Use of the Leva Incontinence System in Treating Bladder Incontinence.

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.

Study Overview

• Status: Completed
• Conditions: Stress Urinary Incontinence
• Intervention / Treatment: Device: Leva Incontinence System For Pelvic Floor Muscle strengthening

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Cambridge, Massachusetts, United States, 02138
      • New England Spine Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 89 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Leva Arm; Subjects will use the leva device twice daily to perform pelvic floor muscle exercises	Device: Leva Incontinence System For Pelvic Floor Muscle strengthening; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 weeks
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).	At 6 weeks
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	6 weeks

Collaborators and Investigators

• Sponsor: Renovia, Inc.
• Investigators: Principal Investigator: Robert Rosenberg, MD, New England Spine Center

Study record dates

Study Major Dates

• Study Start (Actual): April 10, 2017
• Primary Completion (Actual): August 12, 2017
• Study Completion (Actual): October 20, 2017

Study Registration Dates

• First Submitted: May 13, 2018
• First Submitted That Met QC Criteria: May 23, 2018
• First Posted (Actual): May 25, 2018

Study Record Updates

• Last Update Posted (Actual): December 12, 2018
• Last Update Submitted That Met QC Criteria: December 10, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Keywords: Female
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Elimination Disorders; Urinary Incontinence; Enuresis; Urinary Incontinence, Stress
• Other Study ID Numbers: REN-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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