The Empire Strikes Back A Series of Critical Reviewsof Claims Made on Behalf of New Incontinence Products By John D. Perry, PhD |
"Detrol" is the latest entry into the Urge Incontinence sweepstakes, having recently been approved by the FDA. It is being aggressively marketed by the manufacturer, Pharmacia & Upjohn, with extensive television and internet presence.
And, we are warned, a "comprehensive disease management program focused on lower urinary tract conditions including urinary incontinence, overactive bladder, and UTIs", called "Urinary Health Management Program", is coming soon to a Urologist near you!
In a nutshell, Detrol is apparently about 2/3 as effective as DitropanXL (at least, comparing the manufacturer's unpublished clinical results), but it has a distinct advantage: Only 40% of patients complain of dry mouth, compared with 61% for DitropanXL. That would seem to be a big advantage, albeit at a high cost in terms of its effectiveness!
I wonder if you could get the same reduction in effectiveness AND side effects by taking only 2/3 a dose of DitropanXL?
We'll return to the statistics in a minute. But first we must take note of a subtle shift in thinking about Urinary Incontinence over the past decade. The shift coincides with the development and growth of urodynamics.
In the third quarter of this century, most attention was focused on stress incontinence, and the various surgeries and exercises that could be used to deal with it. By the late 1970s, the introduction of urodynamics began to shift attention away from stress incontinence, and towards the definition and treatment of the hyperreflexive bladder.
Books from the 1970-1988 era reflected the "stress incontinence" orientation; that is, they assumed that Stress was most common, and they listed it first. In a chapter in Gartley's "Managing Incontinence" (1985), HIP director Katherine Jeter lists the types of incontinence as "Stress, Urge, Overflow, Total, and Enuresis" (p. 12). And in Oslander's famous "Clinics in Geriatric Medicine" (Nov. 1986), he lists them as "Stress, Urge, Overflow, and Functional". (p. 712).
Back in 1986 I overheard a discussion between two poster presenters at an Aging meeting; they had both posted studies on prevalence, but with very different results. They speculated that the educational environment of Ann Arbor was responsible for the prevalence of Stress Incontinence there, while the requirements of Southern Culture caused Urge Incontinence to prevail in Little Rock.
At the time, most of my colleagues believed that the bias of the physician making the classification was really the decisive factor.
Apparently the 1988 Consensus Development Conference started the pendulum swing. In one of the first books written AFTER that meeting, Jeter and Faller (1990) classify incontinence as "detrusor instability", "Genuine Stress Incontinence", "Overflow" and "Atonic bladder". (p. 14-15)
In her own chapter (4) on Treating and managing incontinence, Jeter mentions, after the standard Nursing Interventions, the Medical and Surgical interventions including "drugs and surgery", and lastly, "behavioral interventions". In each section, the types of incontinence are discussed in the "DI-GSI-O-A" sequence. In the behavioral section, fully ten pages are devoted to Urge Incontinence methods, with only a few sentences mentioning behavioral treatment of Stress Incontinence.
Still, there was no consensus in 1989-90; the highly-respected Kristene Whitmore's Overcoming Bladder Disorders (1990) lists "S-U-O-Mixed" (p. 49).
Many of us who got started thinking "S-U-O" never changed our orientation. To this day, the NAFC (nee HIP) website lists "S-U-O-Reflex and 'Incontinence from surgery'", and even the AUA's own 1998 "drylife" website uses "S-U-Mixed-O".
But the tide had turned for certain with the 1992 publication of the AHCPR's Guideline on Treatment of Incontinence in Adults. They used the "U-S-O-Other" sequence.
Interestingly, the AHCPR says that "Urge incontinence is usually, but NOT ALWAYS, association with ... detrusor overactivity". (p. 6, 1992). (Emphasis added.)
The AHCPR also adds:
Many patients ... have severe urgency associated with bladder hypersensitivity and NO demonstrable detrusor overactivity. This is termed sensory urgency (p. 11).
In the 1996 revision of the AHCPR Guideline, the U-S-M-O-Other sequence wasn't changed.
Interestingly, by the time we get to the ICS-endorsed, Detrol-funded "Incontinence Knowledge Center" on the internet, "Overactive bladder", rather than "Urge Incontinence" dominates the discussion.
The section on Classification includes "Overactive bladder", "Stress Inc.", and Mixed, as well as O, and other conditions, in that order.
The AHCPR's exceptions are glossed over by statements like this "People with overactive bladder experience inappropriate contractions...(they have) ...urge incontinence." and
"Urge incontinence is the ultimate symptom of an overactive bladder and is seen in approximently 38% of women and 33% of men suffering from an overactive bladder."
[Am I the only one who has trouble understanding the syntax of that sentence? What ARE they saying?]]
The section on "Therapies" contains: Section 1: Management of overactive bladder (4 pages) Section 2: Management of stress incontinence (3 pages) Section 3: Pharmacological therapy for overactive bladder ( 2 pages). Section 4: References and Glossary
Of course, this website is financed by a pharmacology company, so we should not be surprised that drugs are singled out for special treatment.
Except, of course, that the International Continence Society claims, on the very same website, to be "an unbiased information resource for ... professionals and ... consumers..."
Of course we don't expect Pharmacia & Upjohn to be unbiased, and they aren't. They claim, on the Professional Information page, that Detrol is "an effective and well-tolerated medication for the treatment of overactive bladder".
They also claim that "17 million Americans" suffer from over-active bladder, but no source is given. (Last time I heard that figure, it applied to ALL urinary incontinence.)
So how effective is it? In three placebo-controlled, 12 week studies, there was a 15 to 21 percent reduction in frequency. That's 10.4 to 11.0 minus 1.6 to 2.2. Let's see; 10.4 minus 1.6 is 8.8, still "urge incontinent" by the ICS definition (>7).
And, actual leaks due to urgency, which were 2.4 to 2.7 before Detrol, dropped by 1.2 to 1.5 leaks per day; that's still over one leak a day, and still "incontinent" by my clinic's definition.
In both frequency and actual leaks, Detrol did significantly better than a sugar pill. Fascinating, EXCEPT that I never thought a sugar pill would reduce frequency or leaks anyway. How about a "real world" comparison? Kathy Burgio found an 85-94% reduction in urge symptoms using only about 4 bi-weekly sessions of biofeedback.
The comparable Detrol figure, 50 to 56 percent, is not exactly impressive -- unless you don't know anything about biofeedback and think the sugar pill is a valid comparison.
Interestingly, it appears that neither the Urology Network nor the ICS-endorsed Incontinence Knowledge Center know anything about Burgio's work or the many other forms of Biofeedback that have been used with Urge Incontinence, and fully described in the literature.
As best I can tell, from five or six visits this week, the word "biofeedback" does NOT even appear in ANY of the "treatment" sections, and isn't even listed in the "glossary" on these Detrol-sponsored websites.
Also missing is any reference to the work of Jeannette Tries, Jeanne McDowell, Joan Coxe, Barbara Woolner, Diane Smith, Jacques Sussett, Linda Cardozo's biofeedback studies, Molly Doroghty, Jo Laycock, Susan Middaugh, Pat O'Donnell, Jane Henderson, Katherine Taylor, or even Kari Bo, to name a few off the top of my head. Not to mention the undersigned, and the many other references to biofeedback in the AHCPR Guideline.
Why do you suppose the makers of Detrol would fail to compare their product to a non-invasive treatment, recommended by the AHCPR, that has a significantly better success rate than sugar pills or Ditropan?
"Good Question!, as the TUMS lady says.
BUT PLEASE! Don't take my word for it!
Visit The Knowledge Center at
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