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Journal of Pediatric Psychology, Vol. 25, No. 4, 2000, pp. 219-224
© 2000 Society of Pediatric Psychology
Commentary: Treatments for Enuresis: Criteria, Mechanisms, and Health Care Policy
University of Memphis
All correspondence should be sent to Arthur C. Houts, Department of Psychology, University of Memphis, Memphis, Tennessee 38152. E-mail: a.houts{at}mail.psych.memphis.edu .
| Introduction |
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Mellon and McGrath (this issue) have done an admirable job of applying the modified Chambless criteria (Task Force on Promotion and Dissemination of Psychological Procedures, 1995
| History and Current Context of Psychological Treatments for Enuresis |
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We are fortunate to have the case of treatments for enuresis to teach a historical lesson about the pitfalls of our current enthusiasm for empirically supported treatments. The treatment of enuresis has a long and very colorful history dating as far back as 1550 B.C. Glicklich (1951
Such a Popperian approach to the issue of identifying empirically supported
treatments is counterintuitive for most of us who have viewed science as an
inductive process. Ollendick
(1999
) recently expressed the
logic of current thinking regarding the empirically supported treatment
movement.
Surely "treatments that work" are desirable and their development and promulgation should be encouraged; after all, to argue the converse, that "treatments that do not work" should be developed and disseminated hardly seems tenable and makes little sense for a profession committed to the welfare of those whom we serve (Ollendick, 1999, p. 1).
Quite the contrary and from a methodological point of view, I believe that what we need most urgently is to identify treatments that do not work. In the case of much positive psychotherapy outcome research for various mental disorders, we already know that people get better with the passage of time, and we believe some inert treatments are effective. Whenever we study a problematic condition such as bedwetting with a natural course toward remission, we need to be particularly attentive to the frog effect and to the burning bird's nest effect. Otherwise, our cumulative wisdom will include all manner of procedures that have "worked" because we may mistake applying the procedure for the natural developmental resolution of the problem.
The process of identifying treatments that definitely do not work could benefit us in two ways. The obvious benefit is to rule out ineffective procedures. Knowing what definitely does not work would clear the air and purchase a small degree of progress even if we could not as yet identify a procedure that did in fact work. One of the great difficulties with developmental problems such as bedwetting is that at any given time, many different things can appear to work. The scientific task is to weed out procedures that may appear to work from those procedures that can be trusted to work reliably, not only because they have passed muster in numerous randomized clinical trials but also because we have verified knowledge about the mechanism through which they produced positive outcomes.
Second, identification of treatments that do not work could provide much needed psychological placebo control groups. For quite some time, treatment outcome researchers have needed a nonpill placebo condition. If a psychological treatment is compared to a pill placebo, the comparison is never exactly parallel because the placebo condition consists not only of an inert treatment but also of the expectancy that one is receiving medication as opposed to a nonmedication treatment. A procedure believable as a psychological treatment but known to be ineffective would provide the much needed parallel placebo condition for various psychological treatments.
The history of the treatment of childhood enuresis has demonstrated that
verbal psychotherapies have not produced outcomes that were much better than
pill placebo controls (Houts, Berman, &
Abramson, 1994
). Some research in the 1960s included treatments
such as supportive counseling and psychotherapy
(De Leon & Mandell, 1966
;
Werry & Cohrssen, 1965
).
However, by the mid-1970s, most psychological research had moved on and was
devoted either to developing alternative behavioral procedures based on
operant conditioning (e.g., Azrin, Sneed,
& Foxx, 1974
) or to improving urine alarm treatments within
Lovibond's (1963
) avoidance
learning formulation (e.g., Young &
Morgan, 1972
). Mellon and McGrath have presented much of that
history in their review, but they have not been nearly so shocked as I have
been to find the return of verbal psychotherapy as "promising." It
is important to reiterate that this judgment was fairly enough required of
Mellon and McGrath, because they duly applied the modified criteria for
empirically supported treatments.
