An Open-Label, Noncomparative, Multicenter Study to Evaluate Efficacy and Safety of NASHADx Gel as a Bulking Agent for the Treatment of Fecal Incontinence

الملخص EN

Fecal incontinence (FI) is the involuntary loss of rectal contents through the anal canal.

Reports of its prevalence vary from 1–21%.

Studies, have demonstrated a positive effect on FI symptoms with injectable bulking agents.

This study evaluated the safety and efficacy of NASHA/Dx gel in the treatment of FI.

One hundred fifteen eligible patients suffering from FI received 4 injections of 1 mL NASHA/Dx gel.

Primary efficacy was based on data from 86 patients that completed the study.

This study demonstrated a ≥50% reduction from baseline in the number of FI episodes in 57.1% of patients at 6 months, and 64.0% at 12 months.

Significant improvements (P<.001) were also noted in total number of both solid and loose FI episodes, FI free days, CCFIS, and FIQL scores in all 4 domains.

The majority of the treatment related AEs (94.9%) were mild or moderate intensity, and (98.7%) of AEs resolved spontaneously, or following treatment, without sequelae.

Results of this study indicate NASHA/Dx gel was efficacious in the treatment of FI.

Treatment effect was significant both in reduction of number of FI episodes and disease specific quality of life at 6 months and lasted up to 12 months after treatment.