Cost‐effectiveness of urethral bulking polydimethylsiloxane‐Urolastic® compared with mid‐urethral sling surgery for stress urinary incontinence: A two‐arm cohort study

Objective To investigate the cost‐effectiveness of urethral bulking polydimethylsiloxane‐Urolastic® (PDMS‐U) compared with mid‐urethral sling (MUS) surgery for stress urinary incontinence (SUI) at 1‐year follow‐up. Design Prospective, two‐arm cohort study with 2‐year follow‐up. Setting International multicentre. Population Women with moderate to severe SUI. Main outcome measures Primary outcome was subjective cure (Patient Global Impression of Improvement). Secondary outcomes: objective cure (negative cough stress test), Urogenital Distress Inventory (UDI‐6), complications and re‐interventions. Cost‐effectiveness outcomes: total costs, quality‐adjusted life year (QALY) using IIQ7‐scores (Incontinence Impact Questionnaire) and EQ‐5D‐5L, incremental cost‐effectiveness ratio (ICER) and monetary benefit (adjusted for baseline confounders). Results In all, 131 PDMS‐U and 153 MUS surgery patients were treated. Subjective cure rates for MUS surgery and PDMS‐U were, respectively: 101/112 (90%) versus 40/87 (46%), adjusted odds ratio (aOR; for age, body mass index [BMI], severity, type of urinary incontinence and previous SUI procedure) was 4.9. Objective cure rates for MUS surgery and PDMS‐U were respectively: 98/109 (90%) versus 58/92 (63%), aOR 5.4. Average total costs for PDMS‐U and MUS surgery were €3567 and €6688. ICER for MUS surgery cost €15 598 per IIQ QALY and €37 408 per EQ‐5D‐5L QALY. With a willingness to pay (WTP) of €25 000, MUS has a 84% chance of being cost‐effective using IIQ, whereas PDMS‐U has a 99% chance of being cost‐effective using EQ‐5D‐5L. Conclusion MUS surgery is more cost‐effective in realising improved disease‐specific quality of life (QoL), while PDMS‐U is more cost‐effective in realising improved generic QoL.