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

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.

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.