After 50 years of biofeedback and electrical stimulation, bladder drill and absorbent products, behavioral therapies are all about to be replaced by a miracle of modern technology -- magnets!

You may already have pads of magnets inside your shoes or under your mattress. But those are puny compared to the giant electromagnets that are now being used to treat -- and cure -- urinary stress incontinence. Think MRI and high tech. This is called "Extracorporeal Magnetic Innervation (ExMI) Therapy, and it is coming soon to a Urologist's Office near you.

You'd better plan now to sell your Continence Clinic, or at least, don't sign another annual lease. There are BIG BUCKS behind "NEOCONTROL".

The secret is a giant magnet in the seat of the chair, which pulses your pelvic muscles on and off for 20 minutes at a time. According to the website, One way to think of NEOCONTROL is as an "automatic Kegel exercise machine".

The treatment is claimed to be pain-free, with no side effects, no disrobing, no contact with the skin. Scientific studies "have shown ... Neocontrol is effective for helping patients regain continence."

And the system is fully automated. You don't even have to remember the patient's name, because everything is encoded in a "credit card" -- name, address, insurance company, treatment history, stimulation parameters, etc.

How good is NEOCONTROL? According to the website, 83% of patients reported "significant improvement" -- that's right up there with Kathy Burgio, apparently.

I'll have some critical comments tomorrow, but I wanted to invite you to visit their website and form your own conclusions first.

PS: If you are really hard-core, the US patent number is 5,725,471 and it's available on the US Pat and Trademark website. It took me a whole night to find that number, so don't lose it!

Last week I reported ["The End is Near", posted on May 31, 1999] on the newly announced electromagnetic treatment for incontinence, being promoted by Neotonus, Inc. of Marietta, GA.  The financial investors call it "Extracorporeal Magnetic Innervation (ExMI)" Therapy, but that is just a $10 name for a "magnetically-coupled" form of "electrical stimulation", and e-stim has been around for as long as there's been electricity.

"ExMI" does what your ordinary EMPI-type e-stim device does, only without wires. So, how good is magnetically-coupled e-stim? As you might have guessed, it's slightly LESS effective than directly coupled e-stim. And e-stim is itself one of the least effective treatments for urinary incontinence.

This is NOT my opinion; I'm merely reporting what the manufacturer's public relations people have been telling the public. The details are readily available on the www.neocontrol.com website. PLEASE -- check it out for yourself.

Actually, there are three sources of information about Neocontrol on their web: (1) Webpages describing FAQs, (2) An abstract from the ICS meeting in Monoco in June, 1998, and (3) an abstract from the AUA in Dallas in June, 1999. Unfortunately, these three sources give conflicting information, so we don't know quite what to believe.

The website itself (June, 1999) and a manufacturer's Press Release dated last year (Aug. 28, 1998), claim that 117 patients have been enrolled in magnetic e-stim therapy, and "48" have completed it. Of those who completed the 8 weeks at twice weekly treatment, "52%" were "completely dry" and another 31% were "improved". That leaves 17% not improved or worse.

In contrast, a Press Release dated May 1, 1999, claims 400 patients have been enrolled. Apparently the web page designers did not read the company's own press releases. (This is available on Urology Network under the title "Fort Worth Patients Gain Access to First "Automatic Kegels' For Treatment of Urinary Incontinence", and refers to the company's exhibit the same day in Dallas.)

We find more "scientific" information in the "Physician Information" section of the Neocontrol website. On the page entitled "Clinical Bibliography" we are offered links to "Published Abstracts", "Peer-reviewed Publications", and "Book Chapters" describing the new therapy. We will take their word for it that this list "includes all published ... literature."

Under "abstracts", there is a single link, to a Galloway et al paper presented at the International Continence Society meeting in Monaco in June, 1998. We are promised more, and advised to "check back soon".

Under "peer reviewed publications", there are none. But we are advised to "check back soon".

Under "book chapters", we learn the only one is an Appell RA et al chapter, yet to be published in a French anthology. Again, "check back soon."

Although it is not listed under "abstracts", we do find a mention under "scientific meetings" (mostly commercial exhibits) of an "abstract" at the AUA in Dallas, May 1-6, 1999. A quick trip to www.auanet.org locates the abstract (No. 1093, also listed as No. 1593) on the 1999 abstracts page of AUA. The paper, "Extracorporeal Magnetic Innervation (ExMI) Therapy for Stress Urinary Incontinence", has a first author of Niall TM, and includes besides Galloway (who presented it), such famous names as Sand, Appell, Beavendam and Whitmore.

