Contigen Bard Collagen implant: the Japanese experience.

This was an open trial to evaluate the efficacy and safety of Contigen Bard Collagen Implant for the treatment of urinary incontinence in patients with either stress incontinence or true incontinence (intrinsic sphincter deficiency). Contigen was injected at two opposing sites in the submucosal tissues of the bladder neck or posterior urethra; this was repeated after 7 days if needed. Patients were evaluated in terms of the frequency and degree of incontinence, the number of pads used, quality of life and the pad weighing test. A global evaluation of the efficacy, safety, and usefulness of the procedure also was performed. Ninety-seven patients were enrolled, and 73 completed one-year of follow-up. At baseline, 66 patients, all females, had genuine stress incontinence (GSI), and 14 patients, 10 male and 4 female, had true incontinence (TI). Improvements in the degree of incontinence were observed in 61% of patients in the GSI group and 8% of patients in the TI group. The frequency of incontinence, number of pads used, and pad test (weight) were significantly (p < 0.0001) decreased in the GSI group. A global evaluation of efficacy found that 68% of patients in the GSI group were cured or improved, and 21% of patients in the TI group were cured or improved. Overall, 88% of the GSI group and 43% of the TI group found the procedure to be useful or slightly. Fifty adverse events were reported in 36 patients, but no patients discontinued treatment for adverse events. The most common adverse events were urinary retention in 24 patients, and difficulty voiding in 10 patients, although both side effects were transient.