Changing paradigm of sacral neuromodulation and external anal sphincter repair for faecal incontinence in specialist centres.

AIM: The aim of this study was to determine whether the paradigm of surgical intervention for faecal incontinence (FI) has changed between 2000 and 2013. METHOD: This was a multi-centre retrospective study of patients who had undergone either sacral neuromodulation (SNM) or delayed sphincter repair or sphincteroplasty (SR) as a primary surgical intervention for FI in five centres in Europe and one in the United States. The flow of patients according to the intervention, sustainability of the treatment at a minimum follow-up of 5 years, complications and requirement for further interventions were recorded. RESULTS: A total of 461 patients (median age 56 years, range 24-90 years, 41 men) had either SNM or SR as an index operation during the study period [SNM 284 (61.6%), SR 177 (38.4%)]. Among SNM patients, there were 169 revisional operations (change of battery and/or lead, re-siting or removal). At the time of last follow-up 203 patients (71.4%) continued to use SNM. Among SR patients, 30 (16.9%) had complications, most notably wound infection (22, 12.4%). During follow-up 32 patients (18.1%) crossed over to SNM. Comparing two 4-year periods (2000-2003 and 2007-2010), the proportion of patients operated on who had a circumferential sphincter defect of less than 90° was 48 (68%) and 45 (46%), respectively (P = 0.03), while those who had SNM as the primary intervention increased from 29% to 89% (P < 0.05). CONCLUSION: The paradigm of surgical intervention for FI has changed with increasing use of SNM.

Improved longevity and efficacy of sacral nerve stimulation by simple adjustments at follow-up.

AIM: Sacral nerve stimulation (SNS) for faecal incontinence (FI) at subsensory amplitudes as low as 50% of the sensory threshold has been found to be effective at 3 months' follow-up. Furthermore, alternative pacemaker settings may improve functional outcome in patients with suboptimal treatment efficacy. In this work we aim to explore if sub-sensory stimulation as low as 50% of sensory threshold is effective at 1-year follow-up. We also aimed to investigate if 31 Hz (frequency) or 90 µs (pulse width) stimulation improved treatment efficacy in dissatisfied patients. METHOD: All patients in whom the stimulation was effective in controlling FI (satisfied group) were encouraged to have the stimulation amplitude reduced. Those in whom the device was less effective (dissatisfied group) were offered alternative frequency settings or pulse width (31 Hz or 90 µs). Patients were follow-up after 12 months and evaluated by a visual analogue scale (VAS) for patient satisfaction, the Cleveland Clinic Continence Score (CCCS), Rockwood Faecal Incontinence Quality of Life Scale (QoL) and a bowel habit diary. RESULTS: Two hundred and nineteen patients were contacted, with a response rate of 71% (n = 155). Those who were successfully contacted comprised 110 (71%) patients classed as satisfied and 45 (29%) as dissatisfied. Seventy-five (68%) of the satisfied patients agreed to have their stimulation amplitude reduced. At 1-year follow-up the median amplitude had reduced from 1.5 V [interquartile range (IQR) 0.85-2.0 V] to 0.75 V (IQR 0.45-1.4 V) (P-value < 0.001) representing an overall reduction of 39% (6.6-62.5%). There were no significant differences in VAS, CCCS or QoL despite subsensory stimulation at 1-year follow-up. In 28% of the dissatisfied patients alternative pacemaker settings improved VAS to satisfactory levels. CONCLUSION: Subsensory stimulation is as effective as stimulation at or above the sensory threshold. High-frequency stimulation (31 Hz) can improve functional outcome in patients with loss of efficacy.

Final results of a European, multicentre, prospective, observational study of Permacol™ collagen paste injection for the treatment of anal fistula.

