The Effect of Footwear Generated Biomechanical Manipulation on Symptoms of Stress Urinary Incontinence (SUI)

February 2, 2024 updated by: Montefiore Medical Center
FGBMM (footwear generated biomechanical manipulation) effects neuromuscular patterns of pelvic muscles. While there have been no published studies to our knowledge investigating the effect of FGBMM on urinary incontinence, FGBMM causes perturbations in balance and gait that create dynamics similar to dynamic lumbosacral stabilization exercises. The investigators propose that FGBMM induces the same bio-mechanical improvements as LPSE (lumbopelvic stabilization exercises) which have shown benefit for incontinence. Instead of instructing patients to co-contract the lower trunk and pelvic floor muscles as commonly done for LPSE, the shoes used in FGBMM can be calibrated in a way that causes this co-contraction to occur without the patient realizing. Beneficial pelvis and spine positioning can also be accomplished by strategic placement of the pods without having to instruct the patient on complicated maneuvers. Capitalizing on the excellent adherence and clinical benefits of FGBMM on related conditions, the investigators propose to evaluate the effects of FGBMM in addition to pelvic floor therapy for improving the symptoms of stress urinary incontinence in an urban inner city population.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

FGBMM (footwear generated biomechanical manipulation) effects neuromuscular patterns of pelvic muscles. While there have been no published studies to our knowledge investigating the effect of FGBMM on urinary incontinence, FGBMM has been shown to cause perturbations in balance and gait that create dynamics similar to dynamic lumbosacral stabilization exercises. In support of this theory, although not published, one of the founders of the technique, Avi Elbaz, has noted anecdotal evidence that patients who had SUI (stress urinary incontinence) and underwent FGBMM for knee or low back pain reported improvement of incontinence. The investigators propose that FGBMM induces the same bio-mechanical improvements as LPSE (lumbopelvic stabilization exercises) which have shown benefit for incontinence. The pods on the footwear can be positioned to challenge the patients balance in a manner similar to the way trampolines are utilized in LPSE. Instead of instructing patients to co-contract the lower trunk and pelvic floor muscles as commonly done for LPSE, the shoes used in FGBMM can be calibrated in a way that causes this co-contraction to occur without the patient realizing. Beneficial pelvis and spine positioning can also be accomplished by strategic placement of the pods without having to instruct the patient on complicated maneuvers. An additional advantage of FGBMM is that this exercise is done with increased intra-abdominal pressure mimicking the condition and the setting when incontinence occurs rather than static exercise that is used in PFT. While performing regular activities, people are naturally squatting and doing other activities that increase intra-abdominal pressure. Furthermore, FGBMM is more practical for people with busy schedules because it can be accomplished with a much smaller time commitment from the patient than traditional PFT since it is done during normal activity. Capitalizing on the excellent adherence and clinical benefits of FGBMM on related conditions, the investigators propose to evaluate the effects of FGBMM in addition to pelvic floor therapy for improving the symptoms of stress urinary incontinence in an urban inner city population.

A potential use of FGBMM using shoes as a addition to traditional pelvic floor therapy may yield a more effective therapy with better adherence. Problems with traditional therapy include poor patient adherence (patients often do not complete the sessions and have poor adherence (about 50%), lack of the continuation in an ongoing program, leading to relapse and need for re treatment or even little clinical benefit. Additionally, access to pelvic floor therapy is limited for many patients since there are not enough available outpatient therapy services to meet the needs of all patients. Finding an additional exercise program that will increase adherence and improve patient outcomes with better clinical benefits is a high priority from both patient care and cost management perspectives.

FGBMM using shoes potentially overcomes many of these issues with improving/modifying abnormal biomechanics of pelvic floor muscles (therefore decreasing incontinence), and a home based exercise program utilizing footwear that causes exercise with normal activity by promoting perturbation. This bio-mechanical approach may significantly improve the symptoms of urinary incontinence in patients with Stress SUI or Mixed urinary incontinence. Capitalizing on the reported excellent adherence and clinical benefit of FGBMM in patients with related conditions, the investigators propose to evaluate the bio-mechanical exercise (wearing an appropriately calibrated shoe at home for a prescribed amount of time each day) as a conservative treatment that may supplement traditional pelvic floor therapy, medications and even surgical intervention for the same in an inner urban city population.

