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Hybrid Fractional Laser Treatment for Symptoms of Urinary Incontinence

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ClinicalTrials.gov Identifier: NCT03180372
Recruitment Status : Active, not recruiting
First Posted : June 8, 2017
Last Update Posted : August 24, 2018
Sponsor:
Information provided by (Responsible Party):
Sciton

Brief 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.

Condition or disease Intervention/treatment Phase
Urinary Incontinence Stress Urinary Incontinence Urge Incontinence Device: Hybrid Fractional Laser Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Change from baseline in Cough Stress Test [ Time Frame: 14 months ]
    A diagnostic test to simulate accidental release of urine when the patient coughs.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. Change from baseline in Female Sexual Function Index (FSFI) [ Time Frame: 14 months ]
    A multidimensional self-report instrument for assessment of female sexual function.

  4. Change from baseline in Histology [ Time Frame: 14 months ]
    Change from baseline in epithelial thickness, collagen, elastin, vascularity, and fibroblast density.

  5. 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.

  6. 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).



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Ages Eligible for Study:   30 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Healthy biological female aged between 30 to 75 years
  2. Is experiencing at least one or a combination of the following symptoms of urinary incontinence (UI)

    1. involuntary urine leakage on effort, exertion, sneezing, coughing
    2. sudden intense urge to urinate followed by involuntary loss of urine
  3. Has been experiencing symptoms of UI for greater than 3 months
  4. Normal urinalysis
  5. Has indicated willingness to participate in the study by signing an informed consent form
  6. Can read, understand and sign informed consent form
  7. Agree to adhere to the treatment and follow-up schedule and post treatment care instructions

Exclusion Criteria:

  1. Undiagnosed abnormal genital bleeding
  2. Has history of pelvic surgery or other energy-based vaginal therapy within 6 months prior to enrollment
  3. Is pregnant or planning to get pregnant within the study period
  4. Is currently breastfeeding
  5. Has an active sexually transmitted infection (STI)
  6. Has equal to or greater than stage III prolapse, according to pelvic organ prolapse quantification system (POP-Q test)
  7. Has signs or symptoms of vaginitis/vulvitis
  8. Has signs or symptoms of acute urinary tract infection (UTI)
  9. Has voiding dysfunction or urinary retention
  10. Has predominantly overactive bladder (OAB) as proven by urodynamics
  11. Is currently taking medication for treating urinary incontinence
  12. Has a known history of neurologic disease
  13. Has history of heart failure
  14. Any medical conditions that might interfere with wound healing
  15. Has history of abnormal wound healing
  16. Has participated in any clinical trial involving an investigational drug or procedure within past 30 days
  17. The investigator feels that for any reason the subject is not eligible to participate in the study.

Information from the National Library of Medicine

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


Locations
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United States, California
Women's Pelvic Health Institute
Los Gatos, California, United States, 95032
United States, Florida
Coyle Institute
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
Sponsors and Collaborators
Sciton

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Responsible Party: Sciton
ClinicalTrials.gov Identifier: NCT03180372     History of Changes
Other Study ID Numbers: DIVACIP001
First Posted: June 8, 2017    Key Record Dates
Last Update Posted: August 24, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No

Additional relevant MeSH terms:
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Urinary Incontinence
Enuresis
Urinary Incontinence, Stress
Urinary Incontinence, Urge
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders