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Use of the Leva Incontinence System in Treating Bladder Incontinence.

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ClinicalTrials.gov Identifier: NCT03536923
Recruitment Status : Completed
First Posted : May 25, 2018
Results First Posted : December 12, 2018
Last Update Posted : December 12, 2018
Sponsor:
Information provided by (Responsible Party):
Renovia, Inc.

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.

Condition or disease Intervention/treatment Phase
Stress Urinary Incontinence Device: Leva Incontinence System For Pelvic Floor Muscle strengthening Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Use of the Leva Incontinence System in Treating Bladder Incontinence.
Actual Study Start Date : April 10, 2017
Actual Primary Completion Date : August 12, 2017
Actual Study Completion Date : October 20, 2017

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Symptoms of Urinary Incontinence at Baseline and at 6 Weeks [ Time Frame: 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 :
  1. Condition-specific Quality of Life Assessment (IIQ-7) at Baseline and 6 Weeks. [ Time Frame: 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.

  2. Number of Participants for Different Categories of Patient Global Impression of Improvement (PGI-I) [ Time Frame: At 6 weeks ]
    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).

  3. Pelvic Floor Muscle Performance (Mean Maximum Duration of Voluntary Pelvic Floor Muscle Contraction) [ Time Frame: 6 weeks ]
    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



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Ages Eligible for Study:   18 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Subject must have a vagina
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03536923


Locations
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United States, Massachusetts
New England Spine Center
Cambridge, Massachusetts, United States, 02138
Sponsors and Collaborators
Renovia, Inc.
Investigators
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Principal Investigator: Robert Rosenberg, MD New England Spine Center
  Study Documents (Full-Text)

Documents provided by Renovia, Inc.:

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Responsible Party: Renovia, Inc.
ClinicalTrials.gov Identifier: NCT03536923     History of Changes
Other Study ID Numbers: REN-01
First Posted: May 25, 2018    Key Record Dates
Results First Posted: December 12, 2018
Last Update Posted: December 12, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Renovia, Inc.:
Female
Additional relevant MeSH terms:
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Urinary Incontinence
Enuresis
Urinary Incontinence, Stress
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders