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.     

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.     

Retrograde colonic irrigation for faecal incontinence after low anterior resection

Background and aims  This study aims to evaluate the therapeutic effect of retrograde colonic irrigation in patients with faecal incontinence after a low anterior resection for a rectal carcinoma. Materials and Methods  Patients with a previous low anterior resection, who were selected for treatment with retrograde colonic irrigation for faecal incontinence between 2005 and 2008, were included in the study. The data from the patients were gathered by chart research and an interview by phone. Results  Thirty patients were included in the study. Three patients died and one patient was not able to answer questions due to a cognitive disorder. The data of the remaining 26 patients were analysed. Five patients had already stopped with the retrograde colonic irrigation treatment due to side effects. Twelve of the 21 patients (57.46%) who still performed RCI became completely (pseudo)continent, three patients (14.2%) were incontinent for flatus and six patients (29.4%) were still incontinent for liquid stool. Five patients stopped with the retrograde colonic irrigation treatment due to side-effects. Conclusion  Retrograde colonic irrigation is an effective method to treat patients with faecal incontinence after a low anterior resection for rectal carcinoma. Retrograde colonic irrigation is not invasive and has only mild side effects.     

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.     

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.     

Efficacy of cyclic sacral nerve stimulation for faecal incontinence

Background

Sacral nerve stimulation (SNS) is an established treatment option for faecal incontinence. Cyclic stimulation will improve the longevity of the implanted stimulator, but little is known about its efficacy. The aim of this retrospective clinical study was to assess the efficacy of cyclic SNS for faecal incontinence.

Methods

Sixty-three patients underwent percutaneous nerve evaluation (PNE) test with a 2-week period of continuous SNS. The PNE test was deemed positive in 42 patients (67 %) who underwent implantation with permanent stimulator. All 42 patients were initially stimulated in a cyclic manner with stimulation for 20 s followed by 8 s without. During follow-up, the stimulator was explanted in 2 patients and permanently turned off in one due to the loss of effect. A postal questionnaire including the Wexner score, a general quality of life (Qol) score, and a bowel habit diary was distributed to 39 patients.

Results

The questionnaire was returned by 29/39 (74 %) of the patients. Median duration of follow-up was 16 (range 3–34) months. The Wexner score and the general QoL score were significantly improved compared to pre-treatment values. Some 18 patients (62 %) were still treated with cyclic stimulation at follow-up, reporting more frequent episodes of urgency without incontinence (p = 0.020) compared to symptoms during the PNE test. Patients who had changed to continuous stimulation due to a suboptimal effect during follow-up reported more frequent episodes of urgency with incontinence (p = 0.034), minor soiling (p = 0.045) and days wearing pads (p = 0.027) compared with symptoms during the PNE test.

Conclusions

Cyclic stimulation seems effective for most patients treated with SNS for faecal incontinence.     

Anorectal function after low anterior resection of the rectum

Impaired neorectal function or sphincter incompetence have been respectively implicated as causative factors of increased frequency of defaecation or incontinence after low anterior resection of the rectum (LARR) for rectal carcinoma, although individual mechanisms of anorectal function have not been fully studied. Functional and laboratory results were evaluated in 19 subjects, who had a LARR for rectal carcinoma before and after the procedure, and were compared to those of normal subjects. LARR worsened anorectal function, mostly by significantly increasing the daily number of defaecations (p<0.001), while major incontinence was reported in three cases. Patients with rectal carcinoma have a decreased resting anal pressure on manometry, as compared to controls (p<0.001). LARR further reduces anal resting pressure (p<0.001) as well as all parameters that express internal sphincter activity, such as presence and amplitude of either slow (p<0.05 and p<0.01) or ultraslow waves. LARR also impaired external anal sphincter activity, as expressed by the reduction in anal squeeze pressure (p<0.001). Anorectal sampling was found reduced in incidence and frequency in LARR patients as compared to controls (p<0.01 and p<0.01), and was impaired even further postoperatively (p<0.001). Rectoanal inhibitory reflex was present in all but three patients postoperative, but significantly impaired as compared to controls. Rectal volumes to elicit transient or permanent desire to defecate, maximal tolerable rectal volume and rectal compliance were also significantly reduced after LARR (p<0.001, p<0.001, p<0.01 and p<0.001 respectively). Large bowel transit was significantly enhanced after LARR (p<0.001). On defaecography, the anorectal angle was found to be more obtuse but in higher position postoperatively as compared to controls (p<0.001). Bowel motion frequency was inversely related to rectal compliance (p<0.001) and length of remaining distal rectal stump, while patients with incontinence exhibited the lowest anal pressures. It is concluded that reduced neorectal capacity after removal of the rectum and impaired anal sphincter function because of stretching and damaged innervation, as well as impaired rectoanal coordination are all responsible for the functional problems after LARR.

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Résumé On attribue à une dysfonction du néorectum ou à une insuffisance sphinctérienne l'augmentation de fréquence des défécations et l'incontinence observée après des résection antérieures basses du rectum pour cancer rectal bien que les différents mécanismes de la fonction anorectale n'aient pas été totalement étudiés. Les résultats fonctionnels et les valeurs de laboratoire ont été déterminés chez 19 patients avant et après résection antérieure basse pour cancer du rectum; ces données ont été comparées à des sujets témoins. La résection antérieure basse du rectum péjore la fonction anale en augmentant essentiellement le nombre d'exonérations quotidiennes (P<0.001) alors que des incontinences majeures sont observées chez 3 patients. Les patients avec un cancer du rectum ont une diminution de la pression anale de repos à la manométrie en comparaison au témoin (P<0.001). La résection antérieure basse, par ailleurs, diminue la pression de repos (P<0.001) de même que tous les paramètres témoignant de l'activité du sphincter interne telles que la présence et l'amplitude d'ondes de contractions lentes (P<0.05 et P<0.01) ou de contractions ultra-lentes. La résection antérieure basse interfère avec l'activité du sphincter externe ainsi qu'en témoigne la réduction de la pression de contraction volontaire (P<0.001). L'échantillonage anorectal était réduit en incidence et fréquence chez des patients opérés comparativement au contrôle (P<0.01 et P<0.001) et était altéré en post-opératoire également (P<0.001). Le réflexe inhibiteur recto-anal était présent chez tous les patients à l'exception de 3 en post-opératoire mais était significativement altéré comparativement au contrôle. Le volume rectal entraînant le besoin trnsitoire ou permanent d'exonérer de méme que le volume maximal tolérable et la compliance rectale était significativement réduite après résection antérieure basse (P<0.001, P<0.001, P<0.01 et P<0.001 respectivement). Le temps de transit colique était significativement accéléré après résection antérieure basse (P<0.001). Sur les défécographies, l'angle ano-rectal était plus obtus et en position plus haute en post-opératoire comparativement au sujet témoin (P<0.001). La fréquence des exonérations était inversement proportionelle à la compliance rectale (P<0.001) et à la longueur du moignon rectal résiduel alors que les patients présentant une incontinence avaient des pressions anales les plus basses. On en conclut que les troubles fonctionnels secondaires à une résection antérieure basse résultent d'une diminution de la capacité du néo-rectum et d'une altération de la fonction sphinctérienne secondaire á la dilatation du néo-rectum et d'une altération de la fonction sphinctérienne secondaire à la dilatation anale et à une atteinte de l'innervation de même qu'à des troubles de la coordination recto-anale.

     

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...     

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 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.