Health Technology Assessment on Sacral Nerve Stimulation for Fecal Incontinence

Condition Description – Fecal incontinence (FI) is a condition characterized by the inability to control bowel movements, leading to involuntary leakage. The condition varies in severity and can significantly impact daily life. FI is associated with additional symptoms and conditions that lower quality of life and may increase the risk of mortality. 

Symptoms of FI vary between patients and make daily life unpredictable and challenging. FI often leads to other symptoms/conditions which decrease quality of life and even increase risk of death. Social stigma around FI discourages patients from seeking medical care, often resulting in mental health deterioration. 

Current treatment options – Surgical treatment, such as sphincteroplasty, is an option for FI in cases where conservative treatments have not been successful. Sphincteroplasty involves repairing the anal sphincter muscles to restore function. Non-surgical treatments, including dietary changes, pelvic floor therapy, and medication, are also used. The current surgical treatment requires hospital admission and longer recovery periods. 

Description of the Assessed Technology(ies) - Sacral nerve stimulation for FI (SNS-FI) is a procedure that involves implanting a device to deliver electrical impulses to the sacral nerves, which control bowel function. The technology is used in a clinical setting and aims to improve continence by modulating nerve activity. SNS-FI does not require hospital admission and typically takes less time to perform than sphincteroplasty. However, SNS-FI does not benefit all patients, and predicting which patients will benefit remains a challenge. For those who respond well, SNS-FI can improve symptoms, though some patients experience discomfort and do not continue with permanent use. 

Health Technology Assessment Committee’s Findings:

After review of the HTA, the Health Technology Assessment Committee found that sacral nerve stimulation has potential as a treatment option for fecal incontinence, though uncertainties remain regarding its efficacy compared to sphincteroplasty. Additionally, HTAC found that: 

• Symptoms of FI vary between patients and make daily life unpredictable and challenging. FI often leads to other symptoms/conditions which decrease quality of life and even increase risk of death. Social stigma around FI can deter patients from seeking treatment and leads to worse mental health. 
• The rate at which FI occurs in the population is expected to be higher than what is reported in literature. FI is more likely to affect women. 
• The current evidence suggests SNS-FI as a potential treatment option instead of a surgical treatment (sphincteroplasty) for FI with positive outcomes for patients. There is uncertainty regarding its efficacy in comparison to other treatments, due to the lack of controlled studies. 
• Predicting which patients respond to and benefit from SNS-FI is difficult to predict. More data is required to better inform patient selection. 
• Among patients that respond positively to SNS-FI, most are satisfied with SNS-FI, but some find it very uncomfortable and do not proceed with permanent use. 
• SNS-FI is expected to cost more for the healthcare system than surgery but may improve the financial situation for many patients as it may reduce use of incontinence supplies and improve a patient’s independence including their ability to work. 
• SNS-FI requires extra training for surgeons and nurses but requires less time to perform than a surgical treatment (sphincteroplasty) and doesn’t typically require being admitted to the hospital. However, SNS-FI requires more follow-up appointments than sphincteroplasty, so it may increase the workload for nurses and specialists. 

SNS-FI is expected to be more costly for the healthcare system compared to sphincteroplasty. However, for patients who respond well to the treatment, SNS-FI may reduce financial strain by lowering the need for incontinence supplies and improving their ability to work. It will be at the discretion of each health authority to assess the value of potential benefits in comparison to the additional implementation cost of sacral nerve stimulation for fecal incontinence.