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

Abstract

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.

Vagus Nerve Stimulation and Sacral Nerve Stimulation for Inflammatory Bowel Disease: A Systematic Review

“…In the iSNS study, registered as NCT02748590 , 48 bipolar electrical stimulation was administered through a 4-electrode SNS lead (Model 3889, Medtronic) implanted within the S3 foramen. The lead was then tunneled to connect with an IPG, specifically the InterStim II (Model 3058, Medtronic), placed in a subcutaneous pocket on the left chest wall.…”

“…During the iSNS intervention, the following stimulation parameters were employed: a frequency of 14 Hz, a current amplitude of 1.1 V, a pulse width of 210 μs, a duty cycle of 100%, and continuous stimulation for a duration of 4 months. 48 …”

“…During the iSNS intervention, the following stimulation parameters were employed: a frequency of 14 Hz, a current amplitude of 1.1 V, a pulse width of 210 µs, a duty cycle of 100%, and continuous stimulation for a duration of 4 months. 48 In the pSNS study, 49 bipolar electrical stimulation was delivered via four stainless steel acupuncture needles (diameter 0.45 mm, length 100-125 mm) inserted bilaterally inside the S3 and S4 foramens and attached to an external stimulator (Transcutaneous Electrical Applicator, Model SNM-FDC01, MedKinetic Medical Device Co. Ltd, Ningbo, China), while the sham electrical stimulation was delivered using the same needles placed 20 mm downward and 8-10 cm lateral from these sacral foramina. The study was performed in Nanjing, China, where 26 adult patients with mild and moderate UC (3 ≤ Mayo score ≤ 10) diagnosed for at least 3 months prior to enrollment were subjected to pSNS with the following parameters: frequency of 5 Hz, current amplitude of 2-10 mA, pulse width of 500 µs, duty cycle of 10% (10 sec every 100 sec), delivered for 1 hour per day for 2 weeks.…”

Neuromodulation and the Gut-Brain Axis: Therapeutic Mechanisms and Implications for Gastrointestinal and Neurological Disorders

“…The targeted stimulation diminishes pain signals and elevates the pain threshold, providing substantial relief to patients burdened by persistent discomfort and abdominal pain. Furthermore, the profound impact of inflammatory processes in the pathology of several GI disorders, including Crohn's disease and ulcerative colitis, cannot be overstated [166,167]. The most widely used animal models of colitis involve the application of inflammatory agents such as dextran sodium sulfate (DSS) or 2,4,6-trinitrobenzene sulfonate (TNBS) through the luminal membrane.…”