Skip to main content
OpenTrials
Completed

NCT Number: NCT03180372

Hybrid Fractional Laser Treatment for Symptoms of Urinary Incontinence

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Urinary Incontinence Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Stress Urinary Incontinence Urge Incontinence Urinary Incontinence, Stress Urinary Incontinence, Urge Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

30 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Women's Pelvic Health Institute, Los Gatos, California, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Hybrid fractional laser

Device

Consecutive and coincident fractional 2940 nm and 1470 nm lasers

Other names: diVa

Primary outcomes

  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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

Sciton

Industry

Registry information

Official study title

Safety and Efficacy of Hybrid Fractional Laser diVa Treatment for Symptoms of Urinary Incontinence

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jun 8, 2017
Registry last updated
Dec 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.