Safety evaluation of mid-urethral slings (SOFT)

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Effectiveness study (incl. comparative)

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Medical condition to be studied:
  Stress urinary incontinence

Population studied

• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Estimated number of subjects:
  330000

Study design details

• Main study objective:
  The main aim of this study is to estimate the incidence of re-interventions after suburethral sling implantation in the short (up to one year of follow-up), medium (between 1 and 5 years of follow-up) and long term (5 years of follow-up).
• Outcomes:
  The primary endpoint is the occurrence of a urological re-intervention identified by the CCAM codes for re-interventions, corresponding to removal or section of the sling. -Patients’ characteristics -Diagnosis of urinary incontinence leading to a sling procedure -Severe (i.e. leading to hospitalization) complications linked to the implantation of slings -Severe and non-severe complications linked to the modifications of the urinary system due to the sling -Reoperation for urinary incontinence -Global direct and indirect costs -Risk factors of complication
• Data analysis plan:
  Women will be followed from the index date (date of implantation) until the first of the following events: exit of the health insurance scheme, death or end of the study 2019 December 31st (and for each objective, the date of the outcome of interest). Incidence of surgical re-intervention and incidence of other related complications will be estimated using Kaplan Meier method. Related rates will be reported at different times of interest. Concerning the risk of non specific complications, the analysis will compare the rate of complications occurring in exposed women with that occurring in unexposed women, each woman who had a mid-urethral sling implantation will be matched with 1 woman who did not have one at the index date (dynamic matching). Matched unexposed women who received a sling during follow-up will be censored at that date in the unexposed group and will start their contribution to the exposed group (time-related exposure). Matching will be done on a propensity score.