Long-term re-procedure rate after mid-urethral slings for stress urinary incontinence

Sari Tulokas,Maarit J Mentula,Päivi Rahkola-Soisalo,Tomi S Mikkola,Mika Gissler

doi:10.1007/s00192-019-04223-1

Abstract

Introduction and hypothesisLong-term safety concerns have risen over the mid-urethral sling operation (MUS) for stress urinary incontinence (SUI), which in some countries has led to litigations and even suspending MUS insertions. We examined the long-term re-procedure rate after MUS operations. The main outcome was re-procedures for SUI. The secondary outcome was surgical interventions due to complications.MethodsWe analysed a retrospective population cohort of 3531 women with MUS operations in 2000–2006 and followed them up until 31 December 2016. Data were collected from a national hospital register and from hospital patient records.ResultsThe median follow-up time was 13 years (IQR 11.6–14.8) for the 3280 women with a retropubic MUS (RP-MUS) and 11 years (IQR 10.3–11.9) for the 245 women with a transobturator MUS (TO-MUS). The cumulative number of re-procedures for SUI was 16 (0.5%) at 1 year, 66 (1.9%) at 5 years, 97 (2.8%) at 10 years and 112 (3.2%) at 17 years. This risk was higher after TO-MUS than after RP-MUS operations (OR 3.6, 95% CI 2.5–5.2, p < 0.001). The cumulative number of any long-term re-procedure was 43 (1.2%) at year 1, 105 (3.0%) at year 5, 144 (4.1%) at year 10 and 163 (4.6%) at year 17.ConclusionsRe-procedures occur up to 17 years after primary MUS insertion, but their incidence is low after the first few postoperative years. Re-procedures for recurrent SUI are more common after TO-MUS than RP-MUS.

Highlights

Introduction and hypothesisLong-term safety concerns have risen over the mid-urethral sling operation (MUS) for stress urinary incontinence (SUI), which in some countries has led to litigations and even suspending MUS insertions
We identified the sample by searching all visits with Nordic Medico-Statistical Committee Classification of Surgical Procedures (NCSP) operation codes for the MUS operation (LEG10, LEG12 and LEG13)
We validated the data on a sample of 1010 women (392 women selected randomly and all the 618 women with a potential complication, see below). We compared their register data and hospital records, which were available for 990 (98.0%) of the selected women. All these women had visits related to urinary incontinence, but we identified four women with a planned MUS operation that was not performed and three women who had undergone a sling operation not included in this study

Summary

Introduction

Introduction and hypothesisLong-term safety concerns have risen over the mid-urethral sling operation (MUS) for stress urinary incontinence (SUI), which in some countries has led to litigations and even suspending MUS insertions. Using surgical mesh in pelvic floor operations has raised concerns about long-term problems such as chronic pain, mesh exposure, dyspareunia, voiding dysfunctions and the need for re-operations to treat complications or recurrent SUI. In previous cohort studies with followup times of up to 10 years, 4.3–4.5% of women received a further surgical treatment for SUI [8, 9], and, including mesh-removal procedures, 4.6–6.9% of women had a re-operation [9, 10]. With our register-based population study, we assess the long-term re-procedure rate after MUS with a follow-up time up to 17 years. The main focus was on re-procedures for SUI, but we evaluated complications and surgical interventions to treat them. We combined register data with hospital records to determine the complication types and their treatment in detail

Methods

Results

Conclusion