Complications of Mesh Procedures for Stress Urinary Incontinence (SUI-mesh)

Newcastle-upon-Tyne Hospitals NHS Trust

Status: Completed

Conditions: Urinary Incontinence; Stress

Treatments: Procedure: Tension-free vaginal tape (TVT); Procedure: Trans-obturator tape (TOT); Procedure: Suprapubic sling (SS)

Study type: Observational

Funder types: Other

Identifiers

NCT02850120

RX029_MESH_SUI

Details and patient eligibility

About

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.

Enrollment: 101,081 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

101,081 participants in 2 patient groups

Unconfounded

Description:

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.

Treatment:

Procedure: Trans-obturator tape (TOT)

Procedure: Suprapubic sling (SS)

Procedure: Tension-free vaginal tape (TVT)

Confounded

Description:

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.

Treatment:

Procedure: Trans-obturator tape (TOT)

Procedure: Suprapubic sling (SS)

Procedure: Tension-free vaginal tape (TVT)