AIM: Permacol™ collagen paste (Permacol™ paste) is an acellular cross-linked porcine dermal collagen matrix suspension for use in soft-tissue repair. The use of Permacol™ paste in the filling of anorectal fistula tract is a new sphincter-preserving method for fistula repair. The MASERATI100 study was a prospective, observational clinical study with the objective to assess the efficacy of Permacol™ collagen paste for anal fistula repair in 100 patients. METHOD: Patients (n = 100) with anal fistula were treated, at 10 European surgical sites, with a sphincter-preserving technique using Permacol™ paste. Fistula healing was assessed at 1, 3, 6 and 12 months post-treatment, with the primary end-point being healing at 6 months. Faecal continence and patient satisfaction were surveyed at each follow-up; adverse events (AEs) were monitored throughout the follow-up. RESULTS: At 6 months postsurgery, 56.7% of patients were healed and the percentage healed was largely maintained, with 53.5% healed at 12 months. Regarding AEs, 29.0% of patients had at least one AE, and 16.0% of patients had one or more procedure-related AE. Most AEs reported were minor and similar to those commonly observed after fistula treatment, and the incidence of serious adverse events was low (4.0% of patients). Regardless of treatment outcome, 73.0% of patients were satisfied or very satisfied with the procedure. CONCLUSION: Permacol™ paste is a promising sphincter-preserving treatment for anal fistulae and has minimal adverse side-effects.

Efficacy of autologous fat graft injection in the treatment of anovaginal fistulas.

BACKGROUND: Injection of autologous fat is an established method within plastic surgery for soft tissue augmentation. The aim of the present study was to determine whether transperineal fat graft injection could promote healing of anovaginal fistulas. METHODS: The procedures were performed at the University Hospital of North Norway, Tromsø, Norway, and at Aarhus University Hospital, Aarhus, Denmark, between May 2009 and September 2016. After abdominal liposuction, fat was injected around the fistula tract that was finally transected percutaneously with a sharp cannula and fat injected between the cut parts. The internal opening was closed with a suture. Patients had a minimum follow-up of 6 months after last fat graft injection. RESULTS: Twenty-seven women underwent 48 procedures. The cause of fistula was obstetric (n = 9), abscess (n = 9), Crohn's disease (n = 7), radiation for anal cancer (n = 1) and endoscopic surgery after radiation for rectal cancer (n = 1). The mean amount of injected fat was 73 ml (SD ± 20 ml), and operating time was 63 min (SD ± 21 min). At median follow-up of 20 months (range 6-87 months) after the last injection, fistulas were healed in 21 women (77%), in 8 women after just one procedure. Healing was achieved in 6 of 7 women (86%) with Crohn's disease and in both women who had undergone radiation therapy. One woman developed an abscess and additional trans-sphincteric fistula 8 weeks after injection. CONCLUSIONS: Fat graft injection for anovaginal fistulas is effective and safe.

Three-year follow-up of sacral nerve stimulation for patients with diarrhoea-predominant and mixed irritable bowel syndrome.

AIM: Our unit has recently shown that sacral nerve stimulation (SNS) has a significantly positive short-term effect on selected patients with diarrhoea-predominant or mixed irritable bowel syndrome (IBS). The aim of the present prospective study was to evaluate the medium-term efficacy of SNS for IBS to establish whether SNS could have a future role in the treatment of IBS. METHOD: Patients with IBS who had previously been implanted with a permanent neurostimulator as part of a randomized, controlled, crossover study, were assessed for medium-term follow-up. The primary end-point was change in the IBS-specific symptom score (Gastrointestinal Symptom Rating Scale-Irritable Bowel Syndrome version questionnaire) from baseline to 3-year follow-up. The secondary end-point was a change in the IBS-specific quality of life score (Irritable Bowel Syndrome-Impact Scale questionnaire) from baseline to 3-year follow-up. RESULTS: Of 26 patients, 20 were eligible for 3-year follow-up. The median IBS-specific symptom score was significantly lower at 3-year follow-up (30, range 13-71) than at baseline (62, 45-80) (P = 0.0001). The effect was observed in all symptom clusters within the score. Also, the median IBS-specific quality of life score was significantly improved at 3-year follow-up (52, 26-169) compared with baseline (135, 82-180, P = 0.0002). The effect was observed in all domains of the score. As per the protocol, 75% of patients were judged therapeutic successes. Seventy per cent of patients had a more than 50% reduction in daily IBS symptoms. CONCLUSION: At medium-term follow-up, SNS continues to be an effective treatment for highly selected patients with diarrhoea-predominant or mixed IBS.

Multicentre observational study of the Gatekeeper for faecal incontinence.

