Hybrid Fractional Laser Treatment for Symptoms of Urinary Incontinence

• ClinicalTrials.gov Identifier: NCT03180372
• Recruitment Status: Completed
• First Posted: June 8, 2017
• Last Update Posted: December 4, 2019
• Sponsor: Sciton
• Information provided by (Responsible Party): Sciton

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
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.

Study Design

• Study Type: Interventional (Clinical Trial)
• 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: August 30, 2019
• Actual Study Completion Date: November 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 Name: diVa

Outcome Measures

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).

Eligibility Criteria

• 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.

Contacts and Locations

Locations

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

More Information

• Responsible Party: Sciton
• ClinicalTrials.gov Identifier: NCT03180372
• Other Study ID Numbers: DIVACIP001
• First Posted: June 8, 2017
• Last Update Posted: December 4, 2019
• Last Verified: December 2019

Individual Participant Data (IPD) Sharing Statement:

• 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; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Behavioral Symptoms; Elimination Disorders; Mental Disorders