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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Unconfounded | All hospital admissions including Tension-free Vaginal Tape (TVT), Trans-obturator tape (TOT) or suprapubic sling (SS) procedures with:
|
| |
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tension-free vaginal tape (TVT) | Procedure | Surgical insertion of Tension-free vaginal tape (TVT) polypropylene mesh in the treatment of stress urinary incontinence. |
|
| 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) |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Women receiving surgical mesh intervention in the treatment of stress urinary incontinence.
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| Name | Affiliation | Role |
|---|---|---|
| Andrew Sims, PhD | Newcastle upon Tyne Hospitals NHS Foundation Trust | Principal Investigator |
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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.
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Nov 17, 2017 | |
| Unrelease | Yes | |
| Release | Mar 27, 2018 | |
| Reset | Oct 26, 2018 | |
| Release | Mar 13, 2019 | |
| Reset | Jun 14, 2019 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Nov 17, 2017 | Yes | |||
| Mar 27, 2018 |
| ID | Term |
|---|---|
| D014549 | Urinary Incontinence |
| D007431 | Intraoperative Complications |
| D011183 | Postoperative Complications |
| ID | Term |
|---|---|
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D053825 | Suburethral Slings |
| ID | Term |
|---|---|
| D019736 | Prostheses and Implants |
| D004864 | Equipment and Supplies |
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| 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. |
|
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 |
| Oct 26, 2018 |
| Mar 13, 2019 | Jun 14, 2019 |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010335 | Pathologic Processes |