Hypothesis / aims of study
For about ten years midurethral mesh sling (MUS) insertion use has declined due to controversy around mesh-related complications. National policy has changed lately and might affect this implantation rate. However, there are little evidence on the long-term prevalence of MUS reoperation. The objective of our study was to examine long-term mesh removal and reoperation rates in women with MUS and explore the risk factors of reoperation. Our study will better assess the prognosis of patients with successful MUS in light of current changes.
Study design, materials and methods
This is a national population-based retrospective cohort study including 217 326 patients aged 18 years or older who had a first MUS insertion for stress urinary incontinence in all public hospitals and private practices nationwide between January 1, 2013, and December 31, 2021. Women were followed up until December 31, 2022.
The primary outcome was the rate of MUS removal (partial or total) and secondary outcomes were reoperation for stress urinary incontinence and any reoperation including mesh removal or other type of surgery for stress urinary incontinence. Cox regression models were performed to assess the risk factors of MUS removal/reoperation. The following factors were assessed the type of MUS (retropubic vs. transobturator), obesity, alcoholic/smoking women, high blood pressure, diabetes, dyslipidemia, anemia, renal or heart failure, strokes, pelvic organ prolapse, hemorrhage, neurogenic disease, hematological cancer, Crohn disease, chronic respiratory or liver condition
Results
The study population consisted of 217 326 women with first MUS insertion, including 5.851 removal and 9.521 reoperations without removal. The median age was 56 years (IQR 47-68).
A total of 46 768 with retropubic (RP) insertion and 170 558 with transobturator (TO) insertion. The median follow-up time was 2.4 years (IQR 1 day-5.2 years).
The majority of removals occurred within the first year (58%) and 40% occurred within the first six months. Removals that took place between 5 and 10 years represent less than 8% of total removal. The rate of MUS removal was 1.6% at 1 year, 2.5% at 5 years and 2.7% at 10 years. Risk of removal declined with age: 3.5% for the 18-39 years-old; 2.8% for the 50-59 years-old and 2.4% for the 70 years at 10 years.
The 10-year removal risk after RO insertion (2.6%) was statistically lower than the risk after RP insertion (3%), p<0.0001.
When looking at comorbidities adjusted on age Cox models show that alcoholic/smoking women and obesity, are risk factors for MUS removal, with respectively hazard ratios (H.R.) of 1.2 (p=0.0004) and 1.1 (p<0.03). The type of MUS had an significant effect with a H.R.= 0.89 for TO (p<0.0001) .
The rate of reoperation for stress urinary incontinence was 2.2% at 1 year, 4% at 5 years and 4.5% at 10 years. The 10-year reoperation risk after TO (4.3%) was statistically lower than the risk after RP (5.2%). The rate of any reoperation, including mesh removal was 3.7% at 1 year, 6.4% at 5 years, 7.1% at 10 years.
The overall complications observed, including erosion, infection, bleeding and pain, were 5.5%; with a higher risk after RP (7.7%) than after TO (5.0%).
Interpretation of results
The rate of MUS removal was 1.6% at 1 year, and it correspond of the 58% of all the removal. This illustrates the necessity of closely follow-up patients especially the first year after surgery, to eliminate potential complications.
Removal rates were lower following TO than RP, as well as reoperation rates for stress urinary incontinence. This can be understood because removal operations are more difficult when it is TO than RP insertion, but that contradicts previous studies with higher reoperation rates after TO. When we compared the complications rate between RP and TO, we also found more complications after RP than TO. Our study did not allow us to study whether these complications appeared according to the specialty of the surgeon and according to the center where the intervention took place. Perhaps this parameter could have explained these differences compared to previous studies.
Risks of removal and any reoperation were also higher among young women. These findings may be associated with the lower benefit-risk balance for reoperation in older patients.