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WELCOME TO THE SIMS LTFU

Long-Term Outcomes of Synthetic Mid-Urethral Slings (Mesh Tapes) In Surgical Treatment of Stress Urinary Incontinence In Women – A Long-term Follow-Up of The SIMS RCT

What is SIMS?

The original SIMS study recruited 600 women with stress urinary incontinence between 2014 and 2017. The study compared two different types of surgery to treat urinary incontinence – standard mid urethral slings (SMUS) and singe-incision mini-slings (SIMS). At three years, the patient reported success rates between the two groups were similar – you can find out more about what the SIMS study has found at https://www.abdn.ac.uk/hsru/what-we-do/trials-unit/portfolio/sims-100/.

The aim of this long-term follow-up study is to establish the long-term benefits and disadvantages of each type of surgery. Most of the women who took part in the original SIMS study agreed to take part in the long-term follow-up study, and we are following them up with questionnaires every year to find out how they are getting on.

The long-term follow-up of the SIMS study is essential to inform patients, health-care commissioners, and health-care professionals alike. It will allow us to provide long-term data on the use of mesh to treat stress urinary incontinence, including information on adverse events, impact on women’s quality of life, and further treatments.


In the long-term follow-up, we will send annual questionnaires (for up to 10 years after joining the study) to participants who agreed to this when they joined the SIMS study. We will ask women to return their completed questionnaire in the prepaid envelope provided.

There is also an interview-based study, where we will invite some women to take part in and interview to explore:

• Their experiences of treatment and the impact on their quality of life
• Their perceptions of the decision making process and decision outcomes
• Their satisfaction with treatment outcomes
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Study news

Recruitment

600/600

Trial sites

Latest addition to sites:

Glangwili General Hospital, Carmarthen
Northampton General Hospital
Queen Elizabeth Hospital, Kings Lynn
Southern General Hospital, Glasgow

Key contacts

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Organisation

Funding acknowledgement

This Project is funded by the National Institute for Health Research (NIHR) HTA Programme [Project reference NIHR133092]. The views expressed are those of the author(s) and do not necessarily those of the NHS, the NIHR or the Department of Health & Social Care.

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 at https://www.abdn.ac.uk/about/privacy/.