Randomized clinical trial of sacral versus percutaneous tibial nerve stimulation in patients with faecal incontinence.

BACKGROUND: Sacral nerve stimulation (SNS) is a well established therapy for faecal incontinence (FI). Percutaneous tibial nerve stimulation (PTNS) is a newer, less invasive, treatment. The effectiveness and acceptability of these treatments have not been compared systematically. METHODS: An investigator-blinded randomized pilot trial of PTNS versus SNS with a parallel qualitative study was performed. Quantitative clinical outcomes and qualitative data from patient interviews were collected for both interventions. RESULTS: Forty patients (39 women; mean age 59 years) met the eligibility criteria; 23 were randomized to receive SNS and 17 to PTNS. Fifteen patients progressed to permanent SNS implantation and 16 received a full course of PTNS. Within-group effect sizes were marginally greater for SNS than for PTNS on available-case analysis. Mean(s.d.) FI episodes per week at baseline, and 3 and 6 months of follow-up were: 11·4(12·0), 4·0(4·0) and 4·9(6·9) respectively for SNS compared with 10·6(11·2), 5·8(6·9) and 6·3(6·9) for PTNS. Mean(s.d.) Cleveland Clinic Incontinence Score values at baseline, and 3 and 6 months were: 16·2(3·0), 11·1(5·2) and 10·4(5·6) for SNS versus 15·1(2·7), 11·7(4·4) and 12·1(5·2) for PTNS. Improvement of at least 50 per cent in FI episodes per week at 6 months was seen in 11 of 18 patients in the SNS group compared with seven of 15 in the PTNS group. Effect estimates for SNS with chronic implanted stimulation were larger (10 of 15 patients at 6 months). Disease-specific and generic quality-of-life improvements complemented clinical outcome data. Qualitative analysis of interview data suggested that both treatments had high acceptability amongst patients. CONCLUSION: In the short term, both SNS and PTNS provide some clinical benefit to patients with FI. Registration numbers: 2010-018728-15 and 10479 (http://public.ukcrn.org.uk/search/StudyDetail.aspx?StudyID=10479).

Combined vertical reduction rectoplasty and sacral nerve stimulation for rectal evacuatory dysfunction and faecal incontinence associated with previous anorectal malformation.

Functional outcomes following surgery for anorectal malformation are variable, with many children experiencing persisting anorectal dysfunction. We describe a 34-year-old female with previous vestibular fistula who experienced lifelong rectal evacuatory dysfunction and faecal incontinence; she was treated in a two stage process producing efficient defecation and almost total continence.

Normalization of substance P levels in rectal mucosa of patients with faecal incontinence treated successfully by sacral nerve stimulation.

BACKGROUND: Sacral nerve stimulation (SNS) may improve faecal incontinence by modulating rectal sensation. This study measured changes in the peripheral expression of various neural epitopes in response to SNS. METHODS: Rectal mucosal biopsies were taken from 12 patients before and after temporary SNS, and from ten responders at 90 days after permanent stimulation. Sections were immunostained for substance P, transient receptor potential vanilloid (TRPV) 1, vasoactive intestinal peptide (VIP) and calcitonin gene-related peptide (CGRP). Levels were compared with those in nine continent controls. RESULTS: Baseline levels of percentage area immunoreactivities of substance P (median 0.51 (95 per cent confidence interval 0.31 to 0.73) versus 0.13 (0.07 to 0.27) per cent; P < 0.001) and TRPV1 (0.76 (0.41 to 1.11) versus 0.09 (0.04 to 0.14) per cent; P < 0.001), but not of VIP (1.26 (0.37 to 2.15) versus 1.28 (0.39 to 2.17); P = 0.943), were significantly greater than in controls. Successful SNS resulted in a significant decrease in substance P immunostaining after temporary (0.15 (0.06 to 0.51) per cent; P = 0.051) and permanent (0.17 (0 to 0.46) per cent; P = 0.051) stimulation. Immunoreactivity of TRPV1, VIP, CGRP and neural markers showed no qualitative change. CONCLUSION: Patients with faecal incontinence demonstrate normalization of raised rectal mucosal substance P levels following successful SNS.

