Hybrid Fractional Laser Treatment for Symptoms of Urinary Incontinence

Completed · Not applicable

Conditions studied: Urinary Incontinence, Stress Urinary Incontinence, Urge Incontinence

In brief

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.

Key facts

Study ID

NCT03180372

Run by

Sciton

People needed

51

Starts

2017-05-19

Expected to finish

2019-11-30

Last updated by the study team

2019-12-04

Who can join

Age: 30 and older, up to 75. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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