Prospective clinical trial comparing Obtape and DUPS to TVT: one-year safety and efficacy results.
نویسندگان
چکیده
OBJECTIVES Obtape and DUPS are modifications of the original TVT procedure. To test these new products in terms of safety and efficacy, we designed a prospective clinical trial with a follow-up of at least 1 yr. METHODS We randomized 190 consecutive females with SUI for this study. They were evaluated by history, ICIQ-SF, physical examination, cystoscopy, UDS, and the 1-h pad test. Patients were reevaluated at 1, 6, and 12 mo. The ICIQ-SF and pad test were repeated at 1-yr follow-up. RESULTS There were 78, 32, and 80 patients in the Obtape, DUPS, TVT arms, respectively. An interim analysis after 32 patients in each arm indicated postoperative retention rates of 3 (9.4%), 6 (18.8%), and 4 (12.5%) patients in Obtape, DUPS, and TVT groups, respectively. Because of higher retention rate and suprapubic discomfort, DUPS was discontinued. At the end of the study, complete retention rates were 6 (7.8%), 6 (18.8%), and 6 (7.5%) in Obtape, DUPS, and TVT, respectively. TVT was the only procedure with bladder perforations at a rate of 14%. However, Obtape and DUPS were associated with more postoperative complications including complete retention, urethrolysis, hematoma, mesh erosion, UTI, and wound infection (13%, 28%, and 8%; p< or =0.025). At 1 yr, 83%, 94%, and 86% of patients in the Obtape, DUPS, and TVT groups were objectively cured (p>0.05). CONCLUSIONS TVT was the only procedure associated with bladder perforation, but there were more postoperative complications with Obtape and DUPS. No statistically significant differences in cure rates were observed at 1-yr follow-up. Longer follow-up is needed to confirm these results.
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ورودعنوان ژورنال:
- European urology
دوره 52 1 شماره
صفحات -
تاریخ انتشار 2007