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MASTER
 

 

 

The SIMS Trial

Adjustable Anchored Single-Incision Mini-Slings Versus Standard Tension-Free Mid-Urethral Slings in the Surgical Management Of Female Stress Urinary Incontinence; A Pragmatic Multicentre Non–Inferiority Randomised Controlled Trial

Urinary incontinence (UI) is a common and distressing condition for women particularly over the age of 40 years. In the UK, it is estimated that 6 million (40%) of this age group have clinically significant UI symptoms, 1 million (6.2%) are bothered by symptoms and 0.33 million (2.2%) find them socially disabling. UI has a negative impact on a woman's social, physical and psychological wellbeing; leading to embarrassment, low self-esteem and social isolation.

The aim of this pragmatic multicentre RCT is to determine the clinical effectiveness and cost-effectiveness of adjustable anchored Single Incision MIni-Slings (SIMS) compares to tension-free Standard Mid-Urethral Slings (SMUS) in the surgical management of female stress urinary incontinence (SUI).

The hypothesis being tested is that patient-reported success rate following surgical treatment with adjustable anchored SIMS procedures is non-inferior to tension-free SMUS while the former is associated with less post-operative pain, shorter hospital stay, earlier recovery and consequently earlier return to usual activities/work and is more cost effective than SMUS.

 Links from our Patient information leaflet

  • The National Institute for Health and Clinical Excellence has produced further information regarding the risks of vaginal slings in August 2013. You are able to access this using the following link: http://publications.nice.org.uk/urinary-incontinence-cg171/recommendations
  • The Medicines and Healthcare products Regulatory Agency (MHRA) produced further information regarding the risks of vaginal slings in November 2012. You are able to access this using the following link: http://www.mhra.gov.uk – go to search box and type ‘synthetic vaginal slings’.

 Information for the public

 NEW information for the public - February 2018

 Further information and links to relevant documents are available under Downloads, Public documents (from the menu on the left hand side of the screen)

General Data Protection Regulation (GDPR) - Participant Information

University of Aberdeen/NHS Grampian is the sponsor for this study based in the United Kingdom. We will be using information from you and your medical records in order to undertake this study and will act as the data controller for this study. This means that we are responsible for looking after your information and using it properly. University of Aberdeen/NHS Grampian will keep identifiable information about you at least 10 years after the study has finished.


Your rights to access, change or move your information are limited, as we need to manage your information in specific ways in order for the research to be reliable and accurate. If you withdraw from the study, we will keep the information about you that we have already obtained. To safeguard your rights, we will use the minimum personally-identifiable information possible.


You can find out more about how we use your information https://www.abdn.ac.uk/about/privacy/.