The Effect of Footwear Generated Biomechanical Manipulation on Symptoms of Stress Urinary Incontinence
Condition: Pelvic Floor Disorders; Stress Urinary Incontinence
MeSH terms: Urinary Incontinence; Enuresis; Urinary Incontinence, Stress; Pelvic Floor Disorders
Study type: Interventional

Summary: 
      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.
    

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.
    

Intervention name(s): Footwear Generated Bio-Mechanical Manipulation (using shoes with pertupods) along with Traditional Pelvic Floor Therapy; Traditional Pelvic Floor Therapy
Intervention type(s): Device; Other
Intervention description(s): 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.; 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Single blinded (evaluator), single-center, randomized controlled trial Interventional and Control group.
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: FGBMM; LPSE; UDI - 6; UIQ - 7