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Clinical Trial Summary

This multi-center clinical trial will evaluate the safety and long-term efficacy of hybrid fractional 2940 nm and 1470 lasers for improvement of symptoms of urinary incontinence.


Clinical Trial Description

Both 2940 nm Er:YAG (Erbium-doped yttrium aluminium garnet) and 1470 nm diode lasers are cleared by the Food and Drug Administration (FDA) for ablation, vaporization, coagulation of soft tissue and for skin resurfacing. Fractional delivery of laser is a well-established method that stimulates tissue remodeling in the dermis while leaving the surrounding tissue intact in order to decrease healing time. The layers of skin and vaginal mucosal tissue exhibit similarities that suggest the clinical results seen with skin resurfacing may be translated to the vaginal tissue. Improved vaginal tissue tone and increased collagen formation in the lamina propria beneath the urethra may lead to improved urinary control. This multi-centered, 18-month prospective clinical trial will determine the safety and long-term effectiveness of hybrid fractional 2940 nm and 1470 nm lasers (Hybrid Fractional Laser) as an alternative non-surgical, non-hormonal treatment for improvement of symptoms of urinary incontinence. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03180372
Study type Interventional
Source Sciton
Contact
Status Completed
Phase N/A
Start date May 19, 2017
Completion date November 30, 2019

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