Hypothesis / aims of study
In many countries, the mid-urethral sling (MUS) for stress urinary incontinence (SUI) is at risk of extinction as collateral damage of the mesh-war. A main criticism is the lack of real-world and long-term data. Therefore a prospective sling database was created in our center.
Study design, materials and methods
The database was created in 09-2016. Demographics and complications were inserted into an electronic record, linked to the medical file. Patient-reported outcome measures (PROMS) were assessed through validated questionnaires (PGI-I, IIQ-7, UDI-6 and PISQ-12) at 0, 3 and 12 months (m).
Results
Between 09-2016 and 10-2019, 460 MUS procedures were performed. Physician-reported data were inserted in 96%, 87% and 59% and PROMS were completed in 88%, 78% and 72% at 0, 3 and 12m respectively. TVT-O was performed in the majority of the procedures (73%). It concerned a primary sling in 89%. Simultaneous surgery was performed in 31% of patients (of which 63% cystocele repair). Success rate (PGI-I 1-2) was 88% at 3m and decreased to 83% at 12m (p = 0.14). IIQ-7 showed a significant improvement at 3m and 12m. According to UDI-6, SUI-related as well as irritative and obstructive symptoms improved after 3 and 12m (p <0.01). In the 57% of patients who were sexually active, 68% were satisfied with their sexual life preoperatively, while this increased to 84% at 12m. For both pain and incontinence during sexual intercourse and fear of unwanted urine loss, there was a significant improvement at 3m and 12m. Peroperatively, there were 5 vaginal and 4 bladder perforations, none with consequences. At 3m, there were 10% urinary tract infections, 2% erosions, 3% retentions and 4% pain complaints. For these complications, 9 patients underwent re-intervention. After 1y there were 4% asymptomatic erosions and 1.2% persistent pain.
Interpretation of results
A linear regression analysis showed worse outcome (PGI-I) at 3m in patients with concomitant cystocele repair and higher post-void residual. Higher SIU complaints resulted in better outcome after 3m. At 12m, patients with a higher BMI and more preoperative urge complaints had worse outcome. The cystocele group had a significant lower PGI-I at 3m compared to the exclusively sling group. However, the latter had a significant decline of success at 12m.