Purpose: Since glutaraldehyde cross-linked collagen was approved for u
se, studies have reported success or improved rates of 63 to 86%. Long
-term efficacy with strictly defined outcome criteria has not been rep
orted. We report our experience with collagen injection therapy for fe
male patients with intrinsic sphincteric deficiency to establish effic
acy, duration of response and clinical predictors of success. Material
s and Methods: A total of 96 women underwent collagen injection via a
periurethral approach with local anesthesia. In all patients history,
physical examination and video urodynamics documented intrinsic sphinc
teric deficiency without urethral hypermobility. Continence success wa
s defined as dry or socially continent (minimal leakage requiring 1 or
no pad daily even with strenuous activity). Median followup was 14.0
months. Results: Of 94 patients 67.0% achieved continence, 38.3% becam
e dry and 28.7% became socially continent. Of 35 patients who achieved
continence with at least 1 year of followup 6 had regression. Therefo
re, 82.9% of those successfully treated remained so at 1 year and none
had de novo detrusor instability. An average of 2.1 procedures and 11
.9 ml. collagen were required to achieve continence. The 31 patients n
ot achieving success underwent an average of 3.2 procedures with 16.1
ml. collagen. No major complications have occurred to date. Conclusion
s: Collagen injection achieves a reasonable rate of continence and goo
d durability at 1 year of followup in female patients with intrinsic s
phincteric deficiency and no urethral hypermobility.