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Purpose: Periurethral collagen injection has been advocated as a safe and effective method of treatment for stress urinary incontinence. This study was conducted to determine the complications associated with transurethral collagen injection for treatment of stress urinary incontinence in women. We report the incidence and management of adverse effects., Materials and Methods: A total of 337 women with at least a 1-year history, physical findings and urodynamic abnormalities consistent with stress urinary incontinence, who required pads or protective clothing, and who had no or only grade 1 cystocele were enrolled in this prospective cohort study. A third party documented adverse effects at each followup., Results: De novo urinary urgency with incontinence was the most frequent and serious complication, occurring in 12.6% of patients, and in many the symptoms were irreversible. Hematuria (5% of patients) and urinary retention (1.9%) were short-lived and resolved spontaneously. Delayed reaction at the skin test site occurred in 0.9% of the patients (3) and was associated with arthralgias in 2., Conclusions: Contrary to previous reports that periurethral collagen injection is complication-free, we found an overall incidence of 20% risk of complications in any given individual.