Comparative Effectiveness of Biofeedback and Injectable Bulking Agents for Treatment of Fecal Incontinence: The Fecal Incontinence Treatment (FIT) Study

Detailed Summary

Patients with severe fecal incontinence (FI), defined as two or more episodes of staining, solid or liquid FI per week, and who meet the inclusion criteria for Injection of Solesta (INJ; an inert bulking agent), or Biofeedback (BIO) will be enrolled. The baseline rate of FI will be assessed using a 2-week daily stool diary. All participants will initially be enrolled into a 4-week trial of Enhanced Medical Management (EMM; education, pelvic floor exercises, and use of non-prescription drugs to normalize stool consistency). Those who demonstrate at least a 75% reduction in FI frequency will not be randomized to one of the two treatment groups but will be followed-up for two years. Those not showing a 75% reduction in FI frequency will be randomized to BIO or INJ and will be evaluated three months later with respect to efficacy for reducing the frequency of fecal incontinence, safety of the interventions, and cost of providing care. All participants who experience a 75% decrease in FI after three months of treatment, compared to baseline, will be followed-up for a further 21 months, for a total of 24 months from the time of treatment initiation. To assess the long-term response to treatment, those who improve less than 75% in FI episodes will be offered an additional treatment with either the treatment to which they were not randomized or sacral nerve stimulation (SNS). Anorectal manometry and Magnetic Evoked Potentials will be used to subtype the physiological basis for FI. Quality of life and psychological factors will be used to assess outcomes.

Study Details

Timeline

Interventions