Phase IIb, multicenter, double-blind, randomized, placebo-controlled, parallel-group study to determine effects of...

To evaluate the efficacy and safety of elocalcitol in the treatment of women with overactive bladder and idiopathic detrusor overactivity.

The study was a multicenter, double-blind, randomized, placebo-controlled, parallel-group trial of women with overactive bladder symptoms recruited from 48 European tertiary referral centers. The participants were randomized to receive either placebo or elocalcitol, 75 μg/d or 150 μg/d for 4 weeks. A 3-day bladder diary, the Urgency Perception Scale, the Patient's Perception of Bladder Condition, and urodynamics were used before and after treatment. Vital signs, laboratory blood tests, 24-hour urine collection, and electrocardiography were also performed to assess the safety. The analysis of covariance test was used to compare the treatment groups. The primary objective was to evaluate the change in bladder volume at the first involuntary detrusor contraction from baseline.

A total of 308 women were studied. No significant change was seen in the urodynamic parameters between the placebo and elocalcitol groups, except for the bladder volume at the first desire to void. The frequency of incontinence episodes was significantly reduced in the elocalcitol group compared with the placebo group (P = .02). The Patient's Perception of Bladder Condition score improved significantly after treatment for the women receiving elocalcitol compared with those receiving placebo (P = .02). Treatment with both doses of elocalcitol was well tolerated, and no differences versus placebo were observed.

Although the primary endpoint was not achieved, elocalcitol appears to be an effective and well-tolerated drug for the treatment of women with overactive bladder and idiopathic detrusor overactivity. However, the multicenter setting for the use of urodynamics might have biased the results of our study.