BACKGROUND: A variety of therapeutic approaches are available for faecal incontinence. Implantation of Gatekeeper prostheses is a new promising option. The primary endpoint of this prospective observational multicentre study was to assess the clinical efficacy of Gatekeeper implantation in patients with faecal incontinence. Secondary endpoints included the assessment of patients' quality of life, and the feasibility and safety of implantation. METHODS: Patients with faecal incontinence, with either intact sphincters or internal anal sphincter lesions extending for less than 60° of the anal circumference, were selected. Intersphincteric implantation of six prostheses was performed. At baseline, and 1, 3 and 12 months after implantation, the number of faecal incontinence episodes, Cleveland Clinic Faecal Incontinence, Vaizey and American Medical Systems, Faecal Incontinence Quality of Life Scale and Short Form 36 Health Survey scores were recorded. Endoanal ultrasonography was performed at baseline and follow-up. RESULTS: Fifty-four patients were implanted. After Gatekeeper implantation, incontinence to gas, liquid and solid stool improved significantly, soiling was reduced, and ability to defer defaecation enhanced. All faecal incontinence severity scores were significantly reduced, and patients' quality of life improved. At 12 months, 30 patients (56 per cent) showed at least 75 per cent improvement in all faecal incontinence parameters, and seven (13 per cent) became fully continent. In three patients a single prosthesis was extruded during surgery, but was replaced immediately. After implantation, prosthesis dislodgement occurred in three patients; no replacement was required. CONCLUSION: Anal implantation of the Gatekeeper in patients with faecal incontinence was effective and safe. Clinical benefits were sustained at 1-year follow-up.

Is the efficacy of sacral nerve stimulation for faecal incontinence dependent on the number of active electrode poles achieved during permanent lead insertion?

AIM: Sacral nerve stimulation (SNS) is effective for faecal incontinence (FI). Little is known about the relationship between the implantation technique and the functional outcome. This study aimed to explore the relationship between the numbers of active electrode poles (AEP) achieved during permanent lead placement and subsequent function, therapeutic amplitude and the need for extra appointments between scheduled follow-up visits. METHOD: One hundred and eighty-six patients with FI who underwent permanent implantation between May 2009 and March 2015 with a tined (barbed) lead (3093/3080, Medtronic) using the straight stylet were registered on the European two-centre SNS prospective database (SNSPD). Correlation between the number of AEP, function, stimulation amplitude and the need for extra visits was analysed. RESULTS: The numbers of patients having an intra-operative motor response on stimulation of one, two, three and four poles were 18 (9.7%), 75 (40.3%), 61 (32.8%) and 32 (17.2%). The Wexner incontinence score was significantly reduced from 15 (±2.8) at baseline to 9.2 (±4.8) at the latest follow-up after a mean 878 ± 561 days (SD; P < 0.001). No correlation was found between the number of AEP and the functional outcome (P > 0.05). Patients with four-AEP had a reduced therapeutic amplitude up to 289 (±146) days of follow-up (P < 0.03). The number of AEP did not influence the need for extra follow-up visits (P < 0.223). CONCLUSION: The functional outcome and number of extra visits after SNS for FI did not depend on the number of AEP achieved. The therapeutic amplitude was reduced during the first postoperative year if four AEP were achieved during lead placement.

A prospective multicentre observational study of Permacol collagen paste for anorectal fistula: preliminary results.

AIM: Permacol collagen paste (Permacol paste) is a new option for the treatment of anorectal fistula. It functions by filling the fistula tract with an acellular crosslinked porcine dermal collagen matrix suspension. The MASERATI 100 study group was set up to evaluate the clinical outcome of Permacol paste in the treatment of anorectal fistula. This paper reports the results from the initial 30 patients enrolled in the MASERATI 100 prospective, observational clinical trial. METHOD: Patients (N = 30) with anal fistula presenting to 10 European academic surgical units were treated with a sphincter-preserving technique using Permacol paste. Fistula healing was assessed at 1, 3, 6 and 12 months after treatment, with the primary end-point of fistula healing at 6 months post-surgery. Faecal continence and patient satisfaction were recorded at each follow-up visit and adverse events were monitored throughout the follow-up. RESULTS: Of the 28 patients with data at 6 months post-surgery, 15 (54%) were healed, and the healing rate was maintained at 12 months. Healing after treatment with Permacol paste was similar for intersphincteric to transsphincteric fistulae and primary or recurrent fistulae. Only one patient exhibited an adverse event (perianal abscess) that was possibly related to the treatment. At the last outpatient visit, over 60% of patients were satisfied or very satisfied with the operation. CONCLUSION: Permacol paste is shown to be effective in treating primary and recurrent cryptoglandular anorectal fistula with minimal unwanted side effects.

