The BC/BS TEC Review

of Pelvic Floor Electrical

Stimulation in the Treatmentof Urinary

IncontinenceJohn D. Perry, PhD

AAPB Representative

Is E-Stim a Drug?

AHCPR decreed incontinence treatments were either

(1) Surgery, or

(2) Pharmaceuticals, or

(3) Behavioral Interventions;

What is Electrical Simulation?

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)”

Clinician Characteristics: (2) Pharmaceuticals

Personal qualities of the clinician are not relevant; drugs must be proven (to FDA) to be effective regardless of the clinician’s or the patient’s belief system.

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]

Is E-Stim a Drug?

1. It certainly isn’t surgery2. It isn’t behavioral therapy3. 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.

Effectiveness of E-stim vs. Placebo

Study Diary Sx Pads Grm

Sand 1995 30% 66%

Luber 1997 14% --

Laycock 1993 -- 66%

Brubaker 1997 No change No change

Yamanishi 1997

33% 56%

Effectiveness of E-stim vs. Alternatives

Study Diary Sx Pads Grm

Bo 1999 30% 13%

Smith 1996 53% --

Olah 1991 60% --

Laycock 1993 No data No data

Hahn 1991 -- 34%

Effectiveness of E-stim vs. Alternatives

Study Diary (Sx) Pads (Grm)

Blowman 1991 (n=7)

100% (with PME)

--

Smith 1996 59% --

Moore 1999 -- 66% (with PME)

Overall Averages for Stim studies

47% improvement

50% improvement

How Effective is 50%?(Burns’ “moderate” = 12/week)

BEFORE AFTER

TEC PFES Conclusion (1)

STRESS UI:

“…literature does not provide strong and consistent evidence that PFES reduces the frequency of incontinent episodes. (27)”

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)”

ConclusionThe 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.