Use of the Leva Incontinence System in Treating Bladder Incontinence.

NCT ID: NCT03536923

Last Updated: 2018-12-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-04-10
• Study Completion Date: 2017-10-20

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.

Conditions

Stress Urinary Incontinence

Keywords

Female

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Leva Arm

Subjects will use the leva device twice daily to perform pelvic floor muscle exercises

Group Type: EXPERIMENTAL

Leva Incontinence System For Pelvic Floor Muscle strengthening

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Renovia, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robert Rosenberg, MD

Role: PRINCIPAL_INVESTIGATOR

New England Spine Center

Locations

New England Spine Center

Cambridge, Massachusetts, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

REN-01

Identifier Type: -

Identifier Source: org_study_id