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 |
| Secondary identifying numbers | 3/069/13 |
- 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
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. 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
Scientific
Aberdeen Maternity Hospital, 2nd Floor
Foresterhill
Aberdeeen
AB25 2ZD
United Kingdom
| Phone | +44 1224 438424 |
|---|---|
| m.abdelfattah@abdn.ac.uk |
Study information
| Study design | Multicentre randomised controlled non-inferiority trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 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(s) | North of Scotland Research Ethics Service Committee 2, 12/12/2013, ref: 13/NS/0143 |
| Condition | 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 | 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 |
| Secondary outcome measures | 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 |
| Overall study start date | 01/12/2013 |
| Overall study end date | 03/11/2027 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target number of participants | 600 |
| Total final enrolment | 600 |
| 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 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 | 30/09/2017 |
Locations
Countries of recruitment
- England
- Scotland
- United Kingdom
- Wales
Study participating centres
Aberdeeen
AB25 2ZB
United Kingdom
TD6 9BS
United Kingdom
Dunfermline
KY12 0SU
United Kingdom
Haywards Heath
RH16 4EX
United Kingdom
York
YO31 8HE
United Kingdom
Wakefield
WF1 4DG
United Kingdom
Wolverhampton
WV10 0QP
United Kingdom
Torquay
TQ2 7AA
United Kingdom
Eaglestone
Milton Keynes
MK6 5LD
United Kingdom
Middlesbrough
TS4 3BW
United Kingdom
Kilmarnock Road
Crosshouse
Ayr
KA2 OBE
United Kingdom
Airdrie
ML6 0JS
United Kingdom
Chester
CH2 1UL
United Kingdom
Cardiff
CF14 4XW
United Kingdom
Worthing
BN11 2DH
United Kingdom
Lincoln
LN2 5QY
United Kingdom
Eastbourne
BN21 2UD
United Kingdom
Fulwood
Preston
PR2 9HT
United Kingdom
Swindon
SN3 6BB
United Kingdom
Upton
Birkenhead
Wirral
CH49 5PE
United Kingdom
Barnsley
S75 2EP
United Kingdom
Gorleston-on-Sea
Great Yarmouth
NR31 6LA
United Kingdom
Kings Lynn
PE30 4ET
United Kingdom
Carmarthen
SA31 3BB
United Kingdom
Sponsor information
University/education
University of Aberdeen/NHS Grampian
Research and Development Office
Foresterhill House Annexe
Foresterhill
Aberdeen
AB25 2ZB
Scotland
United Kingdom
"ROR" |
https://ror.org/016476m91 |
|---|
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | 30/09/2021 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Other |
| 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. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 11/08/2017 | Yes | No | |
| Results article | 01/12/2022 | 16/12/2022 | Yes | No | |
| Other publications | Secondary analysis describing Aberdeen Home Continence Stress Test (HCST) | 13/04/2023 | 14/04/2023 | Yes | No |
| HRA research summary | 28/06/2023 | No | No | ||
| Other publications | Patient preferences for stress urinary incontinence treatments: a discrete choice experiment | 29/08/2023 | 30/08/2023 | Yes | No |
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.
