to either receive 3 laser or 3 sham treatment sessions, 4 weeks apart and 3 follow up visits 3, 6 and 12 months following the last treatment.

Detailed description

Following a screening visit, eligible subjects will be enrolled into the study. Subjects will be randomized into either laser treatment or sham treatment. Each subject will receive 3 treatments 4 weeks apart and 3 follow up visits, at 3, 6 and 12 months following the last treatment. Further demographic information and patient history will be obtained from the subjects' electronic files.

Conditions

• Stress Urinary Incontinence

Interventions

Type	Name	Description
DEVICE	carbon dioxide laser	carbon dioxide laser
DEVICE	sham laser	sham laser

Timeline

• Start date: 2020-03-01
• Primary completion: 2021-11-15
• Completion: 2021-12-31
• First posted: 2021-10-28
• Last updated: 2022-02-07

Locations

1 site across 1 country: Israel