Sacral neuromodulation for refractory ulcerative colitis: safety and efficacy in a prospective observational series of eight patients

PURPOSE: Ulcerative colitis (UC) treatment is mainly based on immunosuppressive therapy. As anti-inflammatory effects of sacral neuromodulation (SNM) have been previously reported in animal models, we conducted a pilot study aimed at assessing clinical, biological, and endoscopic response but also safety of SNM use in UC refractory to medical therapy. METHODS: Adult patients with histologically proven UC resistant to immunosuppressive therapy were invited to enroll in the study. Primary outcome was the rate of UC remission (UCDAI score ≤ 2, without any criteria > 1) at 8 weeks (W8). Secondary outcomes were biological and endoscopic response also evaluated at W8 and W16. Subsequently, every patient was followed every 6 months. Adverse events were prospectively collected for safety assessment during the follow-up. RESULTS: Eight patients, with mean age 47 years old, suffering from UC for 2–13 years were included. There were no complications in relation to SNM procedure. The acceptance of the device was excellent in all patients. Clinical and endoscopic remission was obtained at W8 in one patient (12.5%) and three other patients (37.5%) were responders at W16. At review (mean follow-up of 4 years), two patients (25%) were in remission and two (25%) were responders. CONCLUSION: SNM application is safe in patients suffering from refractory UC. Effects on disease activity were mainly observed after 16 weeks. Larger prospective studies are mandatory, but SNM could be a way to reinforce medical therapy and reduce the use of immunosuppressive drugs.