Recent Commentaries
on
HCFA-hearing related matters
Contents: (click on link to jump there)
1.
Berghmans et al Abstract on Urge Incontinence (February
2000)
2.
Commentary on Berghmans et al on Urge
Incontinence
3.
Comments on Electrical Stimulation
for Stress Incontinence (Sand 1995, Brubaker 1997)
4.
Comments on SANS (leg nerve) stimulation for Incontinence.
5.
Katherine Moore on E-stim for Men (JWOCN) Jan. 2000
6.
Minimalist Therapy for Elderly Incontinence (Weinberger, Goodman, and Carnes, 1999)
Written, complied and edited
by John D. Perry, PhD
New URGE Incontinence Study Published (3/13/00)
With
HCFA/MCAC public hearings less than a month away, you should be aware of a new
article by Berghmans et al that isn't yet indexed on Medline, but IS available
in full (see below) on the internet.
In
order to get this information out quickly, I resist the temptation to
editorialize about "another European academic hatchet job" on
incontinence treatments. Suffice it to
say that the authors obtain their results, as usual, by carefully selecting the
research that was included.
In
addition, their review is ENTIRELY based on "external" factors, such
as randomization and data reporting.
There is absolutely no consideration about the quality of the
interventions, as if it did not matter at all.
But
I can't help but point out that Burgio's JAMA article received the highest
rating on "methodological" form of all the RCTs.
Note
especially that these authors consider behavioral treatment to be a form of
"physical therapy", not behavioral medicine or nursing. (Note the wording of their conclusion
below.)
It
will take some time to prepare a critique, because the paper is so badly
conceived and cryptically presented.
But don't take my word for it.... here's the abstract, and ordering
instructions follow.
====================================
British
Journal of Urology International, Feb 2000 (85:254-263)
Conservative
treatment of urge urinary incontinence in women: a systematic review of
randomized clinical trials.
L.C.M.
BERGHMANS, H.J.M. HENDRIKS, R.A. DE
BIE, E.S.C. VAN WAALWIJK VAN DOORN, K. Bo and PH.E.V. VAN KERREBROECK
Department of Urology, University Hospital Maastricht, The Netherlands, Dutch
National Institute of Health Professions, Amersfoort, The Netherlands,
Department of Epidemiology, University of Maastricht, Maastricht, The
Netherlands, Norwegian University of Sport & Physical Education, Oslo,
Norway Objective: To assess the efficacy of physical therapies for first-line
use in the treatment of urge urinary incontinence (UUI) in women, using a
systematic review of randomized clinical trials (RCTs).
Materials
and methods:
A computer-aided and manual search was carried out for RCTs published between 1980
and 1999 investigating the treatment of UUI defined by the keywords `physical
therapies', e.g. bladder (re)training (including `behavioural' treat- ment),
pelvic floor muscle (PFM) exercises, with or without biofeedback and/or
electrical stimulation. The
methodological quality of the included trials was assessed using methodological
criteria, based on generally accepted principles of interventional research.
Results: Fifteen RCTs were
identified; the methodological quality of the studies was moderate, with a
median (range) score of 6 (3±8.5) (maximum possible 10).
Eight
RCTs were considered of sufficient quality, i.e. an internal validity score of
>5.5 points on a scale of 0-10, and were included in a further
analysis. Based on levels-of-evidence
criteria, there is weak evidence to suggest that bladder (re)training is more
effective than no treatment (controls), and that bladder (re)training is better
than drug therapy. Stimulation types
and parameters in the studies of electrical stimulation were heterogeneous.
There
is insufficient evidence that electrical stimulation is more effective than
sham electrical simulation. To date
there are too few studies to evaluate effects of PFM exercise with or without
biofeedback, and of toilet training for women with UUI.
Conclusion: Although almost all
studies included reported positive results in favour of physical therapies for
the treatment of UUI, more research of high methodological quality is required
to evaluate the effects of each method in the range of physical therapies.
Keywords: Lower urinary tract,
systematic review, urinary urge incontinence, physical therapy, over- active,
biofeedback, electrical stimulation
========================================
Complete
text is available from Healthgate at http://www.blackwell-synergy.com/Journals
for $16.00.
