Complications of Mesh Procedures for Stress Urinary Incontinence

An observational study of Urinary Incontinence and Stress, run by Newcastle-upon-Tyne Hospitals NHS Trust.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

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. Read more about this study

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Urinary Incontinence, Stress
What is being tested?: Tension-free vaginal tape (TVT), Trans-obturator tape (TOT) and Suprapubic sling (SS)
Type of treatment: Surgery or procedure
How many people: 101,081 participants
Where: No sites listed yet
Study dates: Apr 2007to Mar 2015
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Women only
No healthy volunteers
Adult, Older adult

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

Who may be able to join

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.

Who cannot join

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.

About this study

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

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
Being tested: Tension-free vaginal tape (TVT), Trans-obturator tape (TOT), Suprapubic sling (SS)
Keywords: surgical mesh, observational study, intraoperative complications, postoperative complications
Medical subject headings: Urinary Incontinence, Intraoperative Complications, Postoperative Complications

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT02850120
Study group	Role	What they receive
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. Receives: 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. Receives: Procedure: Tension-free vaginal tape (TVT); Procedure: Trans-obturator tape (TOT); Procedure: Suprapubic sling (SS)

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (5)

Type of mesh used
Frequency of each type of mesh procedure (TVT, TOT, SS) used over time
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Occurring within 30 days of surgical mesh insertion procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2007Mar 2015

First posted29 Jul 2016 (estimated)
Study startApr 2007
Primary completionMar 2015
Study completionMar 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Urinary IncontinenceStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Retrospective
Enrolment: 101,081 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02850120
Sponsor's protocol ID: RX029_MESH_SUI
Acronym: SUI-mesh
Status last verified: Jul 2016
First submitted: 18 Jul 2016
Last updated: 29 Jul 2016
Results posted: No
Data monitoring committee: No
Individual data sharing: No: 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.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Urinary Incontinence trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT02850120
Acronym / sponsor ID: SUI-mesh / RX029_MESH_SUI
Conditions: Urinary Incontinence, Stress
Keywords: surgical mesh, observational study, intraoperative complications, postoperative complications
Study type: Observational
Recruitment status: Completed
Enrolment: 101,081 participants (actual)
Lead sponsor: Newcastle-upon-Tyne Hospitals NHS TrustUniversity, hospital or other
Study start: Apr 2007
Primary completion: Mar 2015 (actual)
Study completion: Mar 2015 (actual)
First posted: 29 Jul 2016 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Cohort
Time perspective: Retrospective
Number of arms: 2

Arm	Type	Receives
Unconfounded	–	Procedure: Tension-free vaginal tape (TVT), Procedure: Trans-obturator tape (TOT), Procedure: Suprapubic sling (SS)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.
Confounded	–	Procedure: Tension-free vaginal tape (TVT), Procedure: Trans-obturator tape (TOT), Procedure: Suprapubic sling (SS)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.

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Women receiving surgical mesh intervention in the treatment of stress urinary incontinence.

Key inclusion criteria (1 listed)

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.

Key exclusion criteria (8 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Tension-free vaginal tape (TVT)Surgical insertion of Tension-free vaginal tape (TVT) polypropylene mesh in the treatment of stress urinary incontinence.	Procedure or surgery	Confounded, Unconfounded
Trans-obturator tape (TOT)Surgical insertion of Trans-obturator tape (TOT) polypropylene mesh in the treatment of stress urinary incontinence.	Procedure or surgery	Confounded, Unconfounded
Suprapubic sling (SS)Surgical insertion of Suprapubic sling (SS) polypropylene mesh in the treatment of stress urinary incontinence.	Procedure or surgery	Confounded, Unconfounded

Primary outcome

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

5 secondary outcomes

Type of mesh used
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: 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)
Time frame: Occurring within 30 days of surgical mesh insertion procedure

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2016.
Individual participant dataSharing planned: No. 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.

Related trials for Urinary Incontinence

Recruiting
Safety and Performance of UCon Patch Electrode
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Active, not recruitingPhase 2/3
Examining the Effects of Intra-detrusor Botox at Time of HoLEP in Men With Overactive Bladder Symptoms
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Recruiting
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Andrew Sims, PhD principal investigator

Newcastle upon Tyne Hospitals NHS Foundation Trust

Questions about this trial

What is this clinical trial studying?

An observational study of Urinary Incontinence and Stress, run by Newcastle-upon-Tyne Hospitals NHS Trust.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Long-term complications (time frame: Longitudinal analysis of all episodes of care available in HES (up to 96 months)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02850120.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2016.