In the interest of returning psychotherapy for enuresis back to the realm of the repressed, I offer the following analysis of the verbal psychotherapy studies reviewed by Mellon and McGrath. This analysis also leads to discussion of the problems with criteria for declaring some intervention "promising."
| Repressing Psychotherapy for Enuresis |
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Mellon and McGrath have included four reports on the use of hypnosis to treat enuresis and one report that included a cognitive self-control treatment. In the analysis that follows, I have confined my remarks to the two controlled studies that used random assignment to conditions, because there is no point in considering less rigorous designs in the case of such alternative treatments for enuresis. The fact is that we have over 50 randomized trials showing the effectiveness of urine alarm treatment, so any new treatment has to meet a rather high standard.
Hypnosis apparently qualified as promising on the basis of one controlled
study (Edwards & Van Der Spuy,
1985
), which was also accompanied by two case series and one quasi
experiment. The controlled study provided a good illustration about how
research reports can be misleading. Kenneth Spence was alleged to have said
that he could advance psychology immediately if someone would just give him
enough money to pay other people not to conduct and publish research. Edwards
and Van Der Spuy (1985
)
compared hypnotic trance induction and suggestions with trance alone,
suggestions alone, and no treatment. The statistical reporting in this
research report was completely inadequate. The investigators did not assess
pretreatment differences between the four groups, and they did not provide the
data for a reviewer to do so. This was important because there appeared to be
differences in the groups at baseline with respect to wetting frequency. The
main analyses were conducted as repeated measures analyses of variance on
Z scores of weekly wetting frequency during the 6-week treatment
period, but it was impossible to reconstruct the actual data because no
standard deviations (SDs)were ever reported. The authors stated that
both suggestion conditions resulted in a reduction of wet nights that was
greater than the no-treatment controls in a 6-week treatment period, but it is
impossible to tell if the analyses were done correctly because the authors do
not report degrees of freedom with their F tests. In the main
analysis, no mention was ever made about the number of children who became dry
during the treatment period for each of the four groups. What was later
reported was that after a 6-month follow-up, only 19.4% of the children from
the three hypnosis treatment groups had completely ceased bedwetting. That
outcome speaks for itself. Hypnosis was not effective except when it was
compared to outcome for no-treatment controls. The authors did not even make
that comparison using their own no treatment control data, but they relied
instead on the no-treatment control results from another previously published
study conducted by completely different investigators and published 20 years
earlier. The results from this clinical trial were only marginally better than
what could be expected from investigations of spontaneous cessation of
bedwetting due to maturation and the passage of time. There is nothing
whatsoever promising about hypnotic suggestion to treat bedwetting despite the
fact that the literature contains one adequately designed, if poorly executed,
study.
Similar problems occurred in the report by Ronen, Wozner, and Rahav
(1992
), where the authors
reported outcomes for their new cognitive therapy for bedwetting. These
investigators compared a urine alarm protocol without any relapse prevention
component to their new cognitive behavioral intervention that consisted of
some combination of self-monitoring, self-reinforcement, and learning
self-guided talk. They also included a token economy intervention and a
no-treatment control group in their study. The outcomes from this trial were
also reported in two other publications
(Ronen, Rahav, & Wozner,
1995
; Ronen & Wozner,
1995
), where the same mistakes from the original publication were
repeated. The authors established a criteria of 3 consecutive weeks of dry
nights for the designation of "dry," but they reported statistical
analyses that were inappropriate. They displayed a 4 Group (Urine Alarm, Token
Economy, Cognitive Therapy, No Treatment Control) x 3 Outcome (Dry,
Improved, Dropout) table of the percentage of children in each outcome
category for each of the four groups as their Table 2. The text repeatedly
referred to this table as Table 1, which in fact showed average wetting
frequency for the four groups. The authors reported a chi-square statistical
analysis with nine degrees of freedom on the data presented in their Table 2,
and this resulted in a chi-square value with p
001. The
appropriate degrees of freedom for that omnibus test should have been six, not
nine. Nevertheless, that reported chi-square test showed that at least one of
the several possible one degree of freedom tests within the 4 x 3 table
was statistically significant. In fact, the chi-square test for the comparison
of the 63.2% cure rate for the urine alarm with the 75% cure rate for the
cognitive intervention was never reported, and when I calculated it, the
chi-square value was less than one (.64) and associated with p =.42.
