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.

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.

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 77 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
• Actual Primary Completion Date: August 1, 2019
• Actual Study Completion Date: October 1, 2019

Arms and Interventions

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.

Outcome Measures

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

Eligibility Criteria

• 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.

Contacts and Locations

Locations

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

More Information

• Responsible Party: Renovia, Inc.
• ClinicalTrials.gov Identifier: NCT03632447
• Other Study ID Numbers: REN-05
• First Posted: August 15, 2018
• Last Update Posted: October 8, 2020
• Last Verified: July 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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:

Urinary Incontinence; Enuresis; Urinary Incontinence, Stress; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Behavioral Symptoms; Elimination Disorders; Mental Disorders