Pelvic Floor Muscle Training With a Digital Therapeutic Device to Standard Exercises for Stress Urinary Incontinence

December 8, 2021 updated by: Renovia, Inc.

A Prospective Randomized Trial Comparing Efficacy of Pelvic Floor Muscle Training With a Digital Therapeutic Device to Standard Exercises for the Treatment of Stress Urinary Incontinence: A Remote Digital Trial

A virtual prospective randomized controlled study to evaluate the efficacy of using the leva® Pelvic Digital Health System (PDHS) to perform PFMT compared to a standard home exercise home program for the treatment of SUI/SMUI. The treatment part of the study lasts eight weeks and has two arms. One group will receive routine care consisting of at-home Kegel exercises, and the other will be provided with a leva® device and instructions for use. Subjects in both groups will be assessed at baseline, then at 4 and 8 weeks for change and improvement of their symptoms. They will also be assessed at 6 and12 months after study completion.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This trial is entirely virtual. No office visits, specific locations, or physical examination will be required. Enrollment may occur from any location in the United States

  • A virtual prospective randomized controlled study to evaluate the efficacy of using the leva® PDHS to perform PFMT (leva arm) compared to standard care of a PFM exercise home program (Kegel arm) for the treatment of SUI or SMUI.
  • Following completion of e-consent and screening, including an initial bladder diary and introductory phone call to review the study requirements, subjects are considered officially enrolled.
  • A series of baseline assessments will be administered to all subjects to evaluate symptom severity, frequency and impact.
  • Subjects will then be randomized to either the leva® arm or Kegel arm on a 1 to 1 ratio using block randomization. Prior to initiation of the trial, a randomization sequence will be generated by the ObvioHealth system. Participants will be automatically allocated the next available slot in the sequence at the time of their randomization and assigned to the leva® or Kegel group accordingly.
  • Prior to beginning the program, subjects in the Kegel arm will receive printed instructions for PFMT with Kegel exercises. Subjects in the leva® arm will be shipped the leva® digital device, along with instructions for use and how to download the corresponding digital app. Day 1 of the study begins the day following receipt of materials.
  • Study population: women with SUI or SMUI.
  • The study requires no office visits. All participant data will be entered in the subject's smartphone using a custom designed mobile application. Participants will be able to interact with the app throughout the study period and will be presented with surveys and a voiding diary on a specified schedule during an 8-week treatment period. There will also be expected post-intervention follow up surveys at 6- and 12-months
  • Using virtual recruiting, a total of up to 350 subjects will be enrolled in the trial.
  • Subjects in both arms will have three scheduled phone calls with study staff during the first two weeks of treatment.
  • Subjects can speak to the study staff at any time via an in-app chat function, the phone, or videoconference.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
369

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • University of Alabama *** Virtual Trial May be enrolled from any US Location
    • California
      • Irvine, California, United States, 92618
        • Southern California Permanente Medical Group*** Virtual Trial May be enrolled from any US Location
    • New Mexico
      • Albuquerque, New Mexico, United States, 87112
        • University of New Mexico *** Virtual Trial May be enrolled from any US Location

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 96 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • ≥18 years of age
  • Capable of giving informed consent
  • Possess a smartphone capable of interacting with the ObvioHealth and Renovia apps
  • Self-reported SUI/SMUI symptoms of ≥ three months duration
  • Diagnosis SMUI based on Medical, Epidemiologic and Social Aspects of Aging (MESA) stress symptom score (Percent of total possible stress score) greater than MESA urge symptom score (percent of total possible urge score)
  • English speaking
  • Postmenopausal, post hysterectomy, or willing to use an acceptable method of birth control for the duration of the study
  • Able to complete a bladder diary using the ObvioHealth app
  • Able to complete electronic surveys and upload data
  • Willing to provide contact information and respond to remote contact: phone calls, text messages, email
  • Willing to participate in the 8-week study with follow up at 6-and 12-months, refraining from the pursuit of treatment for Stress UI using other modalities (i.e. will not wear a pessary, participate in pelvic floor Physical Therapy or surgery) during the first 8 weeks

Exclusion Criteria:

  • Absence of a vagina, per patient report
  • Reports seeing or feeling a vaginal bulge or sensation of vaginal bulge
  • Diagnosis of any neuromuscular disease that may contribute to UI (i.e., multiple sclerosis, spinal cord injury, Parkinson's Disease, etc.)
  • Non-ambulatory, per patient report
  • Currently pregnant or <6 months post-partum per patient report
  • Currently (or within the last 1 month) breast feeding
  • Prior surgery for stress UI
  • Previous PFMT: 2 visits within the last 3 months under a supervised therapeutic plan of care
  • Currently taking, or has taken within the last 2 months, medication to treat UI
  • Prior augmentation cystoplasty or artificial sphincter
  • Implanted nerve stimulator for urinary symptoms, active within the past 60 days
  • Participation in another clinical study within 30 days of screening
  • Impaired cognitive function per patient report and evaluation of medication list
  • Contraindication to the use of a vaginal probe
  • Unable to understand instructions on the use of the leva® PDHS
  • Unable to operate a smartphone app with use of Bluetooth and Wi-Fi connectivity

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Leva PDHS arm

Upon randomization, subjects randomized to the leva® arm will receive the leva® PDHS, and instructions for how to download the smartphone app to facilitate use of the device. They will be instructed to use leva® based on the in-app training provided.