Nevertheless, the authors stated in their abstract that "cognitive
intervention was the most effective treatment method, as evidenced by the
highest rate of success and the lowest rate of drop out or relapse"
(Ronen, Wozner, & Rahav,
1992
, p. 1). The one degree of freedom test for the relative
difference in rate of dropout was never reported by the authors, and when I
computed the correct test, there was no difference in dropout between the
cognitive group and the urine alarm group. This erroneous result regarding
rate of dropout was reported again by Ronen and Wozner
(1995
). As for the authors'
claims regarding differences in relapse rate, it was impossible to discern how
they calculated a nine degree of freedom chi-square from a 4 Group x 2
Outcome (Remained Dry vs. Relapsed) table. When I calculated the appropriate
test, the comparison of relapse rate between the cognitive intervention (15%)
and the urine alarm treatment (60%) was statistically significant. At least
one of the three conclusions stated in the abstract was actually supported by
the data presented. The authors of this report did not address the question of
how their results compared to so much previous research that has shown quite
different outcomes. For example, if nothing is done to prevent relapse with
the urine alarm, we have known for over 25 years that the relapse rate is
likely to be 40% or greater. This was never addressed. Why did the authors use
a urine alarm intervention without some relapse prevention method?
What was even more surprising was the finding that 15 out of 20 children
who received the cognitive intervention in this study attained the dryness
criterion. How could that have happened in light of the history of repeated
failure of verbal psychotherapies for bedwetting? The authors did not comment
on that issue. In the introduction to their article, they spoke about the role
of conscious learning of daytime control of bladder function, but they never
addressed the issue of how changing what children said to themselves during
the day could produce a change in physical control over their bladder function
during sleep. In a separate publication that appeared 3 years later, the
authors noted that children in the cognitive intervention also practiced
retention control training, and they practiced urine retention during the day
(Ronen & Wozner, 1995
).
The children were also told that "bedwetting does not depend on bad luck
or illness but, rather, is a function of motivation and willpower"
(Ronen & Wozner, 1995
, p.
10). Apparently, the children in the cognitive intervention group received
rather extensive coaching and therapy sessions from the investigators, whereas
the urine alarm and the token economy interventions were conducted by parents.
All of the children in the no-treatment control group were lost to follow-up.
In sum, there is considerable reason to doubt the care and methodological
rigor with which this study was conducted and reported.
In light of the extensive history of failure of cognitive types of
intervention for bedwetting, the outcome from Ronen, Wozner, and Rahav
(1992
) should be considered an
anomaly. The fundamental idea that children willfully control their thought
processes during sleep and the proposition that such cognitive control
accounts for bedwetting are simply not plausible. If such propositions were
true, then why do we have a history of 3,500 years of parents and
professionals talking to children about stopping bedwetting with little or no
results? The one treatment that we know to work reliably, the urine alarm,
does not require cognitive control and most likely works via a process of
active avoidance conditioning (Houts,
1991
,
1995
). The issue in this case
is about burden of proof. When we have very strong evidence for a dominant
effective treatment, as we do in the history of treatment for enuresis, and
when we have such clear evidence for failure of cognitively mediated
treatments, the burden of proof is on those who propose a new variation of the
failed treatment and a mechanism that has been shown to fail in the past. Why
did such a treatment appear to work in this particular trial? Where is the
evidence that the comparison treatments were faithfully conducted?
