An interventional study of Hybrid Fractional Laser in Urinary Incontinence, Stress Urinary Incontinence and Urge Incontinence, sponsored by Sciton. Completed at 5 sites in United States. Open to female participants aged 30 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-12-04.
Sponsored by Sciton · Not applicable, Interventional, and Treatment
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.
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.
1,363 studies on the registry are indexed under Urinary Incontinence; 228 are open to participants now.
This study's enrollment of 51 is below the median of 66 across 1,011 interventional studies indexed under Urinary Incontinence.
Browse Urinary Incontinence studies →Sciton is the lead sponsor of 15 studies on the registry; 2 are open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Is experiencing at least one or a combination of the following symptoms of urinary incontinence (UI)
Exclusion Criteria:
Hybrid fractional 2940 nm and 1470 nm laser treatment
Device: Hybrid Fractional Laser
Consecutive and coincident fractional 2940 nm and 1470 nm lasers
Also known as: diVa
Change from baseline in Cough Stress Test
A diagnostic test to simulate accidental release of urine when the patient coughs.
Time frame: 14 months
Change from baseline in Incontinence Impact Questionnaire (IIQ-7)
A 7-item self-report instrument designed to assess the impact of urinary incontinence on a patient's life.
Time frame: 14 months
Change from baseline in Urogenital Distress Inventory (UDI-6)
A 6-item self-report instrument that assesses symptom distress and the impact on daily life of urinary incontinence.
Time frame: 14 months
Change from baseline in Female Sexual Function Index (FSFI)
A multidimensional self-report instrument for assessment of female sexual function.
Time frame: 14 months
Change from baseline in Histology
Change from baseline in epithelial thickness, collagen, elastin, vascularity, and fibroblast density.
Time frame: 14 months
Change from baseline in Urodynamic Testing
Quantitative measures of uroflowmetry, post-void residual (PVR) urine, cystometry, leak-point pressure, pressure flow, urethral pressure profile, and the functional urethral length.
Time frame: 14 months
Incidence and severity of treatment-related Adverse Events
Incidence and severity of treatment-related adverse events (i.e. pain, edema, erythema, altered sensation, scarring, and/or potential infection).
Time frame: 14 months
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Dec 2019. You cannot join it, but the record below documents what was studied.
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