Solifenacin in the treatment of urgency and other symptoms of overactive bladder: results from a randomized, double‐blind, placebo‐controlled, rising‐dose trial

Abstract

OBJECTIVES To examine the effects of the antimuscarinic agent solifenacin on urinary urgency, using a range of novel and established outcome measures, as urgency is the principal symptom of the overactive bladder syndrome (OAB). PATIENTS AND METHODS The study (SUNRISE, solifenacin in the treatment of urgency symptoms of OAB in a rising dose, randomized, placebo‐controlled, double‐blind, efficacy trial) was a randomized, double‐blind, 16‐week, placebo‐controlled, multicentre study of solifenacin 5/10 mg in 863 patients with symptoms of OAB for ≥3 months. The primary efficacy variable was the change from baseline to endpoint in the number of episodes of severe urgency with or without urgency incontinence per 24 h, as measured using the Patient Perception of Intensity of Urgency Scale, grade 3 + 4. Secondary efficacy variables included patient‐reported outcomes for bladder condition, urgency bother and treatment satisfaction. A 3‐day voiding diary was used to record micturition frequency and episodes of urgency and incontinence. A 7‐day diary was used to assess speed of onset of effect. RESULTS Solifenacin 5/10 mg was significantly more effective than placebo in reducing the mean number of episodes of severe urgency with or without incontinence per 24 h from baseline to endpoint (−2.6 vs −1.8, P < 0.001). There were also statistically significant differences in favour of solifenacin 5/10 mg over placebo for all secondary variables measured at endpoint, including patient‐reported outcomes. There was a significant improvement in urgency as early as day 3 of treatment. Treatment‐emergent adverse events with solifenacin 5/10 mg were mainly mild or moderate in severity, and only led to discontinuation in 3.6% of patients. CONCLUSION Solifenacin significantly reduced the number of urgency episodes and the extent of urgency bother, and was well tolerated; it was effective as early as day 3 of treatment.

The Forefront for Novel Therapeutic Agents Based on the Pathophysiology of Lower Urinary Tract Dysfunction: Ameliorative Effect of Solifenacin Succinate (Vesicare®), a Bladder-Selective Antimuscarinic Agent, on Overactive Bladder Symptoms, Especially Urgency Episodes

“…The mean number of urgency episodes per 24 h, the primary endpoint, decreased by 3.91 (from 6.15 to 2.24) with solifenacin and by 2.73 (from 6.03 to 3.30) with placebo ( P < 0.0001) (23). Solifenacin was also significantly more effective than placebo in reducing the mean number of episodes of severe urgency from baseline to endpoint (−2.6 vs. −1.8, P < 0.001) (24). Median warning time (defined as the time from first sensation of urgency to voiding), a secondary endpoint, increased 31.5 s (baseline, 67.8 s) with solifenacin, significantly longer ( P = 0.008) than the median increase of 12 s (baseline, 65.0 s) observed with placebo (23).…”

“…In a double-blind, placebo-controlled trial, the efficacy and tolerability of solifenacin treatment for OAB was assessed (23,24). Patients were randomized to once-daily solifenacin (5/10 mg) or placebo for 12 (23) or 16 (24) weeks.…”

Efficacy and tolerability of combined medication of two different antimuscarinics for treatment of adults with idiopathic overactive bladder in whom a single agent antimuscarinic therapy failed

“…All of the patients were diagnosed with idiopathic OAB and demonstrated no prior surgery on lower urinary tract, urinary tract infections and neurological abnormalities based on a detailed history of symptoms, physical examinations and urinalysis. Patients documented the 3-day frequency-volume chart, as well as the Patient's Perception of Intensity of Urgency Scale (PPIUS), 8 at every voiding. The PPIUS is a 5-point scoring system that incorporates the frequency-volume chart and describes the degree of urgency and urgency incontinence felt by the patient.…”

Diagnosis and Treatment of Overactive Bladder

“…Cardozo et al, 2008;Chapple, 2005) Another recent study confirmed that solifenacin was significantly more effective in reducing the mean number of severe urgency episodes with or without incontinence per 24 hours, improved urgency symptoms and was well tolerated. Additionally, no cognitive impairment has been associated with this drug.…”