Scientific reasoning occurs in a web of belief, and that reasoning is inherently conservative. We change our beliefs so as to produce minimal adjustment in the overall web of belief. In this sense, the criterion of declaring an intervention promising on the basis of at least one well-controlled study is misleading. One well-controlled study is not enough, as the case of cognitive treatments for bedwetting shows. The history of investigation in a domain needs to be considered, and the identification of treatments that do not work can be relevant in assessing claims for "new and improved" treatments. It is disturbing enough to think that talking therapy for enuresis may make a comeback, but it is even more disturbing to consider, as Mellon and McGrath have indicated, that the most effective treatment known for children's bedwetting is rarely promulgated by our current health care system.
| Enuresis Treatment and the Health Care System |
|---|
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As Mellon and McGrath have noted in their review, the available evidence regarding what treatments children receive for bedwetting suggests that the front line service providers, pediatricians and family physicians, have traditionally favored medication treatments and have only rarely recommended urine alarm treatment. Although we do not have more recent direct surveys of medical practitioners, there is every reason to believe that the situation has worsened due to massive advertising by the pharmaceutical industry, to typical procedures of managed care organizations, and to the failure of health care professionals actually to practice evidence-based health care.
Over the past 10 years, millions of dollars have been spent promoting
synthetic vasopressin (DDAVP) as a treatment for bedwetting. First approved in
the United States in 1989, this treatment quickly replaced the leading
medication treatment for bedwetting, imipramine, because DDAVP had fewer side
effects and did not carry the mortality risk due to cardiac failure associated
with imipramine. When it was first introduced, DDAVP was available as a nasal
spray. That delivery system was required because the synthesis of the drug was
said to be too costly to be affordable in oral tablets, a route of
administration that required wasting a lot of the compound to achieve adequate
blood levels. In the past 3 years, the drug has been made available in tablet
form. The monthly cost of treating a child with DDAVP is approximately $150.
What should be remembered is that DDAVP rarely stops bedwetting, and when the
child stops taking the medication, the child reverts to wetting
(Moffatt, Harlos, Kirshen, & Burd,
1993
). Given the mechanism by which DDAVP works, one should expect
complete relapse once the medication is withdrawn.
In order to maintain a child on DDAVP for 1 year, the cost would be
approximately $1,800. A 12-week course of urine alarm treatment that included
all supporting materials and regular consultations with a doctoral-level
psychologist would cost only $500. In other words, maintaining a child on
ineffective drug treatment for a year costs over three times what it costs to
cure bedwetting. Why then do most children still receive some type of
pharmaceutical treatment when even leading medical authorities
(Moffatt, 1997
) have clearly
recommended urine alarm treatment as the treatment of choice based on current
outcome evidence?
Currently, third-party payers such as insurance companies and managed care organizations along with medical professionals determine what happens to the majority of bedwetting children. Most insurance policies provide benefits according to what is determined to be medically necessary by a physician, and those insurance policies also typically have different reimbursement policies for providers of psychological services, who are most likely competent to deliver or supervise urine alarm treatments. A medical doctor may judge that urine alarm treatment is medically necessary, but the treatment may not be reimbursable because of limitations of the policy on nonmedical providers. Similar scenarios can and do occur in managed care organizations where enrollee children are restricted to certain provider lists, and many of those organizations relegate mental health services to master's level providers without psychological training in how to use the urine alarm protocol. Managed care organizations commonly do not know about treatment outcome evidence in the case of bedwetting, despite the fact that they are interested in reducing costs and providing evidence-based treatments. As a result of these processes, children who are diagnosed with functional nocturnal enuresis are treated with what is reimbursable and what is familiar, namely, medications.
In addition to not having any easy channel of referral for urine alarm treatment, most pediatricians and family physicians are visited regularly by representatives of the various pharmaceutical companies that manufacture and advertise medication treatments for bedwetting. The culture of professional medicine and the culture of many parents support medication solutions to children's problems. As someone who has followed these cultures surrounding the problem of enuresis for the past 20 years, I am not surprised that urine alarm treatment remains so underutilized. Perhaps it will take another 20 years for a treatment that was devised over 60 years ago finally to be provided on a routine basis to the almost 7 million children affected by enuresis in the United States.
Received August 23, 1999; accepted August 25, 1999
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