Random
Clinical Thoughts on Berghmans et al, "Conservative
Treatment of Urge Urinary Incontinence in women: a systematic review of
randomized clinical trials" (3/13/00)
(BJU
Int Feb. 2000) [see previous post]
THREE
OBSERVATIONS:
1. Confusing Form and Substance
The
81 studies retrieved by computer and friends yielded 15 RCTs that that met
their "inclusion criteria" of (1) RCT design, (2) Urge results
reported separately and (3) interventions included bladder (re)training and/or
pelvic muscle exercises (with or without biofeedback and/or stim), (4) reliable
outcome measures were used, and (5) the report was published in English, German
or Dutch. (Sorry, "others")
At
first glance these criteria seem reasonable, except perhaps for the unwarranted
assumption that "urge" can be easily separated from
"stress" incontinence.
This
apparently led to the exclusion of McDowell et al 1999, with 85 subjects, of
which 74 had urge accidents, which decreased by a statistically significant
amount. McDowell apparently did not
think the distinction was that "real". Most of her subjects had
"mixed" incontinence.
The
15 included studies were rated on their "form"; e.g., how well the
study presented their "inclusion criteria", described randomization
procedures, and presented outcome data.
Oh, yes; they had to have 50 subjects in each group. And less than 10% dropouts.
Where
does the magic number "50" come from?
Why
not "48" (four dozen) or "64" (8^2)?
And
why is 10% the cutoff rate? Wouldn't it
help to know WHY people dropped out?
It
should be obvious that these criteria are entirely arbitrary and
prejudicial. They do, however, allow
the researchers to derive conclusions without any indication that they
understand what actually happened within the various studies.
In
contrast to their rigid "form" analysis, the researchers do not even
consider "substance" in their evaluation. If a study claims to use "bladder retraining", then it
does -- regardless of whether the particular details of that training conform
at any known or accepted or proven standard.
The
result of this external analysis of "form" is to end up comparing
apples AND oranges to drugs and sugar pills.
In
their zeal to find bladder retraining studies, the authors mis-categorize
Burgio's JAMA study as a "retraining" project, despite the fact that
the study's authors describe it as "biofeedback".
This
represents severe category confusion, since biofeedback and bladder retraining
are both forms of behavioral treatment.
For reasons which fairly ooze from the text, these authors prefer to
conceptualize "retraining" as the primary classification.
2. Painting by the numbers
Berghmans
et al established a rigid and formal set of criteria for evaluating urge
incontinence research. To be labeled as
"strong", the evidence had to supported by three high-quality RCTs.
"Weak"
evidence consisted for three or more low-quality studies, or three high quality
studies that had equivocal results.
(Excuse me?)
"Insufficient"
evidence was concluded when there were less than three studies in the
literature, that met the inclusion criteria, regardless of the outcome.
At
first glance this "painting by the numbers" approach to evaluation of
scientific research might appear to be "logical" and
"fair", but is it really a substitute for careful, thoughtful
analysis?
This
is a "bean counter's approach" to science; not surprising, since
Berghmans is an epidemiologist, not a clinician.
But
it does lead to internal contradictions and silly results. For example, Berghmans rates Burgio's 1998
JAMA study as the best of the entire batch of 15 RCTs reviewed -- it scores 8.5, fully 1.5 points higher, on a
scale of 1-10, than any other.
Yet
they conclude that because there is only ONE such study, albeit the best and,
at N=197 also the largest, since no other biofeedback study made the cut, it
was ruled "insufficient evidence" (when comparing biofeedback to
placebo).
The
very same Burgio study, which also compared biofeedback to a drug treatment, is
one of three such "behavioral treatment vs. drug" studies, and since
there are THREE, the evidence for BT over drugs is "weak", but not
"insufficient".
There
is an inconsistency here that should be obvious to anyone who UNDERSTANDS the
literature. In well-documented clinical
trials for the FDA, the drug in question has been shown to be superior to
placebos -- it would not be on the market if it wasn't.
So
how can we conclude that BT is superior to drugs but not to placebos? It just doesn't make sense, but that's the
kind of quandary that Berghmans gets in when "painting by the
numbers".
Looking
at the numbers from a different perspective, Berghmans et al find "weak
(but sufficient) evidence for bladder retraining over no treatment, based on
168 patients in four studies, but "insufficient" evidence for
biofeedback over placebo, based on 197 patients in one large study. Does that make sense? If Burgio had written up her results in
three batches, that would have made three high-quality studies, leading to a
verdict of "strong" evidence in support.
3. Re-defining the professions
Perhaps
the most offensive part of the Berghmans et al study is the attempt to classify
all behavioral interventions as forms of "physical therapy".
The
term (PT) is used five times in the abstract alone. Since one of the authors, Kari Bo, is a world renowned physical
therapist, this is not surprising. It
is, however, a rather blatant "turf grab" that is sure to offend many
other professionals.
