Complications of Mesh Procedures for Stress Urinary Incontinence

Stress Clinical Trial

— SUI-mesh  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02850120
• Other study ID #: RX029_MESH_SUI
• Status: Completed
• Phase: N/A
• First received: July 18, 2016
• Last updated: July 27, 2016
• Start date: April 2007
• Est. completion date: March 2015

Study information

• Verified date: July 2016
• Source: Newcastle-upon-Tyne Hospitals NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101081
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Enuresis
• Stress
• Urinary Incontinence
• Urinary Incontinence, Stress

Intervention

Procedure:
• Tension-free vaginal tape (TVT)
Surgical insertion of Tension-free vaginal tape (TVT) polypropylene mesh in the treatment of stress urinary incontinence.
• Trans-obturator tape (TOT)
Surgical insertion of Trans-obturator tape (TOT) polypropylene mesh in the treatment of stress urinary incontinence.
• Suprapubic sling (SS)
Surgical insertion of Suprapubic sling (SS) polypropylene mesh in the treatment of stress urinary incontinence.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Newcastle-upon-Tyne Hospitals NHS Trust

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	Frequency of 30-day complications	Frequency and nature of complication	Occurring within 30 days of surgical mesh insertion procedure
Secondary	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