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

• ClinicalTrials.gov Identifier: NCT03632447
• Recruitment Status: Completed
• First Posted: August 15, 2018
• Last Update Posted: October 8, 2020
• Sponsor: Renovia, Inc.
• Information provided by (Responsible Party): Renovia, Inc.

Tracking Information

• First Submitted Date: August 13, 2018
• First Posted Date: August 15, 2018
• Last Update Posted Date: October 8, 2020
• Actual Study Start Date: October 24, 2018
• Actual Primary Completion Date: August 1, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 14, 2018)

• 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."
• 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

Original Primary Outcome Measures (submitted: August 13, 2018)

• 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."
• UDI-6 [ Time Frame: 8 weeks after randomization ]
  Urogenital Distress Inventory is a six question validated questionnaire evaluating incontinence symptoms

Current Secondary Outcome Measures (submitted: August 13, 2018)

3-day voiding diary [ Time Frame: 8 weeks after randomization ]

An objective evaluation of urinary incontinence

• Original Secondary Outcome Measures: Same as current

Current Other Pre-specified Outcome Measures (submitted: August 13, 2018)

Adherence [ Time Frame: 8 weeks, 6 months, 12 months ]

Adherence to the exercise regimen will be evaluated

• Original Other Pre-specified Outcome Measures: Same as current

Descriptive Information

• 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
• 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.
• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

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

Condition

• Stress Urinary Incontinence
• Mixed Urinary Incontinence

Intervention

• 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.

Study Arms

• 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.
  Interventions:

  • Device: Leva
  • Device: PFDx
• 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.
  Intervention: Device: PFDx

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: October 6, 2020): 77
• Original Estimated Enrollment (submitted: August 13, 2018): 225
• Actual Study Completion Date: October 1, 2019
• Actual Primary Completion Date: August 1, 2019 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 18 Years to 89 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03632447
• Other Study ID Numbers: REN-05
• 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: Yes
• Product Manufactured in and Exported from the U.S.: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Renovia, Inc.
• Original Responsible Party: Same as current
• Current Study Sponsor: Renovia, Inc.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Renovia, Inc.
• Verification Date: July 2019