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.     

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 sacral spinal nerve stimulation for fecal incontinence: Long-term results with foramen and cuff electrodes

PURPOSE: Sacral spinal nerve stimulation is a new therapeutic approach for patients with severe fecal incontinence owing to functional deficits of the external anal sphincter. It aims to use the morphologically intact anatomy to recruit residual function. This study evaluates the long-term results of the first patients treated with this novel approach applying two techniques of sacral spinal nerve stimulator implantation. METHODS: Six patients underwent either of two techniques for electrode placement: one closed (electrodes placed through the sacral foramen) and one open (cuff electrodes placed after sacral laminectomy). Follow-up evaluation of their continence status ranged from 5 to 66 months. RESULTS: Incontinence improved in all patients. The percentage of incontinent bowel movements decreased during chronic stimulation from a mean of 40.2 percent to 2.8 percent, and the Wexner score decreased from a mean of 17 to 2. The function of the striated anal sphincter improved during chronic stimulation: maximum squeeze pressure increased from a mean of 48.5 mmHg to 92.7 mmHg, and median squeeze pressure increased from a mean of 37.3 mmHg to 72.5 mmHg. No complications were encountered perioperatively or postoperatively. Two devices had to be removed because of intractable pain, in one patient at the site of the electrode after five months and in the other at the site of the impulse generator after 45 months. CONCLUSION: Long-term sacral spinal nerve stimulation persistently improves continence and increases striated anal sphincter function in patients with fecal incontinence owing to functional deficits, but in whom the striated anal sphincter is morphologically intact. Two different operative approaches can be applied effectively.Supported by grants from Bayerischen Chirurgen e.V., Munich, Germany; Wilhelm Sander Stiftung, Neustadt, Germany; and Bakken Research Center, Medtronic, Maastricht, the Netherlands.A preliminary report of this study was presented as a poster at the meeting of The American Society of Colon and Rectal Surgeons, San Antonio, Texas, May 2 to 7, 1998.     

Sphincteroplasty for fecal incontinence in the era of sacral nerve modulation

The role of sphincteroplasty in the treatment of patients with fecal incontinence due to anal sphincter defects has been questioned because the success rate declines in the long-term.A new emerging treatment for fecal incontinence,sacral nerve stimulation,has been shown to be effective in these patients.However,the success rate of sphincteroplasty may depend of several patient-related and surgical-related factors and the outcome from sphincteroplasty has been evaluated differently(with qualitative data) fro...     

Effect of sacral nerve stimulation in patients with fecal and urinary incontinence

PURPOSE: Preliminary studies have shown improvement in fecal incontinence in several patients who received temporary or permanent stimulation. The purpose of this study was to report our experience in sacral nerve stimulation in the treatment of fecal incontinence and to target patients who would benefit most from stimulation. METHODS: Patients with fecal incontinence were studied clinically and manometrically before, during, and after temporary nerve stimulation. If temporary nerve stimulation was clinically successful, the patient was implanted and followed up for six months. RESULTS: Nine patients (6 female) with a mean age of 50.7 ± 12.3 years underwent temporary nerve stimulation. Temporary nerve stimulation was successful in eight patients, six of whom were implanted. Of the patients who could be evaluated, three of five had improved at the six-month follow-up visit, particularly in relation to the number of urgency episodes and delay in postponing defecation. All implanted patients had urinary symptoms. Urinary urgency was also improved by stimulation. During temporary nerve stimulation, the maximal squeeze pressure amplitude increased. After implantation, only the duration of maximal squeeze pressure seemed to improve. CONCLUSION: Sacral nerve stimulation can be used in the management of fecal incontinence, particularly in cases of urge fecal incontinence associated with urinary urgency. This study seems to confirm the effect of sacral nerve stimulation on striated sphincter function.Presented in part at the 7th United European Gastroenterology Week, Rome, Italy, November 13 to 17, 1999; the Brain-Gut 2000 Symposium, Toulouse, France, July 2 to 5, 2000; and the Second International Conference on the Pelvic Floor, Oxford, England, September 9 to 12, 2000.     

