Clincosm LogoSign in Get a demo

Hybrid Fractional Laser Treatment for Symptoms of Urinary Incontinence

Sponsor
Sciton (Industry)
Overall Status
Completed
CT.gov ID
NCT03180372
Collaborator
(none)
51
Enrollment
5
Locations
1
Arm
30.4
Actual Duration (Months)
10.2
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

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
  • Device: Hybrid Fractional Laser
 N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
51 participants
Allocation:
N/A
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
Actual Primary Completion Date :
Aug 30, 2019
Actual Study Completion Date :
Nov 30, 2019

Arms and Interventions

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 Names:
  • diVa

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change from baseline in Cough Stress Test [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) [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) [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) [14 months]

      A multidimensional self-report instrument for assessment of female sexual function.

    4. Change from baseline in Histology [14 months]

      Change from baseline in epithelial thickness, collagen, elastin, vascularity, and fibroblast density.

    5. Change from baseline in Urodynamic Testing [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 [14 months]

      Incidence and severity of treatment-related adverse events (i.e. pain, edema, erythema, altered sensation, scarring, and/or potential infection).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    30 Years to 75 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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)

    3. involuntary urine leakage on effort, exertion, sneezing, coughing

    4. sudden intense urge to urinate followed by involuntary loss of urine

    5. Has been experiencing symptoms of UI for greater than 3 months

    6. Normal urinalysis

    7. Has indicated willingness to participate in the study by signing an informed consent form

    8. Can read, understand and sign informed consent form

    9. 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Women's Pelvic Health Institute Los Gatos California United States 95032
    2 Coyle Institute Pensacola Florida United States 32514
    3 Carolinas Healthcare System Charlotte North Carolina United States 28207
    4 Woodlands Gynecology & Aesthetics The Woodlands Texas United States 77384
    5 The Female Pelvic Medicine Institute of Virginia North Chesterfield Virginia United States 23235

    Sponsors and Collaborators

    • Sciton

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Sciton
    ClinicalTrials.gov Identifier:
    NCT03180372
    Other Study ID Numbers:
    • DIVACIP001
    First Posted:
    Jun 8, 2017
    Last Update Posted:
    Dec 4, 2019
    Last Verified:
    Dec 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Additional relevant MeSH terms:
    Urinary Incontinence
    Enuresis
    Urinary Incontinence, Stress
    Urinary Incontinence, Urge

    Study Results

    No Results Posted as of Dec 4, 2019