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

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.

Study Overview

• Status: Completed
• Conditions: Urinary Incontinence; Stress
• Intervention / Treatment: Procedure: Tension-free vaginal tape (TVT); Procedure: Trans-obturator tape (TOT); Procedure: Suprapubic sling (SS)

• Study Type: Observational
• Enrollment (Actual): 101081

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Women receiving surgical mesh intervention in the treatment of stress urinary incontinence.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Unconfounded; All hospital admissions including Tension-free Vaginal Tape (TVT), Trans-obturator tape (TOT) or suprapubic sling (SS) procedures with: no concomitant procedures,; any concomitant procedures which were considered unlikely to have an effect on outcomes from their mesh insertion, or; only other concomitant procedures which were considered likely to be rescue procedures treating complications caused by the mesh insertion procedure itself.	Procedure: Tension-free vaginal tape (TVT); Surgical insertion of Tension-free vaginal tape (TVT) polypropylene mesh in the treatment of stress urinary incontinence.; Procedure: Trans-obturator tape (TOT); Surgical insertion of Trans-obturator tape (TOT) polypropylene mesh in the treatment of stress urinary incontinence.; Procedure: 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.	Procedure: Tension-free vaginal tape (TVT); Surgical insertion of Tension-free vaginal tape (TVT) polypropylene mesh in the treatment of stress urinary incontinence.; Procedure: Trans-obturator tape (TOT); Surgical insertion of Trans-obturator tape (TOT) polypropylene mesh in the treatment of stress urinary incontinence.; Procedure: Suprapubic sling (SS); Surgical insertion of Suprapubic sling (SS) polypropylene mesh in the treatment of stress urinary incontinence.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Long-term complications	Readmission for further mesh surgery or for symptoms indicating complication	Longitudinal analysis of all episodes of care available in HES (up to 96 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Type of mesh used	Frequency of each type of mesh procedure (TVT, TOT, SS) used over time	Longitudinal analysis of all episodes of care available in HES (up to 96 months)
Frequency of treatment-related adverse events during initial hospital stay for mesh insertion procedure	Frequency of complication	During hospital admission when surgical mesh was inserted (length of hospital stay can vary between patients from 0-100 days)
Nature of treatment-related adverse events as determined by clinical coding practice of ICD-10 codes (Aylin et al. BMJ. 2004)	Nature of complication	During hospital admission when surgical mesh was inserted (length of hospital stay can vary between patients from 0-100 days)
Frequency of 30-day complications	Frequency and nature of complication	Occurring within 30 days of surgical mesh insertion procedure
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)	Nature of complication	Occurring within 30 days of surgical mesh insertion procedure

Collaborators and Investigators

• Sponsor: Newcastle-upon-Tyne Hospitals NHS Trust
• Investigators: Principal Investigator: Andrew Sims, PhD, Newcastle upon Tyne Hospitals NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start: April 1, 2007
• Primary Completion (Actual): March 1, 2015
• Study Completion (Actual): March 1, 2015

Study Registration Dates

• First Submitted: July 18, 2016
• First Submitted That Met QC Criteria: July 27, 2016
• First Posted (Estimate): July 29, 2016

Study Record Updates

• Last Update Posted (Estimate): July 29, 2016
• Last Update Submitted That Met QC Criteria: July 27, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Keywords: observational study; surgical mesh; postoperative complications; intraoperative complications
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Elimination Disorders; Urinary Incontinence; Enuresis; Urinary Incontinence, Stress
• Other Study ID Numbers: RX029_MESH_SUI

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Hospital Episode Statistics data to reproduce results are available from the Health and Social Care Information Centre (HSCIC) via formal application process. Analytic code and its output will be shared.