Prospective clinical trial comparing Obtape and DUPS to TVT: one-year safety and efficacy results.

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.