Sacral nerve stimulation for treatment of fecal incontinence: a novel approach for intractable fecal incontinence

PURPOSE: Many patients with fecal incontinence demonstrate a functional deficit of the internal anal sphincter or the external sphincter muscles without any apparent structural defects. Few patients are amenable to repair or substitution of the sphincter. However, sacral nerve stimulation appears to offer a valid treatment option for fecal incontinence. The objectives of this study were: to evaluate the efficacy of temporary stimulation of the sacral nerve roots (percutaneous nerve evaluation) in patients with functional fecal incontinence; to determine the mechanisms of possible improvement; and to evaluate if temporary stimulation could be reproduced and maintained by implanting a permanent neurostimulation system. METHODS: Twenty-three patients with fecal incontinence, 18 females and 5 males, median age of 54.9 years (range 28-71), underwent a percutaneous nerve evaluation test. Eleven patients (47.8 percent) also had urinary disorders: urge incontinence (4), stress incontinence (3), and retention (4). Associated disorders included perineal and rectal pain (1), spastic paraparesis (1), and syringomyelia (1). All patients underwent a preliminary evaluation using stationary anal manovolumetry, pudendal nerve terminal motor latency measurements, and anal ultrasound. A percutaneous electrode for the stimulation of the sacral nerve roots was positioned at the level of the third sacral foramen (S3) in 20 patients and S2 in 2 patients (1 patient missing). Stimulation parameters used were: pulse width 210 microsec, frequency 25 Hz, and average amplitude of 2.8 V (range 1-6). The electrode was left in place for a minimum of 7 days. Five patients were successively implanted with a permanent sacral electrode with a stimulation frequency of 16 to 18 Hz and amplitude of 1.1- 4.9 V. RESULTS: Seventeen of the 19 patients (89.4 percent) who completed the minimum percutaneous nerve evaluation period of 7 days (median 10.7 (range 7-30)), had a reduction of liquid or solid stool incontinence by more than 50 percent, and fourteen (73.6 percent) were completely continent for stool. The most important changes revealed by manovolumetry were an increase in resting pressure (P < 0.001) and voluntary contraction (P = 0.041), reduction of initial pressure for first sensation (P = 0.049) and urge to defecate (P = 0.002), and a reduction of the rectal volume for urge sensation (P = 0.006). The percutaneous nerve evaluation results were reproduced at a median follow-up of 19.2 months (range 5 to 37) in the 5 patients who received a permanent implant. CONCLUSIONS: Temporary stimulation of the sacral roots (percutaneous nerve evaluation) can be of help in those patients with fecal incontinence, and the results are reproduced with permanent implantation. The positive effect on continence seems to be derived from not only the direct efferent stimulation on the pelvic floor and the striated sphincter muscle, but also from modulating afferent stimulation of the autonomous neural system, inhibition of the rectal detrusor, activation of the internal anal sphincter, and modulation of sacral reflexes that regulate rectal sensitivity and motility.     

Sacral nerve stimulation as a therapy for fecal incontinence

Sacral nerve stimulation (SNS) has developed into the standard procedure in the management of fecal incontinence in the past 20 years. The clinical benefit is reproducible and the patients achieve permanent satisfaction. The method has received high acceptance and continues to spread. This article highlights SNS use in practice in Germany in terms of the recommendations in the literature and guidelines from the manufacturer.We began with a written survey of all German centers active in the therapy for fecal incontinence (152), with 143 being contacted at least twice (143/152; 94,1?%), including 82 items regarding indication, inclusion criteria, contraindication, combined indication, indication for permanent implantation, preoperative diagnostic procedures, nonoperative therapy, operative technique and follow-up of the SNS system and continence. A complete survey was sent back by 70 colorectal surgeons (48.9?%). In terms of classical indications or contraindications for SNS, clear results of 60–97?% were found.Nonuniform replies were found in the secondary indications for SNS, such as anal pain, bloating or irritable bowel syndrome. Interestingly, 37?% of the colorectal surgeons would test patients with a complete spinal injury, although SNS requires residual function of the distal spinal nerves. Nonuniform replies were collected in terms of rare conditions such as anal atresia, cauda equina syndrome and spina bifida. The need of repeated MRI investigations (MRI of the head was not included) was considered to be a contraindication by 55?% of the respondents only, despite the fact that body MRI is contraindicated by the manufacturer. Rather uniform were all items of diagnostic procedures and timing of the operations (70–80?% consensus). Additional uniformity was found in terms of the operative strategy and the steps of follow-up.This German national survey found a strong consensus in the use of sacral nerve stimulation for the management of fecal incontinence.     

