Mid-urethral Slings: A Landmark French Study Assesses the Safety of the Surgical Technique
The study, published in eClinicalMedicine, part of The Lancet group and funded through PHRC, highlights the long-term complications associated with the implantation of synthetic mid-urethral slings in women with stress urinary incontinence. It takes place in a context, in France as well as internationally, of growing concerns about the safety of these devices.
Since the 2000s, the standard treatment has consisted of the implantation of synthetic mid-urethral slings designed to support the urethra and prevent leakage. Two surgical techniques are used, depending on the patient’s profile and the practitioner’s preference:
TVT (Tension-free Vaginal Tape), via the retropubic route
TOT (Trans-Obturator Tape), via the transobturator route
A groundbreaking study conducted on all women operated on in France between 2011 and 2018
Few studies so far have directly compared these two implantation techniques. This research applies the innovative methodological framework of emulated clinical trials using real-world data. The study relies on the medico-administrative data of the French National Health Data System (SNDS) and enabled the analysis of the trajectories of 215,141 women operated on in France between 2011 and 2018 for stress urinary incontinence with placement of either a TVT or TOT sling.
A study useful for better guiding therapeutic choices
The results show a statistically significant difference between the two surgical approaches. At 5 years, 4.13% of women operated on with TVT required a reoperation for sling removal or section, compared with 3.25% for those who underwent TOT.
These findings demonstrate that complications can occur more than 5 years after surgery and describe their nature. They therefore allow for better patient information, and consequently, better guidance in future therapeutic decisions within the framework of shared medical decision-making.