Mid-urethral slings (MUS) at risk of extinction? A prospective single-center study.

Ferong K1, Vossaert P1, Verleyen P1, Ghesquière S1, Platteeuw L1, Van Bruwaene S1

Research Type

Clinical

Abstract Category

Female Stress Urinary Incontinence (SUI)

Abstract 511
Pelvic Floor Dysfunction 2
Scientific Podium Short Oral Session 34
On-Demand
Stress Urinary Incontinence Prospective Study Grafts: Synthetic
1. AZ Groeninge Kortrijk, Belgium
Presenter
K

Kristel Ferong

Links

Abstract

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.
Concluding message
A prospective sling database was created as part of daily clinical practice. With little effort a large amount of data became readily available. While the PROMS data had a satisfactory response rate (72%), only 59% of physician-data were completed at 12m. The MUS showed 83% success with a 2% re-intervention rate. These numbers are used in our center-specific informed consent. A 5 year follow-up is planned.
Figure 1 Predictive factors
Figure 2 Concomitant cystocele repair vs exclusively MUS
Disclosures
Funding NONE Clinical Trial Yes Public Registry No RCT No Subjects Human Ethics Committee Commissie Medische Ethiek AZ Groeninge Kortrijk (1479206631415) Helsinki Yes Informed Consent Yes
18/04/2024 05:30:55