Bilateral compared with unilateral sacral nerve stimulation for faecal incontinence: results of a randomized, single-blinded crossover study.

AIM: This randomized single-blinded crossover study aimed to investigate whether bilateral sacral nerve stimulation (SNS) is more efficient than unilateral stimulation for faecal incontinence (FI). METHOD: Patients with FI who responded during a unilateral test stimulation, with a minimum improvement of 50% were eligible. Twenty-seven patients who were accepted to enter the trial were bilaterally implanted with two permanent leads and pacemakers. Patients were randomized into three periods of 4 weeks' stimulation including unilateral right, unilateral left and bilateral stimulation. Symptoms scores and bowel habit diaries were collected at baseline and in each study period. A 1-week washout was introduced between each study period. RESULTS: Twenty-seven (25 female) patients with a median age of 63 (36-84) years were bilaterally implanted from May 2009 to June 2012. The median number of episodes of FI per 3 weeks significantly decreased from 17 (3-54) at baseline to 2 (0-20) during stimulation on the right side, 2 (0-42) during stimulation on the left side and 1 (0-25) during bilateral stimulation. The Wexner incontinence score improved significantly from a median of 16 (10-20) at baseline to 9 (0-14) with right-side stimulation, 10 (0-15) with left-side stimulation and 9 (0-14) with bilateral stimulation. The differences between unilateral right or unilateral left and bilateral stimulation were non-significant, for FI episodes (P = 0.3) or for Wexner incontinence score (P = 0.9). CONCLUSION: Bilateral SNS therapy for FI is not superior to standard unilateral stimulation in the short term. Equal functional results can be obtained regardless of the side of implantation.

Lack of effect of sacral nerve stimulation for incontinence in patients with systemic sclerosis.

AIM: Systemic sclerosis (SSc) is a multisystem disorder of unknown aetiology leading to the deposition of excessive connective tissue in the skin, blood vessels and internal organs. Gastrointestinal involvement occurs in 90% of cases and the prevalence of faecal incontinence (FI) is 38%. This study comprises the largest case series assessing the efficacy of sacral nerve stimulation (SNS) treatment for incontinence in this patient group. METHOD: A retrospective analysis on prospectively collected data was performed on all SSc patients from our two centres who had undergone SNS for FI. RESULTS: Ten female patients of mean age of 54 (37-72) years had temporary SNS performed. The mean duration of FI was 13 (2-25) years. All had passive FI. Each patient had preprocedure anorectal physiology and endoanal ultrasound examinations documenting internal sphincter atrophy/fragmentation or reduced anal resting pressure. Overall there was no statistically significant difference (P = 0.57) in the total Wexner incontinence scores before (mean 15.1 ± 2.6 SD) and during temporary SNS procedures (mean 13.1 ± 3.6 SD). Two patients with a significant improvement went on to have permanent SNS with only one achieving a favourable outcome at 1 year. CONCLUSION: This study showed that SNS failed to reduce episodes of leakage in nine out of 10 patients with systemic sclerosis affected with incontinence.

Nurse-led clinics can manage faecal incontinence effectively: results from a tertiary referral centre.

AIM: In May 2010, a specialist nurse-initiated assessment and treatment algorithm for faecal incontinence (FI) was introduced at the department of Anal Physiology, Aarhus University Hospital, Denmark. This study aimed to evaluate the effectiveness of and patient satisfaction with the program. METHOD: A medical file audit was preformed on patients evaluated and treated for FI and discharged after September 2010. Patients were invited to participate in a structured telephone interview. This study aimed to enrol 100 patients. Patients were asked if they were satisfied with their current level of continence status (yes/no), and a numerical satisfaction score and Wexner score were recorded. These results were compared to baseline and at time of discharge. RESULTS: One-hundred patients completed the telephone interview; 73 of these patients were satisfied after a median of 420 (range: 114-586) days following discharge from the program. A median of one outpatient consultation followed by one telephone follow-up was required before the patients were discharged. The Wexner score was significantly reduced by 3.9 (±4.4) (P < 0.001) points among the satisfied and non-significantly reduced by 0.52 (± 3.3) (P = 0.42) points among the dissatisfied patients at follow-up compared to baseline. The satisfied and dissatisfied patients at follow-up did not differ in baseline characteristics including Wexner score. CONCLUSIONS: FI can successively be evaluated and conservatively managed by specialist nurses, and these nurses achived high satisfaction rates among their patients. The concept of specialist nurse-led clinics will reduce waiting lists, and descrease the number of patients needing to be evaluated by a surgeon.

