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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.

Tracking Information
First Submitted Date  ICMJE May 13, 2018
First Posted Date  ICMJE May 25, 2018
Results First Submitted Date  ICMJE August 10, 2018
Results First Posted Date  ICMJE December 12, 2018
Last Update Posted Date December 12, 2018
Actual Study Start Date  ICMJE April 10, 2017
Actual Primary Completion Date August 12, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 10, 2018)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: May 23, 2018)
Symptom change from baseline to end of study [ Time Frame: Survey administered 1x weekly for 6 weeks ]
A validated, standardized questionnaire (the short form of the urogenital distress inventory) will be administered weekly to evaluate change in symptoms of urinary incontinence
Change History Complete list of historical versions of study NCT03536923 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 10, 2018)
  • 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.
  • 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).
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: May 23, 2018)
  • Condition-specific quality of life assessment [ Time Frame: Survey administered 1x weekly for 6 weeks ]
    Changes in the quality of life as it is affected by urinary incontinence will be asessed using the Incontinence Impact Questionnaire (IIQ-7), administered weekly
  • Global impression of improvement [ Time Frame: Survey administered 1x weekly for 6 weeks ]
    Change in subject perception of improvement will be evaluated using the standardized survey Patient Global Impression of Improvement (PGI-I)
  • Pelvic floor muscle performance [ Time Frame: Testing administered 1x weekly for 6 weeks ]
    Change in pelvic floor muscle performance will be evaluated using muscle performance testing performed using the leva device.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Use of the Leva Incontinence System in Treating Bladder Incontinence.
Official Title  ICMJE Use of the Leva Incontinence System in Treating Bladder Incontinence.
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Stress Urinary Incontinence
Intervention  ICMJE 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.
Study Arms  ICMJE Experimental: Leva Arm
Subjects will use the leva device twice daily to perform pelvic floor muscle exercises
Intervention: Device: Leva Incontinence System For Pelvic Floor Muscle strengthening
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 23, 2018)
23
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 20, 2017
Actual Primary Completion Date August 12, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Gender Eligibility Description: Subject must have a vagina
Ages  ICMJE 18 Years to 89 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03536923
Other Study ID Numbers  ICMJE REN-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Renovia, Inc.
Study Sponsor  ICMJE Renovia, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Robert Rosenberg, MD New England Spine Center
PRS Account Renovia, Inc.
Verification Date December 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP