Hybrid Fractional Laser Treatment for Symptoms of Urinary Incontinence

NCT ID: NCT03180372

Last Updated: 2019-12-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 51 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-19
• Study Completion Date: 2019-11-30

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.

Conditions

Urinary Incontinence; Stress Urinary Incontinence; Urge Incontinence

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Hybrid Fractional Laser

Hybrid fractional 2940 nm and 1470 nm laser treatment

Group Type: EXPERIMENTAL

Hybrid Fractional Laser

Intervention Type: DEVICE

Consecutive and coincident fractional 2940 nm and 1470 nm lasers

Interventions

Hybrid Fractional Laser

Consecutive and coincident fractional 2940 nm and 1470 nm lasers

Intervention Type: DEVICE

Other Intervention Names

diVa

Eligibility 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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Sciton

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Women's Pelvic Health Institute

Los Gatos, California, United States

Coyle Institute

Pensacola, Florida, United States

Carolinas Healthcare System

Charlotte, North Carolina, United States

Woodlands Gynecology & Aesthetics

The Woodlands, Texas, United States

The Female Pelvic Medicine Institute of Virginia

North Chesterfield, Virginia, United States

Countries

United States

Other Identifiers

DIVACIP001

Identifier Type: -

Identifier Source: org_study_id