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

NCT03194789 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 55

Last updated 2024-02-06

No results posted yet for this study

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.

Conditions

  • Pelvic Floor Disorders
  • Stress Urinary Incontinence

Interventions

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.

Sponsors & Collaborators

  • Apos Medical and Sports Technology Ltd.

    collaborator INDUSTRY

  • Montefiore Medical Center

    lead OTHER

Principal Investigators

  • Anna M Lasak, MD · Montefiore Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-29
Primary Completion
2023-12-12
Completion
2023-12-12
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03194789 on ClinicalTrials.gov