The SIMS trial
Research type
Research Study
Full title
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: The SIMS Trial.
IRAS ID
139199
Contact name
Mohamed S Abdel-fattah
Contact email
Sponsor organisation
University of Aberdeen
Research summary
Urinary incontinence in women is a major issue for the NHS and for society, with the number affected and cost of treatment posing a significant burden on healthcare.
Female Stress Urinary Incontinence (SUI) is the involuntary loss of urine through exercise, laughing, sneezing etc. It is the most common form of incontinence in premenopausal women and can have a significant negative effect on women’s quality of life. Non-surgical treatments seek to increase the support of the urethra with pelvic floor exercises but if these fail then surgery is the only alternative.
In the most common surgical procedure, tension-free standard mid urethral slings (SMUS), a tape is placed under the urethra to add support. An alternative procedures, single-incision mini-sling (SIMS) is designed to have advantages over SMUS and a pilot study has shown SIMS to have fewer operative complications, less pain during and after the procedure, can be done under local anaesthesia, with earlier recovery of participants, shorter hospital stays, earlier return to normal activities and/or work. Economic analysis has also shown potential economic benefit to the NHS resources and wider society.
Before SIMS can be widely implemented in clinical practice it needs robust assessment to ensure (a) it is as effective as the current standard procedures and (b) to prove the potential health and economic benefits. We propose to randomise 650 women, over the age of 18 years, from approximately 25 UK centres to receive either a SIMS or SMUS procedure. The progress of recruited women will be followed up over 3 years, post operatively, measuring potential benefits, risks and costs associated with each procedure.
This study will therefore inform decision making for patients with SUI, their surgeons and the relevant policy makers with regards the most clinically and cost effective procedure for women with SUI.
REC name
North of Scotland Research Ethics Committee 2
REC reference
13/NS/0143
Date of REC Opinion
12 Dec 2013
REC opinion
Further Information Favourable Opinion