Evaluating Safety and Effectiveness of Autologous Fat Injection into the Intersphincter Space for Severe Fecal Incontinence A Randomized, Double-blind, Placebo-controlled Cross-over Study

What this Trial Is About

Fecal incontinence is a common condition that greatly affects quality of life. Current treatments focus on managing bowel movements and rehabilitation, with sacral root neuromodulation used if needed, but over one-third of patients do not find sufficient relief. Researchers are exploring whether injecting a patients own fat into the space between the anal sphincters can reduce incontinence episodes and improve anal muscle function and quality of life. This study is a randomized, placebo-controlled, double-blind trial designed to evaluate this approach in adults with severe fecal incontinence due to sphincter failure. Participants receive injections into the intersphincter space either of autologous fat or saline in a crossover design. One group will get the fat injection at the start and saline after six months, while the other group will receive saline first and fat injections at six months. This allows comparing the effects of fat injections versus placebo over time in the same individuals. Throughout the study, patients will be monitored for changes in the number of fecal incontinence episodes over three months as the primary outcome. Additional assessments include anal resting pressures, patient tolerance of the procedure, and quality of life measures. Follow-up visits and symptom evaluations will help researchers determine the treatments impact and safety. The total study duration spans at least six months per participant with careful monitoring by the research team.

Evaluation of the Efficacy and Safety of Autologous Fat Injection Into the Intersphincter Space in Fecal Incontinence: a Randomized, Placebo-controlled, Cross-over, Double-blind Trial