Quality of life and functional results of submucosal injection therapy using dextranomer hyaluronic acid for fecal incontinence.

The aim of this prospective study was to analyze safety and functional outcome of transanal submucosal injection of dextranomer hyaluronic acid ("bulking agents therapy") in patients with passive fecal incontinence. All patients who underwent transanal injection therapy were prospectively enrolled in this study. Inclusion criteria included fecal incontinence (internal anal sphincter dysfunction) after failed conservative treatment. The procedure was performed in a standardized technique, including submucosal injection of 4 × 1 mL dextranomer hyaluronic acid 5 mm above the dentate line. The primary endpoint focused on symptom improvement provided as the change in incontinence status and quality of life using validated scores (Wexner incontinence score, symptom-specific Fecal Incontinence Quality of Life [FIQoL] scale, and generic EQ-5D-Visual Analogue Scale [EQ-5D-VAS]). Within the observation period (July 2007 to May 2009), a total of 21 patients (17 women) with passive fecal incontinence were treated. Neither morbidity nor adverse events were documented. Three months postoperatively, 61.1% (11/18) showed significant improvement of symptoms (reduction of incontinence episodes and soiling), which was sustained after 20 months in 55.6% (10/18). Wexner incontinence score decreased from 16.8 to 12.3 (P > .05). Significant improvement was documented for FIQoL and EQ-5D-VAS (P < .05). The current results indicate that injection therapy using hyaluronic acid is an innovative and minimally invasive procedure with no morbidity. Although Wexner incontinence score is not significantly influenced, a significant improvement in quality of life was observed in more than 50% of patients.