Sacral nerve neuromodulation improves physical,psychological and social quality of life in patients with fecal incontinence

There are several therapeutic options for fecal incontinence but often they do not achieve good results in the long run. This study dealt with sacral nerve modulation, a new therapeutic option. Twenty-one patients underwent pudendal nerve evaluation (PNE) at our institution. Nine patients were affected by both fecal and urinary incontinence, 3 had fecal incontinence and anal pain, 5 had fecal incontinence and pelvic floor dyssynergia, and 4 had isolated fecal incontinence. They underwent morphological, functional and psychological tests prior to PNE, showing no sphincter rupture, almost normal anal pressures, impaired rectal sensation and deficient psychological pattern. All patients underwent at least two nerve evaluations. Four of 21 patients (19%) were selected to receive a permanent sacral electrode, as PNE seemed to have improved their symptoms by >75%. A median follow-up of 15 months (range, 6–24 months) showed that this method decreases weekly episodes of incontinence and increases maximal squeeze pressure. We demonstrated an increase in basal pressure in 3 of 4 patients (all with isolated fecal incontinence). Rectal sensation threshold decreased in three patients; urge threshold decreased in two patients and increased in two patients, but in each patient we got a stabilization. We evaluated the quality of life by applying the Short Form Health Survey test (SF-36). All 4 patients showed a significant increase in the scores of physical, emotional and social role functioning after the permanent implant. In conclusion, sacral nerve modulation may improve physical, physiological and social quality of life in selected groups of incontinent patients without gross sphincter lesions and with impaired rectal sensation. Received: 6 June 2002 / Accepted: 10 November 2002     

Sacral neuromodulation in patients with fecal incontinence: a single-center study

PURPOSE: Fecal incontinence is a psychologically devastating and socially incapacitating condition. Conventional treatment is likely to improve continence in many patients; however, there remains a group with persisting symptoms who are not amenable for a simple surgical repair. We evaluated the effect of sacral neuromodulation in patients with structurally intact sphincters after failure of conventional treatment.METHODS: Patients aged 18 to 75 years were evaluated. Incontinence was defined as involuntary loss of stool at least once per week, which was objectified by completion of a three-week bowel-habits diary during ambulatory electrode stimulation at the S3 or S4 foramen. Patients were qualified for permanent stimulation when showing a reduction of at least 50 percent in incontinence episodes or days.RESULTS: Seventy-five patients (66 females; mean age, 52 (range, 26–75) years) were treated. Three patients had partial spinal cord injury, two patients a previous low-anterior resection, and nine patients had a previous sphincter repair. Evaluation after trial screening showed that 62 patients (83 percent) had improved continence. Median incontinence episodes per week decreased from 7.5 to 0.67 (P < 0.01), median incontinence days per week from 4 to 0.5 (P < 0.01). The symptomatic response stayed unchanged after implantation of a permanent electrode and pacemaker in 50 patients. After a median follow-up of 12 months, this effect could be sustained in 48 patients. Anal manometry during stimulation showed no increase of sphincter pressures.CONCLUSIONS: Sacral neuromodulation is a feasible treatment option for fecal incontinence in patients with structurally intact sphincters.Presented in part at the Tripartite Colorectal Meeting, Melbourne, Australia, October 27 to 30, 2002, and at the meeting of The American Society of Colon and Rectal Surgeons, New Orleans, Louisiana, June 21 to 26, 2003.Reprints are not available.     

Urinary retention during sacral nerve stimulation for faecal incontinence: report of a case

Sacral nerve stimulation (SNS) was proposed for the treatment of patients with urologic symptoms in 1967 but was not used until 1981. SNS has also proven to be a promising treatment in idiopathic faecal incontinence when conventional treatments have failed. The modality has been used for faecal incontinence since the mid-1990s. Eighty percent of the patients who were selected for percutaneous nerve evaluation (PNE) because of faecal incontinence report an improvement in the symptoms and qualify for a permanent implantation. Accordingly, SNS is now used for faecal incontinence and urologic symptoms. Reflex interactions between the bladder and the distal gastrointestinal tract are well known. The present case shows that SNS for faecal incontinence may significantly influence bladder function.This paper has not been (will not be) presented at any meetings.     

Sacral nerve stimulation for faecal incontinence following a rectosigmoid resection for colorectal cancer

Introduction Following recto-sigmoid resection some patients may become faecally incontinent and remain so despite conservative treatment. This multicentre prospective study assessed the use of sacral nerve stimulation (SNS) in this group.Methods All patients had more than or equal to 4 days of faecal incontinence for solid or liquid stools over a 21-day period following recto-sigmoid resection for colorectal carcinoma. The operation had to have been deemed curative. They had to have failed pharmacological and biofeedback treatment.Results Three male patients met these criteria. One had had a colo-anal and two a colo-rectal anastomosis for rectal carcinoma. All patients had intact internal and external anal sphincters. Two patients had a successful temporary stimulation period and proceeded to permanent implantation. Pre-operative symptom duration was 1 year in the permanently implanted patients. They were followed up for 12 months. SNS improved the number of faecally incontinent episodes in both patients. Ability to defer was improved in both patients from 0–5 min to 5–15 min. The faecal incontinence-specific ASCRS quality of life assessment improved in all four subcategories.Conclusion This study demonstrates that SNS may be effective in the treatment of patients with faecal incontinence following recto-sigmoid resection if conservative treatment has failed.     

