Commentary on the

Electrical Stimulation Utilization Parameters

Submitted to HCFA

By the Continence Coalition (SUNA/WOCN)

Commentary prepared by the

AAPB Special Committee on HFCA/Medicare

December 20, 1999

[Reference: " Electrical Stimulation Utilization Parameters: Definition of Electrical Stimulation Therapy Used in the Treatment of Urinary Incontinence or Other Voiding and Pelvic Disorders", by the Continence Coalition (SUNA/WOCN), December, 1999.]

Trained Biofeedback clinicians and researchers will take issue with many of the undocumented assertions and unsupported claims that have been advanced on behalf of Electrical Stimulation in the SUNA/WOCN document, which we will refer to as "ES-UP".

1. The ES-UP document asserts: "electrostimulation is based on the restoration of normal physiological reflex mechanisms in abnormal nerves and muscles".

We disagree. In fact, ES does not directly restore normal mechanisms, which include cortical and sub-cortical and CNS events; it actually bypasses these mechanisms to artificially induce muscle contractions. Outcome studies show ES is significantly more effective when combined with voluntary pelvic muscle exercises (PME) -- but there is no evidence that the device contributes to better outcomes than the PME alone. The overall symptom reduction rates for PME and electrical stimulation are both very much lower than for biofeedback.

2. ES-UP lists some thirteen "indications for use" of electrical stimulation without explaining the meaning of the term.

The phrase "indications for use" is not a scientific term; it merely shows that various clinicians and researchers have attempted to apply it to the listed conditions, with no indication whatsoever of the outcomes. According to the cited review by Yamanishi and Yasuda (1998), in fully half of reviewed studies electrical stimulation results were no different from results obtained by a sham device (placebo).

3. ES-UP makes sweeping and misleading statements about the effectiveness of electrical stimulation, including "cure rates ranging from 30 - 50% and improvement form [sic] 6 to 90%".

The 6 to 90% improvement cited above refers to "patient improvement rate", which is usually defined as the percentage of patients who obtained a 50% or better individual symptom reduction rate. This is a very different statistic from the original "group average symptom reduction rate", as defined in biofeedback research by Burgio et al. These two alternative ways of describing outcomes are often confused in reviewing research reports.

In general, total "patient improvement rates" are as much as double the equivalent "group average symptom reduction rate". We note that if 50% of the individuals each obtain >50% improvement (individual symptom reductions), all we can say about the group symptom reduction rate is that it is at least 25% [because 50% of 50% = 25%.]

For example, one advertisement for a magnetically coupled form of electrical stimulation boasts that "83% reported 'significant improvement' in their condition." But according to their own website's data, their actual leaks per day only declined from 3.3 to 1.7, a mere 48% group average symptom reduction rate. [AUA, Dallas, 1999]. Burgio consistently got group symptom reduction rates of nearly double that using biofeedback.

Moreover, a patient who still leaks almost twice a day may be "statistically" improved but is not "clinically" improved. A patient who leaks 1.7 times per day after treatment is still "incontinent" by International Continence Society standards.

4. The section "Therapies Suggested prior to use of Electrical Stimulation" implies that PME should be "the first choice of treatment", and implies that electrical stimulation should follow second if PME does not succeed. In this section, research by Bo et al (1998, 1999) is cited in a misleadingly positive fashion.

The Continence Coalition's own "Biofeedback Utilization Parameters" document states that under conditions that would in fact include almost all SI and UI patients ["poor or inappropriate identification or isolation", and "inadequate coordination or fine motor control"] it is "biofeedback," and not (plain) PME that should be "the initial therapy". Different committees prepared the two UP documents, and the chair apparently did not notice this discrepancy. In addition, the cited research by Bo et al does not suggest that stimulation should be used at all. She concluded (1999) that "Training of the pelvic floor muscles is superior to electrical stimulation and vaginal cones in the treatment of genuine stress incontinence".

5. The "Treatment Options" section does not reach any consensus or present any recommendations; it merely lists nine very different "treatment regiments [sic] [that] have been described" in the literature.

The options considered range from twelve 20-minute bi-weekly office sessions to at-home practice two hours a day for three months -- a very wide range indeed, reflecting varying success and standards for outcome evaluation. There is little agreement, even now, about the quality of results that can be expected and how to achieve them with electrical stimulation.

6. The ES-UP description of a "comprehensive office visit" includes a recommendation that "pelvic muscle contractions (via biofeedback)" be used in addition to electrical stimulation.

We support this recognition of the on-going need for monitoring with biofeedback instruments even when using electrical stimulation; it obviously grows out of solid clinical experience rather than any published research. (The issue has never been directly addressed in any electrical stimulation RCTs.)

It recognizes that regular EMG biofeedback monitoring (CPT code 51784) is essential to gauge patient progress and to recommend mid-course corrections for the patient's home practice. While changes in primary symptoms (leaks) will be clear eventually, a regular EMG evaluation can detect muscle changes (or the lack thereof) much earlier. This will result in significant cost savings when the electrical stimulation is not producing any positive results (as many as one-third of patients [e.g., 31% in Richardson et al, 1996].)

We strongly recommend that an EMG "biofeedback" evaluation (51784) be required and documented at each office visit. There is no other way -- in the short term -- to determine if the patient is receiving even minimal benefit from the stimulation device.

In summary, the Continence Coalition's Electrical Stimulation Utilization Parameters seek to put government approval on a relatively ineffective treatment which, while currently in somewhat popular use, has been poorly defined, inadequately researched, and cannot be justified on either scientific or economic grounds. We cannot endorse the Electrical Stimulation Utilization Parameters as submitted by the Continence Coalition.