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Comparing Use of a Digital Health System of Pelvic Floor Exercise Program to Kegel Exercises in Stress Urinary Incontinence

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03632447
Recruitment Status : Active, not recruiting
First Posted : August 15, 2018
Last Update Posted : August 30, 2019
Sponsor:
Information provided by (Responsible Party):
Renovia, Inc.

Brief Summary:
A randomized controlled trial for patients with stress urinary incontinence or stress-dominant mixed incontinence. Subjects will be randomized to 8-weeks of home kegel exercises or 8 weeks of pelvic floor muscle exercises using the leva digital pelvic health system that includes visual biofeedback via smartphone.

Condition or disease Intervention/treatment Phase
Stress Urinary Incontinence Mixed Urinary Incontinence Device: Leva Device: PFDx Not Applicable

Detailed Description:
A randomized controlled trial for patients with stress urinary incontinence or stress-dominant mixed incontinence.Subjects will be randomized to 8-weeks of home kegel exercises or 8 weeks of pelvic floor muscle exercises using the leva digital pelvic health system that includes visual biofeedback via smartphone. Leva subjects will perform guided pelvic floor muscle exercises for 2 1/2 minutes twice daily. Home kegel subjects will perform kegel exercises three times daily. Following 8-weeks of training, subjects will be permitted to continue the exercises or pursue additional therapies as indicated. Subjects randomized to the leva digital health system will be further randomized to receive automated reminders for the remainder of one year, or no additional reminders.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 225 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: Assessments of pelvic floor muscle function accomplished by testing at baseline, 4-weeks (mid-study) and 8-weeks will be performed by blinded assessor
Primary Purpose: Treatment
Official Title: A Prospective Randomized Efficacy Study Comparing a Pelvic Digital Health System Home Program of Pelvic Floor Muscle Exercise to Kegel Exercises in the Treatment of Stress-Predominant Urinary Incontinence
Actual Study Start Date : October 24, 2018
Estimated Primary Completion Date : December 1, 2019
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Leva Arm
Subjects will undergo pelvic floor muscle training using the leva device (a vaginal probe) which provides immediate visual feedback via smartphone regarding the motion of pelvic floor muscles. Subjects will perform exercises 2 1/2 minutes twice daily for 8 weeks. At the beginning of the study, four weeks later, and eight weeks later subjects will undergo pelvic floor muscle testing using the PFDx device and surveys to document response to training. After eight weeks, subjects may pursue any additional treatments they wish, but may continue to use the device. They will be further randomized to receive reminder text messages or no messages over 10 months. Subjects will be asked to complete follow up surveys at 6- and 12-months.
Device: Leva
Subjects randomized to Leva will use a vaginal probe containing motion-based sensors to direct the performance of pelvic muscle exercises.

Device: PFDx
All subjects (in both study arms) will be evaluated using a vaginally placed device that will evaluate pelvic floor motion to document change in pelvic floor muscle function resulting from pelvic floor muscle exercises.

Active Comparator: Kegel Arm
Subjects in this arm will perform pelvic floor muscle exercises (Kegels) for the treatment of stress or mixed urinary incontinence. Subjects will be asked to perform exercises three times daily for 8 weeks. At the beginning of the study, four weeks later, and eight weeks later, subjects will undergo pelvic floor muscle testing (using the PFDx device) and surveys to document response to training. After eight weeks, subjects may pursue any additional treatments they wish, but may continue to use the device.
Device: PFDx
All subjects (in both study arms) will be evaluated using a vaginally placed device that will evaluate pelvic floor motion to document change in pelvic floor muscle function resulting from pelvic floor muscle exercises.




Primary Outcome Measures :
  1. PGI-I [ Time Frame: 8 weeks after randomization ]
    PGI-I, Patient Global Impression of Improvement, is a five-point scale that ranges from "not at all" to "very much better."

  2. UDI-6 [ Time Frame: 8 weeks after randomization ]
    Urogenital Distress Inventory is a six question validated questionnaire evaluating incontinence symptoms. It is scored from 0-100, with higher scores indicating more severely bothersome symptoms


Secondary Outcome Measures :
  1. 3-day voiding diary [ Time Frame: 8 weeks after randomization ]
    An objective evaluation of urinary incontinence


Other Outcome Measures:
  1. Adherence [ Time Frame: 8 weeks, 6 months, 12 months ]
    Adherence to the exercise regimen will be evaluated



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Capable of giving informed consent.
  • Self-reported stress-type UI symptoms of >= three months duration
  • Diagnosis of stress predominant urinary incontinence based on MESA stress symptom score greater than MESA urge symptom score (percent of total possible urge score).
  • UDI-6 score >/= 25
  • Willing to participate in the 8-week study with follow up at 6-and 12-months, refraining from the pursuit of treatment for Stress Urinary Incontinence using other modalities (i.e. will not wear a pessary, participate in pelvic floor PT or surgery) during the first 8- weeks.

Exclusion Criteria:

  • Absence of a vagina.
  • Age <18 years.
  • Stage 3-4 pelvic organ prolapse (as determined by POP-Q).
  • Diagnosis of any neuromuscular disease.
  • Non-ambulatory.
  • Currently pregnant or <12 months post-partum.
  • </= 3 months after failed surgery for stress urinary incontinence.
  • Previous pelvic floor muscle training (PFMT) within the last 12 months under a supervised therapeutic plan of care.
  • Currently taking, or has taken within the last 2 months, medication to treat urinary incontinence.
  • Prior augmentation cystoplasty or artificial sphincter.
  • Implanted nerve stimulator for urinary symptoms.
  • Participation in another clinical study within 30 days of screening.
  • Impaired cognitive function.
  • Contraindication to the use of a vaginal probe.
  • Unable to understand instructions on the use of the leva® Plus Pelvic Digital Health System.
  • Unable to actively recruit the pelvic floor muscles to any degree for attempted volitional contraction.

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): NCT03632447


Locations
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United States, Alabama
University of Alabama
Birmingham, Alabama, United States, 35233
United States, California
Cedars-Sinai Medical Group
Beverly Hills, California, United States, 90211
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
United States, Oklahoma
Univeristy of Oklahoma
Oklahoma City, Oklahoma, United States, 73104
United States, Texas
Urology San Antonio
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Renovia, Inc.
  Study Documents (Full-Text)

Documents provided by Renovia, Inc.:
Study Protocol  [PDF] April 18, 2018
Statistical Analysis Plan  [PDF] August 27, 2019


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Responsible Party: Renovia, Inc.
ClinicalTrials.gov Identifier: NCT03632447    
Other Study ID Numbers: REN-05
First Posted: August 15, 2018    Key Record Dates
Last Update Posted: August 30, 2019
Last Verified: July 2019
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: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Renovia, Inc.:
Digital Health
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