Bladder
retraining, for example, is NOT a form of Physical Therapy; it is an off-shoot
of behavior modification therapies developed by psychologists in the
1950-1970s.
Likewise,
pelvic muscle exercise was developed not by PTs, but by a gynecologist working
closely with psychologists in California.
More recently it has become a nursing intervention as well as an activity
of physical therapists, but that does NOT make it a form of physical therapy.
Pelvic
muscle exercise never got off the ground (Davies, 1932) until (in 1948) Kegel
linked it with what later become known as "biofeedback"; the use of
external instruments to monitor internal activity.
Indeed,
the only CPT code that alludes to pelvic muscles and incontinence, 90911, is a
"physician" code that psychologists and medical doctors use, and
nurses under supervision (or law as in NPs). It is NOT a code that PTs can use; they are limited to generic
"muscle rehab" codes under the PT sections.
Yet
Berghmans and Bo continually attempt to reclassify these treatments as a form
of "physical therapy". They
are treatments that PTs, as well as nurses, doctors and biofeedback technicians
use. But when a PT uses bladder
retraining, that doesn't make her a psychologist, and when a nurse uses
biofeedback that doesn't make him a PT.
We can only imagine that the conceptual confusion was both intentional
and polemic.
Knowledgeable
readers will recall that the first article in this series, dealing with Stress
U.I., concluded that biofeedback was worthless.
Mark
Weatherall of New Zealand re-evaluated the five cited studies, and concluded
that the evidence actually favored biofeedback, in contradiction to Berghmans'
conclusion.
This
year's Urge U.I. conclusion is much
more cautiously worded. The actual
conclusion is "almost all studies included reported positive results in
favor of physical therapies [sic] for the treatment of U.U.I...."
They
also call for "more research", but can anyone cite a field of study
for which that is NOT true?
In
fact, ALL of the these studies were positive for behavioral treatments of UUI,
with two exceptions.
One
e-stim vs. sham stim study found no
differences (are we going to "accept" the null hypothesis????).
Even
more interesting was that one study compared bladder training with and without
prior urodynamic evaluation, and found that urodynamics evaluation made no
difference in the outcome.
Excuse
me? Since when is urodynamic testing a
"treatment"? This has got to
be the ultimate "Painting by the numbers" blunder.
=============================
Hope
you find this helpful.
Electrical Stimulation and STRESS incontinence (3/14/00)
Why
would one study find a significant impact on STRESS urinary incontinence with
E-stim, while a later study finds no effect at all?
As
the TUMS lady used to say, "GOOD Question!"
Sand,
Richardson, Staskin et al, in "Pelvic floor electrical stimulation in the
treatment of genuine stress incontinence: A multicenter, placebo- controlled
trial" (Am J Obstet Gynecol 1995; 173:72-9) reported a modest but significant improvement in weekly leakage
reports (14>10), pad use (6.2>4.1) and pad weight (45>15) after 14
weeks of therapy.
Brubaker,
Benson, Bent et al, in "Transvaginal electrical stimulation for female
urinary incontinence", writing in the same journal two years later
(177:536-540) found NO significant change in stress incontinence rates after 8
weeks of stim therapy.
Brubaker
et al DID find a significant change in detrusor hyperactivity (49% cured, i.e.,
stable on provocation). However, there
was no corresponding change in urinary frequency or in urinary accident rates,
which certainly raises questions about the predictive validity of urodynamic
testing without pelvic muscle evaluation.
At
first glance, the substantial difference in number of therapy sessions --
Sand's patients got 75% more therapy -- might account for the difference.
Unfortunately,
Sand took only "before" and "after" leakage reports, so we
don't know if the extra six weeks made the difference, or if Sand's patients
were also improved at 8 weeks.
One
might be tempted to look at the stimulation devices themselves for
effectiveness clues. Sand used the EMPI
Innova system, while Brubaker used the Hollister/Incare Microgyn II.
The
Innova device delivered two channels of pulses, at 50 Hz and 12.5 Hz. The Microgyn II has only one channel, at 20
Hz.
The
Innova has a 0.3 second pulse duration, compared with 0.1 second for the
Microgyn (i.e., Innova gives three times more stim in each cycle).
The
Innova program was ramped up during therapy, from 5 on/10 off for 15 minutes
(2X daily) progessing to 5/5 for 30
minutes in the final 6 weeks.
The
Microgyn used a 2 on/4 off for 15 minutes throughout the 8 weeks of the study.
In
other words, the Innova group got 15 minutes of current per session for their
final six weeks, while the Microgyn group had already terminated.
