OBJECTIVE: To determine whether the presence of detrusor overactivity (DO) in patients with overactive bladder (OAB) and urgency urinary incontinence (UUI) is a predictor of the response to treatment with fesoterodine. PATIENTS AND METHODS: This phase 2 randomized, multicentre, placebo-controlled trial consisted of a 1-week placebo run-in phase followed by an 8-week double-blind period. Eligible for the study were men and women aged 18-78 years with symptoms or signs of OAB with UUI; they were stratified into two balanced strata depending on the outcome of a baseline urodynamic assessment. By using this particular study design it was possible to investigate whether there were differences between the strata. The primary endpoint was the change from baseline to week 8 in mean voids/24 h. Secondary endpoints were the changes in UUI episodes/week, and for those patients with DO at baseline, the mean changes in volume at first involuntary contraction associated with a feeling of urgency, first desire to void, and strong desire to void, and change in maximum cystometric capacity. Because there were few patients the secondary analyses were considered exploratory. RESULTS: Overall, there were linear dose-response relationships for placebo and the fesoterodine groups for the reduction in the number of voids/24 h and UUI episodes/week. Compared with the placebo group, the least squares mean changes from baseline to week 8 in both variables were significantly improved in patients receiving fesoterodine 4 mg (P = 0.045 and 0.040, respectively), 8 mg (P < 0.001 for both), and 12 mg (P < 0.001 for both). There were no significant differences in treatment responses, as measured by both variables between patients with and without DO. For patients with DO, the mean volume at the first desire to void improved in all fesoterodine treatment groups and worsened in the placebo group. CONCLUSIONS: Regardless of the presence of DO, the response to fesoterodine treatment was dose-proportional and associated with significant improvements in OAB symptoms, indicating that the response to OAB pharmacotherapy in patients with UUI was independent of the urodynamic diagnosis of DO.
RCT Entities:
OBJECTIVE: To determine whether the presence of detrusor overactivity (DO) in patients with overactive bladder (OAB) and urgency urinary incontinence (UUI) is a predictor of the response to treatment with fesoterodine. PATIENTS AND METHODS: This phase 2 randomized, multicentre, placebo-controlled trial consisted of a 1-week placebo run-in phase followed by an 8-week double-blind period. Eligible for the study were men and women aged 18-78 years with symptoms or signs of OAB with UUI; they were stratified into two balanced strata depending on the outcome of a baseline urodynamic assessment. By using this particular study design it was possible to investigate whether there were differences between the strata. The primary endpoint was the change from baseline to week 8 in mean voids/24 h. Secondary endpoints were the changes in UUI episodes/week, and for those patients with DO at baseline, the mean changes in volume at first involuntary contraction associated with a feeling of urgency, first desire to void, and strong desire to void, and change in maximum cystometric capacity. Because there were few patients the secondary analyses were considered exploratory. RESULTS: Overall, there were linear dose-response relationships for placebo and the fesoterodine groups for the reduction in the number of voids/24 h and UUI episodes/week. Compared with the placebo group, the least squares mean changes from baseline to week 8 in both variables were significantly improved in patients receiving fesoterodine 4 mg (P = 0.045 and 0.040, respectively), 8 mg (P < 0.001 for both), and 12 mg (P < 0.001 for both). There were no significant differences in treatment responses, as measured by both variables between patients with and without DO. For patients with DO, the mean volume at the first desire to void improved in all fesoterodine treatment groups and worsened in the placebo group. CONCLUSIONS: Regardless of the presence of DO, the response to fesoterodine treatment was dose-proportional and associated with significant improvements in OAB symptoms, indicating that the response to OAB pharmacotherapy in patients with UUI was independent of the urodynamic diagnosis of DO.
Authors: Miguel Silva-Ramos; Isabel Silva; Olga Oliveira; Sónia Ferreira; Maria Júlia Reis; José Carlos Oliveira; Paulo Correia-de-Sá Journal: PLoS One Date: 2013-05-31 Impact factor: 3.240