Long-term follow-up comparison of durasphere and contigen in the treatment of stress urinary incontinence.

OBJECTIVES.: This study evaluates the long-term clinical success of Durasphere (Carbon Metal Technologies, St. Paul, MN) compared with Contigen (C. R. Bard, Covington, GA) in the treatment of stress urinary incontinence caused by intrinsic sphincter deficiency (ISD). METHODS.: Fifty-two women diagnosed with stress urinary incontinence caused by ISD were treated between March and November of 1998 in a randomized, double-blinded trial comparing Durasphere and Contigen. Pad testing, Stamey Continence Grading, and urodynamics, including abdominal leak point pressures, were performed during the initial evaluation. All patients were diagnosed with ISD and displayed abdominal leak point pressures of </= 90 cm of H2O. RESULTS.: Of 26 patients in each group, 25/26 (96%) Durasphere patients and 21/26 (81%) Contigen patients were available for this follow-up of 2.6 and 2.8 years, respectively, post initial injection. A total of 80% of Durasphere patients and 62% of Contigen patients demonstrated an improvement of >/=1 continence grade at this follow-up. Of these patients, 10/25 (40%) Durasphere patients and 3/21 (14%) Contigen patients are dry. CONCLUSIONS.: Long-term follow-up demonstrated that Durasphere had greater success than Contigen in providing improved continence grades.

RCT Entities:   Population Interventions Outcomes