title: A new injectable bulking agent for treatment of stress urinary incontinence: results of a multicenter, randomized, controlled, double-blind study of Durasphere.
abstract: OBJECTIVE
  To assess the safety and effectiveness of Durasphere compared with bovine collagen in the treatment of stress urinary incontinence (SUI) due to intrinsic sphincter deficiency (ISD).
  
  
  METHODS
  This multicenter, randomized, controlled, double-blind trial was composed 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 participants' ages ranged from 26 to 84 years. All patients had an abdominal leak point pressure of less than 90 cm H(2)O (average 51).
  
  
  RESULTS
  At 12 months after the first injection, the two materials were equivalent 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 examined 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 compared with 47 (69.1%) of 68 women treated with bovine collagen (P value for difference = 0.162). Although the adverse events reported for both groups were similar, the Durasphere group had an increased short-term risk of urgency 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 potential for greater durability of the clinical benefit, with the possibility of a permanent solution for SUI due to ISD in some patients.
authors.affiliation: Mayo Clinic, Rochester, Minnesota, USA
authors.forename: D
authors.initials: D
authors.lastname: Lightner
authors.forename: C
authors.initials: C
authors.lastname: Calvosa
authors.forename: R
authors.initials: R
authors.lastname: Andersen
authors.forename: I
authors.initials: I
authors.lastname: Klimberg
authors.forename: C G
authors.initials: CG
authors.lastname: Brito
authors.forename: J
authors.initials: J
authors.lastname: Snyder
authors.forename: D
authors.initials: D
authors.lastname: Gleason
authors.forename: D
authors.initials: D
authors.lastname: Killion
authors.forename: J
authors.initials: J
authors.lastname: Macdonald
authors.forename: A U
authors.initials: AU
authors.lastname: Khan
authors.forename: A
authors.initials: A
authors.lastname: Diokno
authors.forename: L T
authors.initials: LT
authors.lastname: Sirls
authors.forename: D
authors.initials: D
authors.lastname: Saltzstein
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000818:Animals; D001672:Biocompatible Materials; D002417:Cattle; D003094:Collagen / Q000008:administration & dosage*; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D005936:Glucans / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D008875:Middle Aged; D011788:Quality of Life; D016896:Treatment Outcome; D014546:Urinary Catheterization; D014550:Urinary Incontinence, Stress / Q000628:therapy*; D016055:Urinary Retention / Q000209:etiology / Q000534:rehabilitation; D015040:Zirconium / Q000008:administration & dosage* / Q000009:adverse effects
chemical_list: D001672:Biocompatible Materials; D005936:Glucans; C431745:durasphere; D003094:Collagen; D015040:Zirconium; C028541:zirconium oxide