It is easy to imagine why the Neocontrol people didn't list the Dallas paper in their own list of abstracts, which they claim includes "all published ... literature". It appears that there has been a precipitous decline in the effectiveness of magnetic e-stim even during its first short year. Let's look more carefully at the two published abstracts.

At ICS, 69 patients had enrolled and 36 completed therapy. At Dallas, 11 months later, only 64 were enrolled but 51 of them completed therapy. Strange.

At ICS, "56%" were completely dry, with another 21% improved. At AUA, the cure rate dropped to "34%", with another 32% "improved". Overall, 77% better, vs. 66% better -- and that's with five patients mysteriously disappeared!

At ICS, Pad Usage went from 2.3 pads per day to 0.5 pads. At AUA, Pad Usage went from 2.5 pads per day to 1.3 pads. In 1998, that was a 78% reduction; in 1999, it has dropped to a mere 48% reduction in pads.

It is even worse when we look at the actual Pad weights. At ICS, the pads went from 4.5 oz to 0.5 oz after therapy. At AUA, the pads went from 20 g before to 15 g after. The initial improvement of 89% weight reduction has now dropped to only 25% pad weight improvement. It's hard to believe that these presenters were looking at the same data sheets!

Well, I never liked pads anyway; how about Kathy Burgio's famous statistic, reduction in leaks per day? That should show a real significant result.

At ICS, patients went from 2.3 leaks/day to 0.8 leaks/day, a 65% reduction using Burgio's statistic. At AUA, patients went from 3.3 leaks/day to 1.7 leaks/day, a mere 48% reduction.

Compare that with Burgio and other biofeedback results, of 80-95% symptom reductions, and you see that magnetically coupled e-stim is simply NOT a very effective therapy. Sorry.

It would be tempting -- but erroneous -- to conclude that the authors are fudging their data, and that accounts for the dramatic changes in base rates and outcomes. But there is a simpler explanation, which may be at once more charitable and more damning.

Notice that 5 patients were dropped from the AUA sample, and 15 additional patients completed therapy. With 42% more patients, it is quite possible that, if they were more serious leakers, the baseline mean could easily go up from 2.3 to 3.3 leaks; all it would take would be 15 patients with about 5 leaks per day to raise that mean.

But notice that the symptom reduction rate also went up, from 0.8 "after" to 1.7 "after", just over 100% worse. That, too, is consistent with the addition of 15 cases of severe incontinence, assuming that e-stim works better on mild and moderate cases.

I'm sure that question will be quickly answered when the first full papers are finally published, and we see which patients (mild, moderate, or severe) actually improved how much.

Still, these data are not very encouraging to the investors and clinicians who have been backing coupled e-stim.

By the time we get to Dallas, we are, on average, getting patients from THREE wet pads a day to TWO pads a day.

Sorry, I don't call that much of an improvement, especially after spending an average of $1,000 each for the treatment.

At a buck apiece, it would take 3+ years for the reduction in pad cost to equal the cost of therapy, and early results indicate that the benefits of coupled e-stim don't last even that long.

Bear in mind that studies in which e-stim patients are taught to do conscious Kegel exercises when zapped ("shocked", as the ExMI people say!) get better outcomes than passive patients. But the ExMI people advertise that (unlike Kegels and biofeedback), "Neocontrol... requires no participation. It does all the work for you and exercises the muscles more completely than you could on your own." (Patient mailing, 6/4/99).

(Someone ought to tell the FDA about that last claim; it is utterly without foundation; comparison studies have never been done.  And results from biofeedback studies, where the patient does her own excercise, get much better results.)

So, what can we say about "Neocontrol", "The Revolutionary New Therapy for Incontinence"? "Not exactly."

Interestingly, the cover letter they send with the patient packet puts in bold face:

"90% of all patients would recommend Neocontrol to a friend".

Apparently these people haven't actually worked at treating incontinence very long, or they would know that the biggest problem continence clinics have is that most patients DO NOT tell anyone, friend or foe, that they have been suffering from incontinence and now they are dry (or down to only 2 pads a day, as in this case.) They might tell researchers that, but they won't tell their friends! Word of mouth doesn't apply here.

So, how can a therapy that is only half as good as biofeedback at curing incontinence get to make such extravagant claims? It's all a matter of money, PR, and the growing ignorance of complicated modern medicine.

Just for example, I have a friend who tried Avonex treatment for MS. Some 60,000 people are on this new drug, at $1,000 a month (and insurance pays all of it).

What does the manufacturer actually claim for the drug? Only that "33% don't get worse"; they don't even claim that anyone gets better! And, how many people give up the fully-paid therapy because of bad side effects? "We don't keep data on that", a spokesperson said on the telephone recently.

There's a pattern here somewhere, if only I could put my finger on it.