Third-party prospective evaluation of patient outcomes after dynamic graciloplasty.

BACKGROUND: Dynamic graciloplasty (DGP) is a complex procedure designed to improve bowel function in patients with end-stage faecal incontinence. Outcomes of DGP were examined in comparison with stoma formation or continued medical management. METHODS: This third-party evaluation comprised a prospective case-comparison study of patient-based and clinical outcomes at a London hospital. Forty-nine patients who underwent DGP during 5 years from 1997 were compared with 87 patients with similar bowel disorders who did not undergo DGP. Outcome measures were quality of life (QoL), symptoms, anxiety and depression. RESULTS: At 2 years after surgery, bowel-related QoL and continence had improved by more than 20 per cent compared with the preoperative status for two-thirds of patients who had DGP (P < 0.001). Two-thirds were continent all or most of the time, although one-third experienced disordered bowel evacuation. Large deteriorations on the Nottingham Health Profile pain score occurred in 11 of 34 patients who had DGP, compared with seven of 57 patients in comparison groups (P = 0.027). Patients in comparison groups experienced no significant changes in measured outcomes over the 2 years of follow-up. CONCLUSION: Although DGP is associated with a high level of morbidity, it deserves consideration as an alternative to life with severe and refractory faecal incontinence or stoma formation in people in whom conventional treatments have failed.

The Colorectal Development Unit: impact on functional outcome for the electrically stimulated gracilis neoanal sphincter.

OBJECTIVE: A Colorectal Development Unit (CDU) was established to treat patients with end stage faecal incontinence with the electrically stimulated gracilis neoanal sphincter (ESGN). The aim of this study was to investigate the impact of the CDU on functional outcome and complications. METHODS: From March 1997 to March 2003, 53 patients underwent ESGN formation. Results were compared with 65 patients undergoing ESGN surgery prior to the establishment of the unit (pre-CDU) between 1988 and 1997, which were similar with regard to age, sex, aetiology and follow-up. RESULTS: Thirty-three (70%) CDU patients had a good functional outcome defined as continence to solid and liquid stool, a significant improvement when compared to the pre-CDU group, successful in 29 (45%) (P = 0.01). Episodes of technical complications leading to stimulator replacement were significantly reduced, from 25 to 3 over time (P < 0.001). Severe septic episodes were significantly reduced from 21 to four (P = 0.003) but there was no significant change in the incidence of postoperative evacuatory dysfunction. CONCLUSION: Since setting up a CDU, a successful outcome has been achieved in 33 (70%) of 47 patients undergoing ESGN surgery, which represents a significant improvement over time. This is probably related to improved patient assessment and selection, more reliable equipment and increased operative and peri-operative experience that come with a multidisciplinary team approach.

Use of a continent colonic conduit for treatment of refractory evacuatory disorder following construction of an electrically stimulated gracilis neoanal sphincter.

BACKGROUND: This study reports the outcome from the addition of a continent colonic conduit (CCC) to an electrically stimulated gracilis neoanal sphincter in patients with severe evacuatory disorder following formation of a neosphincter for end-stage faecal incontinence. METHODS: One hundred and twenty patients had an electrically stimulated gracilis neoanal sphincter constructed for end-stage faecal incontinence. Seven patients developed severe evacuatory disorders; construction of a CCC was required in six patients and an antegrade continence enema procedure in one. RESULTS: Median follow-up of the seven patients was 77 (range 6-96) months. Six patients with evacuatory disorders had a successful outcome, defined as continence to solid and liquid stool as well as correction of the evacuatory disorder. A stoma was formed in one patient. Patients who had previously undergone anorectal reconstructive surgery were more likely to develop an evacuatory disorder following construction of an electrically stimulated gracilis neoanal sphincter than patients operated on for other reasons (chi2 = 28.13, 1 d.f., P < 0.001). CONCLUSION: Construction of a CCC is a useful technique for the majority of patients with severe evacuatory disorders following the formation of an electrically stimulated gracilis neoanal sphincter, for whom the only alternative would be an end stoma. A CCC may be incorporated with construction of an electrically stimulated gracilis neoanal sphincter in patients at significant risk of postoperative severe evacuatory disorders.

