Behavioral Therapy in Prostatectomy Patients with Persistent, Long-Term Incontinence
Men with postoperative incontinence issues persisting at least 1 year after receiving a radical prostatectomy were found to have fewer incontinence episodes after 8 weeks of behavioral therapy when compared with a control group; however, adding biofeedback and pelvic floor electrical stimulation did not offer an additional benefit, according to new study findings. The results of the recent randomized trial were recently published in the Journal of the American Medical Association [2011;305(2):151-159]. Previous studies have found that perioperative training of pelvic floor muscles reduces the duration and severity of incontinence immediately after surgery, but according to the trial’s researchers, no studies have been done to test the impact of behavioral therapy in patients who have had persistent incontinence >1 year after surgery. Incontinence can be a common postoperative condition with physical, emotional, and psychological implications for prostatectomy patients. Researchers in this study evaluated the effectiveness of an 8-week behavioral therapy regimen with and without the addition of biofeedback and pelvic floor electrical stimulation in patients with persisting incontinence 1 to 17 years after a radical prostatectomy was performed. Study participants (n=208) were randomly assigned to the following: (1) behavioral therapy, (2) behavioral therapy with in-office biofeedback and daily at-home pelvic floor electrical stimulation, or (3) delayed treatment. Behavioral therapy included 4 visits during an 8-week period focusing on pelvic floor muscle training and bladder control strategies, while members of the behavior-plus group also underwent in-office dual-channel electromyograph biofeedback and daily at-home pelvic floor electrical stimulation at 20 Hz with a current up to 100 mA. The delayed treatment group (control group) had clinic visits every 2 weeks during the 8-week period; however, after 8 weeks they were given the choice of receiving either behavioral therapy with or without the biofeedback and electrical stimulation. All 3 groups kept daily bladder diaries to track their progress. The trial was conducted at a university and at 2 Veterans Affairs continence clinics from January 2003 to June 2009. The primary outcome of the study was identified as the reduction in the number of incontinence episodes at 8 weeks as measured with a 7-day bladder diary. The diary was scored by researchers who were blinded to the group assignments. Upon the trial’s completion, researchers found that the behavioral therapy group and the behavior-plus group had significantly decreased episodes of mean incontinence after 8 weeks when compared with the delayed treatment group. The behavioral therapy group decreased the mean incontinence episodes from 28 to 13 per week for a 55% reduction (95% confidence interval [CI], 44%-66%), whereas the behavior-plus group had a reduction from 26 to 12 episodes for a 51% reduction (95% CI, 37%-65%) and the delayed therapy group had a decrease of 25 to 21 incontinence episodes for a reduction of 24% (95% CI, 10%-39%). The study’s authors noted that the improvements seen by the active treatment groups were sustained for the 12-month follow-up period. Researchers did not find any significant difference in the reduction of incontinence episodes between the behavioral therapy group and the behavior-plus group (P=.69). In addition to a reduction in incontinence episodes, 90% of those in the behavioral therapy group and 91% of those in the behavior-plus group described their leakage as either “better” or “much better” compared with only 10% in the delayed treatment group. Those in the active therapy groups (behavioral therapy and behavior-plus) also reported feeling fewer restrictions due to incontinence and reported less pad use than the control group. Adherence to the exercises and bladder control strategies was also high for both active therapy groups, with the behavior therapy group reporting a 100% adherence rate at 8 weeks and the behavior-plus group reporting a 93% adherence rate. Researchers acknowledged that the study may have been limited because it was not blinded.