Clinical Trial: Effectiveness and Safety of a Novel Anal Insert Device for Treatment of Faecal Incontinence.
Aliment Pharmacol TherJul 21, 2026 (epub)
Adil E Bharucha, Ramesh Lamichhane, Joel G Fletcher et al.
✦ AI-curated · Sources linked
In 30 seconds
This clinical trial evaluated the safety and effectiveness of the StaySure anal insert device in patients with medically-refractory faecal incontinence (FI). Among 59 participants, the device led to a 69% reduction in weekly FI episodes (from 5.4 to 2.1, p < 0.001), with 76.3% achieving a ≥50% reduction in FI frequency during the treatment period.
Key findings
- 69% reduction in weekly FI episodes from 5.4 to 2.1 (p < 0.001).
- 76.3% of participants achieved a ≥50% reduction in FI frequency.
- FIQoL score improved from 1.9 to 2.3 (p < 0.001).
- No treatment-related serious adverse events reported.
Why it matters
Faecal incontinence significantly impacts quality of life, and current treatment options often yield suboptimal results. The StaySure device offers a new, effective alternative for patients with moderate to severe symptoms.