Trials / Completed
CompletedNCT03180372
Hybrid Fractional Laser Treatment for Symptoms of Urinary Incontinence
Safety and Efficacy of Hybrid Fractional Laser diVa Treatment for Symptoms of Urinary Incontinence
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 51 (actual)
- Sponsor
- Sciton · Industry
- Sex
- Female
- Age
- 30 Years – 75 Years
- Healthy volunteers
- Accepted
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.
Detailed 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Hybrid Fractional Laser | Consecutive and coincident fractional 2940 nm and 1470 nm lasers |
Timeline
- Start date
- 2017-05-19
- Primary completion
- 2019-08-30
- Completion
- 2019-11-30
- First posted
- 2017-06-08
- Last updated
- 2019-12-04
Locations
5 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03180372. Inclusion in this directory is not an endorsement.