Abstract
Introduction and hypothesisFew studies in literature have assessed the long-term durability and mesh-related complications of mid-urethral slings (MUSs). The aim of this study is to assess the efficacy and safety of retro-pubic tension-free vaginal tape (TVT) 20 years after implantation for the treatment of female stress urinary incontinence (SUI).MethodsA prospective observational study was conducted in two urogynaecologic units in two countries. All the patients involved were consecutive women with urodynamically proven pure SUI treated by TVT. The patients underwent preoperative clinical and urodynamic evaluations. Subjective outcomes, objective outcomes and adverse events were recorded during the follow-up period.ResultsFifty-two patients underwent a TVT surgical procedure. Twenty years after surgery, 32 out of 36 patients (88.8%) declared themselves cured (p = 0.98). Similarly, 33 out of these 36 patients (91.7%) were objectively cured (p = 0.98). No significant deterioration of subjective and objective cure rates was observed over time (p for trend 0.50 and 0.48). Fifteen of the 36 patients (41.6%) at the 20-year follow-up reported the onset of de novo overactive bladder (OAB) (p = 0.004). No significant vaginal bladder or urethral erosion or de novo dyspareunia was recorded and no patient required tape release or resection during this period. The cause of death of seven out of ten women who died in the last year of the follow-up period was coronavirus disease 19 (COVID 19).ConclusionsThe 20-year results of this study showed that TVT is a highly effective and safe option for the treatment of SUI. The impact of COVID 19 on the mortality rate of elderly women has drastically reduced the number of eligible patients for future evaluations in our region.
Highlights
Introduction and hypothesisFew studies in literature have assessed the long-term durability and mesh-related complications of mid-urethral slings (MUSs)
The notice issued by the United States Food and Drug Administration (US FDA) considered MUSs to be relatively safe [5], in July 2018 the British government announced that the use of mesh for the treatment of POP and urinary incontinence (UI) was to be paused
Women with a previous history of radical pelvic surgery, psychiatric and neurologic disorders, concomitant vaginal prolapse > stage 1 according to the Pelvic Organ Prolapse Quantification (POP-Q) system [12], overactive bladder (OAB) symptoms, urodynamically proven DO and postvoid residual > 100 ml were excluded from the study
Summary
Introduction and hypothesisFew studies in literature have assessed the long-term durability and mesh-related complications of mid-urethral slings (MUSs). The aim of this study is to assess the efficacy and safety of retro-pubic tension-free vaginal tape (TVT) 20 years after implantation for the treatment of female stress urinary incontinence (SUI). Conclusions The 20-year results of this study showed that TVT is a highly effective and safe option for the treatment of SUI. The impact of COVID 19 on the mortality rate of elderly women has drastically reduced the number of eligible patients for future evaluations in our region. Since their introduction [1], tension-free vaginal tape midurethral slings (Gynecare TVT System®) have been considered the most effective and safest procedure for the treatment of female stress urinary incontinence [2–4]. There is not enough evidence available on the longlasting benefits of MUS procedures to be able to recommend these techniques with a robust level of evidence
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