Critical Review:

"Data-Based Evidence Supporting the Effectiveness of Incon Therapy ™ Treatment for Urinary Incontinence"

Published by ERA III Medical Ltd.

Address: 4683 Winterset Drive, Columbus, Ohio -- Phone: 1-800-838-4823

Reviewed by John D. Perry, PhD, Webmaster

This document has been widely circulated in several editions by representatives of Incon Therapy™, which purports to be "A Revolutionary New Treatment of the Incontinent Population". The current document was mailed to me at my email request by T. Lance McKinnon, COO of the Tennessee based Incon Care Group, LLC, d.b.a. Incon Therapy™.

"Data-Based Evidence" is essentially composed of two parts: (1) an examination of the AHCPR Guideline on Incontinence and (2) A summary of several small and unpublished studies concerning the effectiveness of Incon Therapy.

(1) The Guideline:

The first ten pages of this document are an elaboration of the 1996 AHCPR Incontinence Guideline from the point of view of Incon Therapy. Unfortunately, many sections of the Guideline are presented verbatim without quotation marks, indentation, or other indication of the source. Statements by and about Incon Therapy are interspersed with these quotations, making it determine where the Guideline ends and the additional material begins. This sometimes creates the impression that the Guideline endorses Incon Therapy, which is not true. The Guideline recommends biofeedback in general, not any specific company's product.

The Guideline comments (which are themselves the subject of a critical review on this website) are presented without criticism, except for selective inclusion. In addition, comments about individual research papers are often incorrectly attributed to the primary source, when in fact the quoted material is almost always taken from the Guideline itself, rather than the original.

The document concludes with a three-page Reference list; all but one item of which is also listed in the Guideline's own reference list.

(2) The Incon Data:

The only data supporting the effectiveness of Incon Therapy (as opposed to biofeedback in general) is a single page (actually, 2/3 page), number 11. Two Canadian studies and an Ohio State University study are presented. In order to determine precisely what is being claimed by and for Incon Therapy, I have included in the following table (1) a longer, more detailed synopsis of these three projects from a version of the same paper prepared for potential investors, and (2) discussion of the same studies from a book by Bryce Finley, "Cure your urinary incontinence in five weeks", privately published in Christina Lake, British Columbia.

In 1991, in Calgary, Incon Therapy used a four-week model [i.e., four clinical visits]; in 1993, in Alberta, they added an extra week, thus the book's title, which was based on five clinical visits. When they crossed over into the US, the model was changed to twelve clinical visits in six weeks for the Ohio State Study. The obvious question is -- WHY?

According to Incon Therapy's own words, each successive study merely "reaffirmed the previous success" rates (i.e., they did NOT get "better" rates). We are forced to conclude that American patients proved some 2.4 to 3.0 times more difficult to treat than their northern neighbors. That's very strange!

Alternatively, if they really did get an 85% success rate with just four visits in Calgary, how come they are now soaking American patients for twelve visits? According to the Ohio State Study, tripling the amount of therapy did not significantly increase the outcome. (i.e., 85% is not significantly different from 87.5% when the exact numbers are constrained by the small "n".)

It should be pointed out that none of this data is from peer-reviewed sources, and it is virtually impossible to find a professional name to associate with the "results". (Although ten people are "thanked" for the Ohio State study, there is no indication of who played what role in it.)

The following table attempts to compare the data reported on each study from the three sources mentioned. Every attempt has been made to be accurate and complete.

Summary of Research Data Supporting Incon Therapy

Note A:

According to Finley's book, the effectiveness of the therapy in the Canadian studies was based on a "standardized form developed in the Faculty of Medicine, Queens University, Ontario, Canada" (but apparently never published anywhere).

This totally unique and unusual means of assessing incontinence consists of five categories that are "measured" by means of a subjective rating scale: (1) frequency of urine leak, (2) Amount of urine leak, (3) Protection and changes, (4) Activities or stress, and (5) Urge.

These items are ranked on a 3 or 4 point scale; for instance, the first item was ranked "3 - more than twice and day" pre-therapy, and "0 - less than once per week" post-therapy [see below for details]. In other words, a patient who had leaks in three out of 4 weeks would be rated "zero" -- or "cured" using the Incon record-keeping method! Strangely, in #2, "Amount", there is NO ZERO score; the "best" category is "1 - a few drops, slight dampness".

Apparently Incon researchers believe it is normal for a woman to leak a few drops a day. This is at variance with every single published study on the subject, which insist that "cured" means "dry", not "a few drops a day".

In the landmark Perry, Hullett and Bollinger (1988) study, "cured" was defined as "not a single accident in the past 30 consecutive days". Most other studies require zero accidents in the previous week or since the last office visit. But Incon Therapy calls a patient "cured" if she has only "a few drops" every day. "Slight Dampness" is considered "cured".

Lest the reader think we exaggerate, a summary of the Incon Therapy rating scale is reproduced below, exactly as printed on page 89 in Finley's book.