Recent innovations in the management of fecal incontinence.

The importance of having a reproducible scoring system to objectively assess the severity of fecal incontinence and its response to treatment is stressed, and a number of methods are described. The approach to conservative treatment and investigation is outlined. Recent advances in the surgical management of fecal incontinence including the electrically stimulated gracilis neosphincter, sacral nerve stimulation, the artificial anal sphincter, internal anal sphincter augmentation, rectal augmentation, and antegrade colonic irrigation are described in detail.

Rectal augmentation and stimulated gracilis anal neosphincter: a new approach in the management of fecal urgency and incontinence.

PURPOSE: The aim of this study was the development of a procedure which would successfully treat selected patients presenting with incapacitating urgency and fecal incontinence. Some patients presenting with urgency and fecal incontinence, with an intact anorectum but deficient sphincter mechanism, have low rectal compliance. Management is problematic, because correction of the sphincter defect does not abolish the incapacitating urgency caused by rectal hypersensitivity. METHODS: This was a prospective study of three female patients with urgency and fecal incontinence who underwent combined rectal augmentation using a segment of distal ileum and stimulated gracilis anal neosphincter. All patients had low rectal volumes and two exhibited a temporal relationship between high-amplitude (>60 mmHg) rectal pressure waves and urgency on prolonged ambulatory anorectal manometry. RESULTS: Urgency was abolished and continence restored in all individuals. When the level of stimulation was not optimal or had been discontinued, patients experienced only passive incontinence with no urgency. Postoperative physiology revealed elevated thresholds to rectal distention and a reduction in the number of high-amplitude rectal pressure waves in all cases. CONCLUSIONS: Combined rectal augmentation with stimulated gracilis anal neosphincter may be of benefit to some patients with distressing urgency and fecal incontinence not previously helped by current techniques.

Preliminary results of a multicentre trial of the electrically stimulated gracilis neoanal sphincter.

BACKGROUND: The electrically stimulated gracilis neoanal sphincter was initially developed to treat refractory incontinence. Good early results were reported from the two centres that pioneered the technique. The aim of this study was to assess the operation in a prospective multicentre setting. METHODS: The procedure was performed on 64 patients from seven centres worldwide and was performed in stages. All patients were evaluated clinically and manometrically before and after operation. RESULTS: There was a high incidence of infective and hardware-related complications. At a median of 10 months following closure of the defunctioning stoma 56 per cent had experienced a good functional result. The major functional problems comprised evacuatory difficulties experienced by 25 per cent. CONCLUSION: The technique is effective in treating otherwise refractory incontinence. It is, however, a complex procedure and the morbidity rate may be high, particularly during the learning curve, factors that necessitate careful patient selection. Presented to the Association of Surgeons of Great Britain and Ireland in Bournemouth, UK, April 1997 and the European Council of Coloproctology in Edinburgh, UK, June 1997; and published in abstract form as Br J Surg 1997; 88(Suppl): 39 and Int J Colorectal Dis 1997; 12: 144

The electrically stimulated gracilis neo-anal sphincter.

Many patients with incontinence gain no relief from their symptoms following traditional surgical treatment and by necessity resort to a stoma. A number of attempts have been made to replace damaged or excised sphincters using the gracilis muscle to fashion a neo-anal sphincter. The results of the published series using the technique of unstimulated graciloplasty for the treatment of anal incontinence and in total anorectal reconstruction are reviewed. The results of these series are conflicting. In an effort to improve on these results the electrically stimulated neo-anal sphincter has been developed. The rationale behind its development and its evolution are discussed. The efficacy of the procedure in treating patients with incontinence or as part of total anorectal reconstruction is assessed.

The electrically stimulated gracilis neosphincter incorporated as part of total anorectal reconstruction after abdominoperineal excision of the rectum.

