Carbon coated zirconium beads in beta-glucan gel and bovine glutaraldehyde cross-linked collagen injections for intrinsic sphincter deficiency: continence and satisfaction after extended followup.
OBJECTIVE
The durability of Durasphere (Carbon Medical Technologies, Saint Paul, Minnesota), used to treat stress urinary incontinence, has not been shown beyond 12 months of followup. Women treated with Durasphere and Contigen (Bard, Inc., Covington, Georgia) at 1 institution between 1996 and 2000 were compared to determine patient satisfaction and urinary continence after extended followup.


METHODS
Between April 1996 and September 2000, 56 women were treated with Durasphere at this institution, of whom 43 were available for extended followup. Aged matched patients treated with Contigen were analyzed for comparison. Patient satisfaction and continence at last followup were subjectively assessed via telephone interview. Survival methods (Kaplan-Meier and Cox proportional hazards model) were used to analyze time to failure as a function of treatment group and other potential predictors.


RESULTS
Treatment groups (Contigen and Durasphere) were similar with respect to all baseline factors. Treatment was initially effective in 63% of Durasphere and Contigen cases (p = 1.0). At 24 and 36 months Durasphere remained effective in 33% and 21% of patients compared with 19% and 9% for Contigen, respectively. At last followup only 9 patients (21%) treated with Durasphere and 2 (5%) treated with Contigen (median followup 51 and 62 months, respectively) claimed that treatment was still effective. After controlling for differences in followup time there was no significant difference in time to failure between the treatment groups (p = 0.25). A third of patients in each group believed that treatment was a success.


CONCLUSIONS
Neither Contigen nor Durasphere provides durable improvement in continence. Despite this outcome a third of patients in the 2 groups were satisfied with the treatment outcome.
Chrouser
K L
KL
Mayo Clinic, Rochester, Minnesota, USA.
Fick
F
F
Goel
A
A
Itano
N B
NB
Sweat
S D
SD
Lightner
D J
DJ
D000283:Administration, Intravesical; D000368:Aged; D001672:Biocompatible Materials; D003094:Collagen / Q000008:administration & dosage*; D005500:Follow-Up Studies; D005782:Gels; D005936:Glucans; D006801:Humans; D008297:Male; D017060:Patient Satisfaction; D013997:Time Factors; D014550:Urinary Incontinence, Stress / Q000628:therapy*; D015040:Zirconium
D001672:Biocompatible Materials; D005782:Gels; D005936:Glucans; C431745:durasphere; C048470:glutaraldehyde-cross-linked collagen; D003094:Collagen; D015040:Zirconium