Tension-free vaginal mesh (TVM) surgery for pelvic organ prolapse (POP) has fewer variance in the skill and concept of the surgeon compared to the conventional native tissue repair (NTR). It is a minimally invasive procedure with few recurrence and it has spread rapidly in Japan. However, the FDA warning in 2008 concerning potential risk of complications has resulted a headwind against TVM surgery especially in Europe and the United States. In Japan, on the other hand, laparoscopic sacrocolpopexy (LSC) became covered by insurance in 2014. Many reports suggested its potential superiority in incidence of perioperative complications and patient satisfaction compared with TVM surgery. Therefore, the trend of treatment selection has shifted from TVM surgery to LSC. We examined the characteristics of TVM surgery and LSC using Diagnosis Procedure Combination (DPC) database in Japan.

Clinical data about female patients undergoing tension-free vaginal mesh (TVM group; n=2388) or laparoscopic sacrocolpopexy (LSC group; n=625) from April 2014 to March 2015 were extracted from DPC database. We compared trends of number performed, age, risk, anaesthesia time, cost, and the rate of adverse events between these groups. Univariate and multivariate analyses were conducted with variables of age, comorbidity, cost and hospital volume.

Among total POP surgery in Japan, the number of cases of TVM surgery reached a peak (about 5,000 cases / year, about 35% of the total) in 2012, turned down after the FDA warning (About 27% of the total in 2014). Meanwhile, the LSC already accounted for about 6% of total in 2014.The average age at the time of surgery was significantly younger in LSC group (median TVM: 71 vs. LSC: 66 years, p < 0.001). When compared using Charlson comorbidity index, the number of high risk patient was significantly large in TVM group (p < 0.05). In addition, the number of LSC in high volume hospital was more than twice as large as TVM in 2014 (p < 0.001). The TVM group showed shorter operation time than LSC group (median 150 vs. 286 min, p < 0.001), and the total fee of surgery in TVM group was also significantly lower (median $6952 vs. $8414, p < 0.001) (Table 1.). We observed no significant difference between the TVM group and the LSC group in perioperative complications other than genitourinary system, however, there was a tendency to require more blood transfusion in the TVM group. Perioperative adverse events of genitourinary tract were frequently observed in the TVM group with significance (5.7 vs. 1.1%, p < 0.001), particularly with lower urinary tract symptoms like urethral stenosis、urinary retention and dysuria (p < 0.01) (Table 2.).  All adverse events of the surgery were frequently observed in the TVM group (7.1 vs. 1.9%, p < 0.001). In multivariate analysis of perioperative outcomes, the high age significantly associated with increased adverse events and cost. In addition, increased number of coexisting diseases significantly associated with increased cost. High volume hospital had significantly less adverse events and less cost. LSC significantly associated with less adverse events.

DPC database analysis demonstrated favourable/acceptable outcomes of both TVM and LSC. TVM had significantly more genitourinary adverse events, while it showed a benefit of cost performance both for patients and hospitals. LSC showed less genitourinary adverse events (e.g. voiding dysfunction), while it (may) required longer operation time. These findings may provide a novel evidence for appropriate choice of the surgical options for POP.

These data indicated that that appropriate selection of both operations is important in surgical treatment for POP.