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Functional Movement and Pelvic Floor Fitness

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Welcome

•  Bruce Crawford MD, FPMRS –  Board Certified Urogynecologist –  Director, Center for Pelvic Floor Medicine –  CEO, Insight Biodesign LLC

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Pelvic Floor Disorders

•  Bladder Control Problems •  Bowel Control Problems •  Sexual Dysfunction •  Pelvic Organ Prolapse

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Bladder Control Problems

•  Stress Urinary Incontinence –  20% adult female population –  10% risk of surgery

•  Overactive Bladder –  15 – 25% adult population –  Same for Men as for Women –  Huge impact on QOL

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Bowel Control Problems

•  Anal Incontinence –  10% adult female population

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Pelvic Organ Prolapse

•  POP (cystocele, uterine prolapse, rectocele) –  42% of women ages 40 – 60

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Evidence Based Medicine •  Lancet. 2014 Mar 1;383(9919):796-806. doi: 10.1016/S0140-6736(13)61977-7. Epub 2013 Nov 28. •  Individualised pelvic floor muscle training in women with pelvic organ prolapse (POPPY): a multicentre randomised

controlled trial. •  Hagen S1, Stark D2, Glazener C3, •  Lancet. 2014 Jul 5;384(9937):28. •  Pelvic organ prolapse is common and is strongly associated with childbirth and increasing age. Women with prolapse are

often advised to do pelvic floor muscle exercises, but evidence supporting the benefits of such exercises is scarce. We aimed to establish the effectiveness of one-to-one individualised pelvic floor muscle training for reducing prolapse symptoms.

•  METHODS: •  We did a parallel-group, multicentre, randomised controlled trial at 23 centres in the UK, one in New Zealand, and one in

Australia, between June 22, 2007, and April 9, 2010. Female outpatients with newly-diagnosed, symptomatic stage I, II, or III prolapse were randomly assigned (1:1), by remote computer allocation with minimsation, to receive an individualised programme of pelvic floor muscle training or a prolapse lifestyle advice leaflet and no muscle training (control group). Outcome assessors, and investigators who were gynaecologists at trial sites, were masked to group allocation; the statistician was masked until after data analysis. Our primary endpoint was participants' self-report of prolapse symptoms at 12 months. Analysis was by intention-to-treat analysis. This trial is registered, number ISRCTN35911035.

•  FINDINGS: •  447 eligible patients were randomised to the intervention group (n=225) or the control group (n=222). 377 (84%) participants

completed follow-up for questionnaires at 6 months and 295 (66%) for questionnaires at 12 months. Women in the intervention group reported fewer prolapse symptoms (ie, a significantly greater reduction in the pelvic organ prolapse symptom score [POP-SS]) at 12 months than those in the control group (mean reduction in POP-SS from baseline 3.77 [SD 5.62] vs 2.09 [5.39]; adjusted difference 1.52, 95% CI 0.46-2.59; p=0.0053). Findings were robust to missing data. Eight adverse events (six vaginal symptoms, one case of back pain, and one case of abdominal pain) and one unexpected serious adverse event, all in women from the intervention group, were regarded as unrelated to the intervention or to participation in the study.

•  INTERPRETATION: One-to-one pelvic floor muscle training for prolapse is effective for improvement of prolapse symptoms. Long-term benefits should be investigated, as should the effects in specific subgroups.

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Pelvic Floor Disorders

•  Bladder Control Problems 25% •  Bowel Control Problems 10% •  Pelvic Organ Prolapse 42%

–  Total Prevalence May Be 50 – 60% of Adult Female Population

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Treatment of Pelvic Floor Disorders

•  Bladder Control Problems –  Kegel’s –  Medications (anticholinergics, β3 Agonist) –  PTNS –  Surgery

•  Bowel Control Problems –  Kegel’s –  Fiber –  Solesta –  Surgery

•  Pelvic Organ Prolapse –  Kegel’s –  Pessary Device –  Surgery

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Treatment of Pelvic Floor Disorders

•  Bladder Control Problems –  Kegel’s –  Medications (anticholinergics, β3 Agonist) –  PTNS –  Surgery

