SIMS Trial

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

Stress urinary incontinence (SUI) is the most common type of urinary incontinence (UI) in pre-menopausal women, accounting for almost 50% of cases. Surgical procedures for the management of female SUI have been continuously evolving over the last four decades with the ultimate aim of providing an effective and truly ambulatory surgical procedure. In the most common surgical procedure, tension-free, standard mid-urethral slings (SMUS), a synthetic mesh (tape) is placed under the urethra to add support by creating a sub-urethral hammock. An alternative procedure known as adjustable anchored single-incision mini-sling (SIMS) is designed to have advantages over tension-free SMUS in that it avoids the blind insertion trajectory into the pelvic cavity or the thigh muscles while maintaining the concept of the hammock support to the urethra. The aim of the current study is to conduct a health economic evaluation alongside a randomised controlled trial comparing these two interventions.

The SIMS Trial builds on earlier work in the SIMS pilot study. A 4 year follow up to the SIMS pilot study is also underway.

Project website for the SIMS Trial, at the Centre for Healthcare Randomised Trials.

The ISRCTN is ISRCTN93264234

HERU researchers involved in this research project: Mary Kilonzo

External collaborators: M Abdel-Fattah, J N'Dow (Other Applied Health Sciences, University of Aberdeen); R Assassa (Mid Yorkshire Hospitals NHS Trust); G MacLennan, K McCormack, J Norrie (HSRU, University of Aberdeen); J Wardle (Continence Foundation)

Publications

Abdel-Fattah, M., Maclennan, G., Kilonzo, M., Assassa, R.P., Mccormick, K., Davidson, T., Mcdonald, A., N'dow, J., Wardle, J. and Norrie, J. (2017) 'The SIMS trial: adjustable anchored single-incision mini-slings versus standard tension-free midurethral slings in the surgical management of female stress urinary incontinence. A study protocol for a pragmatic, multicentre, non-inferiority randomised controlled trial', BMJ Open, 7(8), e015111.