Back to resultsUse of the Leva Incontinence System in Treating Bladder Incontinence.
Primary Purpose
Stress Urinary Incontinence
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Leva Incontinence System For Pelvic Floor Muscle strengthening
Sponsored by
About this trial
This is an interventional treatment trial for Stress Urinary Incontinence focused on measuring Female
Eligibility Criteria
Inclusion Criteria
- Subjects must be female.
- Subjects must be capable of giving informed consent.
- Subjects should be at least 18 years of age and less than 89 years of age
- Subjects must have a diagnosis of or symptoms of predominant mild to moderate urinary incontinence based on the results of the completed urinary incontinence surveys.
Exclusion Criteria:
- Absence of a vagina.
- Positive drug or alcohol test at the screening visit.
- Post-menopausal defined as absence of a period for over 12 months.
- Pregnancy or being less than 12 months post-partum.
- Greater than three vaginal deliveries or prior operative delivery (e.g. use of vacuum, forceps or abdominal pressure).
- Symptoms of stage II or greater pelvic organ prolapse.
- BMI >31 kg/m2.
- Diagnosis of any neurological disorder.
- Prior lower back or pelvic surgery, including prior surgery for stress urinary incontinence (SUI).
- Prior pelvic radiation.
- Current or recurrent vaginal infections (>three per year).
- Painful bladder syndrome, active or chronic pelvic pain.
- Concurrent Pelvic Floor Muscle Exercises (PFME) under a supervised therapeutic plan of care.
- Previous supervised pelvic floor muscles rehabilitation in the past 12 months for the treatment for urinary incontinence or any other pelvic floor disorder.
- Currently taking medication to treat incontinence.
- Impaired cognitive function.
- Unable to tolerate use of the leva device.
Sites / Locations
- New England Spine Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Leva Arm
Arm Description
Subjects will use the leva device twice daily to perform pelvic floor muscle exercises
Outcomes
Primary Outcome Measures
Symptoms of Urinary Incontinence at Baseline and at 6 Weeks
A validated, standardized questionnaire (the short form of the urogenital distress inventory, UDI-6) will be used to evaluate change in symptoms of urinary incontinence. Minimum score = 0, Maximum score = 100, lower scores indicate fewer symptoms.
Secondary Outcome Measures
Condition-specific Quality of Life Assessment (IIQ-7) at Baseline and 6 Weeks.
Condition specific quality of life as it is affected by urinary incontinence will be assessed using the Incontinence Impact Questionnaire (IIQ-7). Minimum value 0, Maximum value 100, lower scores indicate improvement.
Number of Participants for Different Categories of Patient Global Impression of Improvement (PGI-I)
Subject perception of improvement will be evaluated using the standardized survey Patient Global Impression of Improvement (PGI-I). Categories of improvement include: Very Much Better, Much Better, A Little Better, No Change, Worse(any degree).
Pelvic Floor Muscle Performance (Mean Maximum Duration of Voluntary Pelvic Floor Muscle Contraction)
Change in pelvic floor muscle performance will be evaluated using muscle performance testing performed using the leva device. Subjects were asked to lift and squeeze pelvic floor muscles for as long as possible. The length of time a subject can "hold" the lift was recorded
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03536923
Brief Title
Use of the Leva Incontinence System in Treating Bladder Incontinence.
Official Title
Use of the Leva Incontinence System in Treating Bladder Incontinence.
Study Type
Interventional
2. Study Status
Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
April 10, 2017 (Actual)
Primary Completion Date
August 12, 2017 (Actual)
Study Completion Date
October 20, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Renovia, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This open-label proof-of-concept study is designed to evaluate the impact of the leva digital incontinence system on the treatment of stress and mixed urinary incontinence in women over a six week period. Subjects will participate in a 2.5 minute exercise program twice daily (performed at a clinic with therapist assistance 5x weekly, and at home once daily on weekdays and twice daily on weekends. Validated surveys (UDI-6, IIQ-7 and PGI-I) will be used to evaluate symptom relief. A battery of pelvic floor muscle exercises will be performed weekly to evaluate progress in muscle strengthening.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Urinary Incontinence
Keywords
Female
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
23 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Leva Arm
Arm Type
Experimental
Arm Description
Subjects will use the leva device twice daily to perform pelvic floor muscle exercises
Intervention Type
Device
Intervention Name(s)
Leva Incontinence System For Pelvic Floor Muscle strengthening
Intervention Description
The leva device is placed vaginally for 2.5 minutes twice daily, and pelvic floor muscle exercises are performed based on guidance from data sent from the device to their mobile phone.
Primary Outcome Measure Information:
Title
Symptoms of Urinary Incontinence at Baseline and at 6 Weeks
Description
A validated, standardized questionnaire (the short form of the urogenital distress inventory, UDI-6) will be used to evaluate change in symptoms of urinary incontinence. Minimum score = 0, Maximum score = 100, lower scores indicate fewer symptoms.
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Condition-specific Quality of Life Assessment (IIQ-7) at Baseline and 6 Weeks.
Description
Condition specific quality of life as it is affected by urinary incontinence will be assessed using the Incontinence Impact Questionnaire (IIQ-7). Minimum value 0, Maximum value 100, lower scores indicate improvement.
Time Frame
6 weeks
Title
Number of Participants for Different Categories of Patient Global Impression of Improvement (PGI-I)
Description
Subject perception of improvement will be evaluated using the standardized survey Patient Global Impression of Improvement (PGI-I). Categories of improvement include: Very Much Better, Much Better, A Little Better, No Change, Worse(any degree).
Time Frame
At 6 weeks
Title
Pelvic Floor Muscle Performance (Mean Maximum Duration of Voluntary Pelvic Floor Muscle Contraction)
Description
Change in pelvic floor muscle performance will be evaluated using muscle performance testing performed using the leva device. Subjects were asked to lift and squeeze pelvic floor muscles for as long as possible. The length of time a subject can "hold" the lift was recorded
Time Frame
6 weeks
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Subject must have a vagina
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria
Subjects must be female.
Subjects must be capable of giving informed consent.
Subjects should be at least 18 years of age and less than 89 years of age
Subjects must have a diagnosis of or symptoms of predominant mild to moderate urinary incontinence based on the results of the completed urinary incontinence surveys.
Exclusion Criteria:
Absence of a vagina.
Positive drug or alcohol test at the screening visit.
Post-menopausal defined as absence of a period for over 12 months.
Pregnancy or being less than 12 months post-partum.
Greater than three vaginal deliveries or prior operative delivery (e.g. use of vacuum, forceps or abdominal pressure).
Symptoms of stage II or greater pelvic organ prolapse.
BMI >31 kg/m2.
Diagnosis of any neurological disorder.
Prior lower back or pelvic surgery, including prior surgery for stress urinary incontinence (SUI).
Prior pelvic radiation.
Current or recurrent vaginal infections (>three per year).
Painful bladder syndrome, active or chronic pelvic pain.
Concurrent Pelvic Floor Muscle Exercises (PFME) under a supervised therapeutic plan of care.
Previous supervised pelvic floor muscles rehabilitation in the past 12 months for the treatment for urinary incontinence or any other pelvic floor disorder.
Currently taking medication to treat incontinence.
Impaired cognitive function.
Unable to tolerate use of the leva device.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Rosenberg, MD
Organizational Affiliation
New England Spine Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
New England Spine Center
City
Cambridge
State/Province
Massachusetts
ZIP/Postal Code
02138
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Use of the Leva Incontinence System in Treating Bladder Incontinence.
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