Permanent sacral nerve modulation for fecal incontinence and associated urinary disturbances

Background and aims Sacral nerve modulation (SNM) using an implantable pulse generator is gaining increasing acceptance in the treatment of several functional disturbances of the urinary and intestinal tract. This new therapeutic approach offers new possibilities in the treatment of fecal incontinence (FI) by means of its possible effects on anorectal physiology.Patients and methods Fourteen patients with FI, six of whom had associated urinary disturbances, underwent permanent SNM after successful peripheral nerve evaluation tests. All had a clinical evaluation including FI grading systems (American Medical systems, AMS; Continence Grading System, CGS) and quality of life questionnaires (Fecal Incontinence Quality of Life, FIQL), and anorectal physiology tests performed before and during electrostimulation. Two patients had a lead displacement which was repositioned. Median follow-up was 14 months (range 6–48 months).Results AMS scores decreased significantly from 101 to 67 after 24 months CGS scores from 15 to 2 after 2 months. The median number of episodes of major incontinence per 2 weeks decreased from 14 to 1 after 24 months. FIQL scores improved significantly in the nine patients tested from an overall score of 1.59 to 3.3, with improvement in all areas of the FIQL. Four of the six patients with associated urinary disturbances had a significant improvement in their symptoms. Anal resting and squeezing tone did not change significantly, nor did rectal volumetry, compliance, rectoanal inhibitory reflex, or length of the anal high-pressure zone, while 24-h rectal manometry showed inhibition of the spontaneous rectal motility complexes after meal and on awakening in the only two patients undergoing this investigation.Conclusion Although the mechanism of action of SMN is still unclear and requires further investigations, clinical results are very encouraging, confirming the role of this new and safe procedure in the treatment of FI and associated urinary disturbances.     

Evaluation of the sacroanal motor pathway by magnetic and electric stimulation in patients with fecal incontinence

PURPOSE: The aim of this controlled study was to examine whether it was feasible to use magnetic stimulation as a new diagnostic tool to evaluate the motor function of the sacral roots and the pudendal nerves in patients with fecal incontinence. PATIENTS AND METHODS: Nineteen consecutive patients (17 females) with a median age of 67 (range, 36–78) years referred for fecal incontinence and 14 healthy volunteers (six females) with a median age of 42 (range, 23–69) years were examined. Latency times of the motor response of the external anal sphincter were measured after electric transrectal stimulation of the pudendal nerve and magnetic stimulation of the sacral roots. RESULTS: The success rates of pudendal nerve terminal motor latency and sacral root terminal motor latency measurements were 100 and 85 percent, respectively, in the control group and 94 and 81 percent, respectively, in the fecal incontinence group. Median left pudendal nerve terminal motor latency was 1.88 (range, 1.4–2.9) milliseconds in the control group and 2.3 (range, 1.8–4) milliseconds in the fecal incontinence group (P<0.006). Median right pudendal nerve terminal motor latency was 1.7 (range, 1.3–3.4) milliseconds in the control group and 2.5 (range, 1.7–6) milliseconds in the fecal incontinence group (P<0.003). Median left sacral root terminal motor latency was 3.3 (range, 2.1–6) milliseconds in the control group and 3.7 (range, 2.8–4.8) milliseconds in the fecal incontinence group (P<3 0.03). Median right sacral root terminal motor latency was 3 (range, 2.6–5.8) milliseconds in the control group and 3.9 (range, 2.5–7.2) milliseconds in the fecal incontinence group (P=0.15). CONCLUSIONS: Combined pudendal nerve terminal motor latency and sacral root terminal motor latency measurements may allow us to study both proximal and distal pudendal nerve motor function in patients with fecal incontinence. Values of sacral root terminal motor latency have to be interpreted cautiously because of the uncertainty about the exact site of magnetic stimulation and the limited magnetic field strength.     