OBJECTIVE: The authors investigated the feasibility and effectiveness of combining electrically stimulated gracilis neoanal (ESGN) sphincter and a coloperineal anastomosis in selected patients after abdominoperineal excision of the rectum (APER). SUMMARY BACKGROUND DATA: The ESGN is effective in the treatment of idiopathic fecal incontinence. METHODS: Between March 1989 and September 1993, 12 patients (9 men, 3 women) with a median age of 59.25 years (range, 45-70) underwent the procedure. The underlying disease was adenocarcinoma in 10, anal malignant melanoma in 1, and a sweat gland tumor in the other. In all patients, a sphincter saving resection was contraindicated. The procedure was performed in stages. Stage 1 involved a conventional APER with the formation of a perineal stoma. Eleven patients underwent a vascular delay procedure. All patients were defunctioned. In stage 2, the gracilis was mobilized, transposed around the anal canal, and the electrodes and hardware needed for electrical stimulation were implanted. Once muscle conversion was complete, the defunctioning stoma was closed. RESULTS: Eight patients were closed successfully. In seven of the eight patients, complete physiologic measurements were taken. Median basal and maximum neosphincter pressures were 30 and 122 cm H2O, respectively, at the start of electrical stimulation and 22.5 and 76.2 cm H2O, respectively, after 1 year. Median functioning neosphincter pressure was 36 cm H2O at 1 year. All of the patients whose stomas were closed experienced episodes of incontinence to solid stool and wore pads for persistent fecal soiling. They all reported difficulty in evacuation. Despite imperfect continence, no patient wished to go back to life with a stoma. CONCLUSIONS: The incorporation of ESGN as part of total anorectal reconstruction is technically feasible. The majority of patients are satisfied with their function and pleased to avoid a permanent stoma.

Dynamic myoplasty: surgical transfer and stimulation of skeletal muscle for functional substitution or enhancement.

Dynamic myoplasty combines muscle transfer with electrical stimulation to provide contractile function that augments or replaces impaired organ function. Dynamic cardiomyoplasty was the first clinical application in which a skeletal muscle, latissimus dorsi, was transferred and stimulated to provide cardiac assistance, a function different from its original one. The problem of early muscle fatigue that was encountered in the initial implementation of the method was solved by training the muscle with electrical stimulation and thus changing its fiber composition. With intramuscular electrodes, the conditioned latissimus dorsi is stimulated in synchrony with the heart muscle. Safeguards are built into the two-channel implanted stimulator to avoid excessively high pulse rates. Clinicians report that 80% of patients with moderate to severe heart failure prior to operation showed a clinical improvement of 1.6 New York Heart Association classes. Alternative methods of providing cardiac assistance that are also being investigated include wrapping the muscle around the aorta, creating a skeletal muscle ventricle, and using the muscle to power an implantable pump. These latter techniques are still under preclinical investigation. Compared with heart transplant, cardiomyoplasty has the great advantage of not being subject to tissue rejection. The second principal application of dynamic myoplasty is treatment of fecal incontinence through creation of an electrically stimulated skeletal muscle neosphincter (ESMNS). The gracilis muscle of the leg is mobilized, wrapped around the anal canal, and conditioned with electrical stimulation to become more fatigue resistant. To achieve continence, the muscle is continuously stimulated except when the patient wishes to defecate. Overall success rates in achieving continence are 60-65%. Both cardiomyoplasty and the ESMNS technique, and their associated devices, are being refined through ongoing clinical trials.

The long head of the biceps femoris: anatomic basis for its possible use in the construction of an electrically stimulated neoanal sphincter.

Electrical stimulation of the nerve to the gracilis muscle following its transposition around the anal canal creates an artificial sphincter capable of actively opposing intrarectal pressure. Not all patients have an available or suitable gracilis. This paper describes the anatomic basis for the use of the long head of the biceps femoris as a potential electrically stimulated neoanal sphincter. The muscle was found to have an adequate length and a suitable arc of rotation for transposition around the anal canal. In 75 percent of thighs studied the neurovascular anatomy of the long head of the biceps femoris was compatible with its utilization in this manner as an alternative to the gracilis.