Chapter 4.2.1 76 Nineteen of 101 (18.8%) patients implanted with heavier-weight mesh had a reintervention for graft-related complications, compared to 5/238 (2.1%) of patients with lightweight mesh (HR 4.6 (95% CI 1.9-11.2). As displayed in Figure 2, the cumulative incidence of both diagnosis of graftrelated complications as well as reintervention for graft-related complications increase with time. Moreover, no graft-related complications presented within the first year of surgery (Table 4). The number of patients reporting PGIC scores of 4 or higher was comparable in both groups (heavier weight: 71/84 [84.9%]; lightweight: 154/178 [86.5%]; HR 0.8; 95%-CI 0.6-1.1)). The distribution of PGIC scores in both groups is shown in Figure 3. No differences in patient satisfaction were observed in relation to the occurrence of graft-related complications: a PGIC score of 4 or higher was reported by 88.9% (32/36) of patients who developed graft-related complications vs. 85.4% (193/226) in patients who did not (RR 1.3; 95%-CI 0.5-3.5). Of the 191 patients clinically examined, nine (4.7%) had anatomical failure at the apex at a median follow-up of 85.6 months. The recurrence rate for apical prolapse was comparable between the two cohorts (heavier weight: 1/60; 1.7%, lightweight (8/131; 6.1%; HR 0.3; 95% CI 0.1-1.4). There were no reinterventions for recurrent apical prolapse in the heavier-weight mesh group (0/101, 0.0%) and one in the lightweight group (1/238, 0.4%). Reintervention rates for any form of vaginal prolapse in 339 patients who underwent an operation were not different between groups (Figure 4). A post-hoc power analysis revealed, based on the parameters of the present study and a significance level of 0.05, a power of 96.1%.
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