NCT02861391

Evaluation of the Safety and Efficacy of Carbon Dioxide (CO2) Acupulse Laser Treatment on Urinary Stress Incontinence.

Evaluation of the Safety and Efficacy of CO2 Acupulse Laser Treatment on Women With Urinary Stress Incontinence.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 125 (actual)
• Sponsor: Rambam Health Care Campus · Academic / Other
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The study is intended to assess the safety and efficacy of CO2 AcuPulse laser treatment in patients with stress urinary incontinence (SUI). Eligible subjects will either receive 3 laser or sham treatment sessions, 4 weeks apart and 4 Follow Up visits, at 1, 3, 6, and 12 months following the last treatment.

Detailed description

Following a screening visit, eligible subjects will be enrolled into the study. Eligibility will be decided depending on the level of SUI the patient has. Each subject will receive either 3 laser or sham treatments 4 weeks apart and 4 Follow Up visits, at 1, 3, 6, and 12 months following the last treatment. Further demographic information and patient history will be obtained from the subjects' electronical files.

Conditions

• Exposure Laser

Interventions

Type	Name	Description
DEVICE	CO2 AcuPulse Laser	Each subject will receive 3 laser treatments 4 weeks apart and 3 Follow Up visits, at 1, 3, and 6 months following the last treatment.
DEVICE	Sham Laser	Each subject will receive 3 sham treatments 4 weeks apart and 3 Follow Up visits, at 1, 3, and 6 months following the last treatment.

Timeline

• Start date: 2019-10-04
• Primary completion: 2021-11-01
• Completion: 2022-01-30
• First posted: 2016-08-10
• Last updated: 2023-01-17

Locations

1 site across 1 country: Israel