In other words, there was no "zero" response option -- Indicating NO LEAKS -- in the "amount" category; the BEST one could hope to do would be to have "a few drops every day", and that was counted as "dry"! Stated differently, Incon doesn't know how many got fully dry, because that wasn't a possible answer.

Although not described as such, the typical responses listed in the table above seem to represent the "modal", or most common responses, pre and post therapy. Thus the 14 point-items pre-therapy represent an "average" score of 13.4, and the 1 (0+1+0+0+0=1) items correspond to an average score of 2.4 post therapy. Obviously everyone got 1 point for the "amount" item, but it is not clear which items contributed the other 1.4 points to the 2.4 point total.

A corresponding bar graph in Finley's book suggests that actually about 1.4 points came from the first three items, and about a half-point each from the last two. But precise data is not published, either in Finley or in the Incon publications, on any of these Canadian studies.

"Note B": The published table claims that "100%" of 40 patients treated had "post treatment continence" some 1 to 4 years later. This is unusually high, since ordinarily some patients regress, if for no other reason than declining general health. However, "post treatment continence" is not defined; if "a few drops every day" is still the highest category, that may explain the "100%". On the other hand, the text says that this study "reaffirmed the earlier success rates" (p. 19). But the previously reported success rate was only 85%, not 100%. Other researchers have reported that patients who continue vigorous exercise on their own often get even better (dryer) over time; however, no one has ever reported that ALL subjects did that exercise.

Ohio State Study:

It is not known whether the Ohio State data was based on conventional definitions of continence or the special "Incon scale" which assumes that some leakage is normal. Since there is no report of any change in method, we assume the same method was used at Ohio State.

It is important to notice that the 8 subjects in the Ohio State study had only moderate incontinence -- 2.5 leaks per day, or 17.5 per week. Burns' (1993) "severe incontinence" groups, in contrast, averaged 32 to 40 leaks per week.

The most noteworthy aspect of this study is the small number of subjects (10+10) and the high number of dropouts (20% of experimentals, 60% of controls).

The randomization of subjects was not effectively accomplished, since the experimental group (at 2.5 accidents/day) had 50% LESS accidents than the control group (at 3.75). Most studies report accidents per week, where 17.5 is noticably lower than 26.25. On the other hand, the control group did not change in either accidents or EMG levels, which is as expected, and the exercise group DID get (1) stronger and (2) dryer at appropriate rates.

In Summary:

I must admit that prior to undertaking the above analysis of Incon Therapy's claims, I was a little threatened by their claims of results "as good as Burgio's" without the use of intra-vaginal or intra-anal sensors. There have been assorted modest claims of success with surface patch electrodes over the years, but never have any significant improvement numbers been published in studies with surface electrodes. Now Incon Therapy claims superior results with surface electrodes -- in as yet unpublished studies.

The limitations of surface electrodes was one of the reasons why I invented the vaginal and anal EMG sensors in 1975! We had patch electrodes available to us for years -- the problem was that they were necessarily too far away from the internal pelvic muscles which we were trying to train. One enterprising scientist went so far as to apply tiny suction-cup EKG electrodes to the vaginal wall, in an attempt to get closer to the muscles of interest (and avoid cross-contamination by irrelevant superficial muscles). The suction-cup study was never replicated. And, to this day, no published study using surface patch electrodes has ever produced "Burgio-class" results.

We conclude that:

1. The Incon Therapy data has never been published in peer-reviewed journals, and it may not be sufficient "clean" to ever be published.

2. So long as Incon Therapy defines "cured" as leaking "a few drops every day", their data cannot be compared with studies which define "cured" as "dry".

3. The best Incon data (Ohio State) is based on only eight subjects, seven of which apparently became "cured" only by Incon's lower standards. In contrast, several tens of thousands of patients have been treated within intra-vaginal or intra-anal sensors.

4. The Ohio State study had an unusually high drop-out rate (20% of experimental group, and 60% of the control group. A cross-over design might have reduced the drop-out rate in the control group.

5. The subjects in the Ohio State study were not effectively randomized. (The control group had 50% more accidents per day than the experimental group.)

6. Incon Therapy defined "stress incontinence" as leakage during "fast walking or running", which is somewhat limited compared with the normal definition (any physical stressor, such as lifting objects, walking, coughing, etc.)

7. The Economics of Incon Therapy is a matter for additional discussion. IT uses 12 office sessions in 6 weeks, and charges a flat fee of $3,000 (or $3,200?). The Perry Protocol calls for tapering office visits to let patients practice on their own -- typically, 5 office visits over 8 weeks, or $500 (+/-) for visits and $300 for home trainer rental. It is not clear that insurance carriers will approve a therapy that is 4 times more expensive yet is less effective.

InContiNet Invites Dialog

InContiNet welcomes, and will publish without charge, contrary or complimentary viewpoints. If you would like to contribute material to this or any item on this website, please submit your comments directly by email (so they can be posted easily).

Copyright 1997 by InContiNet. All rights reserved.
This page is located at http://www.InContiNet.com/incon.htm
Click Here to return to our Home Page
Click Here to return to the Critical Reviews Menu
Version of May 04, 2005