Neuromodulation for fecal incontinence: An effective surgical intervention

Fecal incontinence is a disabling symptom with medical and social implications,including fear,embarrassment,isolation and even depression.Most patients live in seclusion and have to plan their life around the symptom,with secondary impairment of their quality of life.Conservative management and biofeedback therapy are reported to benefit a good percentage of those affected.However,surgery must be considered in the nonresponder population.Recently,sacral nerve electrostimulation,lately named neuromodulation,has been reported to benefit patients with fecal incontinence in randomized controlled trials more than placebo stimulation and conservative management,by some unknown mechanism.Neuromodulation is a minimally invasive procedure with a low rate of adverse events and apparently favorable cost-efficacy profile.This review is intended to expand knowledge about this effective intervention among the non-surgically skilled community who deals with this disabled group of patients.     

Sacral Nerve Stimulation is more Effective than Optimal Medical Therapy for Severe Fecal Incontinence: A Randomized,Controlled Study

Purpose This randomized study was designed to compare the effect of sacral neuromodulation with optimal medical therapy in patients with severe fecal incontinence. Methods Patients (aged 39–86 years) with severe fecal incontinence were randomized to have sacral nerve stimulation (SNS group; n = 60) or best supportive therapy (control; n = 60), which consisted of pelvic floor exercises, bulking agent, and dietary manipulation. Full assessment included endoanal ultrasound, anorectal physiology, two-week bowel diary, and fecal incontinence quality of life index. The follow-up duration was 12 months. Results The sacral nerve stimulation group was similar to the control group with regard to gender (F:M = 11:1 vs. 14:1) and age (mean, 63.9 vs. 63 years). The incidence of a defect of ≤ 120° of the external anal sphincter and pudendal neuropathy was similar between the groups. Trial screening improved incontinent episodes by more than 50 percent in 54 patients (90 percent). Full-stage sacral nerve stimulation was performed in 53 of these 54 “successful” patients. There were no septic complications. With sacral nerve stimulation, mean incontinent episodes per week decreased from 9.5 to 3.1 (P < 0.0001) and mean incontinent days per week from 3.3 to 1 (P < 0.0001). Perfect continence was accomplished in 25 patients (47.2 percent). In the sacral nerve stimulation group, there was a significant (P < 0.0001) improvement in fecal incontinence quality of life index in all four domains. By contrast, there was no significant improvement in fecal continence and the fecal incontinence quality of life scores in the control group. Conclusions Sacral neuromodulation significantly improved the outcome in patients with severe fecal incontinence compared with the control group undergoing optimal medical therapy. *Deceased. Read at the meeting of The American Society of Colon and Rectal Surgeons, St. Louis, Missouri, June 2 to 6, 2007.     

Innovations in Fecal Incontinence: Sacral Nerve Stimulation

OBJECTIVE The aim of this study was to present an overview of sacral nerve stimulation in the treatment of fecal incontinence. We describe the evolution in technique, patient selection, and indications, and review results and complications.METHODS All articles on sacral nerve stimulation for fecal incontinence that were recovered on MEDLINE search were reviewed. With multiple articles from an institution, the most recent reports with the longest follow-up and largest cohort of patients were selected, unless information from earlier reports was relevant.RESULTS The technique of sacral stimulation is well established, carries little risk, and continues to be refined (e.g., a less invasive approach has been proposed). Patient selection is based on a two-stage diagnostic test stimulation (acute and subchronic), for which the predictive value is high. On this basis, permanent sacral nerve stimulation has proved effective in both single-center and multicenter trials in patients with a functional deficit but limited morphologic lesions or no morphologic lesions. The clinical benefit derives from multiple symptomatic improvements contributing to better bowel control and from substantially improved quality of life. The underlying mechanism of action remains undefined, but both somatic and autonomic function appears affected.CONCLUSION Sacral nerve stimulation offers a safe treatment mode in a patient population in whom conservative treatment has failed and traditional surgical approaches would have limited success. The high predictive value of the diagnostic approach offers a unique therapeutic advantage.Presented in part at the International Colorectal Disease Symposium, Fort Lauderdale, Florida, February 13 to 15, 2003.     

