Adjustable anchored Single-Incision Mini-Slings versus standard tension-free mid-urethral slings in the surgical management of female stress urinary incontinence

ISRCTN	ISRCTN93264234
DOI	https://doi.org/10.1186/ISRCTN93264234
Protocol serial number	3/069/13
Sponsor	University of Aberdeen (UK)
Funder	NIHR Evaluation, Trials and Studies Coordinating Centre (NETSCC) - NIHR Health Technology Assessment Programme - HTA (UK) ref: 12/127/157

Submission date: 10/01/2014
Registration date: 14/01/2014
Last edited: 30/08/2023

Recruitment status: No longer recruiting
Overall study status: Ongoing
Condition category: Urological and Genital Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

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. The study has been extended to include a 10 year follow-up.

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 November 2027 (updated 08/07/2021, previously: November 2020) (updated 01/02/2021, previously: February 2021) (updated 11/01/2021, previously: 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

Contact information

Dr Mohamed Abdel-Fattah
Scientific

Aberdeen Maternity Hospital, 2nd Floor
Foresterhill
Aberdeeen
AB25 2ZD
United Kingdom

Phone	+44 1224 438424
Email	m.abdelfattah@abdn.ac.uk

Study information

Primary study design	Interventional
Study design	Multicentre randomised controlled non-inferiority trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
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
Study acronym	SIMS
Study objectives	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(s)	North of Scotland Research Ethics Service Committee 2, 12/12/2013, ref: 13/NS/0143
Health condition(s) or problem(s) studied	Adult women with stress urinary incontinence
Intervention	Current intervention as of 17/05/2022: 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. The study has been extended to include a long-term follow-up at 10 years. This will also include a qualitative component to explore: 1. Patient experiences of treatment and impact on QoL 2. Patient perceptions of decision process and decision outcomes (e.g., decisional regret and decisional conflict) 3. Patient satisfaction with treatment outcomes All women who received their allocated treatment and have not withdrawn their consent within the initial follow-up period (3 years) are eligible to participate in the qualitative component of the long-term follow-up. Purposive (nonprobability) sampling will be used to ensure the diverse characteristics of the population sampled (e.g. arm of study, study outcome including those who have experienced mesh-related AEs such as erosion, pain and or further surgery to remove mesh). The study team anticipates interviewing a minimum of 23 to 27 participants in total. Previous 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
Primary outcome measure(s)	Current primary outcome measure as of 08/07/2021: 1. Patient-reported success rate measured by the validated Patient Global Impression of Improvement (PGI-I) at 12 months and 10 years 2. Incremental cost per QALY gained at 12 months and 10 years Previous primary outcome measure: 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
Key secondary outcome measure(s)	Current secondary outcome measures as of 08/07/2021: 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, yearly up to 3 years, and 10 years 6. Impact on sexual function derived from ICIQ-FLUTsex/ or PISQ-IR measurements at 12 months, yearly up to 3 years, and 10 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) 8. Composite outcome of success using PGI-I and no requirements for further continence surgery at 10 years 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 Previous 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
Completion date	03/11/2027

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Female
Target sample size at registration	600
Total final enrolment	600
Key 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
Key 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
Date of first enrolment	04/02/2014
Date of final enrolment	30/09/2017

Locations

Countries of recruitment

United Kingdom
England
Scotland
Wales

Study participating centres

Aberdeen Royal Infirmary

Foresterhill
Aberdeeen
AB25 2ZB
United Kingdom

Borders General Hospital

Melrose
TD6 9BS
United Kingdom

Queen Margaret Hospital

Whitefield Road
Dunfermline
KY12 0SU
United Kingdom

Princess Royal Hospital

Lewes Road
Haywards Heath
RH16 4EX
United Kingdom

York Teaching Hospital

Wigginton Road
York
YO31 8HE
United Kingdom

Pinderfields Hospital

Aberford Road
Wakefield
WF1 4DG
United Kingdom

New Cross Hospital

Wolverhampton Road
Wolverhampton
WV10 0QP
United Kingdom

Torbay Hospital

Newton Road
Torquay
TQ2 7AA
United Kingdom

Milton Keynes Hospital

H8 Standing Way
Eaglestone
Milton Keynes
MK6 5LD
United Kingdom

James Cook University Hospital

Marton Road
Middlesbrough
TS4 3BW
United Kingdom

Ayrshire Maternity Unit

University Hospital Crosshouse
Kilmarnock Road
Crosshouse
Ayr
KA2 OBE
United Kingdom

Monklands Hospital

Monkscourt Avenue
Airdrie
ML6 0JS
United Kingdom

Countess of Chester Hospital

Liverpool Road
Chester
CH2 1UL
United Kingdom

University Hospital of Wales

Heath Park
Cardiff
CF14 4XW
United Kingdom

Worthing Hospital

Lyndhurst Road
Worthing
BN11 2DH
United Kingdom

Lincoln County Hospital

Greetwell Road
Lincoln
LN2 5QY
United Kingdom

Eastbourne District General Hospital

Kings Drive
Eastbourne
BN21 2UD
United Kingdom

Royal Preston Hospital

Sharoe Green Lane North
Fulwood
Preston
PR2 9HT
United Kingdom

Great Western Hospital

Marlborough Road
Swindon
SN3 6BB
United Kingdom

Arrowe Park Hospital

Arrowe Park Road
Upton
Birkenhead
Wirral
CH49 5PE
United Kingdom

Barnsley Hospital

Gawber Road
Barnsley
S75 2EP
United Kingdom

James Paget Hospital

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

Queen Elizabeth Hospital

Gayton Road
Kings Lynn
PE30 4ET
United Kingdom

Hywel Dda University Health Board

Job's Well Road
Carmarthen
SA31 3BB
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Other
IPD sharing plan	The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article		01/12/2022	16/12/2022	Yes	No
Protocol article	protocol	11/08/2017		Yes	No
HRA research summary			28/06/2023	No	No
Other publications	Secondary analysis describing Aberdeen Home Continence Stress Test (HCST)	13/04/2023	14/04/2023	Yes	No
Other publications	Patient preferences for stress urinary incontinence treatments: a discrete choice experiment	29/08/2023	30/08/2023	Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

30/08/2023: Publication reference added.
14/04/2023: Publication reference added.
16/12/2022: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.
17/05/2022: The intervention has been updated.
08/07/2021: The following changes were made to the trial record:
1. The overall end date was changed from 03/11/2020 to 03/11/2027.
2. The primary outcome measure and secondary outcome measures have been updated.
3. The plain English summary has been updated to reflect the changes above.
01/02/2021: The following changes were made to the trial record:
1. The overall end date was changed from 14/02/2021 to 03/11/2020.
2. The intention to publish date was changed from 31/01/2022 to 30/09/2021.
3. The plain English summary was updated to reflect these changes.
11/01/2021: The following changes were made to the trial record:
1. The overall end date was changed from 31/01/2021 to 14/02/2021.
2. The target number of participants was changed from 650 to 600.
3. The recruitment end date was changed from 30/11/2016 to 30/09/2017.
4. The trial participating centre Hywel Dda University Health Board was added.
5. The plain English summary was updated to reflect these changes.
16/03/2020: The following changes have been made:
1. The overall trial end date has been changed from 28/02/2020 to 31/01/2021.
2. The intention to publish date has been changed from 28/02/2021 to 31/01/2022.
14/02/2018: Publication reference added
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.