Cost-effectiveness of urethral bulking polydimethylsiloxane-Urolastic (R) compared with mid-urethral sling surgery for stress urinary incontinence: A two-arm cohort study

Objective: To investigate the costeffectiveness of urethral bulking polydimethylsiloxaneUrolastic (R) (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 costeffectiveness 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 euro 3567 and euro 6688. ICER for MUS surgery cost euro 15 598 per IIQ QALY and euro 37 408 per EQ- 5D- 5L QALY. With a willingness to pay (WTP) of euro 25 000, MUS has a 84% chance of being costeffective using IIQ, whereas PDMS- U has a 99% chance of being costeffective using EQ-5D-5L.Conclusion: MUS surgery is more costeffective in realising improved disease specific quality of life (QoL), while PDMS- U is more costeffective in realising improved generic QoL.