A new injectable bulking agent for treatment of stress urinary incontinence: Results of a multicenter, randomized, controlled, double-blind study of durasphere

Objectives. To assess the safety and effectiveness of Durasphere compared w ith bovine collagen in the treatment of stress urinary incontinence (SUI) d ue to intrinsic sphincter deficiency (ISD). Methods. This multicenter, randomized, controlled, double-blind trial was c omposed of 355 women diagnosed with SUI due to ISD and used a standardized pad test and the Stamey continence grade as the primary endpoints. The part icipants' ages ranged from 26 to 84 years. All patients had an abdominal le ak point pressure of less than 90 cm H2O (average 51). Results. At 12 months after the first injection, the two materials were equ ivalent with respect to the improvement in continence grade and pad weight testing. Less Durasphere was injected to obtain comparable clinical results (Durasphere 4.83 mL versus bovine collagen 6.23 mL, P <0.001). When examin ed 1 year after the date of the last treatment, 49 (80.3%) of the 61 women treated with Durasphere showed improvement of 1 continence grade or more co mpared with 47 (69.1%) of 68 women treated with bovine collagen (P value fo r difference = 0.162). Although the adverse events reported for both groups were similar, the Durasphere group had an increased short-term risk of urg ency and urinary retention. Conclusions. The use of Durasphere for the treatment of SUI due to ISD was equally effective as bovine collagen and used less material. The U.S. Food and Drug Administration granted market approval for Durasphere on September 13, 1999. The product design and initial clinical data suggest the potenti al for greater durability of the clinical benefit, with the possibility of a permanent solution for SUI due to ISD in some patients. UROLOGY 58: 12-15 , 2001. (C) 2001, Elsevier Science Inc.