Behavioral Therapy to Enable Women with Urge Incontinence to Discontinue Drug Treatment

Abstract

Background Women with urge urinary incontinence are commonly treated with antimuscarinic medications, but many discontinue therapy. Objective To determine whether combining antimuscarinic drug therapy with supervised behavioral training, compared to drug therapy alone, improves the ability of women with urge incontinence to achieve clinically important reductions in incontinence episodes and to and sustain these improvements after discontinuing medication. Design Two-stage, multi-center, randomized clinical trial (BE-DRI trial) (July 2004 – January 2006). Setting Nine university-affiliated outpatient clinics. Patients 307 women with urge predominant incontinence. Interventions Ten weeks of open-label, extended-release tolterodine alone (N = 153) or combined with behavioral training (N = 154) (Stage 1), followed by discontinuation of therapy and follow-up at 8 months (Stage 2); 237 participants completed the trial. Measurements The primary outcome, measured at 8 months, was defined as not taking drug or receiving any other therapy for urge incontinence and ≥70% 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/bother and health-related quality-of-life. Study staff who performed outcome evaluations were blinded to group assignment, but participants and interventionists were not. Results At 8 months, there was no difference in successful discontinuation of drug therapy between combined therapy and drug alone (41% in both groups, 95% confidence interval on difference: -12% to +12%). A higher proportion of patients in combined therapy achieved ≥70% reduction of incontinence than in drug therapy alone at 10 weeks (69% vs. 58%; difference = 11%; 95% confidence interval: -0.3 to +22.1). Combined therapy yielded better outcomes over time on the Urogenital Distress Inventory and Overactive Bladder Questionnaire (both P<0.001), at both time points on patient satisfaction and perceived improvement, but not health-related quality-of-life. Adverse events were uncommon in both groups (12 events in 6 participants, 3 in each group). Limitations Inclusion of behavioral components (daily bladder diary and recommendations for fluid management) in the drug alone group may have attenuated group differences. Assigned treatment was completed by 68% of participants and 8 month outcome status was assessed on 77%. Conclusions The addition of behavioral training to drug therapy is of possible benefit for reducing incontinence frequency during active treatment, but does not improve women's ability to discontinue drug therapy and maintain improvement in urinary incontinence. Further, combined therapy has a beneficial effect on patient satisfaction, perceived improvement, and reducing other bladder symptoms.

Author Response

“…Women in the combined drug and behavioral therapy group received the fluid management handout; however, those with Ն70 oz/d urine output also received individualized fluid management counseling. 3,5 Therefore, there was a difference in fluid management methods between the groups. All participants kept bladder diaries, as data from the diaries were used as study outcomes.…”

“…However, because both groups kept the bladder diary, this self-monitoring effect was controlled so that any effects of behavioral training would not be attributed to this modality. 3,5 Sran et al raised several concerns regarding the appropriateness of the pelvic-floor muscle (PFM) exercise protocol used in combined therapy arm. Sran et al stated, "In the study by Borello-France and colleagues, the PFMs were digitally assessed at each visit, but the exercise progression followed a set protocol regardless of the findings of the PFM assessment."…”

“…Fluid management recommendations were provided in a handout that described normal fluid intake and the importance of distributing intake throughout the day. 3,5 Many providers, when prescribing antimuscarinics, advise patients to avoid excess fluids to enhance drug efficacy. Thus, UITN scientists believed it was important to provide the fluid management handout to women in the drug-only group.…”

“…A group that received behavioral therapy alone, although interesting, would not have added to the stated aims of the BE-DRI study, which focused on the usefulness of behavioral therapy to allow more patients to effectively discontinue medications and maintain improvement. 3,5 Sran et al raised the concern that participants in the drug-only group received some behavioral intervention component. The drug-only group received written recommen-…”

“…3,5 Sran et al suggested that "inclusion of a treatment group that received behavioral therapy alone would have provided more clinically relevant results." A group that received behavioral therapy alone, although interesting, would not have added to the stated aims of the BE-DRI study, which focused on the usefulness of behavioral therapy to allow more patients to effectively discontinue medications and maintain improvement.…”