Study Type

Interventional

Enrollment (Actual)

55

Phase

  • 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 Contact

Study Contact Backup

Study Locations

  • United States
    • New York
      • Bronx, New York, United States, 10461
        • Montefiore Medical Center - Medical Park Campuses

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

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Stress or Mixed Urinary Incontinence, based on UDI-6.
  • Females between the ages of 18-75 years.
  • Weight less than 350 lbs.
  • Ambulatory and active patients that can participate in a rehabilitation program that includes daily walking
  • Able to walk at least 50 meters and scored positive on the STEADI test
  • Able to understand, read and sign the informed consent form
  • English or Spanish speaking

Exclusion Criteria:

  • Prior surgery for incontinence
  • Pelvic Floor Therapy within past 6 months.
  • Currently pregnant
  • Predominantly Urge Incontinence.
  • Patients with more than 3 falls in the last 52 weeks, OR any balance related fall with an injury in the last 52 weeks.
  • Patients exhibiting a lack of physical or mental ability to perform or comply with the study procedure.
  • Patients with a history of pathological osteoporotic fracture
  • Any major cardiovascular comorbidities prohibiting enrollment in an active exercise program
  • Active heart disease (ischemia or heart failure admissions within 24 weeks) and Active COPD (exacerbation within 24 weeks)
  • Active malignancies on ongoing treatment
  • Patient with neurological gait pattern.
  • Patient requiring assistive device during gait analysis.

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Traditional Pelvic Floor Therapy
up to six sessions, with one session every alternate week.
Other: Traditional Pelvic Floor Therapy
Participant will receive traditional pelvic floor therapy of six sessions, up-to one sessions every alternate week. This will involve exercise and modalities as decided by medical providers and therapists. Participants will also have a home exercise program prescribed along with each session and for the remainder of six months.
Experimental: FGBMM plus Traditional pelvic floor therapy
Treatment with FGBMM using shoes with pertupods daily at home along with traditional pelvic floor therapy sessions.
Device: Footwear Generated Bio-Mechanical Manipulation (using shoes with pertupods) along with Traditional Pelvic Floor Therapy
Participants will have FGBMM using shoes with pertupods along with traditional pelvic floor therapy over the course of six months. This will include five sessions of gait assessment and re-calibration with daily at home exercise with the device (shoes) over the course of six months. Along with that, participant will receive traditional pelvic floor therapy of six sessions, up-to one sessions every alternate week. This will involve exercise and modalities as decided by medical providers and therapists. Participants will also have a home exercise program prescribed along with each session and for the remainder of six months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Severity of Stress Urinary Incontinence
Time Frame: Six months
Improvement in symptoms of Stress Urinary Incontinence (SUI) measured by Urinary Distress Inventory) UDI - 6 questionnaire
Six months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pelvic Floor Muscle Activity
Time Frame: Six months
Assessment of Pelvic Floor Muscle Activity by surface EMG (electromyography)
Six months
Gait assessment
Time Frame: Six months
Objective assessment of patient's gait measured by gait analysis equipment.
Six months
Adherence to treatment
Time Frame: Six months
Compliance to FGBMM and PFT using questionnaire.
Six months
6 minute walk test
Time Frame: Six months
objective assessment using maximum distance comfortably walked in 6 minutes on a 100 foot closed course
Six months
Medication costs
Time Frame: six months
changes in medication costs assessed by patient interview
six months
Healthcare utilization
Time Frame: six months
Changes in healthcare facility utilization assessed by patient interview
six months
Quality of Life as determined by the Urinary Impact Questionnaire (UIQ-7)
Time Frame: Six months
Change in Quality of Life from baseline will be determined with the use of the UIQ-7 questionnaire. Specifically, the UIQ-7 questionnaire is used to measure the impact of bladder, bowel, and vaginal symptoms on a woman's daily activities, relationships and emotions. The UIQ-7 is a subscale of the PFIQ-7 and consists of 7 questions related to urinary symptoms and its effect on function, social health, and mental health. Responses for each question range from 0 (=not at all) to 3 (=quite a bit). Scores are summarized. A lower score indicates less impact on quality of life based on urinary symptoms.
Six months

Collaborators and Investigators

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

Sponsor

Montefiore Medical Center

Collaborators

Apos Medical and Sports Technology Ltd.

Investigators

  • Principal Investigator: Anna M Lasak, MD, Montefiore Medical Center

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)

November 29, 2017

Primary Completion (Actual)

December 12, 2023

Study Completion (Actual)

December 12, 2023

Study Registration Dates

First Submitted

June 19, 2017

First Submitted That Met QC Criteria

June 20, 2017

First Posted (Actual)

June 21, 2017

Study Record Updates

Last Update Posted (Estimated)

February 6, 2024

Last Update Submitted That Met QC Criteria

February 2, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016-7163

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Undecided about sharing the data.

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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