Methods | RCT. Follow‐up at 3, 6 and 12 months. Women allocated to each arm by a central telephone randomisation system. Not blinded ? operation obvious to all medical and nursing personnel. 3 hospitals | |
Participants | 165 women randomly assigned to 2 groups. Baseline demographics and symptomology were similar: age, height, weight, symptom years, previous surgery, number and type of concurrent problems between both groups Inclusion criteria: participants > 18 years and urodynamically proven SUI exclusion criteria: evidence of neurological disease; urodynamic evidence of detrusor instability and hypocompliance |
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Interventions | A (81): standard sling insertion (long) B (84): sling on a string (short) |
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Outcomes | Primary outcome was to compare QoL scores in both groups over time. Success rate was measured by recurrence of stress leakage as reported in participant questionnaire Secondary outcomes were measured by participant's QoL, clinical indicators (such as immediate post‐operative complications, time to first void, pad tests); administrative indicators, pain scores and participant satisfaction Participant satisfaction at 12 months: A: 57/73, B: 62/82 Stress leakage at 12 months: A: 14/72, B: 16/72 Stress leakage at 3 years: A: 35/75, B: 30/70 Stress leakage at 6 years: A: 42/73, B: 34/69 De novo urgency: A: 6/81,B: 2/84 Pad test volumes (mL): A: 7.71, B: 4.61; P = 0.56 Mean operative time (min): A: 62 (range 38‐135), B: 54 (25 to 140) P = 0.001, (P used to calculate SD: 15.33 in each group) Mean blood loss (mL): A: 274 (50‐800), B: 230 (50‐700) P = 0.07 Length of stay (ds): A: 6.48, B: 6.73 Voiding dysfunction 12 months: A: 19/81, B: 17/84 Readmission within 3 months: A: 19/79, B: 9/83 Surgery to release sling: A: 1/81, B: 4/84 Further continence surgery: A: 2/56, B: 5/69 Pain at 3 months: A: 52/78, B: 42/82 Adverse effects: perioperative surgical complications: A: 34/81, B: 31/84; bladder perforation A 2/81, B 3/84; UTI A 10/81, B 6/84 |
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Notes | Detailed outcome measures at 3, 6 and 12 months were provided. Both groups showed improvement in their QoL with no significant statistical difference between allocated operation. 46 participants had previously undergone one or more forms of incontinence surgery. Data updated from new publication |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated randomisation schedule |
Allocation concealment (selection bias) | Low risk | Remote telephone randomisation |
Blinding (performance bias and detection bias) All outcomes | High risk | Not blinded. Operation performed obvious to all medical and nursing personnel involved in the assessment |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Ouctome data were analysed according to the randomised group, per protocol and best possible. 21 women lost to follow‐up by 12 months, 23 lost by 3 years. The similar losses from each arm were unlikely to affect the final analysis. Actual numbers with outcome reported |