Current management of fecal incontinence:Choosing amongst treatment options to optimize outcomes

The severity of fecal incontinence widely varies and can have dramatic devastating impacts on a person’s life.Fecal incontinence is common,though it is often underreported by patients.In addition to standard treatment options,new treatments have been developed during the past decade to attempt to effectively treat fecal incontinence with minimal morbidity.Non-operative treatments include dietary modifications,medications,and biofeedback therapy.Currently used surgical treatments include repair(sphincteroplasty),stimulation(sacral nerve stimulation or posterior tibial nerve stimulation),replacement(artificial bowel sphincter or muscle transposition)and diversion(stoma formation).Newer augmentation treatments such as radiofrequency energy delivery and injectable materials,are minimally invasive tools that may be good options before proceeding to surgery in some patients with mild fecal incontinence.In general,more invasive surgical treatments are now reserved for moderate to severe fecal incontinence.Functional and quality of life related outcomes,as well as potential complications of the treatment must be considered and the treatment of fecal incontinence must be individualized to the patient.General indications,techniques,and outcomes profiles for the various treatments of fecal incontinence are discussed in detail.Choosing the most effective treatment for the individual patient is essential to achieve optimal outcomes in the treatment of fecal incontinence.     

Sacral Nerve Stimulation for Fecal Incontinence Following Surgery for Rectal Prolapse Repair: A Multicenter Study

PURPOSE: A proportion of patients have fecal incontinence secondary to a full-thickness rectal prolapse that fails to resolve following prolapse repair. This multicenter, prospective study assessed the use of sacral nerve stimulation for this indication. METHODS: Patients had to have more than or equal to four days with fecal incontinence per 21-day period more than one year after surgery. They had to have failed conservative treatment and have an intact external anal sphincter. RESULTS: Four female patients aged 42, 54, 68, and 65 years met the inclusion criteria. Three of the four patients had had more than one operation for recurrent full-thickness rectal prolapse before sacral nerve stimulation, one of whom had undergone a further operation for recurrence following stimulation. One patient had undergone one operation for prolapse repair. The preoperative duration of symptoms was ten, eight, three, and nine years, respectively. Although patients had an intact external anal sphincter, one patient had a fragmented internal anal sphincter. The frequency of fecal incontinent episodes changed from 11, 24.7, 5, and 8 per week at baseline to 0, 1.5, 5.5, and 1 per week at latest follow-up. Ability to defer defecation was also improved in two of three patients who had this documented. Fecal incontinence-specific quality of life assessment showed an improvement in all four domains. CONCLUSION: Sacral nerve stimulation should be considered for patients with ongoing fecal incontinence following full-thickness rectal prolapse repair if they prove resistant to conservative treatment.     

Sacral Nerve Stimulation for Fecal Incontinence Related to Obstetric Anal Sphincter Damage

Purpose Sphincter repair is the standard treatment for fecal incontinence secondary to obstetric external anal sphincter damage; however, the results of this treatment deteriorate over time. Sacral nerve stimulation has become an established therapy for fecal incontinence in patients with intact sphincter muscles. This study investigated its efficacy as a treatment for patients with obstetric-related incontinence. Methods Fecally incontinent patients with external sphincter defects who would normally have undergone overlapping sphincter repair as a primary or repeat procedure were included. Eight consecutive women (median age, 46 (range, 35–67) years) completed temporary screening; all eventually had permanent implantation. Results Six of eight patients had improved continence at median follow-up of 26.5 (range, 6–40) months. Fecal incontinent episodes improved from 5.5 (range, 4.5–18) to 1.5 (range, 0–5.5) episodes per week (P = 0.0078). Urgency improved in five patients, with ability to defer defecation improving from a median of <1 (range, 0–5) minute to 1 to 5 (range, 1 to >15) minutes (P = 0.031, all 8 patients). There was no change in anal manometry or rectal sensation. There was significant improvement in lifestyle, coping/behavior, depression/self-perception, and embarrassment as measured by the American Society of Colon and Rectal Surgery fecal incontinence quality of life score. Conclusions Sacral nerve stimulation is potentially a safe and effective minimally invasive treatment for fecal incontinence in patients with de novo external anal sphincter defects or defects after unsuccessful previous external anal sphincter repair, although numbers remain small. Dr. Michael Kamm is a consultant to and received research support from Medtronic, however, study design, performance, analysis, and reporting have been conducted without the influence of Medtronic.     

