1. An Examination of the Blue Cross/Blue Shield Biofeedback Technology Assessment Report (TAR) John D. Perry, PhD AAPB Representative

2. 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

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

4. 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. PME+BFB) Compared with Broad PFES Objective: …to determine whether PFES improves health outcomes of patients with urinary incontinence.

5. 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

6. TAR Conclusion … the evidence is not sufficient to demonstrate an additional benefit for biofeedback above that obtained by PME alone.

7. 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 )

8. 1. Wells et al 1991 (79% Sx ) The PME Alone group actually included: 7 monthly vaginal palpations (with verbal biofeedback) 7 monthly EMG evaluations

9. 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)

10. In Contrast, PME Alone is far less effective PME Alone defined as: Verbal instruction only, with no hands on biofeedback and no EMG testing 27% Sx Sampselle et al (March 2000)

11. Stress Inc. = No Sig. Dif. StudyOutcome BFB-PME Blue Cross Review Biofeedback Quality Review Burns 1993 61 – 54% Least Prone to bias Poor Quality: untrained; PME got 2 EMGs Berghmans 1996 53 – 60% Least Prone to bias Poor Quality; stim electrode; PMEs got vag palp. & verbal feedback Ceresoli 1993 62 – 60% Potential Bias Poor Quality; 6 vs. 13 weeks

12. Stress Inc. = Sig. Dif. but… StudyOutcome BFB–PME Blue Cross Review Biofeedback Quality Burgio 1986 80 – 51%Potential Bias Excellent; but PMEs got vag. Palp. & verbal biofeedback Glavind 1986 91 – 22%Potential Bias Excellent Shepherd 1983 83 – 25% Potential Bias, no sig. test Excellent, used home trainers like Kegel

13. 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 PME+BFB vs. PME-Alone report. A study that should have qualified for inclusion, Burgio 1998, got 81% Symptom Improvement

14. Levels of Pelvic Muscle Exercise Written instruction 27% Sampselle 2000 Add Vaginal Palpation and verbal feedback 51 - 60% Berghmans 1996; Burgio 1986 Add EMG testing 54 - 77% Burns 1993, Wells 1991 Add formal biofeedback training 80 - 94% Burgio 1998, 1986; Sussett, Kegel, etc.

15. 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)

16. Historical Origin of PME Arnold Kegel, the gynecologist who invented PME, conceived and practiced his method as instrument-assisted exercises 1956

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

18. 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

20. 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