•  Bowel Control Problems –  Kegel’s –  Fiber –  Solesta –  Surgery

•  Pelvic Organ Prolapse –  Kegel’s –  Pessary Device –  Surgery

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Bladder Control is a Fitness Issue

•  Arnold Kegel

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Bladder Control is a Fitness Issue

•  Joseph Pilates

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Exercise Physiology

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Pilates

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www.pfilates.com

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Video EMG Synchronization – Clinical Instrument

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VESy Clip

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Our New Model : Mobile VESy Pfilates

•  Centralization of VESy Pfilates Services •  Frictionless Introduction of VESy Pfilates

•  Drivers –  Clinical Need –  Surgical Liability –  Passive Income for Host Practices

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Balance Sheet

Monthly Gross Revenue (8 patients/week) $10,080.00

Expenses (4,704) Net Revenue $ 5,376.00

$ 64,512.00 Income Annually

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Mobile VESy Pfilates

•  The Science •  The Mechanics •  The Administration

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VESy Pfilates The Science

•  The Pfilates Data •  VESy Lab Data •  Clinical Data

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Average Difference From Isolated Pelvic Floor Contraction

0.00%

10.00%

20.00%

30.00%

40.00%

50.00%

60.00%

70.00%

80.00%

90.00%

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Series1

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Ranking of Pfilates Movements

Rank Movement AverageDifferenceFromIsolatedCTN

Range(%)

1 Lunges 81.1% -5.6–350

2 Bridge 66.2% -33–247

3 Squat 50.9% -14–185

4 Hovering 49.0% -28–175

5 BuKerfly 24.1% -16–123

6 SideLayingStraightLegCircle 21.1% -29–116

7 Corkscrew 17.7% -38–116

8 CatintoCow 12.2% -34-97

9 SideLayingbentkneeliQ 7.9% -35–118

10 All4’sbentkneeliQ 2.9% -39–77

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Posi%on Movements

Standing 2(strong)

SideLaying 2(weak)

Supine 3(mixed)

Kneeling 1(Strong)

All4s 2(weak)

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0.00%

10.00%

20.00%

30.00%

40.00%

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60.00%

70.00%

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Series1

The Essential Pfilates Concept

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The Essential Pfilates

•  Lunge •  Squat •  Bridge •  Hovering

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Application of the VESy Data

•  Decision Making Regarding Assignment of Movements •  Time/Effort Spent on a Given Movement

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Probability In Top 3

76.92%

46.15%

11.54%7.69%

3.85%

76.92%

7.69%

84.62%

11.54%

3.85%

0.00%

10.00%

20.00%

30.00%

40.00%

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Series1

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Optimization Using VESy

-50.00%

0.00%

50.00%

100.00%

150.00%

200.00%

250.00%

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Clinical Data TheVideo-EMGSynchronizationMethodofPelvicFloorRehabilitationisAssociatedwithImprovementinLowerUrinaryTractSymptomsandPelvicFloorStrength

Crawford,BruceMD.,Noia,CarolRMA.

Objective:Toassessclinicalresponsetoa4weekprogramofpelvicfloorrehabilitationusingthePfilatesMethodincombinationwithVideo-EMGSynchronization(VESy)foroptimizationofeachpatientshomeexerciseprogram.

Methods:RetrospectivechartreviewofpatientsparticipatinginpelvicfloorrehabilitationthroughtheCenterforPelvicFloorMedicinebetween2012and2013.

TheVESy/PfilatesMethod

EachpatientreceivedthePfilatesDVDatleast1weekpriortothestartoftheprogram.Patientsunderwentaninitial,seated,twochannel,pelvicfloorbiofeedbacksessiontodeterminetheirabilitytoperformavoluntarypelvicfloorcontraction.Subsequentlypatientsunderwentbaselinepelvicfloormanometryusingavaginalballoonprobe.EachsubjectthenparticipatedinaVESysessionconsistingof4channelwirelessEMG(pelvicfloor,gluteals,abdominals,lowerextremityadductors)synchronizedtovideo.Tenvideo-EMGclipswererecorded(oneforeachofthe10Pfilatesmovements)andanalyzedtodeterminethethreemovementsthatprovidedthegreatestpelvicfloorengagementandcoordination.Thesethreeclipsweremadeavailabletopatientsonlineand“reminder”emailsweresentondays1,3,5,10,and18.Patientsfollowedupafter4weeksforafinalmanometryandquestionerassessment.

