Condition category
Urological and Genital Diseases
Date applied
10/01/2014
Date assigned
14/01/2014
Last edited
22/11/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Stress incontinence is the involuntary leakage of urine during physical activity, effort, exercise, or simply coughing or laughing. The aim of the study is to compare the current surgical treatment with a newer type of surgery. The current standard surgical treatment, Standard Mid-urethral Slings (SMUS), involves insertion of a special sling (mesh/ tape) underneath the urethra (bladder outlet) to provide support and help to prevent urinary leakage. The standard procedures have good success rates (85%) and high patient satisfaction rates. They require the patient to have a general anaesthetic. The newer procedure (SIMS: Single Incision Mini-Slings) has more recently been developed. This is a mini-version of the standard procedure 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 less discomfort. It has been shown to have earlier recovery and earlier return to work and normal activities.

Who can participate?
Women who are scheduled for having surgery to treat stress urinary incontinence (SUI) can participate in this study. The potential participants are only approached to participate in the study if/when they have made their informed decision, according to the local standard clinical practice, to undergo SMUS procedure, Potential participants will be advised to refer to the trial patient information leaflets and discuss with their surgeons.

What does the study involve?
Women are randomly allocated to one of the two surgery types provided that their surgeon agrees that either type of surgery is suitable and after following the local standard clinical care procedures. All women are asked to complete assessment questionnaires at certain time points - before surgery and again at 4 weeks,3 months and annual for 3 years after surgery. Women also complete a 14-day diary immediately after their operation

What are the possible risks of participating?
There are no benefits associated with participating. Obviously there are risks associated with any surgical procedure but we do not think that there are disadvantages or additional risks to participants by participating in the study. 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 standard clinical care, prior to surgery. Steps are always taken to ensure that these risks are minimised.

Where is the study run from?
Aberdeen Royal Infirmary and 22 other NHS hospitals (UK)

When is the study starting and how long is it expected to run for?
December 2013 to February 2020

Who is funding the study?
National Institute for Health Research (UK)

Who is the main contact?
Centre for Healthcare Randomised Trials
chart@abdn.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Dr Mohamed Abdel-Fattah

ORCID ID

Contact details

Aberdeen Maternity Hospital
2nd Floor
Foresterhill
Aberdeeen
AB25 2ZD
United Kingdom
+44 1224 438424
m.abdelfattah@abdn.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

3/069/13

Study information

Scientific 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

Acronym

SIMS

Study hypothesis

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.

Ethics approval

North of Scotland Research Ethics Service Committee 2, 12/12/2013, ref: 13/NS/0143

Study design

Multicentre randomised controlled non-inferiority trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Adult women with stress urinary incontinence

Intervention

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.

Intervention type

Other

Phase

Not Applicable

Drug names

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

01/12/2013

Overall trial end date

28/02/2020

Reason abandoned

Eligibility

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

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

650

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

04/02/2014

Recruitment end date

30/11/2016

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Aberdeen Royal Infirmary
Foresterhill
Aberdeeen
AB25 2ZB
United Kingdom

Trial participating centre

Borders General Hospital
Melrose
TD6 9BS
United Kingdom

Trial participating centre

Queen Margaret Hospital
Whitefield Road
Dunfermline
KY12 0SU
United Kingdom

Trial participating centre

Princess Royal Hospital
Lewes Road
Haywards Heath
RH16 4EX
United Kingdom

Trial participating centre

York Teaching Hospital
Wigginton Road
York
YO31 8HE
United Kingdom

Trial participating centre

Pinderfields Hospital
Aberford Road
Wakefield
WF1 4DG
United Kingdom

Trial participating centre

New Cross Hospital
Wolverhampton Road
Wolverhampton
WV10 0QP
United Kingdom

Trial participating centre

Torbay Hospital
Newton Road
Torquay
TQ2 7AA
United Kingdom

Trial participating centre

Milton Keynes Hospital
H8 Standing Way Eaglestone
Milton Keynes
MK6 5LD
United Kingdom

Trial participating centre

James Cook University Hospital
Marton Road
Middlesbrough
TS4 3BW
United Kingdom

Trial participating centre

Ayrshire Maternity Unit
University Hospital Crosshouse Kilmarnock Road Crosshouse
Ayr
KA2 OBE
United Kingdom

Trial participating centre

Monklands Hospital
Monkscourt Avenue
Airdrie
ML6 0JS
United Kingdom

Trial participating centre

Countess of Chester Hospital
Liverpool Road
Chester
CH2 1UL
United Kingdom

Trial participating centre

University Hospital of Wales
Heath Park
Cardiff
CF14 4XW
United Kingdom

Trial participating centre

Worthing Hospital
Lyndhurst Road
Worthing
BN11 2DH
United Kingdom

Trial participating centre

Lincoln County Hospital
Greetwell Road
Lincoln
LN2 5QY
United Kingdom

Trial participating centre

Eastbourne District General Hospital
Kings Drive
Eastbourne
BN21 2UD
United Kingdom

Trial participating centre

Royal Preston Hospital
Sharoe Green Lane North Fulwood
Preston
PR2 9HT
United Kingdom

Trial participating centre

Great Western Hospital
Marlborough Road
Swindon
SN3 6BB
United Kingdom

Trial participating centre

Arrowe Park Hospital
Arrowe Park Road Upton Birkenhead
Wirral
CH49 5PE
United Kingdom

Trial participating centre

Barnsley Hospital
Gawber Road
Barnsley
S75 2EP
United Kingdom

Trial participating centre

James Paget Hospital
Lowestoft Road Gorleston-on-Sea
Great Yarmouth
NR31 6LA
United Kingdom

Trial participating centre

Queen Elizabeth Hospital
Gayton Road
Kings Lynn
PE30 4ET
United Kingdom

Sponsor information

Organisation

University of Aberdeen (UK)

Sponsor details

University of Aberdeen/NHS Grampian
Research and Development Office
Foresterhill House Annexe
Foresterhill
Aberdeen
AB25 2ZB
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

NIHR Evaluation, Trials and Studies Coordinating Centre (NETSCC) - NIHR Health Technology Assessment Programme - HTA (UK) ref: 12/127/157

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

The dissemination plans include HTA monograph; presentation at international scientific meetings; and publications in high-impact open access journals; the results will be included in the updates of NICE and EAU (European Association of Urology) guidelines; these two specific guidelines directly influence practice in the UK and worldwide specialists respectively. In-addition, plain English language summary of the main findings/results will be presented for relevant patient organisations.

IPD Sharing plan:
The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication.

Intention to publish date

28/02/2021

Participant level data

Other

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

22/11/2016: The list of trial participating centres has been added. 10/11/2016: The recruitment dates have been updated from 01/12/2013 - 31/05/2019 to 04/02/2014 - 30/1/2016 and the overall trial end date has been updated from 31/05/2019 to 28/02/2020.