OBJECTIVE: To compare the efficacy of flexible-dose solifenacin 5/10 mg with and without simplified bladder training in patients with overactive bladder (OAB) syndrome. PATIENTS AND METHODS: SOLAR (SOLifenacin Alone and with simplified bladder Re-training) was a multicentre, prospective, randomized, parallel-group, open-label study in patients with OAB. After a 2-week, single-blind, placebo run-in, 643 patients were randomized to treatment with either solifenacin 5 mg once daily (od) alone (323) or 5 mg od combined with simplified bladder training (320) for 8 weeks. At week 8, patients in both groups could request a dose increase to solifenacin 10 mg od for the remaining 8 weeks of the study. The primary efficacy endpoint was the change from baseline in the mean number of micturitions/24 h after 8 weeks. Secondary efficacy measures were the change in micturition frequency and other voiding diary variables at week 16. Patient-reported outcomes were also assessed, including patient Perception of Bladder Condition, Incontinence Quality of Life, and Treatment Satisfaction using a visual analogue scale score; tolerability was also assessed. RESULTS:Solifenacin given alone was effective in improving all measures of OAB evaluated in the study. When simplified bladder training was used combined with solifenacin there was a further significant improvement in micturition frequency at week 8, and this difference was maintained through to week 16. The use of simplified bladder training with solifenacin also significantly improved treatment satisfaction at week 16 over the responses to solifenacin given alone. There was no significant difference between the treatment groups at week 16 in urgency, incontinence or other secondary variables measured. The most common adverse event reported was dry mouth in both treatment groups; there was a low rate of discontinuation due to adverse events in the total study group. CONCLUSION: Combined treatment with solifenacin and simplified bladder training was more effective than solifenacin alone in reducing micturition frequency at weeks 8 and 16, and improving treatment satisfaction at week 16 in patients with OAB. Simplified bladder training did not improve on the benefits of solifenacin alone in the symptoms of urgency or incontinence.
RCT Entities:
OBJECTIVE: To compare the efficacy of flexible-dose solifenacin 5/10 mg with and without simplified bladder training in patients with overactive bladder (OAB) syndrome. PATIENTS AND METHODS: SOLAR (SOLifenacin Alone and with simplified bladder Re-training) was a multicentre, prospective, randomized, parallel-group, open-label study in patients with OAB. After a 2-week, single-blind, placebo run-in, 643 patients were randomized to treatment with either solifenacin 5 mg once daily (od) alone (323) or 5 mg od combined with simplified bladder training (320) for 8 weeks. At week 8, patients in both groups could request a dose increase to solifenacin 10 mg od for the remaining 8 weeks of the study. The primary efficacy endpoint was the change from baseline in the mean number of micturitions/24 h after 8 weeks. Secondary efficacy measures were the change in micturition frequency and other voiding diary variables at week 16. Patient-reported outcomes were also assessed, including patient Perception of Bladder Condition, Incontinence Quality of Life, and Treatment Satisfaction using a visual analogue scale score; tolerability was also assessed. RESULTS:Solifenacin given alone was effective in improving all measures of OAB evaluated in the study. When simplified bladder training was used combined with solifenacin there was a further significant improvement in micturition frequency at week 8, and this difference was maintained through to week 16. The use of simplified bladder training with solifenacin also significantly improved treatment satisfaction at week 16 over the responses to solifenacin given alone. There was no significant difference between the treatment groups at week 16 in urgency, incontinence or other secondary variables measured. The most common adverse event reported was dry mouth in both treatment groups; there was a low rate of discontinuation due to adverse events in the total study group. CONCLUSION: Combined treatment with solifenacin and simplified bladder training was more effective than solifenacin alone in reducing micturition frequency at weeks 8 and 16, and improving treatment satisfaction at week 16 in patients with OAB. Simplified bladder training did not improve on the benefits of solifenacin alone in the symptoms of urgency or incontinence.
Authors: Andy Wolff; Revan Kumar Joshi; Jörgen Ekström; Doron Aframian; Anne Marie Lynge Pedersen; Gordon Proctor; Nagamani Narayana; Alessandro Villa; Ying Wai Sia; Ardita Aliko; Richard McGowan; Alexander Ross Kerr; Siri Beier Jensen; Arjan Vissink; Colin Dawes Journal: Drugs R D Date: 2017-03