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

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ClinicalTrials.gov Identifier: NCT03194789
Recruitment Status : Recruiting
First Posted : June 21, 2017
Last Update Posted : November 17, 2020
Sponsor:
Collaborator:
Apos Medical and Sports Technology Ltd.
Information provided by (Responsible Party):
Anna Lasak, Montefiore Medical Center

Tracking Information
First Submitted Date  ICMJE June 19, 2017
First Posted Date  ICMJE June 21, 2017
Last Update Posted Date November 17, 2020
Actual Study Start Date  ICMJE November 29, 2017
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 20, 2017)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 20, 2017)
  • Quality of life [ Time Frame: Six months ]
    Assessed with a questionnaire Urinary Impact Questionnaire (UIQ-7)
  • Pelvic Floor Muscle Activity [ Time Frame: Six months ]
    Assessment of Pelvic Floor Muscle Activity by surface EMG (electromyography)
  • Gait assessment [ Time Frame: Six months ]
    Objective assessment of patient's gait measured by gait analysis equipment.
  • Adherence to treatment [ Time Frame: Six months ]
    Compliance to FGBMM and PFT using questionnaire.
  • 6 minute walk test [ Time Frame: Six months ]
    objective assessment using maximum distance comfortably walked in 6 minutes on a 100 foot closed course
  • Medication costs [ Time Frame: six months ]
    changes in medication costs assessed by patient interview
  • Healthcare utilization [ Time Frame: six months ]
    Changes in healthcare facility utilization assessed by patient interview
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of Footwear Generated Biomechanical Manipulation on Symptoms of Stress Urinary Incontinence
Official Title  ICMJE The Effect of Footwear Generated Biomechanical Manipulation on Symptoms of Stress Urinary Incontinence
Brief 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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)
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
Condition  ICMJE
  • Pelvic Floor Disorders
  • Stress Urinary Incontinence
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • Active Comparator: Traditional Pelvic Floor Therapy
    up to six sessions, with one session every alternate week.
    Intervention: Other: Traditional Pelvic Floor Therapy
  • Experimental: FGBMM plus Traditional pelvic floor therapy
    Treatment with FGBMM using shoes with pertupods daily at home along with traditional pelvic floor therapy sessions.
    Intervention: Device: Footwear Generated Bio-Mechanical Manipulation (using shoes with pertupods) along with Traditional Pelvic Floor Therapy
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 20, 2017)
64
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 30, 2022
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Gender Eligibility Description: The investigators traditionally see stress urinary incontinence patients, most commonly females, in our clinics everyday. The investigators only have about one patient visit per month in our clinics as 'males with same disorder.' To get a significant number of male patients in our study with the same condition will need at least 7-10 years approximately.
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Atira H. Kaplan, MD 917-331-0611 akaplan@montefiore.org
Contact: Anna M. Lasak, MD 718-920-9171 alasak@montefiore.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03194789
Other Study ID Numbers  ICMJE 2016-7163
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: Undecided about sharing the data.
Responsible Party Anna Lasak, Montefiore Medical Center
Study Sponsor  ICMJE Montefiore Medical Center
Collaborators  ICMJE Apos Medical and Sports Technology Ltd.
Investigators  ICMJE
Principal Investigator: Anna M. Lasak, MD Montefiore Medical Center
PRS Account Montefiore Medical Center
Verification Date November 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP