Complications of Mesh Procedures for Stress Urinary Incontinence

NCT02850120 | Completed

• 1 other identifier: RX029_MESH_SUI
• Study Type: observational
• Target: 101,081
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Urinary Incontinence; Stress

Keywords

surgical mesh; observational study; intraoperative complications; postoperative complications

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Type of mesh used

  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

  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)

  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

  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)

  Occurring within 30 days of surgical mesh insertion procedure

Study Arms (2)

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.

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

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); Procedure: Trans-obturator tape (TOT); Procedure: Suprapubic sling (SS)

Interventions

Tension-free vaginal tape (TVT) PROCEDURE

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

Confounded; Unconfounded

Trans-obturator tape (TOT) PROCEDURE

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

Confounded; Unconfounded

Suprapubic sling (SS) PROCEDURE

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

Confounded; Unconfounded

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Newcastle-upon-Tyne Hospitals NHS Trust: lead

MeSH Terms

Conditions

Urinary Incontinence; Intraoperative Complications; Postoperative Complications

Interventions

Suburethral Slings

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Prostheses and Implants; Equipment and Supplies

Study Officials

• Andrew Sims, PhD

  Newcastle upon Tyne Hospitals NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2016
• First Posted: July 29, 2016
• Study Start: April 1, 2007
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: July 29, 2016

Record last verified: 2016-07

Data Sharing

• IPD Sharing: Will not share