Clinical trial NCT02850120: Complications of Mesh Procedures for Stress Urinary Incontinence
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Urinary Incontinence
Stress
Keywords: surgical mesh
observational study
intraoperative complications
postoperative complications
Lead sponsor: Newcastle-upon-Tyne Hospitals NHS Trust
Sponsor class: OTHER
First posted: 2016-07-29
Enrollment: 101081
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women receiving surgical mesh intervention in the treatment of stress urinary incontinence.

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Women with an Office of Population Censuses and Surveys Classification of Surgical Operations and Procedures 4th revision (OPCS-4) procedure code for an introduction of a Tension-free Vaginal Tape (TVT: M53.3), Trans-Obturator Tape (TOT: M53.6) or Supra-pubic Sling (SS: M52.1) surgical mesh procedure recorded in any of the 24 procedure fields captured in HES, and a recorded diagnosis of stress urinary incontinence based on International Classification of Diseases 10th revision (ICD-10) diagnoses: N39.3, N39.4, R32: T83.1, T83.4, T83.5, T83.6, T83.6, T83.8, T83.9, Z46.6, in any of the 20 diagnosis fields captured in HES.

Exclusion Criteria:

* Duplicate episode of care (exact match on patient identifier; admission date and method; discharge date, destination and method; hospital, gender, age, all procedure codes and all diagnostic codes)
* 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.

Primary outcomes:
measure: Long-term complications
timeFrame: Longitudinal analysis of all episodes of care available in HES (up to 96 months)
Secondary outcomes:
measure: Type of mesh used
timeFrame: Longitudinal analysis of all episodes of care available in HES (up to 96 months)
measure: Frequency of treatment-related adverse events during initial hospital stay for mesh insertion procedure
timeFrame: During hospital admission when surgical mesh was inserted (length of hospital stay can vary between patients from 0-100 days)
measure: Nature of treatment-related adverse events as determined by clinical coding practice of ICD-10 codes (Aylin et al. BMJ. 2004)
timeFrame: During hospital admission when surgical mesh was inserted (length of hospital stay can vary between patients from 0-100 days)
measure: Frequency of 30-day complications
timeFrame: Occurring within 30 days of surgical mesh insertion procedure
measure: 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)
timeFrame: Occurring within 30 days of surgical mesh insertion procedure
Other outcomes:
Locations:
Study officials:
affiliation: Newcastle upon Tyne Hospitals NHS Foundation Trust
name: Andrew Sims, PhD
role: PRINCIPAL_INVESTIGATOR
References: