Introduction and Objectives
Urgency is the fundamental symptom of overactive bladder syndrome (OAB),1 and is regarded as a driver for many other OAB symptoms.2
Improvement of urgency is an important treatment target,3 as it could be expected to provide improvement in other OAB symptoms. Although urgency is difficult to quantify, results are now available from two randomised, double‐blind studies that assessed the effects of solifenacin on urgency through the use of six validated, urgency‐specific, assessment scales.
Methods
The European SUNRISE and North American VENUS studies were prospective, randomised, double‐blind, placebo‐controlled and multicentre. They included male and female patients aged >18 yrs with symptoms of OAB for >3 months and >3 (SUNRISE) or >1 (VENUS) episodes of urgency/24h with or without incontinence. The starting dose of solifenacin was 5mg od, but patients could request a dose increase to 10mg at predetermined times (Table 1).
Table 1: Summary of key criteria for SUNRISE and VENUS
In SUNRISE, the primary variable was the change in the mean number of episodes of severe urgency with or without urgency incontinence from baseline to endpoint, assessed using the Patient Perception of Intensity of Urgency Scale (PPIUS) (severe urgency ‐ Grade 3: ‘I could not postpone voiding but had to rush to the toilet in order not to wet myself’., urgency incontinence ‐ Grade 4: ‘I leaked before arriving at the toilet’). In VENUS, the primary variable was the change in mean number of urgency episodes/24h recorded in 3‐day micturition diaries.
Both studies also used objective and subjective urgency measures as secondary variables. For SUNRISE, these were a change in all grades of PPIUS (1‐4), and reduction of urgency bother assessed using a 0‐100mm visual analogue scale (VAS). VENUS measured changes in ‘Warning Time’ from first sensation of urgency to micturition, and also changes in the Indevus Urgency Severity Scale (IUSS: a validated single‐item measure of urgency severity) and the Urgency Perception Scale (UPS: a validated 3‐point scale for perception of urgency when a patient feels the desire to urinate).
Results
Solifenacin was significantly more effective than placebo for all primary and secondary urgency variables in both studies (Table 2).
Table 2: Mean baseline values and mean changes from baseline to endpoint for primary and secondary urgency variables for the Full Analysis Set from each study. Warning time is given as median values.
Conclusions
SUNRISE and VENUS are the only OAB studies to have evaluated urgency as a primary efficacy variable, along with the use of several other validated urgency scales as secondary variables. Solifenacin 5/10mg was consistently significantly more effective than placebo in reducing all objective and subjective measures of urgency, including patient‐reported outcomes. Solifenacin is currently the only antimuscarinic proven to have a consistent effect across a wide range of urgency variables, including a significant treatment effect versus placebo in prolonging Warning Time.
References
- Abrams P et al. Neurourol Urodyn 2002;21:167‐178
- Chapple CR et al. BJU Int 2005;95:335‐340
- Payne CK, Kelleher C. BJU Int 2007;99:101‐106