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

Primary Purpose

Stress Urinary Incontinence, Mixed Urinary Incontinence

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Leva
PFDx
Sponsored by
Renovia, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stress Urinary Incontinence focused on measuring Digital Health, Female

Eligibility Criteria

18 Years - 89 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Alabama
  • Cedars-Sinai Medical Group
  • Northwestern University
  • Massachusetts General Hospital
  • Cleveland Clinic
  • Univeristy of Oklahoma
  • Urology San Antonio

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Leva Arm

Kegel Arm

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

PGI-I
PGI-I, Patient Global Impression of Improvement, is a five-point scale that ranges from "not at all" to "very much better."
UDI-6
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

3-day voiding diary
An objective evaluation of urinary incontinence

Full Information

First Posted
August 13, 2018
Last Updated
October 6, 2020
Sponsor
Renovia, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03632447
Brief Title
Comparing Use of a Digital Health System of Pelvic Floor Exercise Program to Kegel Exercises in Stress Urinary Incontinence
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
October 24, 2018 (Actual)
Primary Completion Date
August 1, 2019 (Actual)
Study Completion Date
October 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Renovia, Inc.

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Urinary Incontinence, Mixed Urinary Incontinence
Keywords
Digital Health, Female

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
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
Allocation
Randomized
Enrollment
77 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Leva Arm
Arm Type
Experimental
Arm Description
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.
Arm Title
Kegel Arm
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Leva
Intervention Description
Subjects randomized to Leva will use a vaginal probe containing motion-based sensors to direct the performance of pelvic muscle exercises.
Intervention Type
Device
Intervention Name(s)
PFDx
Intervention Description
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 Measure Information:
Title
PGI-I
Description
PGI-I, Patient Global Impression of Improvement, is a five-point scale that ranges from "not at all" to "very much better."
Time Frame
8 weeks after randomization
Title
UDI-6
Description
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
Time Frame
8 weeks after randomization
Secondary Outcome Measure Information:
Title
3-day voiding diary
Description
An objective evaluation of urinary incontinence
Time Frame
8 weeks after randomization
Other Pre-specified Outcome Measures:
Title
Adherence
Description
Adherence to the exercise regimen will be evaluated
Time Frame
8 weeks, 6 months, 12 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
University of Alabama
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
Cedars-Sinai Medical Group
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Univeristy of Oklahoma
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Urology San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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