| Methods | RCT randomised by closed envelope delivered to surgeon by a third party. Procedures by one surgeon. Follow‐up 6 months | |
| Participants | 53 women (mean age 45.12 years) with SUI were randomised, all had similar background characteristics (age, BMI, parity, grade of associated cystocoele) Inclusion criteria were age > 21 years, Predominant symptom of SUI, willing to give informed consent, life expectancy > 1 year, normal upper urinary tract and normal manual dexterity Exclusion: pelvic or vaginal surgery within 6 months, urge incontinence as predominant symptom, > grade 2 cystocele, associated urethral pathology e.g. diverticulum, associated bladder pathology e.g. fistula, culture proven, active urinary tract infection |
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| Interventions | A (25): autologous fascial sling B (28): TVT |
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| Outcomes | Cure, i.e. complete dryness with no usage of pad and negative cough‐stress test Not cured at 6 months: A: 2/25, B: 2/28 Operative time (mean (SD)): A: 68 (23), B: 48 (25) min Time to catheter removal (mean (SD)): A: 6.6 (5.3), B: 4.3 (2.6) d Complications: bladder perforation: A: 1/25, B: 2/28; de novo detrusor overactivity at 6 months: A: 1/23, B: 0/24; stitch sinus at 1 week: A: 0/25, B 1/28; vaginal erosion: A: 0/25, B: 0/28; wound pain at 6 months: A: 7/25, B: 2/28; voiding dysfunction: A: 7/25, B: 3/28 |
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| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Not mentioned |
| Allocation concealment (selection bias) | Low risk | Closed, opaque envelopes held by a non‐involved 3rd party who revealed the allocation after participant had been anaesthetised, just before start of surgery |
| Blinding (performance bias and detection bias) All outcomes | Unclear risk | No details provided |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | No missing data |
BMI = body mass index IIQ = Incontinence Impact Questionnaire ISD = Intrinsic sphincter dysfunction ITT = intention to treat MMK = Marshall‐Marchetti‐Krantz MUCP = maximum urethral closure pressure POP = pelvic organ prolapse QoL = quality of life RCT = randomised controlled trial SEAPI = SEAPI QMM incontinence classification system SUI = stress urinary incontinence TVT = tension‐free vaginal tape UDI = Urinary Distress Inventory UDS = urodynamics UI = urinary incontinence USI = urodynamic stress incontinence UTI = urinary tract infection UUI = urge urinary incontinence VLPP = Valsava leak point pressure