Stimulated graciloplasty for treatment of intractable fecal incontinence

INTRODUCTION: Patients with end-stage fecal incontinence, in whom all standard medical and surgical treatment has failed or is not expected to be effective, can be treated by stimulated graciloplasty. The aim of the present study was to assess the efficacy of stimulated graciloplasty by both direct nerve and intramuscular perineural stimulation techniques and to evaluate various parameters relative to outcome. METHODS: A prospective analysis of all patients who underwent this procedure was undertaken. All patients were preoperatively investigated by anal manometry, electromyography, pudendal nerve terminal motor latency assessment, endoanal ultrasound, and an enema retention test. They were further assessed with an incontinence scoring system and a Quality of Life Questionnaire. Postoperative evaluation included anorectal manometry, incontinence score registry, and a Quality of Life Questionnaire. In our initial experience the stimulation system electrodes were fixed directly to the nerve (direct nerve stimulation graciloplasty); later in the study the stimulation system electrodes were fixed intramuscularly close to the nerve branches (intramuscular perineural stimulation graciloplasty). RESULTS: From May 1993 to February 1998, 27 patients underwent 33 gracilis transpositions for fecal incontinence, 30 of which were stimulated. Six of the patients with direct nerve stimulation graciloplasty eventually had the direct nerve stimulator removed and replaced with an intramuscular electrode stimulator. After an mean follow-up (until the time of exit from study) of 12.5 (range, 1–23) months for direct nerve stimulation graciloplasty and 21 (range, 8–27) months for intramuscular perineural stimulation graciloplasty, 13 graciloplasties (43 percent) were successful. There was no correlation between outcome of surgery and age, duration or cause of symptoms, body habitus, manometric or electromyographic parameters, prior sphincter repair, the presence of a pre-existing stoma, or any immediate postoperative complications. However, the number of patients with intramuscular perineural stimulation graciloplasty who had a successful outcome (continent, 69 percent; improved but not fully continent, 23 percent; incontinent, 8 percent) was significantly higher than patients with direct nerve stimulation graciloplasty (improved but not fully continent, 10 percent; incontinent, 90 percent). CONCLUSION: The success of stimulated graciloplasty is dependent on the method of nerve stimulation, whereas surprisingly, none of the many other factors assessed influenced outcome.Supported in part by educational grants from NICE Technology, Inc. of Ft. Lauderdale, Florida and Medtronic, Inc. of Minneapolis, Minnesota. Dr. Mavrantonis was supported in part by a grant from the Onassis Educational Foundation.Read at the meeting of the American Society of Colon and Rectal Surgeons, San Antonio, Texas, May 2 to 7, 1998.     

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 in Fecal Incontinence

PURPOSE: The effect of sacral nerve stimulation was studied in 45 patients with fecal incontinence.METHODS: All patients were initially tested in general anesthesia. Sacral nerves 2, 3, and 4 were tested on both sides. If a perineal/perianal muscular response to sacral nerve stimulation could be obtained, electrodes were implanted for a three-week test-stimulation period. If sacral nerve stimulation resulted in at least a 50 percent reduction in incontinence episodes during the test period, a system for permanent sacral nerve stimulation was implanted.RESULTS: When tested in general anesthesia, 43 of 45 patients had a muscular response to sacral nerve stimulation and had electrodes implanted for the three-week test period. Percutaneous electrodes were used in 34 patients, and 23 of these had at least a 50 percent reduction in incontinence episodes, whereas the electrodes dislocated in 7 patients and 4 had a poor response. Permanent electrodes with percutaneous extension electrodes were used primarily in 9 patients and after dislocation of percutaneous electrodes in an additional 6 patients; 14 of these had a good result. In the last patient, no clinical response to stimulation with the permanent electrode could be obtained. A permanent stimulation system was implanted in 37 patients. After a median of six (range, 0–36) months follow-up, five patients had the system explanted: three because the clinical response faded out, and two because of infection. Incontinence score (Wexner, 0–20) for the 37 patients with a permanent system for sacral nerve stimulation was reduced from median 16 (range, 9–20) before sacral nerve stimulation to median 6 (range, 0–20) at latest follow-up (P < 0.0001). There was no differences in effect of sacral nerve stimulation in patients with idiopathic incontinence (n = 19) compared with spinal etiology (n = 8) or obstetric cause of incontinence (n = 5). Sacral nerve stimulation did not influence anal pressures or rectal volume tolerability.CONCLUSIONS: Sacral nerve stimulation in fecal incontinence shows promising results. Patients with idiopathic, spinal etiology, or persisting incontinence after sphincter repair may benefit from this minimally invasive treatment.Presented at the meeting of The American Society of Colon and Rectal Surgeons, New Orleans, Louisiana, June 21 to 26, 2003.Reprints are not available.