Contasure-Needleless® single incision sling compared with transobturator TVT-O® for the treatment of stress urinary incontinence: long-term results

Abstract

Introduction and hypothesis: This study compared transobturator tension-free vaginal tape (TVT-O®) and Contasure-Needleless (C-NDL®) at long-term follow-up .

Methods: Non-inferiority, prospective, single-centre , quasi-randomised trial started in September 2006 and finished in April 2011 to compare C-NDL® with transobturator vaginal tape (TVT-O®) mesh in the treatment of stress urinary incontinence (SUI) . Epidemiological information, intraoperative and postoperative complications, subjective estimates of blood loss and pain levels were recorded. We also analysed the postoperative stress test, the subjective impression of improvement using the Sandvik Severity Index and the quality of life during follow-up using the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) .

Results: Two hundred and fifty-seven women with primary SUI were scheduled to receive TVT-O® or C-NDL® and were followed up at least 3 years after the procedure . One hundred and eleven women in the C-NDL® group (84.7%) had a negative stress test, compared with 54 women (88.9%) in the TVT-O® group (p = 0.0065 for the non-inferiority test). The postoperative Sandvik Severity Index was 0 or better than the preoperative score in 90.7% of patients in the C-NDL® group and 95.4% of patients in the TVT-O® group (p = 0.0022). The complication rate was similar in both groups. There were significant differences (p = 0.02) in postoperative pain within the TVT-O® group. The degree of satisfaction was not statistically significant between the two groups.

Conclusions: The outcomes for the C-NDL® group were similar to those of the TVT-O® group, adding the concept of "single incision tape" to the tension-free sling option.