News Author: Nick Mulcahy
CME Author: Désirée Lie, MD, MSEd
January 20, 2011 — In men suffering from urinary incontinence a year or more after prostatectomy, a behavioral training program resulted in a significant reduction in urinary incontinence episodes, according to a new study.
The program consisted of pelvic floor muscle training, bladder control strategies, and fluid management.
The mean number of incontinence episodes decreased from 28 to 13 per week (55% reduction; 95% confidence interval [CI], 44% to 66%) after behavioral therapy, which was significantly greater than the reduction from 25 to 21 (24% reduction; 95% CI, 10% to 39%) observed among controls (P = .001)
The study is authored by Patricia Goode, MD, from the University of Alabama-Birmingham, and colleagues, and is published in the January 12 issue of Journal of the American Medical Association.
However, before "roundly endorsing" this approach, it is important to examine other outcomes in the study, according to an expert who penned an accompanying editorial. Those outcomes are not as impressive, writes David Penson, MD, MPH, from the Department of Urologic Surgery at Vanderbilt University in Nashville, Tennessee.
He notes that, despite being statistically significant, the above-mentioned 55% reduction in incontinence episodes means that the men in the therapy group still had about 2 episodes a day.
In the end, Dr. Penson acknowledges that "behavioral therapy appears better than no therapy." But he declares that "if this is as good as this therapy gets, it is important to rethink how to best treat men with this problem."
Primary prevention might be best, he suggests.
In other words, clinicians should increase the use of active surveillance in men with localized prostate cancer, such as the men in the current study.
Because of the vagaries of prostate-specific antigen screening, the overdiagnosis rate of screen-detected cancer that would not present clinically during the patient's lifetime is estimated to be 23% to 42%, says Dr. Penson.
Because most of these men will be treated and many will have adverse effects, the overtreatment of prostate cancer is the underlying problem here, he suggests.
"A patient with this type of low-risk cancer, therefore, is exposed to the adverse effects of aggressive interventions, such as surgery or radiation, with little or no benefit," writes Dr. Penson, echoing many other experts who have published studies and editorials in the past few years.
But What About the Guys With Problems?
Urinary incontinence is a huge problem after prostatectomy, say the study authors.
As many as 65% of men are incontinent to some degree up to 5 years after surgery, they write, and loss of bladder control can be a physical, emotional, psychosocial, and economic burden for men who experience it.
Dr. Penson notes that stress urinary incontinence can be especially "bothersome" and, 5 years after surgery, has a rate of 14% to 28%.
Behavioral therapy has been previously shown to improve postoperative recovery of continence. "Several randomized trials have examined the effectiveness of perioperative pelvic floor muscle training and shown a significant reduction in duration and severity of incontinence in the early postoperative period," write Dr. Goode and her study coauthors.
The contribution of this study is that it tests, for the first time, the effectiveness of behavioral therapy for incontinence persisting more than a year after prostatectomy.
Most of the subjects in the study had undergone surgery at least 5 years previously (range, 1 to 17 years).
In the study, which was performed on men attending continence clinics at 2 Veteran Affairs hospitals and 1 university hospital, consisted of 208 men stratified by type and frequency of incontinence and randomized into 3 groups: 8 weeks of behavioral therapy (pelvic floor muscle training and bladder control strategies); behavioral therapy plus in-office dual-channel electromyographic biofeedback and daily home pelvic floor electrical stimulation; and delayed treatment, which served as the control group.
Notably, the researchers found that the addition of biofeedback and pelvic floor electrical stimulation provided no additional benefit.
The primary outcome of the study was the number of incontinence episodes at 8 weeks, measured with a 7-day bladder diary. As mentioned above, it was statistically significantly better in the treatment groups than in the control group.
Importantly, this improvement was durable. After 8 weeks of therapy, a 1-year follow-up visit was conducted. The investigators found that there was 50% reduction (95% CI, 39.8% to 61.1%; 13.5 episodes per week) in the behavioral-therapy group, which was comparable to the reduction seen immediately after the initial 8 weeks.
"Our findings indicate that no matter how long it's been since surgery, behavioral interventions can help men reduce the number of incontinent episodes they experience," said Dr. Goode in a press statement. "There is no guarantee that they'll be completely dry, but behavioral therapy will help reduce incontinence and improve quality of life."
Another outcome measure used in the study was the American Urological Association symptom index (AUA-7), which measures lower urinary tract symptoms.
However, Dr. Penson was not impressed with the results with this measure.
At 8 weeks, the behavioral-therapy group had a decrease in AUA-7 score of 2.5 points. This score is considered just a "slight improvement," according to an earlier study that defined clinically meaningful change for this instrument, Dr. Penson points out. He also notes that, at 6 and 12 months after the initiation of behavioral therapy, the decline in the AUA-7 score was less than 4 points, "the threshold for moderate improvement."
Where to Find Help
Dr. Goode and her colleagues have a different perspective about the study outcomes.
They note that 16% of men in the treatment groups achieved complete continence with therapy.
They also point out that, on average, men with incontinence reduced the problem by about half in the therapy groups. "A recent study determined that a 40% reduction in incontinence frequency was the threshold required to achieve a clinically important improvement on the validated Incontinence Quality of Life Questionnaire," they write.
Yet another measure showed that the therapy worked well, say the study authors. "The improvement in the Incontinence Impact Questionnaire score, which reflects the impact of incontinence on daily life, was 22.9 to 29.9," they write. This range exceeds the "minimally important difference" of 6.5 to 17.0.
The study authors credit bladder control strategies as being an important part of the therapy success.
"Many of the participants in our trial reported that they had tried pelvic floor muscle exercises after their surgery but had stopped when they failed to improve sufficiently," say the authors, who suggest that muscle control must be strategic.
They describe the bladder control strategies for stress and urge incontinence. "The strategy for preventing stress incontinence was to contract pelvic floor muscles just before and during activities that caused leakage, such as coughing or lifting," they write. Calm is also encouraged. "The urge-control strategy involved instructions to not rush to the toilet but instead to stay still and contract the pelvic floor muscles repeatedly until urgency abated and then proceed to the bathroom at a normal pace."
The authors believe that behavioral therapy should be offered to all men with urinary incontinence after prostate surgery.
"Behavioral therapy should be offered to men with persistent postprostatectomy incontinence because it can yield significant, durable improvement in incontinence and quality of life," they write.
However, there are a couple of obstacles for men who might benefit from the therapy, suggest the authors. "Behavioral therapy works, but unfortunately many men are not aware that it is an option or don't know where to find the therapy," said Kathryn Burgio, PhD, a study coauthor, in a press statement.
Some physical therapists offer behavioral therapy, say the authors, and 2 organizations — the Wound, Ostomy and Continence Nurses Society and the National Association for Continence — maintain a database of practitioners.
This study was supported by grant R01 DK60044 from the National Institute of Diabetes and Digestive and Kidney Diseases and by the Department of Veterans Affairs Birmingham–Atlanta Geriatric Research, Education, and Clinical Center. Dr. Goode reports receiving a research grant from Pfizer. Study coauthors also report industry ties, as noted in the paper.
http://www.medscape.org/viewarticle/735971?src=cmemp
regards, taniafdi ^_^
