Urinary incontinence affects more than 10 million Americans and accounts for billions of dollars annually in societal costs. Antimuscarinics and behavioral treatments are both safe and effective first-line treatments for urge incontinence. Most patients do not achieve complete continence with either therapy alone. Adding behavioral training to pharmacologic treatment is an appealing approach to improving outcomes and to possible discontinuation of drug therapy. Evidence for the efficacy of combination therapy over either treatment alone is scarce and inconclusive. Here we review 3 new journal articles that examine this controversy from different perspectives.
Behavioral Therapy to Enable Women With Urge Incontinence to Discontinue Drug Treatment: A Randomized Trial
Burgio KL, Kraus SR, Menefee S, et al.
Ann Intern Med 2008;149:161–169..
This National Institutes of Health-sponsored study evaluated whether combining antimuscarinic drug therapy with supervised behavioral training, compared with drug therapy alone, improves the ability of women with urge incontinence to achieve clinically important reductions in incontinence episodes and to sustain these improvements after discontinuing drug therapy. This was a multicenter, randomized clinical trial at 9 university-affiliated outpatient clinics and included women with urge-predominant incontinence.
A total of 307 women received 10 weeks of open-label, extended-release tolterodine. Research participants were randomized into 1 of 2 treatment groups. One group received tolterodine alone (n = 153). In addition to the medication, the second group also received behavioral training (n = 154). The primary outcome, measured at 8 months after treatment, was no receipt of drugs or other therapy for urge incontinence and a 70% or greater reduction in frequency of incontinence episodes. Secondary outcomes were reduction in incontinence, self-reported satisfaction and improvement, and scores on validated questionnaires measuring symptom distress and bother and health-related quality of life. Six months after the treatments were discontinued, 41% of women in both groups reported that they were still off drug therapy and still had at least 70% reduction in the frequency of incontinence episodes (compared with baseline) without additional treatment. It is important to keep in mind that only 68% of the women completed the 10-week treatment.
Study results conclude that the addition of behavioral training to drug therapy may reduce incontinence frequency during active treatment, but does not improve the ability to discontinue drug therapy and maintain improvement in urinary incontinence. However, behavioral intervention was insufficient to help women stay off drug therapy and sustain treatment gains after short-term drug therapy.
Prospective Randomized Comparison of Oxybutynin, Functional Electrostimulation, and Pelvic Floor Training for Treatment of Detrusor Overactivity in Women
Arruda RM, Castro RA, Sousa GC, et al.
Int Urogynecol J 2008;19:1055–1061..
The purpose of this study was to compare the effectiveness of oxybutynin, functional electrostimulation (FES), and pelvic floor training (PFT) for treatment of women with detrusor overactivity. Sixty-four women were randomized to oxybutynin (n = 22), FES (n = 21), or PFT (n = 21) and treated for 12 weeks. Seventy-seven percent of the women treated with oxybutynin, 52% with FES, and 76% with PFT reported subjective symptomatic improvement. Sixty-four percent of women treated with oxybutynin, 52% with FES, and 57% with PFT reported urgency resolution. Results from urodynamic evaluation were normal in 36% treated with oxybutynin, in 57% treated with FES, and in 52% treated with PFT.
This study concludes that all treatments were equally effective. Subjective reduction of urge incontinence episodes was associated with symptomatic improvement.
A Comparison of the Efficacy of Darifenacin Alone vs. Darifenacin Plus a Behavioural Modification Programme upon the Symptoms of Overactive Bladder
Chancellor MB, Kianifard F, Beamer E, et al.
Int J Clin Pract 2008;62:606–613..
This study assessed the benefit of adding a behavioral modification program (BMP) to treatment with darifenacin for relieving the symptoms of overactive bladder (OAB). This was a 12-week randomized, open-label, parallel-group, multicenter study of male and female subjects with OAB, who underwent a 2-week washout and 1-week screening period for OAB followed by 12 weeks of darifenacin (with voluntary uptitration from 7.5 mg daily to 15 mg daily at week 2) alone or in combination with a BMP.
The primary outcome measure was the change in the number of micturitions per day. Secondary outcomes included urge urinary incontinence episodes per day, urgency episodes per day, pads used per day, and nocturnal voids per day. Health-related quality of life was also assessed. Of 592 patients screened, 395 were randomized: 190 to darifenacin alone and 205 to darifenacin with BMP. Darifenacin alone and darifenacin plus BMP both produced significant and comparable reductions in micturitions per day. A similar result was seen in the secondary efficacy variables, which included urge urinary incontinence episodes, urgency episodes, pads used, and nocturnal voids.
A key finding of this study was that treatment with darifenacin provides a degree of normalization of micturition frequency and an improvement in health-related quality of life that cannot be further enhanced by behavioral therapy.
The take-home message from these 3 different studies is that behavioral and antimuscarinics both work for OAB symptoms, but the addition of behavioral therapy to an appropriate antimuscarinic is not always justified. Two treatments are not always better than one.