Plain English Summary
Background and study aims
Stress incontinence is the unconscious leakage of urine during effort, exercise, or simply coughing or laughing. It may be caused by weakness in the bladder muscles. The aim of the study is to compare the current surgical treatment with a new type of surgery. The current standard surgical treatment, Standard Mid-urethral Slings (SMUS), involves insertion of a special sling (tape) underneath the urethra (bladder outlet) to provide support and help to prevent urinary leakage. The standard tapes have good success rates (85%) and high patient satisfaction rates. They require the patient to have a general anaesthetic. The new procedure (SIMS: Single Incision Mini-Slings) has recently been developed. This is a mini-version of the standard tape and uses the same type of tape material. However, it requires a single cut in the vagina and is less invasive, and hence can be performed under local anaesthetic with minimal discomfort. It has been shown to have earlier recovery and earlier return to work and normal activities.
Who can participate?
Women who are having surgery to treat stress urinary incontinence (SUI) can participate in this study.
What does the study involve?
Women will be randomly allocated to one of the two surgery types provided that their urologist agrees that either type of surgery is suitable. All women will be asked to complete assessment questionnaires at certain time points - before surgery and again at 4 weeks and 3 months after surgery. Women will also complete a 14-day diary immediately after their operation and simple questionnaire at 4 & 12 weeks.
What are the possible risks of participating?
We do not think that there are any possible disadvantages or additional risks to participants. Whichever group women are allocated to, their operation will be performed by a competent and trained surgeon. There are risks associated with all procedures and anaesthetics which will be explained to women, as per routine clinical care, prior to surgery. Steps are always taken to ensure that these risks are minimised.
Where is the study run from?
This study is being co-ordinated by the Centre for Healthcare Randomised Trials (CHaRT) at the University of Aberdeen, UK.
When is the study starting and how long is it expected to run for?
Recruitment will start in early 2014 and the study will end in mid-2019.
Who is funding the study?
National Institute for Health Research (NIHR) (UK).
Who is the main contact?
Centre for Healthcare Randomised Trials
Dr Mohamed Abdel-Fattah
Aberdeen Maternity Hospital
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 hypothesis being tested is that the patient-reported success rate following surgical treatment with the adjustable anchored Single Incision Mini-Slings (SIMS) procedure is non-inferior to the tension-free Standard Mid-urethral Slings (SMUS) procedure 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.
North of Scotland Research Ethics Service Committee 2
Multicentre randomised controlled non-inferiority trial
Primary study design
Secondary study design
Randomised controlled trial
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Adult women with stress urinary incontinence
The interventions being compared are:
1. Tension-free standard mid-urethral slings (SMUS) including RP-TVT and TO-TVT
2. Adjustable anchored single-incision mini-slings (SIMS)
SMUS will be performed under general anaesthetic (GA) or deep intravenous sedation while adjustable anchored SIMS will be done under local anaesthetic (LA) as an opt-out policy.
All participants, in both arms, will receive pre-and post-operative analgesia and antibiotics as appropriate. A cystoscopy (rigid or flexible) will be performed in all women following insertion of the sling, regardless of the study arm. No vaginal packs or catheters will be routinely inserted.
Postoperatively all participants will undergo voiding assessment including assessment for post-voiding residual urine volume (PVR) using a bedside bladder-scanner.
Primary outcome measures
1. Patient-reported success rate measured by the validated Patient Global Impression of Improvement (PGI-I) at 12 months
2. Incremental cost per QALY gained at 12 months
Secondary outcome measures
1. Complications including: lower urinary tract injuries; haemorrhage (blood loss ≥ 200 ml); post-operative voiding dysfunction; pain, mesh extrusion/erosion, dyspareunia, long-term self-catheterisation, new-onset urgency/urgency incontinence assessed as appropriate at 3 and 12 months then yearly up to 3 years
2. Post-operative pain using a pain Numerical Rating Scale (NRS) assessed day 1-14
3. Objective success rates assessed by 24-hour pad test at 12 months and yearly up to 3 years
4. Other lower urinary tract symptoms using the International Consultation on Incontinence Questionnaire - Female Lower Urinary Tract Symptoms long form (ICIQ-FLUTS) and/or short form (ICIQ-SF) at 3 and 12 months and yearly up to 3 years
5. Health-related quality of life (QoL) profile (area under the curve) derived from EQ-5D, pain scores and ICIQ-LUTS quality of life measurements at 1, 3 and 12 months and yearly up to 3 years
6. Impact on sexual function derived from ICIQ-FLUTsex/ or PISQ-IR measurements at 12 months and yearly up to 3 years
7. Recurrence of SUI, re-operation rates for SUI, further treatment received such as physiotherapy, medical treatment (selective noradrenaline re-uptake inhibitors and/ or anti-muscarinic treatment)
Secondary economic outcomes include:
1. NHS and patient primary and secondary care resource use and costs at 3 months, 12 months and yearly up to 3 years
2. Incremental cost-effectiveness derived from responses to the ICIQ-LUTS over the follow-up period at 12 months and yearly up to 3 years
3. Incremental net benefit (NB) calculated from the responses to the discrete choice experiment (DCE) at 12 months
Overall trial start date
Overall trial end date
Participant inclusion criteria
1. Women aged 18 years or over with stress urinary incontinence (SUI), who have been referred to one of the collaborating units from across the UK, and for whom surgery has been indicated
2. Women will have completed their families, failed or declined conservative treatment (supervised pelvic floor muscle training - PFMT)
3. All women will have urodynamic stress incontinence, or urodynamic mixed urinary incontinence with predominant SUI bothering symptoms
4. The small group of women with pure symptoms and signs of SUI and no symptoms of overactive bladder (OAB) or voiding dysfunction (VD) can be included without urodynamic investigations as per the updated NICE guidelines
Target number of participants
Participant exclusion criteria
1. Anterior or apical prolapse ≥ pelvic organ prolapse quantification score (POP-Q) Stage 2
2. Previous incontinence surgery (for SUI or OAB)
3. Mixed incontinence with pre-dominant OAB symptoms (defined as OAB failed to be controlled on conservative treatment such as bladder retraining, PFMT and/or anti-muscarinic treatment)
4. Neurological conditions e.g. MS, spinal cord injuries
5. Concomitant surgery at time of SUI surgery
6. Previous pelvic irradiation
7. Pregnancy or planning for a family
8. Inability to understand the information leaflet and consent form in English
Recruitment start date
Recruitment end date
Countries of recruitment
Trial participating centre
Aberdeen Maternity Hospital, 2nd Floor
NIHR Evaluation, Trials and Studies Coordinating Centre (NETSCC) - NIHR Health Technology Assessment Programme - HTA (UK) ref: 12/127/157
Funding Body Type
Funding Body Subtype
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting