Sacral neuromodulation with the InterStim™ system for faecal incontinence: results from a prospective French multicentre observational study

Abstract

Aim:The aim of this work was to evaluate the effectiveness, patient satisfaction and quality of life (QoL) and the safety of sacral neuromodulation (SNM) with the InterStim TM system for the treatment of faecal incontinence (FI) and establish whether results published predominantly by expert sites are generalisable.Method: This is a prospective, multicentre, observational study that invited all French sites treating FI with the InterStim™ system to enrol subjects indicated for an SNM therapy evaluation. Data were collected at three follow-up visits within 1 and 15 months. Therapeutic effectiveness was evaluated by the reduction in leakages per week and improvements over time in the ability to defer defaecation and QoL (as measured with the Faecal Incontinence Quality of Life score). Safety was assessed through reported adverse events.Results: A total of 221 subjects with a mean age of 62.1 years were tested (184 women) and 178 received a permanent implant. For all implanted subjects with diary data at baseline and follow-up, a reduction in leakage of more than 50% was observed in 80%, 76% and 83% at 1-3, 4-8 and 9-15 months, respectively. The mean number of leakage episodes and urgency improved significantly compared with the baseline (p < 0.0001).Subjects showed improvements in QoL and time to defer defaecation and were generally satisfied with their therapy. The main device-related adverse event was the requirement to undertake reprogramming (in 52% of subjects with actions following an event). The rates of infection (in 6% of subjects) and surgical revision (in 10% of subjects) were in agreement with literature reports. Conclusion:This study confirms the clinical effectiveness, safety and positive effect of SNM on QoL as well as high patient satisfaction for the treatment of FI in real-life.

The American Society of Colon and Rectal Surgeons’ Clinical Practice Guidelines for the Management of Fecal Incontinence

“…148 Sacral Neuromodulation May Be Considered as a First-Line Surgical Option for Incontinent Patients With or Without Sphincter Defects SNM was approved by the FDA in 2011 for fecal and urinary incontinence. [149][150][151][152][153][154] With this approach, patients undergo a 2-week evaluation after placing a test lead in the operating room or a 1-week evaluation with percutaneous leads placed in the office setting; patients with at least a 50% improvement in FI episodes during their evaluation period are offered full system implantation. 155 In a pooled analysis of 61 SNM studies, a median of 79% of patients experienced 50% or more improvement in weekly FI episodes in the short term (ie, 0-12 mo), and a median of 84% of patients experienced 50% or more improvement at >36 months follow-up.…”

Avaliação da qualidade de vida em pacientes submetidos a neuromodulação sacral para incontinência fecal

“…Mellgren e colaboradores obtiveram 90% de sucesso após aplicação do dispositivo em pacientes com falha nas outras modalidades terapêuticas e após três anos da implantação definitiva 86% dos pacientes continuaram com redução importante da IF 26 . Meurette e colaboradores em estudo multicêntrico recente com 221 pacientes com IF relataram que 80% dos implantados com NMS obtiveram pelo menos 50% de melhora prolongada da incontinência 27 . Apesar do mecanismo de ação não ser completamente conhecido, o NMS pode promover a estimulação de reflexos viscerais e da musculatura esfincteriana, modulação nervosa e alterações na motilidade colônica, alteração na sensibilidade retal e na coordenação entre o reto e os esfíncteres, através de um bloqueio de fibras C-aferentes promovendo uma modulação na inibição do arco reflexo sacral, resultando em contratilidade retal, com impacto positivo em pacientes com IF 5 .…”