Anticholinergic therapy vs. onabotulinumtoxina for urgency urinary incontinence

Abstract

Background: Anticholinergic medications and onabotulinumtoxinA are used to treat urgency urinary incontinence, but data directly comparing the two types of therapy are needed.

Methods: We performed a double-blind, double-placebo-controlled, randomized trial involving women with idiopathic urgency urinary incontinence who had five or more episodes of urgency urinary incontinence per 3-day period, as recorded in a diary. For a 6-month period, participants were randomly assigned to daily oral anticholinergic medication (solifenacin, 5 mg initially, with possible escalation to 10 mg and, if necessary, subsequent switch to trospium XR, 60 mg) plus one intradetrusor injection of saline or one intradetrusor injection of 100 U of onabotulinumtoxinA plus daily oral placebo. The primary outcome was the reduction from baseline in mean episodes of urgency urinary incontinence per day over the 6-month period, as recorded in 3-day diaries submitted monthly. Secondary outcomes included complete resolution of urgency urinary incontinence, quality of life, use of catheters, and adverse events.

Results: Of 249 women who underwent randomization, 247 were treated, and 241 had data available for the primary outcome analyses. The mean reduction in episodes of urgency urinary incontinence per day over the course of 6 months, from a baseline average of 5.0 per day, was 3.4 in the anticholinergic group and 3.3 in the onabotulinumtoxinA group (P=0.81). Complete resolution of urgency urinary incontinence was reported by 13% and 27% of the women, respectively (P=0.003). Quality of life improved in both groups, without significant between-group differences. The anticholinergic group had a higher rate of dry mouth (46% vs. 31%, P=0.02) but lower rates of catheter use at 2 months (0% vs. 5%, P=0.01) and urinary tract infections (13% vs. 33%, P<0.001).

Conclusions: Oral anticholinergic therapy and onabotulinumtoxinA by injection were associated with similar reductions in the frequency of daily episodes of urgency urinary incontinence. The group receiving onabotulinumtoxinA was less likely to have dry mouth and more likely to have complete resolution of urgency urinary incontinence but had higher rates of transient urinary retention and urinary tract infections. (Funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development and the National Institutes of Health Office of Research on Women's Health; ClinicalTrials.gov number, NCT01166438.).

Figure 1. Screening, Randomization, Treatment, and Follow-up

One of the 121 participants who was analyzed as treated with onabotulinumtoxinA (and placebo anticholinergic) was actually treated with active anticholinergic medication (and placebo onabotulinumtoxinA).

Figure 2. Reduction from Baseline in Number of Episodes of Urgency Urinary Incontinence (UUI) per Day

The primary outcome of the study (the adjusted mean reduction from baseline in the number of episodes of urgency urinary incontinence per day) is shown in the modified intention-to-treat population, according to treatment group. I bars indicate 95% confidence intervals.

Figure 3. Adequate Control of Symptoms during Off-Treatment Follow-up

The percentage of participants who had adequate control of symptoms during a 6-month off-treatment follow-up phase is shown in the modified intention-to-treat population, according to the treatment group to which the participants had been randomly assigned at the beginning of the study. Adequate control was defined as a score of 4 or 5 on the Patient Global Symptom Control (PGSC) instrument and no off-study treatment for urinary incontinence at prior visits. Responses on the PGSC to the statement, “This treatment has given me adequate control of my urinary leakage” range from 1 (disagree strongly) to 5 (agree strongly).