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Completed

NCT Number: NCT02850120

Complications of Mesh Procedures for Stress Urinary Incontinence

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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Key information

Conditions

Urinary Incontinence Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Intraoperative Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms Stress Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tension-free vaginal tape (TVT)

Procedure

Surgical insertion of Tension-free vaginal tape (TVT) polypropylene mesh in the treatment of stress urinary incontinence.

Trans-obturator tape (TOT)

Procedure

Surgical insertion of Trans-obturator tape (TOT) polypropylene mesh in the treatment of stress urinary incontinence.

Suprapubic sling (SS)

Procedure

Surgical insertion of Suprapubic sling (SS) polypropylene mesh in the treatment of stress urinary incontinence.

Primary outcomes

  1. Long-term complications

    Time frame: Longitudinal analysis of all episodes of care available in HES (up to 96 months)

    Readmission for further mesh surgery or for symptoms indicating complication

Secondary outcomes

  1. Type of mesh used

    Time frame: Longitudinal analysis of all episodes of care available in HES (up to 96 months)

    Frequency of each type of mesh procedure (TVT, TOT, SS) used over time

  2. Frequency of treatment-related adverse events during initial hospital stay for mesh insertion procedure

    Time frame: During hospital admission when surgical mesh was inserted (length of hospital stay can vary between patients from 0-100 days)

    Frequency of complication

  3. Nature of treatment-related adverse events as determined by clinical coding practice of ICD-10 codes (Aylin et al. BMJ. 2004)

    Time frame: During hospital admission when surgical mesh was inserted (length of hospital stay can vary between patients from 0-100 days)

    Nature of complication

  4. Frequency of 30-day complications

    Time frame: Occurring within 30 days of surgical mesh insertion procedure

    Frequency and nature of complication

  5. 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)

    Time frame: Occurring within 30 days of surgical mesh insertion procedure

    Nature of complication

Sponsors and collaborators

Lead sponsor

Newcastle-upon-Tyne Hospitals NHS Trust

Other

Registry information

Official study 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

Acronym: SUI-mesh

Important dates

Study start
2007
Primary completion
2015
Study completion
2015
First posted
Jul 29, 2016
Registry last updated
Jul 29, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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