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| Name | Class |
|---|---|
| Apos Medical and Sports Technology Ltd. | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Traditional Pelvic Floor Therapy | Active Comparator | up to six sessions, with one session every alternate week. |
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| FGBMM plus Traditional pelvic floor therapy | Experimental | Treatment with FGBMM using shoes with pertupods daily at home along with traditional pelvic floor therapy sessions. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Severity of Stress Urinary Incontinence | Improvement in symptoms of Stress Urinary Incontinence (SUI) measured by Urinary Distress Inventory) UDI - 6 questionnaire | Six months |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life as determined by the Urinary Impact Questionnaire (UIQ-7) | Change in Quality of Life from baseline will be determined with the use of the UIQ-7 questionnaire. Specifically, the UIQ-7 questionnaire is used to measure the impact of bladder, bowel, and vaginal symptoms on a woman's daily activities, relationships and emotions. The UIQ-7 is a subscale of the PFIQ-7 and consists of 7 questions related to urinary symptoms and its effect on function, social health, and mental health. Responses for each question range from 0 (=not at all) to 3 (=quite a bit). Scores are summarized. A lower score indicates less impact on quality of life based on urinary symptoms. |
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Inclusion Criteria:
Exclusion Criteria:
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.
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| Name | Affiliation | Role |
|---|---|---|
| Anna M Lasak, MD | Montefiore Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Montefiore Medical Center - Medical Park Campuses | The Bronx | New York | 10461 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28197646 | Background | Ng K, Cheung RYK, Lee LL, Chung TKH, Chan SSC. An observational follow-up study on pelvic floor disorders to 3-5 years after delivery. Int Urogynecol J. 2017 Sep;28(9):1393-1399. doi: 10.1007/s00192-017-3281-z. Epub 2017 Feb 14. | |
| 28346721 | Background | de Souza Abreu N, de Castro Villas Boas B, Netto JMB, Figueiredo AA. Dynamic lumbopelvic stabilization for treatment of stress urinary incontinence in women: Controlled and randomized clinical trial. Neurourol Urodyn. 2017 Nov;36(8):2160-2168. doi: 10.1002/nau.23261. Epub 2017 Mar 27. |
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Single blinded (evaluator), single-center, randomized controlled trial Interventional and Control group.
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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.
|
| 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. |
|
| Six months |
| Pelvic Floor Muscle Activity | Assessment of Pelvic Floor Muscle Activity by surface EMG (electromyography) | Six months |
| Gait assessment | Objective assessment of patient's gait measured by gait analysis equipment. | Six months |
| Adherence to treatment | Compliance to FGBMM and PFT using questionnaire. | Six months |
| 6 minute walk test | objective assessment using maximum distance comfortably walked in 6 minutes on a 100 foot closed course | Six months |
| Medication costs | changes in medication costs assessed by patient interview | six months |
| Healthcare utilization | Changes in healthcare facility utilization assessed by patient interview | six months |
| 25981205 | Background | Barzilay Y, Segal G, Lotan R, Regev G, Beer Y, Lonner BS, Mor A, Elbaz A. Patients with chronic non-specific low back pain who reported reduction in pain and improvement in function also demonstrated an improvement in gait pattern. Eur Spine J. 2016 Sep;25(9):2761-6. doi: 10.1007/s00586-015-4004-0. Epub 2015 May 16. |
| 27059833 | Background | Ghaderi F, Mohammadi K, Amir Sasan R, Niko Kheslat S, Oskouei AE. Effects of Stabilization Exercises Focusing on Pelvic Floor Muscles on Low Back Pain and Urinary Incontinence in Women. Urology. 2016 Jul;93:50-4. doi: 10.1016/j.urology.2016.03.034. Epub 2016 Apr 5. |
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| 26874810 | Background | Tahtinen RM, Cartwright R, Tsui JF, Aaltonen RL, Aoki Y, Cardenas JL, El Dib R, Joronen KM, Al Juaid S, Kalantan S, Kochana M, Kopec M, Lopes LC, Mirza E, Oksjoki SM, Pesonen JS, Valpas A, Wang L, Zhang Y, Heels-Ansdell D, Guyatt GH, Tikkinen KAO. Long-term Impact of Mode of Delivery on Stress Urinary Incontinence and Urgency Urinary Incontinence: A Systematic Review and Meta-analysis. Eur Urol. 2016 Jul;70(1):148-158. doi: 10.1016/j.eururo.2016.01.037. Epub 2016 Feb 10. |
| 24167010 | Background | Utomo E, Korfage IJ, Wildhagen MF, Steensma AB, Bangma CH, Blok BF. Validation of the Urogenital Distress Inventory (UDI-6) and Incontinence Impact Questionnaire (IIQ-7) in a Dutch population. Neurourol Urodyn. 2015 Jan;34(1):24-31. doi: 10.1002/nau.22496. Epub 2013 Oct 26. |
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| 21641268 | Background | Hides J, Stanton W, Mendis MD, Sexton M. The relationship of transversus abdominis and lumbar multifidus clinical muscle tests in patients with chronic low back pain. Man Ther. 2011 Dec;16(6):573-7. doi: 10.1016/j.math.2011.05.007. Epub 2011 Jun 8. |
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| ID | Term |
|---|---|
| D059952 | Pelvic Floor Disorders |
| D014550 | Urinary Incontinence, Stress |
| ID | Term |
|---|---|
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D011248 | Pregnancy Complications |
| D052801 | Male Urogenital Diseases |
| D014549 | Urinary Incontinence |
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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