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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hybrid Fractional Laser | Experimental | Hybrid fractional 2940 nm and 1470 nm laser treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hybrid Fractional Laser | Device | Consecutive and coincident fractional 2940 nm and 1470 nm lasers |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in Cough Stress Test | A diagnostic test to simulate accidental release of urine when the patient coughs. | 14 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 14 months |
| Change from baseline in Urogenital Distress Inventory (UDI-6) |
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Inclusion Criteria:
Healthy biological female aged between 30 to 75 years
Is experiencing at least one or a combination of the following symptoms of urinary incontinence (UI)
Has been experiencing symptoms of UI for greater than 3 months
Normal urinalysis
Has indicated willingness to participate in the study by signing an informed consent form
Can read, understand and sign informed consent form
Agree to adhere to the treatment and follow-up schedule and post treatment care instructions
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Women's Pelvic Health Institute | Los Gatos | California | 95032 | United States | ||
| Coyle Institute |
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| ID | Term |
|---|---|
| D014549 | Urinary Incontinence |
| D014550 | Urinary Incontinence, Stress |
| D053202 | Urinary Incontinence, Urge |
| ID | Term |
|---|---|
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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A 6-item self-report instrument that assesses symptom distress and the impact on daily life of urinary incontinence.
| 14 months |
| Change from baseline in Female Sexual Function Index (FSFI) | A multidimensional self-report instrument for assessment of female sexual function. | 14 months |
| Change from baseline in Histology | Change from baseline in epithelial thickness, collagen, elastin, vascularity, and fibroblast density. | 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. | 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). | 14 months |
| Pensacola |
| Florida |
| 32514 |
| United States |
| Carolinas Healthcare System | Charlotte | North Carolina | 28207 | United States |
| Woodlands Gynecology & Aesthetics | The Woodlands | Texas | 77384 | United States |
| The Female Pelvic Medicine Institute of Virginia | North Chesterfield | Virginia | 23235 | United States |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |