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

Sponsor

Renovia, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT03632447

Collaborator

(none)

Enrollment

Locations

Arms

11.2

Actual Duration (Months)

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Condition or Disease	Intervention/Treatment	Phase
Stress Urinary Incontinence Mixed Urinary Incontinence	Device: Leva Device: PFDx	N/A

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

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 :

Oct 24, 2018

Actual Primary Completion Date :

Aug 1, 2019

Actual Study Completion Date :

Oct 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.

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

Outcome Measures

Primary Outcome Measures

PGI-I [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 [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

3-day voiding diary [8 weeks after randomization]
An objective evaluation of urinary incontinence

Other Outcome Measures

Adherence [8 weeks, 6 months, 12 months]
Adherence to the exercise regimen will be evaluated

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 89 Years

Sexes Eligible for Study:

Female

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama	Birmingham	Alabama	United States	35233
2	Cedars-Sinai Medical Group	Beverly Hills	California	United States	90211
3	Northwestern University	Chicago	Illinois	United States	60611
4	Massachusetts General Hospital	Boston	Massachusetts	United States	02114
5	Cleveland Clinic	Cleveland	Ohio	United States	44195
6	Univeristy of Oklahoma	Oklahoma City	Oklahoma	United States	73104
7	Urology San Antonio	San Antonio	Texas	United States	78229

Sponsors and Collaborators

Renovia, Inc.

Investigators

None specified.

Study Documents (Full-Text)

More Information

Publications

None provided.

Responsible Party:

Renovia, Inc.

ClinicalTrials.gov Identifier:

NCT03632447

Other Study ID Numbers:

REN-05

First Posted:

Aug 15, 2018

Last Update Posted:

Oct 8, 2020

Last Verified:

Jul 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Keywords provided by Renovia, Inc.

Digital Health

Female

Additional relevant MeSH terms:

Urinary Incontinence

Enuresis

Urinary Incontinence, Stress

Study Results

No Results Posted as of Oct 8, 2020