An Examination of the

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• An Examination of the
• Blue Cross/Blue Shield
• Biofeedback Technology
• Assessment Report (TAR)

John D. Perry, PhD AAPB Representative
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Required Financial Disclosure

• Inventor of EMG vaginal sensor (1975)
  Quarter-century of personal investment
• Senior Fellow Biofeedback Certification
  Institute of America (BCIA)
• Since 1994, 100 of my income has come from EMG
  Sensor royalties
• AAPB received a grant from Thought Technology
  Ltd. to cover my expenses

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Overview

• Based on selective literature review
• Cited papers contradict TAR conclusion
• TARs academic objective is of debatable value in
  the real world

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TARs Objective

• ...to determine whether adding biofeedback as an
  aid to performing pelvic muscle exercise results
  in a greater improvement in urinary incontinence,
  as compared to pelvic muscle exercises alone.

Is Narrow (PME vs. PMEBFB) Compared with Broad
PFES Objective to determine whether PFES
improves health outcomes of patients with
urinary incontinence.
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Is the TAR Objective Relevant?

• Continence therapy is typically staged, starting
  with PME and progressing to biofeedback
• HCFAs present (regional) policies for
  biofeedback call for the exclusion of patients
  who have not yet failed PME Alone

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TAR Conclusion

• the evidence is not sufficient to
  demonstrate an additional benefit for biofeedback
  above that obtained by PME alone.

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Is PME alone effective?

• TAR claims
• several controlled trials of PME exist and
  collectively these trials establish the
  effectiveness of PME. (p.4)

But they cited only two studies 1. Wells et al
1991 (79 Sx ?) 2. Burns et al 1993 (54 Sx ?)
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1. Wells et al 1991 (79 Sx ?)
The PME Alone group actually included? 7
monthly vaginal palpations (with verbal
biofeedback) ? 7 monthly EMG evaluations
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2. Burns et al 1993 (54 Sx ?)

• PME Alone group actually included two EMG
  evaluations (pre- and post-treatment) using a
  biofeedback instrument with an EMG sensor
  (below)

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In Contrast, PME Alone is far less effective

• PME Alone defined asVerbal instruction only,
  with no hands on biofeedback and no EMG testing
  
• 27 Sx ?
• Sampselle et al (March 2000)

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Stress Inc. No Sig. Dif.
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Stress Inc. Sig. Dif. but
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Urge Incontinence

• Burton et al, 1988, is cited as finding no sig.
  dif. between BFB and PME alone.
• But Burton called his control group behavioral
  treatment 11 Urge patients got bladder training
  and 3 Stress patients got PME instruction.
  Outcomes are not shown by treatment.
• Burton does not qualify for inclusion in this
  PMEBFB vs. PME-Alone report.
• A study that should have qualified for inclusion,
  Burgio 1998, got 81 Symptom Improvement

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Levels of Pelvic Muscle Exercise
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In Historical Perspective

• TAR asks about the benefits of adding Biofeedback
  to PME Alone but
• Historically, PME Alone results from
  subtracting Biofeedback from Kegels original
  training program (1948)

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Historical Origin of PME

• Arnold Kegel, the gynecologist who invented PME,
  conceived and practiced his method as
  instrument-assisted exercises

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Kegels patients were required to keep records
of their biofeedback results
Am. J. Obst. Gynec. 36(2) 1948
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Summary

• TAR is an evaluation NOT of technology, but of
  research design
• Examination of even the cited papers contradicts
  TAR conclusion
• Real-world decisions must be based on the best
  available evidence
• Biofeedback is Breakthrough Technology

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What is Biofeedbacks Added Value?

• Results in 6 weeks, not 6 months
• Increases patient awareness of differences in
  muscle state
• Ensures that exercises are done correctly
• Provides structure for clinical exercise program
• Provides documentation