Results:38chartswereselectedforreview.100%ofpatientscompletedthefirstthreevisitsand69%returnedattheendof4weeksforafinalassessment.Twenty-fivepatientscompletedpreandpostpelvicfloormanometry.Eighteenpatientscompletedpreandpostbladdersymptomquestioners(UDI-6).Twelvepatientsprovidedanestimateofglobalimprovementinlowerurinarytractfunction.Themeanimprovementinpelvicfloorstrength,asestimatedusingvaginalballoonmanometry,was33%(13.2–16.9cmH2O,p=.006).ThemeanimprovementinUDI-6scorewas33%(9.3–6.3,p=.001).Amongpatientswithascoregreaterthan0onpreUDI-6(n=10)theaverageimprovementinoverallbladdersymptomswas74%atthe4weekfollowupvisit.

Conclusions:CompletionoftheVESy/Pfilatesprogramofpelvicfloorrehabilitationisassociatedwithshorttermimprovementinpelvicfloorstrengthandbladdersymptoms.

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Clinical Data

•  25 Subjects •  Pelvic Floor Strength: 33% improvement (p=.006) •  UDI-6 Score: 33% improvement (p=.001) •  Global Assessment Score: 74% Improvement at week 6

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Mobile VESy Pfilates The Mechanics

Week 1 Pelvic Floor EMG (Initial Assessment)

assessment of endurance and coordination Week 2 Pelvic Floor Manometry

baseline strength assessment Week 3 VESy Optimization

modified gait analysis to identify “best movements” introduction of vesylab.com

Week 7 Pelvic Floor Manometry (Reassessment)

3d bladder diary UDI-6, IIQ 7

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Mobile VESy Pfilates The Mechanics

Ø  Week 1 Pelvic Floor EMG (Initial Assessment)

assessment of endurance and coordination

Week 2 Pelvic Floor Manometry baseline strength assessment

Week 3 VESy Optimization modified gait analysis to identify “best movements” introduction of vesylab.com

Week 7 Pelvic Floor Manometry (Reassessment) 3d bladder diary UDI-6, IIQ 7

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Pelvic Floor EMG

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Mobile VESy Pfilates The Mechanics

Week 1 Pelvic Floor EMG (Initial Assessment) assessment of endurance and coordination

Ø  Week 2 Pelvic Floor Manometry

baseline strength assessment

Week 3 VESy Optimization modified gait analysis to identify “best movements” introduction of vesylab.com

Week 7 Pelvic Floor Manometry (Reassessment) 3d bladder diary UDI-6, IIQ 7

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Pelvic Floor Manometry

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Mobile VESy Pfilates The Mechanics

Week 1 Pelvic Floor EMG (Initial Assessment) assessment of endurance and coordination

Week 2 Pelvic Floor Manometry baseline strength assessment

Ø  Week 3 VESy Optimization

modified gait analysis to identify “best movements” introduction of vesylab.com

Week 7 Pelvic Floor Manometry (Reassessment) 3d bladder diary UDI-6, IIQ 7

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Mobile VESy Pfilates The Mechanics

Week 1 Pelvic Floor EMG (Initial Assessment) assessment of endurance and coordination

Week 2 Pelvic Floor Manometry baseline strength assessment

Week 3 VESy Optimization modified gait analysis to identify “best movements” introduction of vesylab.com

Ø  Week 7 Pelvic Floor Manometry (Reassessment)

3d bladder diary UDI-6, IIQ 7

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Mobile VESy Pfilates: Administration

•  We Provide –  Contracting with Providers and PTs –  Billing and Collections Support (coding, prior authorization) –  Pfilates Kits, Folders, Questionnaires –  Access to vesylab.com (19.99/mo) –  All Clinical Documentation –  Appointment Confirmation

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Mobile VESy Pfilates: Administration

•  You Provide:

–  Scheduling –  Billing, Prior Authorization (if needed) –  Facility (minimum 10 x 10 room, exam table)

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Getting Going

1.  Contracting with Insight Biodesign LLC 2.  Join vesylab.com 3.  Select Start Date