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

Sponsor

Montefiore Medical Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT03194789

Collaborator

Apos Medical and Sports Technology Ltd. (Industry)

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Condition or Disease	Intervention/Treatment	Phase
Pelvic Floor Disorders Stress Urinary Incontinence	Device: Footwear Generated Bio-Mechanical Manipulation (using shoes with pertupods) along with Traditional Pelvic Floor Therapy Other: Traditional Pelvic Floor Therapy	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

64 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Single blinded (evaluator), single-center, randomized controlled trial Interventional and Control group.Single blinded (evaluator), single-center, randomized controlled trial Interventional and Control group.

Masking:

Single (Outcomes Assessor)

Masking Description:

Randomized single blinded (evaluator) controlled trial. The outcomes assessor will be masked in the study. Assessor will be independent of randomization, trial coordination and care providers.

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Nov 29, 2017

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Jun 30, 2023

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Severity of Stress Urinary Incontinence [Six months]
Improvement in symptoms of Stress Urinary Incontinence (SUI) measured by Urinary Distress Inventory) UDI - 6 questionnaire

Secondary Outcome Measures

Quality of life [Six months]
Assessed with a questionnaire Urinary Impact Questionnaire (UIQ-7)
Pelvic Floor Muscle Activity [Six months]
Assessment of Pelvic Floor Muscle Activity by surface EMG (electromyography)
Gait assessment [Six months]
Objective assessment of patient's gait measured by gait analysis equipment.
Adherence to treatment [Six months]
Compliance to FGBMM and PFT using questionnaire.
6 minute walk test [Six months]
objective assessment using maximum distance comfortably walked in 6 minutes on a 100 foot closed course
Medication costs [six months]
changes in medication costs assessed by patient interview
Healthcare utilization [six months]
Changes in healthcare facility utilization assessed by patient interview

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.