Clinical trial NCT03180372: 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
Overall status: COMPLETED
Phase: NA
Conditions: Urinary Incontinence
Stress Urinary Incontinence
Urge Incontinence
Lead sponsor: Sciton
Sponsor class: INDUSTRY
First posted: 2017-06-08
Enrollment: 51
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change from baseline in Cough Stress Test
timeFrame: 14 months
Secondary outcomes:
measure: Change from baseline in Incontinence Impact Questionnaire (IIQ-7)
timeFrame: 14 months
measure: Change from baseline in Urogenital Distress Inventory (UDI-6)
timeFrame: 14 months
measure: Change from baseline in Female Sexual Function Index (FSFI)
timeFrame: 14 months
measure: Change from baseline in Histology
timeFrame: 14 months
measure: Change from baseline in Urodynamic Testing
timeFrame: 14 months
measure: Incidence and severity of treatment-related Adverse Events
timeFrame: 14 months
Other outcomes:
Locations:
city: Los Gatos
country: United States
facility: Women's Pelvic Health Institute
state: California
city: Pensacola
country: United States
facility: Coyle Institute
state: Florida
city: Charlotte
country: United States
facility: Carolinas Healthcare System
state: North Carolina
city: The Woodlands
country: United States
facility: Woodlands Gynecology & Aesthetics
state: Texas
city: North Chesterfield
country: United States
facility: The Female Pelvic Medicine Institute of Virginia
state: Virginia
Study officials:
References: