Hybrid Fractional Laser Treatment for Symptoms of Urinary Incontinence
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03180372|
Recruitment Status : Active, not recruiting
First Posted : June 8, 2017
Last Update Posted : August 24, 2018
|Condition or disease||Intervention/treatment||Phase|
|Urinary Incontinence Stress Urinary Incontinence Urge Incontinence||Device: Hybrid Fractional Laser||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Safety and Efficacy of Hybrid Fractional Laser diVa Treatment for Symptoms of Urinary Incontinence|
|Actual Study Start Date :||May 19, 2017|
|Estimated Primary Completion Date :||November 23, 2018|
|Estimated Study Completion Date :||November 30, 2018|
Experimental: Hybrid Fractional Laser
Hybrid fractional 2940 nm and 1470 nm laser treatment
Device: Hybrid Fractional Laser
Consecutive and coincident fractional 2940 nm and 1470 nm lasers
Other Name: diVa
- Change from baseline in Cough Stress Test [ Time Frame: 14 months ]A diagnostic test to simulate accidental release of urine when the patient coughs.
- Change from baseline in Incontinence Impact Questionnaire (IIQ-7) [ Time Frame: 14 months ]A 7-item self-report instrument designed to assess the impact of urinary incontinence on a patient's life.
- Change from baseline in Urogenital Distress Inventory (UDI-6) [ Time Frame: 14 months ]A 6-item self-report instrument that assesses symptom distress and the impact on daily life of urinary incontinence.
- Change from baseline in Female Sexual Function Index (FSFI) [ Time Frame: 14 months ]A multidimensional self-report instrument for assessment of female sexual function.
- Change from baseline in Histology [ Time Frame: 14 months ]Change from baseline in epithelial thickness, collagen, elastin, vascularity, and fibroblast density.
- Change from baseline in Urodynamic Testing [ Time Frame: 14 months ]Quantitative measures of uroflowmetry, post-void residual (PVR) urine, cystometry, leak-point pressure, pressure flow, urethral pressure profile, and the functional urethral length.
- Incidence and severity of treatment-related Adverse Events [ Time Frame: 14 months ]Incidence and severity of treatment-related adverse events (i.e. pain, edema, erythema, altered sensation, scarring, and/or potential infection).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03180372
|United States, California|
|Women's Pelvic Health Institute|
|Los Gatos, California, United States, 95032|
|United States, Florida|
|Pensacola, Florida, United States, 32514|
|United States, North Carolina|
|Carolinas Healthcare System|
|Charlotte, North Carolina, United States, 28207|
|United States, Texas|
|Woodlands Gynecology & Aesthetics|
|The Woodlands, Texas, United States, 77384|
|United States, Virginia|
|The Female Pelvic Medicine Institute of Virginia|
|North Chesterfield, Virginia, United States, 23235|