The
Microgyn group got only 5 minutes of current in each of their sessions.
So
we have 3 times longer pulses for 3 times longer sessions, or NINE TIMES as
much electrical stimulation for the Innova group.
Is
that significant? Since the Innova
group got statistically significant reductions in pads and leaks, it would
appear so. Of course the reductions
were quite small (6.2 pads > 4.1 per week) compared to typical biofeedback
comes; a 33% reduction vs. Burgio's typical 85%.
Interestingly,
Brubaker collected pad use information in patient diaries, but that data was
not published. There is a comment that
diaries were incomplete, which is blamed on the "lack of
compensation" for research subjects.
A
more plausible explanation is that the research staff failed to stress the
importance of the diaries. In our own
clinical trials, we had 100% compliance with pad reports -- because we insisted
on it. And our patients were all paying
top dollar in a fee-for-service clinic.
In
both Sand and Brubaker there is a lack of detail about the precise patient
instructions, either explicit or implicit, with respect to concomitant
voluntary pelvic muscle exercises. In
other studies, such augmentation has often played a significant role.
One
obvious difference here is that in the Sand project, patients were subject to
pelvic muscle evaluation before and after electrical stimulation; in Brubaker
they were not. Sand used the relatively
crude Gynex perineometer, but nevertheless was able to report a statistically
significant increase in vaginal muscle strength, from 10.6 mmHg before to 15.2
after. [This is only a modest result
compared with biofeedback improvements (e.g., Sussett, 18 > 72 after)].
The
fact that voluntary squeezes were measured and recorded in Sand but not in
Brubaker certainly invites speculation about the expectations held by the
research subjects.
The
substantial differences in the amount of stimulation provided by the two
devices might lead to suggestions of technological superiority.
However,
prior to using the Innova product, Sand and Wheeler reported on
"Transvaginal Electrical Stimulation for Incontinence" in a monograph
that was privately printed by Hollister in 1989. [I haven't found that this was ever published in a peer-reviewed
journal; anyone know?] In that report, using an early prototype of their
Microgyn II, they found a significant reduction in leakage on pad test (24 gms
before > 5 gms after), as well as a modest improvement in vaginal muscle
strength (12 > 16), after only SIX weeks of 2 X 15 minutes therapy. So maybe device differences are NOT at
fault.
It
is worth noting that these 84 subjects were also subjected to before and after
measurements of their voluntary vaginal muscle contractions, using a Contimed
II biofeedback device.
The
issue of voluntary contractions (Kegels) during e-stim treatment is extremely
important, ever since Lamhut, Jackson and Wall (1992) discovered that among
elderly and demented patients -- who were presumably unable to do covert
contractions -- a substantial minority were actually made WORSE by the same
Microgyn II device. They concluded: "it
was ineffective in improving urinary incontinence."
In
fact, there was a tendency for the treatment to worsen the incontinence. [abstract]
The
issue of what is really effective about e-stim needs to be addressed in future
research. It would be valuable to
compare levels of patient cooperation, ranging from implied Kegels to explicit
Kegels to biofeedback-trained Kegels as levels of treatment along with the
stimulator device. Until such research
is done, we will have a difficult time evaluating the very contradictory
research results discussed above.
SANS approved -- but is it really better? 3/14/00
A
distinguished senior member of one of these lists sent the following private
reply to my RCT comments on e-stim studies:
My own gut feeling is clinical results are mostly
limited by the non-specific nature of all intravaginal stims, i.e. they hit ALL effector mechanisms. By way of contrast, the Medtronic InterStim
(an implant) and the UroSurge SANS (needle electrodes) are more "targeted"
and appear to be more effective, at least for urge/OAB.
I
was interested to hear that the SANS device, developed just down the Freeway in
SF, is "more effective" than the non-specific stimulators using patch
or vaginal/anal electrodes. So I put
"UroSurge" into www.google.com, and instantly found their website,
along with press releases, clinical reports, and even a "real player"
video of their needle insertion technique.
Sure
enough, the SANS was approved by the FDA on February 8, 2000.
BUT
IS IT TRUE that the SANS method (e-stim in the leg) is "more
effective" than the prior alternatives?
Here's what UroSurge claims.
Initially,
Dr. Stoller at UCSF reported an 80%
"success" rate [i.e., greater than 50% improvement in symptoms],
based on 98 patients.
Apparently
this data has not been published, however.
In
a "collaborative study", unnamed investigators reported a 71%
"success" rate [at a much lower rate,
25%
or more, improvement in symptoms.] This data is based on only 29 to 42
subjects. Let's look at the details:
Before
After Median % change Daytime frequency 13.5 10.0 -29.2% For starters, remember
that Burgio (JAMA, 1998)
obtained
an (-)81% mean change using only a couple of sessions of biofeedback
treatment. By what calculus is 29%
"more effective" than 81%?
The
more commonly reported stat for these figures is the "mean" % change,
but that's only 25.9%; no wonder they use the median!
Even
more to the point, after 12 weeks of SANS therapy, these patients are still
having 10 voids a day -- three more than the ICS definition of urge
incontinent!
Nighttime
voiding went from 4.0 to 3.0, a 15% improvement, and still
"incontinent" by ICS >2 standards.
24
hour voiding frequency went from 14.9 to 11.3, a paltry 22% median (24.1% mean)
change.
Daytime
incontinence episodes (leaks) went from 4.4 to 2.5, a 40% median (57% mean)
improvement, but still not even close to biofeedback's 80%. [Data from: http://www.urosurge.com/study/sans_clinical_results.html.]
So why, we might ask, would anyone want to have a needle inserted into their
leg 10 times for 20-30 minutes each week when they can obtain far better
results with biofeedback?
"More
effective" than previous stim?
Here's what some others claim:
|
Sand,
Richardson, et al (1995) |
62%
improved >50% |
|
Sand
& Wheeler (1989) |
81-85%
improved (at all) |
|
Neotonus
website (ICS) |
77%
improved (at all) |
|
Neotonus
(AUA 99) |
66%
improved (at all) |
|
Interstim
website |
75%
improved > 50% (includes "selected" patients) |
|
EMPI
(advertisement) |
60-90%
effective (whatever that means) |
|
The
latest SANS report: based
on 107 patients, 12 wks: |
|
|
Litwiller
et al (AUA 2000) |
ca. 75% improved (at all) |
|
Compare: |
|
|
Burgio
(JAMA 1998) |
90.5%
improved > 50% |
It
is difficult to understand where the idea came from that SANS was "more
effective" that other forms of stim; based on the data above, it seems
right smack in the middle of the e-stim world.
Perhaps EMPI should send them a brochure.
Based
on the same physiology.
AND,
when we stop to think about it, why would we expect anything different? For years conventional (perineal, perianal,
vaginal and anal) electrodes have been used to stimulate the sacral nerves at
S2-S3 and cause reflex inhibition of bladder contractions. It works.
Not as well as voluntary contractions of the same muscles, but it works
moderately well.
The
SANS device does the same thing, except it uses the posterior tibial nerve -- a
3 foot longer pathway that arrives at the same spinal junction.
Since
both conventional and SANS stimulation use the S2-S3 nerves, why would we
expect the results to be any different?
And they aren't.
About
the only advantage of the SANS system is that it allows urologists to treat
pelvic problems without having the patient undress. But since when has that been a problem for urologists?
Many years ago there was a Swedish study that tried
to use forehead EMG electrodes to treat pelvic cramps (dysmenorrhea). The explanation was that it was "more
convenient" to attach electrodes to the forehead than to the
genitals. At the time, prior to the
invention of vaginal/anal inserted electrodes, that was, of course true. But now we treat the pelvic muscle problem
directly.
Somehow
I think there's a parallel here.<g> On the down side, we have to break the skin a dozen times with
very fine needles to stick the posterior tibial nerve. We are not told what the risk of infection
or complications are for this procedure; it is probably slight, but as the old
Vermont saying goes, "It depends whose ox is being gored!"
UroSurge
boasts that an advantage of SANS is that it doesn't require "vaginal or
rectal probes which can be uncomfortable or painful". Uncomfortable, yes. But never "painful", at least not
among urge patients. This is a bit of a
cheap shot, but perhaps it is the best they can offer. Still, as an empirical claim, it really
should be based on collected data, not salesman's jargon.
Dishonesty
in advertising.
The
UroSurge website contains a patient handout that describes the alternatives to
SANS as "bladder training and pelvic muscle exercises" only --
neither conventional electrical stimulation nor biofeedback are even
mentioned. Misleading? You bet.
The
Litwiller et al paper that will be presented at AUA by Dr. Govier states, in
its Conclusion:
"Percutaneous peripheral afferent nerve
stimulation with the PercSANS treatment presents a minimally invasive and
potentially therapeutic alternative to other current treatment options
(open-surgery or pharmacological intervention, and the associated riskd [sic]
for patients diagnosed with documented urgency/frequency due to pelvic floor
dysfunction."
[Quoted in its entirety from their website.] Note
that members of the AUA will be told that "surgery or drugs" are the
only alternative treatments for urge incontinence. That's not likely to go over any more.
On
the other hand, sticking thin needles into extremities does LOOK a lot like
"electro-acupuncture", which is a an up and coming
"alternative" medicine. If
Medicare doesn't cover it, probably consumers will pay out of pocket
anyway.
Since
SANS -- unlike conventional stim -- cannot be done at home, the procedure
allows for much higher per patient charges.
10-12 office MD visits to achieve the same results as one office visit
and ten weeks of home stim. That's the
definition of a profit center!
Unlike
biofeedback, which requires intensive labor, the SANS system requires only a
few seconds time to insert the needle, adjust the stimulator so the toes don't
flex, and leave the patient alone for half an hour. A good technician ought to be able to "treat" 5 to 10
patients simultaneously, in rotation, and bill Medicare for each one.
NOW
I understand why SANS is "more effective" than conventional
stim. I've got to stop thinking like a
clinician, and start thinking like a business person. [But I'm probably too old to learn.] Happy Zapping!
Katherine Moore on E-stim for men (3/18/00)
Has
Dr. Katherine Moore changed her mind
about the efficacy of electrical stimulation?
An article in January 2000 issue of the Journal of WOCN suggests that
she has.
In
the document "Electrical Stimulation Utilization Parameters", which
Moore drafted and the Continence Coalition sent to HCFA last fall, Moore was
enthusiastic about the role of stim in treating *Stress* Incontinence.
She
wrote:
"Electrical
stimulation has been reported to be effective for stress incontinence with cure
rates ranging from 30-50% and improvement form [sic] 6 to 90% (Yamanishi,
1998)"
This
was noteworthy, since no comparable endorsement was even given in the U.P. for
Urge Incontinence.
In
fact, "Stress incontinence" was listed at the top of the list for
"Medical Necessity and Indications of Use", ahead of "Urge
incontinence".
And
"Post radical prostatectomy (moore 1999) [sic]" was also on the
"indications" list recommended to HCFA.
But
in the article just published in JWOCN, "Treatment of Urinary Incontinence
in Men with Electrical Stimulation: Is Practice Evidence-Based?" Moore
takes a much more sanguine view of the stim-stress connection.
After
an enthusiastic discussion of the role of stim in treating "detrusor
instability (urge incontinence)", Moore dismisses the application for
Stress incontinence in two paragraphs.
She mentions six studies -- none of them by name -- and notes that only
two (actually, Sand 1995 and Yamanishi 1997) found any statistically
significant improvement, while four found no significant differences.
And,
while Sand et al did find a "statistically significant" difference
between stim and a sham device, the "improvement" failed to reach
*clinical* significance; i.e., stim patients were still "incontinent"
by I.C.S. standards. Yamanishi likewise
reported "statistical", but not "clinical" significance.
Sand's
project involved 52 women but NO men; while Yamanishi's subjects included only
six men among their 50 subjects.
Moore
concludes that "...the evidence for electrical stimulation in treatment of
stress incontinence is weak."
She
goes on to say "The equivocal results indicate that practitioners need to
consider carefully before recommending electrical stimulation as the first line
treatment for stress urinary incontinence."
(I just LOVE understatement!)
Similar
conclusions follow her analysis of the use of electrical stimulation for
post-prostate incontinence.
The
first such study (in 1976) found only three of 16 subjects improved. The second (1981) found 6 out of 8 improved,
but apparently they were also doing Pelvic Muscle Exercises, so it is
impossible to give stim all the credit.
One unpublished study (a thesis) showed "positive results" for
stim when combined with PMEs, but two others -- including Moore's own 1999
report -- found "no differences" to support stim.
Thus
Moore concludes, with characteristic understatement:
"...stimulation alone or combined with (PME) does
not significantly enhance treatment outcomes in men with incontinence after
radical prostatectomy." (p. 29)
Moore
remains convinced that "The primary role of electrical stimulation appears
to be in the treatment of urge incontinence in both men and women"
(p. 29) but even that conclusion is
apparently a bit shaky.
Hasan
1996 studied 30 men (and 41 women) and found "(statistically) significant
improvement" in voids and pad use (presumably equal for both sexes).
But
Bower, Moore et al in a 1998 "replication" that included 19 men,
apparently only found urodynamic improvements.
Likewise
Brubaker 1997 found big urodynamic improvements -- but no symptom improvement.
Primus
1996 found symptom improvement, and all cases of "sensory urge
incontinence" were cured. In
contrast, Bower, Moore et al found NO sensory subjects improved.
Urodynamic
test improvements are probably relatively meaningless to our clinical patients. I have had many patients complain of
urgency, frequency, and urinary accidents; I've never had a patient complain of
an abnormal urodynamics test.
The
entire discussion of "Evidence-Based Practice" (like so many other
such discussions) has been based on finding STATISTICAL significance, NOT
clinical significance. In virtually all
studies, electrical stimulation has only been shown superior to "no
treatment".
Before
subjecting patients to stim, the clinician really should address the question
"Am I offering my patients the best possible treatment?"
When
you compare Burgio's 81% symptom reduction rate for biofeedback with the
results of stim studies, the answer is clear.
When
pads used "after" treatment are still more than one a day, the
patient has NOT been given an effective treatment.
The
responsible clinician will spend the time and money needed to get proper
training, so as to offer patients the best possible treatment.
Finally,
there are some minor errors in the report that you should be aware of when
reading it:
1. In Table 4, page 27, the footnote to Primus
should be #24, not #36, which is a different Primus report.
2. On page 29, the reference to a study of 63
post prostatectomy men should be #1, Moore and Estey, 1999; not #21.
3. On page 24, Moore says "... a placebo effect of incontinence therapy as
high as 39% has been reported.
[footnote to Burgio, JAMA, 1998]".
But
Burgio, in her JAMA paper, clearly says:
"The control group was intended to control not
only for the placebo effect but also for the effects of clinic visits,
self-monitoring (bladder diary), and therapist contact."
"Self-monitoring"
has a long history and favorable status as an independent therapy in its own
right as a form of "Behavior Modification", and should not be
confused with "placebo effects".
Minimalist Therapy for Elderly Incontinence (3/20/00)
A
recent report underscores the hazards of conducting only "Medline"
abstract-level research.
According
to the abstract, elderly subjects received "pelvic muscle exercises,
bladder retraining, estrogen replacement, biofeedback, functional electrical
stimulation and pharmacologic therapy" -- but "subjects
considered pelvic muscle exercises, delayed voiding, and caffeine restriction
most effective in reducing incontinence severity".
Taken
out of context, these results are not only misleading but erroneous. One has to read the whole text to find out
that 64% of the 53 patients received only "instruction" in pelvic
muscle exercise, and only 42% received instruction in bladder retraining.
In
fact, only five patients received any electrical stimulation, and only one
(1) received biofeedback.
Data
was not presented which would allow comparisons between treatments, presumably
an acknowledgement of the small sample size in these groups.
It
does not appear, therefore, that "hard" behavioral therapies played
much of a role at the University of Wisconsin's Geriatric Continence Center. This in spite of having access to e-stim and
biofeedback on an InCare office computerized system, one of the most expensive
made.
The
paper under discussion is Weinberger MW, Goodman BM, and Carnes M. "Long-Term Efficacy of Nonsurgical
Urinary Incontinence Treatment in Elderly Women". Journal of Gerontology, 1999,
54a:3, M117-M121.
In
fairness to the authors, the article is not about comparisons between
treatments per se, but about geriatric patient's one-year recall and
satisfaction with their treatment. But
on the other hand, the poor wording of the abstract will undoubtedly lead to
this work being misquoted for years to come.
In
contrast to their minimalist treatment, patients at the Clinic appear to have
received an excellent diagnostic workup (but, then, isn't that always the way?)
A
team consisting of a geriatrician, and a urogynecologist, as well as unnamed
residents, fellows and nurse practitioners "evaluated and treated...all
patients", but it seems likely that not all team members saw all patients
-- which raises questions about the uniformity of the therapy.
The
Evaluation included history and physical, 72-hour voiding diary, urine culture,
Q-tip test, and a "simplified" urodynamics evaluation, consisting of
"eye-ball cystometry" and a standing stress test.
The
report states that "Biofeedback, using a perineometer connected to a video
graphic display (InCare, Libertyville, IL) was used to teach women [note
plural] with weak pelvic muscle strength how to perform pelvic muscle
exercises." (p. M118)
But
in Table 3 we learn that only one woman (singular) received biofeedback therapy
(and she was so unimpressed with it that a year later she forgot the
fact.)
Likewise,
it is not clear how women "with weak pelvic muscle strength" were
defined; presumably by the usually unreliable "finger" test. And it isn't clear why 64% of the patients
were given verbal instruction in pelvic muscle exercise if they did NOT have
"weak pelvic muscle strength".
Perhaps they meant to say that only women (or a woman) with VERY weak
muscles got biofeedback, the rest got verbal instruction.
Interestingly,
only "refractory incontinence" was later treated with electrical
stimulation. It was not a first-line
treatment.
The
interventions were not long (median visits only 3) nor terribly
successful. Only 12 patients
("22%", but actually 23%) became "dry", and only another 25
(47%) "improved" at all.
Fully 8 ("16%", but actually 15%) were "unchanged"
by the treatment.
It
is important to note, however, that these figures represent "patient
reports", not objective (pad) or even diary reports.
Apparently
another 8 patients (15%) failed to HAVE a final clinic visit, since the
reported numbers don't add up to 53 (nor 100%). We don't know if they no longer had the initial problem, or no
longer trusted the treatment.
The
ineffectiveness of the Clinic's "verbal instruction and bladder
retraining" treatment is actually acknowledged by the authors, who note
that, based on *subjective opinions* of the patients, "improvement was
significant (p=.005; see Figure 1)"
But
in the very next sentence we read:
"There was, however, no statistically
significant reduction in the mean number of daily incontinence episodes."
Excuse
me? What was the purpose of their
clinic visits? To gather baseline data
for a future study of patient recall?
An
examination of "Figure 1 (and 2)" shows what really happened over
"12 to 25 months"; the patients had the same number of leaks, but
they all rated their problem as "less severe" than initially; i.e.,
they learned to live with it. Now
that's creative therapeutics!
It
is worth noting that the patient population had somewhat "moderate"
incontinence; 2.7 leaks per day (+/- 3) and 2.0 (+/- 2.3) pads per day.
I'm
going to remember this study every time I hear the band play "On,
Wisconsin..."
In
the "Discussion" section, the authors make two major errors in
discussing the work of Baigis-Smith, Smith, Rose & Newman, 1989.
They
state that Baigis-Smith found that those "with the mildest incontinence at
presentation experienced the greatest improvement following treatment".
Actually,
what Baigis-Smith et al reported was this:
Those people with the mildest incontinence at the
baseline visit had the fewest or no urinary accidents after the end..."
(p.232)
That
is a very different result. Obviously
those with the fewest symptoms before treatment would have fewer, or even NO
accidents, at the end.
Conversely,
those with a large number of accidents at the start, even with the 78% overall
improvement rate, might still have a measurable number of accidents at the
end.
(E.g., a 78% reduction in accidents starting at 2
per day would be only 0.4 per day after, whereas 20 per day with a 78%
reduction would be 4 leaks a day at the end.)
On
the second point, these authors stated that Baigis-Smith et al provided
"treatment with pelvic muscle exercises and habit training" (just
like they did).
In
fact, Baigis-Smith used EMG biofeedback in the office with 100% of their
patients, using the "Clinical Perineometer from Farrall Instruments. In what they called a "focused
treatment" model, patients were allowed to continue with the biofeedback
so long as they were showing demonstrable improvement.
In
addition, although not documented in the text, patients were allowed to use an
EMG home trainer for two or more weeks; the project leased and used eight
"Personal Perineometers" also made by Farrall.
All
patients received full interventions including formal biofeedback at all
visits; the mean duration of treatment was 3 visits (with two weeks between),
plus formal EMG evaluations at 3, 6, and 12 month follow up, for an average of
six clinic visits (and six biofeedback sessions.)
In
contrast, the Wisconsin project averaged only three visits and no biofeedback.
The
New Jersey biofeedback protocol resulted in a 78% symptom reduction, with 76%
of patients improved > 60%, and 98% improved > 30%.
The
Wisconsin verbal protocol resulted in NO measurable reduction in leaks, only a
change in patient complaints.
It
should be further noted that the Baigis-Smith project -- unlike many less
successful programs, actually saw their symptom improvement rates go UP after
termination of "focused treatment". Cured, for instance, increased
from 37% to 59% a year later.
Whether
this can be attributed to more effective teaching of at-home skills, or the
reinforcing properties of biofeedback sessions at 3, 6 and 12 months is unclear
-- but it is still impressive.
The
project is all the more impressive since the express purpose was NOT to
determine how effective biofeedback could be, but how many senior citizens
could receive significant personal benefit from a time- and cost-limited
intervention.
Finally,
the nurse that directed the NJ clinic, Diane Smith, had received extensive
personal training in the lab of Kathy Burgio, and several consultations and
visits over two years from this author (JDP).
Wisconsin
did not have either of these advantages.
QED.
Copyright © 2000 by Incontinet.com