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Hybrid Fractional Laser Treatment for Symptoms of Urinary Incontinence

Primary Purpose

Urinary Incontinence, Stress Urinary Incontinence, Urge Incontinence

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Hybrid Fractional Laser
Sponsored by
Sciton
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urinary Incontinence

Eligibility Criteria

30 Years - 75 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Women's Pelvic Health Institute
  • Coyle Institute
  • Carolinas Healthcare System
  • Woodlands Gynecology & Aesthetics
  • The Female Pelvic Medicine Institute of Virginia

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Hybrid Fractional Laser

Arm Description

Hybrid fractional 2940 nm and 1470 nm laser treatment

Outcomes

Primary Outcome Measures

Change from baseline in Cough Stress Test
A diagnostic test to simulate accidental release of urine when the patient coughs.

Secondary Outcome Measures

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.
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.
Change from baseline in Female Sexual Function Index (FSFI)
A multidimensional self-report instrument for assessment of female sexual function.
Change from baseline in Histology
Change from baseline in epithelial thickness, collagen, elastin, vascularity, and fibroblast density.
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.
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).

Full Information

First Posted
June 6, 2017
Last Updated
December 3, 2019
Sponsor
Sciton
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1. Study Identification

Unique Protocol Identification Number
NCT03180372
Brief Title
Hybrid Fractional Laser Treatment for Symptoms of Urinary Incontinence
Official Title
Safety and Efficacy of Hybrid Fractional Laser diVa Treatment for Symptoms of Urinary Incontinence
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
May 19, 2017 (Actual)
Primary Completion Date
August 30, 2019 (Actual)
Study Completion Date
November 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sciton

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Incontinence, Stress Urinary Incontinence, Urge Incontinence

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
51 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hybrid Fractional Laser
Arm Type
Experimental
Arm Description
Hybrid fractional 2940 nm and 1470 nm laser treatment
Intervention Type
Device
Intervention Name(s)
Hybrid Fractional Laser
Other Intervention Name(s)
diVa
Intervention Description
Consecutive and coincident fractional 2940 nm and 1470 nm lasers
Primary Outcome Measure Information:
Title
Change from baseline in Cough Stress Test
Description
A diagnostic test to simulate accidental release of urine when the patient coughs.
Time Frame
14 months
Secondary Outcome Measure Information:
Title
Change from baseline in Incontinence Impact Questionnaire (IIQ-7)
Description
A 7-item self-report instrument designed to assess the impact of urinary incontinence on a patient's life.
Time Frame
14 months
Title
Change from baseline in Urogenital Distress Inventory (UDI-6)
Description
A 6-item self-report instrument that assesses symptom distress and the impact on daily life of urinary incontinence.
Time Frame
14 months
Title
Change from baseline in Female Sexual Function Index (FSFI)
Description
A multidimensional self-report instrument for assessment of female sexual function.
Time Frame
14 months
Title
Change from baseline in Histology
Description
Change from baseline in epithelial thickness, collagen, elastin, vascularity, and fibroblast density.
Time Frame
14 months
Title
Change from baseline in Urodynamic Testing
Description
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
Title
Incidence and severity of treatment-related Adverse Events
Description
Incidence and severity of treatment-related adverse events (i.e. pain, edema, erythema, altered sensation, scarring, and/or potential infection).
Time Frame
14 months

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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) involuntary urine leakage on effort, exertion, sneezing, coughing sudden intense urge to urinate followed by involuntary loss of urine 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: Undiagnosed abnormal genital bleeding Has history of pelvic surgery or other energy-based vaginal therapy within 6 months prior to enrollment Is pregnant or planning to get pregnant within the study period Is currently breastfeeding Has an active sexually transmitted infection (STI) Has equal to or greater than stage III prolapse, according to pelvic organ prolapse quantification system (POP-Q test) Has signs or symptoms of vaginitis/vulvitis Has signs or symptoms of acute urinary tract infection (UTI) Has voiding dysfunction or urinary retention Has predominantly overactive bladder (OAB) as proven by urodynamics Is currently taking medication for treating urinary incontinence Has a known history of neurologic disease Has history of heart failure Any medical conditions that might interfere with wound healing Has history of abnormal wound healing Has participated in any clinical trial involving an investigational drug or procedure within past 30 days The investigator feels that for any reason the subject is not eligible to participate in the study.
Facility Information:
Facility Name
Women's Pelvic Health Institute
City
Los Gatos
State/Province
California
ZIP/Postal Code
95032
Country
United States
Facility Name
Coyle Institute
City
Pensacola
State/Province
Florida
ZIP/Postal Code
32514
Country
United States
Facility Name
Carolinas Healthcare System
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28207
Country
United States
Facility Name
Woodlands Gynecology & Aesthetics
City
The Woodlands
State/Province
Texas
ZIP/Postal Code
77384
Country
United States
Facility Name
The Female Pelvic Medicine Institute of Virginia
City
North Chesterfield
State/Province
Virginia
ZIP/Postal Code
23235
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Hybrid Fractional Laser Treatment for Symptoms of Urinary Incontinence

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