The overactive bladder-symptom composite score: a composite symptom score of toilet voids, urgency severity and urge urinary incontinence in patients with overactive bladder.
OBJECTIVE
To our knowledge there is no index in urology that yields a single, quantifiable and clinically interpretable measure of overactive bladder (OAB) symptoms, including urgency, 24-hour voiding frequency and urge urinary incontinence (UUI). Urgency is the most difficult of these symptoms to measure. The Indevus Urgency Severity Scale (Indevus Pharmaceuticals, Lexington, Massachusetts) was recently developed and validated to capture urgency severity per toilet void. The scale has been combined with 24-hour frequency and UUI episodes to create the OAB Symptom Composite Score (OAB-SCS). We present this composite score.


METHODS
Two multicenter trials were performed to determine the effects of trospium chloride given as 20 mg tablets vs placebo. A total of 1,157 patients, including 581 who received placebo and 576 who received trospium, were randomly assigned to treatment. Daily OAB-SCS totals were obtained for each patient for each day during the 7-day diary collection period for every visit.


RESULTS
The average baseline OAB-SCS value was 36. The mean change from baseline in the trospium and placebo groups was 5 and 1 OAB-SCS points in patients with mild OAB, 10 and 5 in patients with moderate OAB, and 13 and 9 in patients with severe OAB, respectively.


CONCLUSIONS
The OAB-SCS discriminated between placebo and pharmacologically treated (trospium chloride) patients with OAB in this study. The OAB-SCS is an improvement over individual symptoms alone. It is easy to implement and interpret and it will prove to be a clinically relevant tool in clinical trials in which patient diary data are captured.
Zinner
Norman
N
Indevus Pharmaceuticals, Inc., Lexington, Massachusetts, USA.
Harnett
Mark
M
Sabounjian
Luann
L
Sandage
Bobby
B
Dmochowski
Roger
R
Staskin
David
D
D001561:Benzilates; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009662:Nortropanes / Q000627:therapeutic use*; D010276:Parasympatholytics / Q000627:therapeutic use*; D012720:Severity of Illness Index; D014549:Urinary Incontinence / Q000150:complications / Q000175:diagnosis* / Q000188:drug therapy* / Q000503:physiopathology
D001561:Benzilates; D009662:Nortropanes; D010276:Parasympatholytics; C003330:trospium chloride