NCT03180372

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2017

Typical duration for not_applicable

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 19, 2017

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

June 6, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 8, 2017

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2019

Completed
Last Updated

December 4, 2019

Status Verified

December 1, 2019

Enrollment Period

2.3 years

First QC Date

June 6, 2017

Last Update Submit

December 3, 2019

Conditions

Urinary IncontinenceStress Urinary IncontinenceUrge Incontinence

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in Cough Stress Test

    A diagnostic test to simulate accidental release of urine when the patient coughs.

    14 months

Secondary Outcomes (6)

  • Change from baseline in Incontinence Impact Questionnaire (IIQ-7)

    14 months

  • Change from baseline in Urogenital Distress Inventory (UDI-6)

    14 months

  • Change from baseline in Female Sexual Function Index (FSFI)

    14 months

  • Change from baseline in Histology

    14 months

  • Change from baseline in Urodynamic Testing

    14 months

  • +1 more secondary outcomes

Study Arms (1)

Hybrid Fractional Laser

EXPERIMENTAL

Hybrid fractional 2940 nm and 1470 nm laser treatment

Device: Hybrid Fractional Laser

Interventions

Hybrid Fractional LaserDEVICE

Consecutive and coincident fractional 2940 nm and 1470 nm lasers

Also known as: diVa
Hybrid Fractional Laser

Eligibility Criteria

Age30 Years - 75 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Women's Pelvic Health Institute

Los Gatos, California, 95032, United States

Location

Coyle Institute

Pensacola, Florida, 32514, United States

Location

Carolinas Healthcare System

Charlotte, North Carolina, 28207, United States

Location

Woodlands Gynecology & Aesthetics

The Woodlands, Texas, 77384, United States

Location

The Female Pelvic Medicine Institute of Virginia

North Chesterfield, Virginia, 23235, United States

Location

MeSH Terms

Conditions

Urinary IncontinenceUrinary Incontinence, StressUrinary Incontinence, Urge

Condition Hierarchy (Ancestors)

Urination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 6, 2017

First Posted

June 8, 2017

Study Start

May 19, 2017

Primary Completion

August 30, 2019

Study Completion

November 30, 2019

Last Updated

December 4, 2019

Record last verified: 2019-12

Data Sharing

IPD Sharing
Will not share

Locations

US(5)