Stress Clinical Trial
Official title:
Complications Following Tension-free Vaginal Tape (TVT), Trans-obturator Tape (TOT) and Suprapubic Sling (SS) Procedures for Stress Urinary Incontinence: 8-year Retrospective Cohort Study Using Hospital Episodes Statistics Data
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.
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