Complications from mesh procedures (i.e. insertion of tension-free vaginal tapes (TVT), trans-obturator tapes (TOT) and suprapubic slings (SS)) used during surgical treatment of stress urinary incontinence have caused major concern around the world. The investigators aim to conduct a retrospective cohort study using administrative inpatient data from the Hospital Episode Statistics (HES) database to determine the complications of all first-time surgical mesh procedures in the treatment of stress urinary incontinence (SUI) in women treated in a National Health Service (NHS) hospital in England who were discharged from hospital between 1st April 2007 and 31st March 2015. The primary outcome measure is the number and types of complications (occurring peri-procedurally, within 30 days of the mesh procedure and those occurring during follow-up). Additional outcomes recorded include: the numbers and types of mesh procedures, including those with potentially confounding concomitant procedures.
Study Type
OBSERVATIONAL
Enrollment
101,081
Surgical insertion of Tension-free vaginal tape (TVT) polypropylene mesh in the treatment of stress urinary incontinence.
Surgical insertion of Trans-obturator tape (TOT) polypropylene mesh in the treatment of stress urinary incontinence.
Surgical insertion of Suprapubic sling (SS) polypropylene mesh in the treatment of stress urinary incontinence.
Long-term complications
Readmission for further mesh surgery or for symptoms indicating complication
Time frame: Longitudinal analysis of all episodes of care available in HES (up to 96 months)
Type of mesh used
Frequency of each type of mesh procedure (TVT, TOT, SS) used over time
Time frame: Longitudinal analysis of all episodes of care available in HES (up to 96 months)
Frequency of treatment-related adverse events during initial hospital stay for mesh insertion procedure
Frequency of complication
Time frame: During hospital admission when surgical mesh was inserted (length of hospital stay can vary between patients from 0-100 days)
Nature of treatment-related adverse events as determined by clinical coding practice of ICD-10 codes (Aylin et al. BMJ. 2004)
Nature of complication
Time frame: During hospital admission when surgical mesh was inserted (length of hospital stay can vary between patients from 0-100 days)
Frequency of 30-day complications
Frequency and nature of complication
Time frame: Occurring within 30 days of surgical mesh insertion procedure
Nature of treatment-related adverse events occurring within 30 days of mesh procedure as determined by clinical coding practice of ICD-10 codes (Aylin et al. BMJ. 2004)
Nature of complication
Time frame: Occurring within 30 days of surgical mesh insertion procedure
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