After adjusting for patient-related factors and site variation, more than 40% of hospitals will change quartile rank with respect to deep surgical site infection. Identifying a quartile of hospitals that are statistically different from others was not feasible in our collaborative because only 2 of 12 hospitals were outliers. These findings suggest that under the Hospital Acquired Condition Reduction program, many hospitals will be unjustly penalized.

Objectives: To compare subjective and objective cure, morbidity and discomfort following MiniArcÔ and MonarcÔ sub-urethral sling in women with stress urinary incontinence. Materials and Methods: We performed a randomized controlled trial in two Dutch, two Belgian and one French teaching hospitals. Women with symptomatic stress urinary incontinence were eligible. Women with prior stress urinary incontinence surgery and/or a pelvic prolapse stage R2 (ICS) were excluded. Women were randomly allocated to a SIMS (MiniArcÔ) or transobturator SMUS (MonarcÔ). Follow-up (FU) will be continued until 36 months after randomization. In this abstract we report 24 months FUdata. Primary outcome was subjective cure, defined as being not or mildly bothered by stress urinary incontinence. Secondary outcomes were objective cure (defined as a negative cough stress test with at least 300 ml bladder filling), generic quality of life, operation time, morbidity, and reinterventions. We hypothesized that the cure rate with MiniArcÔ was noninferior to the cure rate with MonarcÔ and less painful. We needed 85 patients per group to have 90% power to detect a drop in the lower bound of the confidence interval of cure from 90% to 75% using a one-sided test with a 0,025. We also would have 90% power, with a two-sided test a 0,05, to detect a 20% difference (8 points) in the VAS pain score. Anticipating that 10% patients would not be evaluable we included 192 patients. Results: We randomized 193 women: 97 were allocated to MiniArcÔ and 96 to MonarcÔ. There were no statistically significant differences in patient characteristics (mean age 53 years, mean BMI 26 kg/m 2 ). At 24 months follow-up, subjective cure was 84% in the MiniArcÔ group and 88% in the MonarcÔ group. Objective cure was 91% in the MiniArcÔ group and 92% in the MonarcÔ group. Operating time was shorter in the mini-arc group (11 vs 16 minutes, p \ 0.01) and blood loss was less (20 mL vs 50 mL, p \ 0.01). All patients left the hospital at the day of surgery, regardless the performed procedure. The mean pain VAS score during the first three postoperative days was 9 following MiniArc and 22 following Monarc (Mann-Whitney U test, p \ 0.01). During the first two year follow-up, 42 adverse events occurred in the MiniArcÔ group and 56 in the MonarcÔ group (11 vs. 15 patients had a urinary tract infections and 5 vs. 8 patients had a post voiding residual bladder volume of more than 150 mL. In the MiniArcÔ group two retropubic TVTs were performed because of failure. Three re-operations had to be performed in the MonarcÔ group; one to correct a tape exposure, one to release the tape unilateral because of obstructive micturition and one retropubic TVT was performed because of failure. Generic quality of life scores as measured with the SF-36 questionnaire at 24 months follow-up, showed similar physical and social functioning for both interventions. Conclusion: At two years follow-up, MiniArcÔ proved to be non-inferior to MonarcÔ with respect to subjective and objective cure rates. Complicati...