Adult women with stress urinary incontinence Urological and Genital Diseases Stress incontinence
Conditions
Interventions
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 mi
Sponsors
University of Aberdeen (UK)
Eligibility
Sex/Gender
Female
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
England, Scotland, United Kingdom, Wales
Outcome results
None listed