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

NCT03194789 | Completed FDA Device

• 1 other identifier: 2016-7163
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

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.

Conditions

Pelvic Floor Disorders; Stress Urinary Incontinence

Keywords

FGBMM; LPSE; UDI - 6; UIQ - 7

Outcome Measures

Primary Outcomes (1)

• Severity of Stress Urinary Incontinence

  Improvement in symptoms of Stress Urinary Incontinence (SUI) measured by Urinary Distress Inventory) UDI - 6 questionnaire

  Six months

Secondary Outcomes (7)

• Quality of Life as determined by the Urinary Impact Questionnaire (UIQ-7)

  Six months

• Pelvic Floor Muscle Activity

  Six months

• Gait assessment

  Six months

• Adherence to treatment

  Six months

• 6 minute walk test

  Six months

Study Arms (2)

Traditional Pelvic Floor Therapy

ACTIVE COMPARATOR

up to six sessions, with one session every alternate week.

Other: Traditional Pelvic Floor Therapy

FGBMM plus Traditional pelvic floor therapy

EXPERIMENTAL

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

Interventions

Footwear Generated Bio-Mechanical Manipulation (using shoes with pertupods) along with Traditional Pelvic Floor Therapy DEVICE

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.

FGBMM plus Traditional pelvic floor therapy

Traditional Pelvic Floor Therapy OTHER

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.

Traditional Pelvic Floor Therapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Gender Eligibility Details: 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.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Montefiore Medical Center: lead
• Apos Medical and Sports Technology Ltd.: collaborator

Study Sites (1)

Montefiore Medical Center - Medical Park Campuses

The Bronx, New York, 10461, United States

Location

Related Publications (29)

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MeSH Terms

Conditions

Pelvic Floor Disorders; Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Pregnancy Complications; Male Urogenital Diseases; Urinary Incontinence; Urination Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Anna M Lasak, MD

  Montefiore Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: June 19, 2017
• First Posted: June 21, 2017
• Study Start: November 29, 2017
• Primary Completion: December 12, 2023
• Study Completion: December 12, 2023
• Last Updated: February 6, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)