PURPOSE: Since glutaraldehyde cross-linked collagen was approved for use, studies have reported success or improved rates of 63 to 86%. Long-term efficacy with strictly defined outcome criteria has not been reported. We report our experience with collagen injection therapy for female patients with intrinsic sphincteric deficiency to establish efficacy, duration of response and clinical predictors of success. MATERIALS 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 sphincteric deficiency without urethral hypermobility. Continence success was 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% became dry and 28.7% became socially continent. Of 35 patients who achieved continence with at least 1 year of followup 6 had regression. Therefore, 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 not achieving success underwent an average of 3.2 procedures with 16.1 ml. collagen. No major complications have occurred to date. CONCLUSIONS: Collagen injection achieves a reasonable rate of continence and good durability at 1 year of followup in female patients with intrinsic sphincteric deficiency and no urethral hypermobility.
PURPOSE: Since glutaraldehyde cross-linked collagen was approved for use, studies have reported success or improved rates of 63 to 86%. Long-term efficacy with strictly defined outcome criteria has not been reported. We report our experience with collagen injection therapy for female patients with intrinsic sphincteric deficiency to establish efficacy, duration of response and clinical predictors of success. MATERIALS 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 sphincteric deficiency without urethral hypermobility. Continence success was 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% became dry and 28.7% became socially continent. Of 35 patients who achieved continence with at least 1 year of followup 6 had regression. Therefore, 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 not achieving success underwent an average of 3.2 procedures with 16.1 ml. collagen. No major complications have occurred to date. CONCLUSIONS: Collagen injection achieves a reasonable rate of continence and good durability at 1 year of followup in female patients with intrinsic sphincteric deficiency and no urethral hypermobility.