Complications of Mesh Procedures for Stress Urinary Incontinence
NCT ID: NCT02850120
Last Updated: 2016-07-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
101081 participants
OBSERVATIONAL
2007-04-30
2015-03-31
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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Unconfounded
All hospital admissions including Tension-free Vaginal Tape (TVT), Trans-obturator tape (TOT) or suprapubic sling (SS) procedures with:
1. no concomitant procedures,
2. any concomitant procedures which were considered unlikely to have an effect on outcomes from their mesh insertion, or
3. only other concomitant procedures which were considered likely to be rescue procedures treating complications caused by the mesh insertion procedure itself.
Tension-free vaginal tape (TVT)
Surgical insertion of Tension-free vaginal tape (TVT) polypropylene mesh in the treatment of stress urinary incontinence.
Trans-obturator tape (TOT)
Surgical insertion of Trans-obturator tape (TOT) polypropylene mesh in the treatment of stress urinary incontinence.
Suprapubic sling (SS)
Surgical insertion of Suprapubic sling (SS) polypropylene mesh in the treatment of stress urinary incontinence.
Confounded
All hospital admissions for insertion of Tension-free Vaginal Tape (TVT), Trans-obturator tape (TOT) or suprapubic sling (SS) procedures with concomitant procedures likely to affect outcomes.
Tension-free vaginal tape (TVT)
Surgical insertion of Tension-free vaginal tape (TVT) polypropylene mesh in the treatment of stress urinary incontinence.
Trans-obturator tape (TOT)
Surgical insertion of Trans-obturator tape (TOT) polypropylene mesh in the treatment of stress urinary incontinence.
Suprapubic sling (SS)
Surgical insertion of Suprapubic sling (SS) polypropylene mesh in the treatment of stress urinary incontinence.
Interventions
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Tension-free vaginal tape (TVT)
Surgical insertion of Tension-free vaginal tape (TVT) polypropylene mesh in the treatment of stress urinary incontinence.
Trans-obturator tape (TOT)
Surgical insertion of Trans-obturator tape (TOT) polypropylene mesh in the treatment of stress urinary incontinence.
Suprapubic sling (SS)
Surgical insertion of Suprapubic sling (SS) polypropylene mesh in the treatment of stress urinary incontinence.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Male gender
* Missing age
* Aged less than 18 years
* Invalid or missing admission method
* Missing admission date
* Patients with recorded episodes of care in HES which appear after a reported date of death.
* Concomitant mesh surgery for pelvic organ prolapse surgery, or surgical mesh repair, removal, renewal or subsequent mesh insertion.
18 Years
FEMALE
No
Sponsors
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Newcastle-upon-Tyne Hospitals NHS Trust
OTHER
Responsible Party
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Principal Investigators
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Andrew Sims, PhD
Role: PRINCIPAL_INVESTIGATOR
Newcastle upon Tyne Hospitals NHS Foundation Trust
Other Identifiers
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RX029_MESH_SUI
Identifier Type: -
Identifier Source: org_study_id