"This randomized controlled trial clearly demonstrated that behavioral therapy with pelvic floor muscle exercises, strategies to prevent stress and urge leakage, fluid management, and self-monitoring with bladder diaries is an effective treatment for postprostatectomy incontinence persisting even years after surgery," Goode and colleagues concluded.
Patients in the study had experienced urinary leakage for at least a year after radical prostatectomy -- the mean time since surgery for the 208 participants was nearly five years, and was more than 10 years for some.
Those with a history of incontinence prior to surgery were excluded, as were patients with low numbers of incontinence episodes and those with significant incomplete emptying with urination.
about half the patients had tried pelvic floor muscle exercises and a quarter had received alpha-blockers and/or antimuscarinic drugs.
The study was a three-arm randomized trial. The primary intervention, behavioral therapy and pelvic floor muscle exercises, lasted eight weeks and was included in two of the treatment arms.
One of the intervention arms also included dual-channel biofeedback therapy at the same visits as the behavioral therapy, along with daily 20-Hz electrical stimulation of the pelvic floor at home with currents adjusted up to 100 mA to achieve palpable contractions. Goode and colleagues called this the "behavior plus" intervention.
Behavioral therapy in both intervention groups was provided in four sessions. Patients were given instructions on various bladder control strategies, such as deliberately contracting pelvic floor muscles prior to and during activities that tended to trigger leakage.
Both arms included instruction in fluid management as well.
Patients kept daily bladder diaries noting the number of urinations, leakage episodes (the primary outcome), urine pads used, and subjective assessments of the severity of incontinence.
Those in the control group also completed the bladder diaries during the eight-week study period but otherwise had no treatment. Afterward, they were offered their choice of the two interventions.
In addition to outcomes tracked in the bladder diaries, most patients were assessed with the Expanded Prostate Cancer Index Composite (EPIC), the Incontinence Impact Questionnaire (IIQ), the Short Form-36, and American Urological Association (AUA) symptom scores for voiding and storage.
Most study outcomes at the end of the treatment phase significantly favored the two intervention groups, with little difference between them.
In addition to the reduction in mean weekly incontinence episodes, patients receiving the behavioral therapy and exercise training had significantly greater improvements in EPIC scores within the urinary domain and the incontinence subscale.
Scores for the latter increased 13.1 points for the main intervention and 12.3 points for "behavior plus" versus a 2.9-point increase in the control group (P<0.001).
Total IIQ scores decreased 13.9 and 15.7 points in the main and "behavior plus" groups, respectively, compared with an increase of 1.1 points in the control group (P=0.03).
For a few outcomes, neither intervention group had significant improvement relative to the control group. Among them were AUA voiding scores, the IIQ subscales for physical activity and social relationships, and the mental component of the Short Form-36.
In each case, though, there were trends favoring the interventions.
Goode and colleagues were also able to reevaluate about 80 patients a year after the treatment period. For the most part, they found, the improvements seen at the end of treatment were maintained.
Adherence to the exercises and bladder control strategies during the follow-up period was good, rated at 91% and 81%, respectively, for the main intervention and "behavior plus" at 12 months.
The researchers asserted that, on the basis of their study, the behavioral therapy and exercise program "is an effective treatment" for long-term incontinence resulting from prostatectomy.
In an accompanying editorial, though, another researcher sounded a skeptical note.
David F. Penson, MD, MPH, of Vanderbilt University in Nashville, contended that many of the statistical improvements were of questionable clinical significance.
As an example, he cited the reduction of weekly incontinence episodes from 28 to 13 in the main intervention group.
"Although clearly better than the three [sic] episodes a day before treatment, two incontinent episodes a day certainly would be problematic for many men," Penson wrote.
He also noted that 38% of the combined intervention groups reported no change in the number of leakage pads they used. "Would these patients conclude that behavioral treatment was successful?" he wrote.
"If this is as good as this therapy gets, it is important to rethink how best to treat men with this problem," Penson asserted.
He suggested that a more fundamental solution would be to perform fewer prostatectomies in the first place. He cited studies indicating that 23% to 42% of these procedures are for indolent tumors that could be left alone with active surveillance.
"It is time that patients with prostate cancer and their physicians consider this option more seriously," Penson declared.
Goode and colleagues noted some limitations to their study, including the lack of blinding and the possibility that clinical trial participation boosted adherence rates beyond what could be expected from patients in routine practice.
Also, they noted, the study design made it impossible to separate the contributions of the interventions' individual components.
The study was funded by the National Institute of Diabetes and Digestive and Kidney Diseases and the Department of Veterans Affairs.
Study authors reported relationships with numerous pharmaceutical companies including Pfizer, Astellas, GlaxoSmithKline, Johnson & Johnson, Ferring, Boehringer Ingelheim, Vantia, and Novartis.
Penson declared he had no relevant financial interests.