Sacral nerve stimulation as a treatment for fecal incontinence

BACKGROUND & AIMS: Sacral nerve stimulation is a proven therapeutic option for the treatment of some forms of urinary incontinence. Very recently, preliminary reports have given evidence for its efficacy in fecal incontinence (FI) too. METHODS: Since November 1998, 20 patients have been treated for severe FI. The cause of FI was mainly neurologic (n = 15), and was idiopathic in 5 patients. After temporary (subchronic) external stimulation over a period of 10-14 days, patients whose continence status improved underwent implantation of a permanent quadripolar lead and a subcutaneously implanted pulse generator. RESULTS: Acute (needle) testing revealed a positive pelvic floor response in 16 patients who underwent subsequent permanent implantation. The median number of incontinence episodes decreased from 6 episodes (3-15/21 days) to 2 (0-5/21 days). The time period of retention of a volume of saline causing an urge until definitive defecation was 2 minutes (range, 0-5 minutes) preoperatively and increased to 7.5 minutes (2-15 minutes) postoperatively. Results of preoperative and postoperative (3 months) anal manometry showed a statistically significant increase in maximal resting and squeeze pressures. CONCLUSIONS: Sacral nerve stimulation seems to be a new and promising modality for patients with certain types of FI in whom conventional treatment options have failed to achieve an improvement.     

Sacral nerve stimulation for treatment of fecal incontinence

PURPOSE: Many patients with fecal incontinence demonstrate a functional deficit of the internal anal sphincter or the external sphincter muscles without any apparent structural defects. Few patients are amenable to repair or substitution of the sphincter. However, sacral nerve stimulation appears to offer a valid treatment option for fecal incontinence. The objectives of this study were: to evaluate the efficacy of temporary stimulation of the sacral nerve roots (percutaneous nerve evaluation) in patients with functional fecal incontinence; to determine the mechanisms of possible improvement; and to evaluate if temporary stimulation could be reproduced and maintained by implanting a permanent neurostimulation system. METHODS: Twenty-three patients with fecal incontinence, 18 females and 5 males, median age of 54.9 years (range 28–71), underwent a percutaneous nerve evaluation test. Eleven patients (47.8 percent) also had urinary disorders: urge incontinence (4), stress incontinence (3), and retention (4). Associated disorders included perineal and rectal pain (1), spastic paraparesis (1), and syringomyelia (1). All patients underwent a preliminary evaluation using stationary anal manovolumetry, pudendal nerve terminal motor latency measurements, and anal ultrasound. A percutaneous electrode for the stimulation of the sacral nerve roots was positioned at the level of the third sacral foramen (S3) in 20 patients and S2 in 2 patients (1 patient missing). Stimulation parameters used were: pulse width 210µsec, frequency 25 Hz, and average amplitude of 2.8 V (range 1–6). The electrode was left in place for a minimum of 7 days. Five patients were successively implanted with a permanent sacral electrode with a stimulation frequency of 16 to 18 Hz and amplitude of 1.1–4.9 V. RESULTS: Seventeen of the 19 patients (89.4 percent) who completed the minimum percutaneous nerve evaluation period of 7 days (median 10.7 (range 7–30)), had a reduction of liquid or solid stool incontinence by more than 50 percent, and fourteen (73.6 percent) were completely continent for stool. The most important changes revealed by manovolumetry were an increase in resting pressure (P<0.001) and voluntary contraction (P=0.041), reduction of initial pressure for first sensation (P=0.049) and urge to defecate (P=0.002), and a reduction of the rectal volume for urge sensation (P=0.006). The percutaneous nerve evaluation results were reproduced at a median follow-up of 19.2 months (range 5 to 37) in the 5 patients who received a permanent implant. CONCLUSIONS: Temporary stimulation of the sacral roots (percutaneous nerve evaluation) can be of help in those patients with fecal incontinence, and the results are reproduced with permanent implantation. The positive effect on continence seems to be derived from not only the direct efferent stimulation on the pelvic floor and the striated sphincter muscle, but also from modulating afferent stimulation of the autonomous neural system, inhibition of the rectal detrusor, activation of the internal anal sphincter, and modulation of sacral reflexes that regulate rectal sensitivity and motility.     

