OBJECTIVES: To determine the clinical efficacy, safety, and durability of endoscopically injected glutaraldehyde cross-linked (GAX) collagen for the treatment of intrinsic sphincter deficiency (ISD) in women. METHODS: Forty-two women with a mean age of 64 years (range, 28 to 88) underwent injection of GAX collagen for ISD. Collagen was injected via a transurethral or periurethral approach. Treatment outcome was based on the change in stress leak point pressures (SLPP) and individual incontinence grades before and after collagen injection. RESULTS: With a mean follow-up of 46 months (range, 10 to 66), 83% were cured (n = 17), greatly improved (n = 5), or improved (n = 13), and 17% were unchanged (n = 3) or worse (n = 4). The median number of treatments was 2 (range, 1 to 8). The 22 women greatly improved or cured required a mean of 2.4 collagen injection treatments, whereas the 20 women who were improved, unchanged, or worse had a mean of 4.1 treatments (P = 0.009). The mean amount of collagen injected per patient was 28.3 cc (range, 2.5 to 85). The group of women who were greatly improved or cured had a mean of 17.5 cc of collagen injected, whereas those who were improved, unchanged, or worse had a mean of 39.5 cc injected (P = 0.002). Mean pretreatment SLPPs of women improved, greatly improved, or cured versus the women unchanged or worse were not significantly different (P = 0.015). The 35 women who were improved or cured had a significant increase in mean SLPP of 65.4 cm H2O (P = 0.001) compared to a mean change in SLPP of 14.7 cm H2O in those women who were unchanged or worse (P = 0.038). CONCLUSIONS: GAX collagen injection for the treatment of stress urinary incontinence secondary to ISD appears to be safe, effective, and durable; hence, it should be considered the treatment of choice in appropriately selected female patients.
OBJECTIVES: To determine the clinical efficacy, safety, and durability of endoscopically injected glutaraldehyde cross-linked (GAX) collagen for the treatment of intrinsic sphincter deficiency (ISD) in women. METHODS: Forty-two women with a mean age of 64 years (range, 28 to 88) underwent injection of GAX collagen for ISD. Collagen was injected via a transurethral or periurethral approach. Treatment outcome was based on the change in stress leak point pressures (SLPP) and individual incontinence grades before and after collagen injection. RESULTS: With a mean follow-up of 46 months (range, 10 to 66), 83% were cured (n = 17), greatly improved (n = 5), or improved (n = 13), and 17% were unchanged (n = 3) or worse (n = 4). The median number of treatments was 2 (range, 1 to 8). The 22 women greatly improved or cured required a mean of 2.4 collagen injection treatments, whereas the 20 women who were improved, unchanged, or worse had a mean of 4.1 treatments (P = 0.009). The mean amount of collagen injected per patient was 28.3 cc (range, 2.5 to 85). The group of women who were greatly improved or cured had a mean of 17.5 cc of collagen injected, whereas those who were improved, unchanged, or worse had a mean of 39.5 cc injected (P = 0.002). Mean pretreatment SLPPs of women improved, greatly improved, or cured versus the women unchanged or worse were not significantly different (P = 0.015). The 35 women who were improved or cured had a significant increase in mean SLPP of 65.4 cm H2O (P = 0.001) compared to a mean change in SLPP of 14.7 cm H2O in those women who were unchanged or worse (P = 0.038). CONCLUSIONS:GAX collagen injection for the treatment of stress urinary incontinence secondary to ISD appears to be safe, effective, and durable; hence, it should be considered the treatment of choice in appropriately selected female patients.