1. The BC/BS TEC Review of Pelvic Floor Electrical Stimulation in the Treatment of Urinary Incontinence John D. Perry, PhD AAPB Representative

2. Is E-Stim a Drug? AHCPR decreed incontinence treatments were either (1)Surgery, or (2)Pharmaceuticals, or (3)Behavioral Interventions; What is Electrical Simulation?

3. Clinician Characteristics: (1) Surgery Success of any surgical procedure depends on operator expertise…Prospective comparisons often include different surgeons with different degrees of experience and expertise. (1992, p. 48)

4. Clinician Characteristics: (2) Pharmaceuticals Personal qualities of the clinician are not relevant; drugs must be proven (to FDA) to be effective regardless of the clinicians or the patients belief system.

5. Clinician Characteristics: (3) Behavioral All behavioral techniques involve educating the patient and providing positive reinforcement for effort and progress (p.27) …require personal (and caregiver) involvement and continued practice. If motivated, most people…show improvement…(p. 28) [These do not apply to E-Stim]

6. Is E-Stim a Drug? 1.It certainly isnt surgery 2.It isnt behavioral therapy 3.It works like a drug – regardless of patient efforts or beliefs. Therefore, we should either treat it like a drug, or establish a new fourth category.

7. Effectiveness of E-stim vs. Placebo StudyDiary SxPads Grm Sand 199530%66% Luber 199714%-- Laycock 1993--66% Brubaker 1997No change Yamanishi 199733%56%

8. Effectiveness of E-stim vs. Alternatives StudyDiary SxPads Grm Bo 199930%13% Smith 199653%-- Olah 199160%-- Laycock 1993No data Hahn 1991--34%

9. Effectiveness of E-stim vs. Alternatives StudyDiary (Sx)Pads (Grm) Blowman 1991 (n=7) 100% (with PME) -- Smith 199659%-- Moore 1999--66% (with PME) Overall Averages for Stim studies 47% improvement 50% improvement

10. How Effective is 50%? (Burns moderate = 12/week) BEFOREAFTER

11. TEC PFES Conclusion (1) STRESS UI: …literature does not provide strong and consistent evidence that PFES reduces the frequency of incontinent episodes. (27)

12. TEC PFES Conclusion (2) URGE UI: No conclusions can be drawn from either trial (29) Post-Prostate: …does not demonstrate that the addition of PFES to PME improves outcome…(29)

13. Conclusion The Association for Applied Psychophysiology and Biofeedback (AAPB) ARGREES with the major conclusions of the TEC report on PFES. In addition, we question spending public funds for a technique which is decidedly less effective than other readily available alternatives, namely, biofeedback.