Within the app, subjects will be instructed to use the leva® device to perform PFMT according to the training program provided through the smartphone app associated with the device. This entails 2 ½ minute training sessions, three times daily, 7 days per week for a total of 8 weeks.
Device: Leva Pelvic Digital Health System
Pelvic floor muscle training using the pelvic digital health system to treat pelvic floor disorders, specifically stress urinary incontinence.
Other: Kegel arm
Subjects randomized to the Kegel arm will be provided links to view instructions on how to perform PFMT (written instructions per the handout adapted from Voices for PFD, the patient advocacy arm of the American Urogynecologic Society), as well as an audio/visual didactic instructing them to perform Pelvic Floor Muscle Exercises (PFME) three times daily, seven days per week throughout the 8-week study period.
Other: Kegel exercises
Pelvic floor muscle training (PFMT), commonly referred to as "Kegel" exercises, is a first line conservative treatment for pelvic floor disorders, specifically stress urinary incontinence (SUI) or stress-predominant mixed urinary incontinence (SMUI).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Efficacy - Urogenital Distress Inventory (UDI-6)
Time Frame: Baseline, 4 weeks, 8 weeks, 6 months and 12 months
UDI-6 is a validated questionnaire assessing symptom presence and degree of bother. It will be used to compare the degree of symptom change in the leva arm vs the Kegel arm within and between groups.
Baseline, 4 weeks, 8 weeks, 6 months and 12 months
Efficacy - Bladder diaries
Time Frame: Baseline and 8 weeks
Bladder diaries evaluating the average number of stress-incontinence episodes in 3 days will be compared within and between groups
Baseline and 8 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Survey evaluations of incontinence Pelvic Organ Prolapse Distress Inventory (POPDI-6)
Time Frame: Baseline, 4 weeks, 8 weeks, 6 months and 12 months
POPDI-6 to assess the impact that pelvic floor disorders have on the health related quality of life in women
Baseline, 4 weeks, 8 weeks, 6 months and 12 months
Patient Reported perception of general health Short Form-20 (SF-20)
Time Frame: Baseline, 4 weeks, 8 weeks, 6 months and 12 months
SF-20 survey on the participants perception of their general health.
Baseline, 4 weeks, 8 weeks, 6 months and 12 months
Self-reported adherence
Time Frame: 4 weeks, 8 weeks
Visual Analog Score for self-reported adherence to the prescribed therapy, 0% = did not adhere to the prescribed treatment regimen/did not perform any Pelvic Floor exercises to 100% = adhered to the prescribed treatment regimen
4 weeks, 8 weeks
Correlations between self-reported adherence and device reported adherence in the leva group
Time Frame: 4 weeks, 8 weeks
Self-reported adherence and Device-reported adherence in the Leva group will be correlated
4 weeks, 8 weeks
Incidence of Treatment-Emergent Adverse Events (Safety and tolerability)
Time Frame: Through study completion, an average of 1 year
Monitored for adverse events and serious adverse events
Through study completion, an average of 1 year
Feedback on perception of treatment - likelihood of recommending to a friend
Time Frame: 4 weeks, 8 weeks
Visual Analog Score of likelihood of recommending to a friend Scale from 0-100%. 0%= Will not recommend to a friend to 100%=Will definitely recommend to a friend.
4 weeks, 8 weeks
Feedback on perception of treatment - interest in surgical treatment
Time Frame: 4 weeks, 8 weeks
Visual Analog Score of interest in surgical treatment for urinary incontinence. Scale from 0-100%. 0%= Not interested at all in surgical treatment to 100%=Extremely interested in surgical treatment.
4 weeks, 8 weeks
Survey evaluations of incontinence Colorectal-Anal Distress Inventory-8 (CRADI-8)
Time Frame: Baseline, 4 weeks, 8 weeks, 6 months and 12 months
CRADI-8 to assess the impact that pelvic floor disorders have on the health related quality of life in women
Baseline, 4 weeks, 8 weeks, 6 months and 12 months
Survey evaluations of incontinence Pelvic Floor Distress Inventory (PFDI-20)
Time Frame: Baseline, 4 weeks, 8 weeks, 6 months and 12 months
PFDI-20 to assess the impact that pelvic floor disorders have on the health related quality of life in women
Baseline, 4 weeks, 8 weeks, 6 months and 12 months
Survey evaluations of incontinence Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-IR)
Time Frame: Baseline, 4 weeks, 8 weeks, 6 months and 12 months
PISQ-IR to assess the impact that pelvic floor disorders have on the health related quality of life in women
Baseline, 4 weeks, 8 weeks, 6 months and 12 months
Survey evaluations of incontinence Patient Global Impression of Severity (PGI-S)
Time Frame: Baseline, 4 weeks, 8 weeks, 6 months and 12 months
PGI-S is the participants description of how their urinary tract condition is currently.
Baseline, 4 weeks, 8 weeks, 6 months and 12 months
Survey evaluations of incontinence Patient Global Impression of Improvement (PGI-I)
Time Frame: 4 weeks, 8 weeks, 6 months and 12 months
PGI-I is the participants description on how their urinary symptoms are now, compared with how they were before they began the study.
4 weeks, 8 weeks, 6 months and 12 months
Survey evaluations of incontinence Pelvic Floor Impact Questionnaire (PFIQ)
Time Frame: Baseline, 4 weeks, 8 weeks, 6 months and 12 months
PFIQ to assess the impact that pelvic floor disorders have on the health related quality of life in women
Baseline, 4 weeks, 8 weeks, 6 months and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Renovia, Inc.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Alabama at Birmingham
OBVIO HEALTH USA, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Milena Weinstein, MD, Massachusetts General Hospital
  • Principal Investigator: Gena Dunnivan, MD, University of New Mexico
  • Principal Investigator: Noelani M Guaderrama, MD, Southern California Permanentae

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 23, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 5, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 7, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 11, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 9, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 8, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • OBVIO-REN-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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