Medium-term outcome of percutaneous tibial nerve stimulation in the treatment of fecal incontinence

Introduction

Fecal incontinence (FI) is a multifactorial disease that affects patients’ quality of life. The aim of this study was to evaluate the efficacy of posterior tibial nerve stimulation (PTNS) in the treatment of FI and to assess the medium-term results.

Methods

A prospective cohort of patients with FI treated with PTNS between 2012 and 2014 was analysed. Endoluminal ultrasound and anorectal physiologic studies were performed in all patients. The efficacy of PTNS was assessed using a validated questionnaire (Cleveland Clinic Incontinence Score) at baseline, after treatment, and 2 years later. The Vaizey score was also used at 2-year follow-up to assess urge incontinence.

Results

Fifty-six patients (38 females; mean age 59.7 years) with FI were treated. The causes of FI were mainly obstetric injury and previous colorectal surgery. A decrease of 50% from baseline CCIS was seen in 41.1% of patients after PTNS. One-third maintained a minimum of 50% decrease of their initial CCIS after 2 years. Comparing CCIS at baseline, after treatment, and at 2-year follow-up, a statistically significant difference was observed (p?<?0.0001 and p?<?0.0004 respectively). Medium-term improvement was not maintained in patients with passive and mixed FI, while it was maintained in those with urge incontinence. At 2 years, patients with mild incontinence maintained the greatest response.

Conclusions

PTNS is a safe, effective, non-invasive treatment for FI with good results in almost half of the patients at the end of the treatment. There is also an acceptable maintained response at 2-year follow-up. It seems to be most successful in patients with mild incontinence and urge incontinence.

     

Sacral nerve stimulation (SNS), posterior tibial nerve stimulation (PTNS) or acupuncture for the treatment for fecal incontinence: a clinical commentary

Sacral nerve stimulation (SNS) has become an established therapy worldwide for the treatment for fecal incontinence. A large number of papers have been published over the years, and SNS is generally considered very effective with improved continence and quality of life for most patients. However, the results are mostly expressed in the semi-quantitative terms, that is, patients’ diaries translated into score points. The clinical value of SNS is questionable, especially as the patient groups are usually small and/or etiologically heterogenic and the follow-up period mostly short. The Health Technology Assessment organization in the west region of Sweden has recently evaluated the SNS with regard to evidence, efficacy and risks. Economic and ethical aspects raise serious questions on this expensive and not entirely risk-free treatment in routine medical care. Similar criticism has also been raised by other reviewers proposing a more thorough scientific assessment with well-designed randomized trials and comparison with other similar methods of treatment.     

Sacral nerve stimulation versus percutaneous posterior tibial nerve stimulation in the treatment of severe fecal incontinence in men

Background

Sacral nerve stimulation and percutaneous posterior tibial nerve stimulation have been described previously as effective treatments for fecal incontinence. Nevertheless, there does not exist any study that compares the efficiency of both. The aim of this study was to compare the use of SNS and PPTNS in males with FI.

Methods

We conducted a prospective cohort study on men with FI treated with SNS or PTNS in the Coloproctology Unit of the University General Hospital of Elche and Reina Sofia of Murcia between January 2010 and December 2011. Preoperative assessment included physical examination, anorectal manometry, and anal endosonography. Anal continence was evaluated using the Wexner continence grading system. Quality of life was evaluated using the Fecal Incontinence Quality of life Scale.

Results

Nineteen patients were included (ten patients SNS and nine PPTNS). SNS improved FI in nine of the ten patients. The mean Wexner score decreased significantly from a median of 14 (12–16) (preoperative) to 4 (1–8) (6-month revision) (p = 0.007). PTNS improved FI in seven of the nine patients. The mean Wexner score decreased significantly from a median of 12 (11–19) (preoperative) to 5 (4–7) (6-month revision) (p = 0.018). Both treatments produced symptomatic improvement without statistical differences between them.

Conclusions

Our study was nonrandomized with a relatively small number of patients. PPTNS had similar efficiency to the SNS in our men population. However, more studies are necessary to exclude selection bias and analyze long-term results.

     

Posterior tibial nerve stimulation and faecal incontinence: a review

Purpose  

Faecal incontinence is a common and important multifactorial disorder with a range of treatment options. Over the last two decades, neuromodulation via sacral nerve stimulators has been shown to be effective for both faecal and urinary incontinence, although associated with complications. Peripheral neuromodulation, via the posterior tibial nerve, is widely used in urinary incontinence; however, its use in faecal incontinence, whilst evolving is limited to eight small heterogeneous studies.     

Sacral nerve stimulation versus percutaneous tibial nerve stimulation for faecal incontinence: a systematic review and meta-analysis

Aims

Percutaneous tibial nerve stimulation (PTNS) and sacral nerve stimulation (SNS) are both second-line treatments for faecal incontinence (FI). To compare the clinical outcomes and effectiveness of SNS versus PTNS for treating FI in adults.

Method

A literature search of MEDLINE, Embase, Science Citation Index Expanded and Cochrane was performed in order to identify studies comparing SNS and PTNS for treating FI. A risk of bias assessment was performed using The Cochrane Collaboration’s risk of bias tool. A random effects model was used for the meta-analysis.

Results

Four studies (one randomised controlled trial and three nonrandomised prospective studies) reported on 302 patients: 109 underwent SNS and 193 underwent PTNS. All included studies noted an improvement in symptoms after treatment, without any significant difference in efficacy between SNS and PTNS. Meta-analysis demonstrated that the Wexner score improved significantly with SNS compared to PTNS (weighted mean difference 2.27; 95% confidence interval 3.42, 1.12; P?<?0.01). Moreover, SNS was also associated with a significant reduction in FI episodes per week and a greater improvement in the Fecal Incontinence Quality of Life coping and depression domains, compared to PTNS on short-term follow-up. Only two studies reported on adverse events, reporting no serious adverse events with neither SNS nor PTNS.

Conclusion

Current evidence suggests that SNS results in significantly improved functional outcomes and quality of life compared to PTNS. No serious adverse events were identified with either treatment. Further, high-quality, multi-centre randomised controlled trials with standardised outcome measures and long-term follow-up are required in this field.

     

Double-blind crossover study of sacral nerve stimulation for fecal incontinence

PURPOSE: Patients with fecal incontinence not amenable to simple repair may have to undergo major reconstructive surgery or resort to a stoma. Sacral nerve stimulation is an alternative approach that may diminish incontinence by altering sphincter and rectal motor function. This study is the first double-blind trial examining the effectiveness of this therapy. METHODS: Two patients with passive fecal incontinence who had been implanted for nine months with a permanent sacral nerve stimulator and electrode were studied using fecal incontinence diaries, anorectal physiological tests, and quality-of-life assessments (SF-36 health survey). The trial period consisted of two two-week periods, with the stimulator turned on for two weeks and off for two weeks. The main investigator and the patients were blinded to the status of the stimulator. RESULTS: There was a dramatic difference between the number and severity of episodes of incontinence when the stimulator was turned onvs. turned off (Patient 1, 20vs. 2 episodes; Patient 2, 4vs. 0 episodes; offvs. on). There was an increase in squeeze pressure (Patient 1, 70vs. 100 cm H₂O; Patient 2, 60vs. 90 cm H₂O; offvs. on), with moderate increases in resting pressure and rectal threshold and urge volumes. Quality-of-life measurements showed a marked improvement prestimulationvs. nine months after permanent stimulation. CONCLUSIONS: There is a marked, unequivocal improvement in symptoms of fecal incontinence with sacral nerve stimulation shown in this double-blind crossover trial. Sacral nerve stimulation improves the quality of life in selected patients with fecal incontinence.A grant and all the equipment used in this study were supplied by Medtronic INTERSTIM, Maastricht, the Netherlands.     

Chronic posterior tibial nerve transcutaneous electrical nerve stimulation (TENS) to treat fecal incontinence (FI)

Aim  

Transcutaneous electrical nerve stimulation (TENS) is a possible alternative to sacral nerve stimulation because the neurophysiologic targets might be similar but the former method is non-invasive and cheaper. The aim of the study was to assess both symptom and quality of life (QoL) improvements in patients suffering from severe FI.     

First experiences with pudendal nerve stimulation in fecal incontinence: a technical report

Sacral nerve stimulation (SNS) is an established treatment for refractory lower urinary tract and bowel dysfunction. In some urological patients, SNS does not have satisfactory results. Pudendal nerve stimulation (PNS) has recently been proposed for these patients and successfully tested. Given the sometimes unsatisfactory results after SNS in fecal incontinence (FI), we tested PNS on patients suffering from FI. We used the device and implantation technique described by Spinelli et al. By making a slight change in the device, we developed a quick and easy-to-use method for successful PNS implantation, based on electrophysiological response. We present the results of a feasibility study, in which we tested the effectiveness of PNS with our modified implantation technique on 2 patients, with very satisfactory early results in a 4-month follow-up.