Effectiveness of Bulking Agent (Solesta) Therapy in Fecal Incontinence in Patients Refractory to Conventional Therapies.

BACKGROUND: Fecal incontinence is a problem that imposes considerable socioeconomic consequences. Despite many medical therapies, unmet needs remain. A new treatment option is a biocompatible bulking agent (Solesta) administered by submucosal injection in the distal rectum. The aims of this study are as follows: (1) To evaluate the efficacy and safety of this bulking agent in decreasing the severity of fecal incontinence (FI) and improving quality of life. (2) To obtain objective evidence of changes in anorectal physiology by high-resolution anorectal manometry pretreatment and posttreatment.

MATERIALS AND METHODS: From January 2014 to June 2015, 17 patients who had failed medical therapy for FI received stabilized hyaluronate injected submucosally into the rectum under direct anoscopic visualization. The treatment was considered successful if patients achieved >50% reduction in FI events during monitoring for up to 12 months.

RESULTS: After the first treatment session, 14 patients (82.3%) had a successful outcome. The remaining 3 patients received a second therapy 3 months later to achieve this result. At last follow-up, 7 of the 17 patients (41%) were having no FI events. The remaining patients had reduction in fecal accidents from a mean of 6.4/week baseline to 2.8/week during follow-up.

CONCLUSIONS: Intrarectal injection of stabilized hyaluronate is effective for treating FI in patients who had failed standard medical treatments and is technically easy and safely performed as an outpatient procedure.