Long-term anorectal, urinary and sexual dysfunction causing distress after radiotherapy for anal cancer: a Danish multicentre cross-sectional questionnaire study.

AIM: The objective of primary radiotherapy for anal cancer is to remove cancer while maintaining anorectal function. However, little is known about anorectal function among long-term survivors without colostomy. Using a cross-sectional questionnaire study, we examined symptoms and distress related to the dysfunction of pelvic organs after radiotherapy for anal cancer. METHOD: A questionnaire regarding anorectal, urinary and sexual symptoms was sent to anal cancer patients without recurrence or colostomy, diagnosed during 1996-2003, and treated with curative intent (chemo)radiotherapy at three Danish centres. For each symptom we assessed frequency and severity and the level of symptom-induced distress (no, little, moderate or great distress). RESULTS: Of 94 eligible patients, 84 (89%) returned the completed questionnaire at a median of 33 months after radiotherapy. Incontinence for solid stools, liquid stools and gas occurred at least monthly in 31%, 54% and 79% of patients, respectively. Overall 40% of patients reported great distress from incontinence for solid or liquid stools at least monthly. Faecal urgency occurring at least monthly was experienced by 87% of patients and caused great distress in 43%. Stress, urge or another type of urinary incontinence occurred at least monthly in 45% and caused great distress in 21%. Urinary urgency occurred at least monthly in 48% but only caused great distress in 14%. Sexual desire was severely decreased in 58% and only 24% were satisfied with their sexual function. CONCLUSION: Distressing long-term anorectal and sexual dysfunction was common after radiotherapy for anal cancer, and morbidity due to urinary dysfunction was moderate.

Long-term function and morphology of the anal sphincters and the pelvic floor after primary repair of obstetric anal sphincter injury.

AIM: More than 50% of women experience deteriorating continence over time following primary repair of obstetric anal sphincter injuries. The objectives of this study were to assess the function and morphology of the anal sphincters and pelvic floor in women with long-term faecal incontinence after sphincter repair (primary end-point) and to evaluate their correlation with severity of incontinence (secondary end-point). METHOD: The participants in this prospective study were recruited from a cohort of all women who sustained third or fourth degree obstetric sphincter injury reconstruction (cases) from January 1976 to November 1991. The women who delivered immediately before and after each case, without sustaining obstetric damage, were included as controls. Cases and controls were stratified into three categories: (i) continent; (ii) minor incontinence; and (iii) severe incontinence. The function and morphology of the anal sphincters and pelvic floor were evaluated by MRI, three-dimensional endoanal ultrasonography and anorectal physiology tests. RESULTS: Fifty-nine women (29 cases/30 controls; mean age 51/53 years; mean follow-up 23.7/24.1 years, respectively) were assessed. Morphologically, cases had a significantly shorter anterior external anal sphincter length compared with controls when evaluated by three-dimensional endoanal ultrasonography (8.6 vs 10.2 mm; P = 0.03). Functionally, cases with severe incontinence had a significantly shorter anterior sphincter length compared with cases with minor incontinence (7.7 vs 10.4 mm; P = 0.04). No correlation could be found between anal pressures and severity of incontinence in the case group. CONCLUSIONS: Cases had a significantly shorter anterior external anal sphincter length. Functionally, anterior sphincter length correlated with increased severity of incontinence.

Primary and secondary restorative proctocolectomy for familial adenomatous polyposis: complications and long-term bowel function.

AIM: The aim of the study was to evaluate intra-operative difficulties, complications and long-term bowel function in polyposis patients undergoing conversion of an ileorectal anastomosis to an ileoanal pouch, compared with patients with a primary ileoanal pouch operation. METHOD: A national register-based retrospective study was performed with clinical follow-up and a questionnaire on long-term bowel function. RESULTS: There were 84 patients in the study: 59 (70%) had a primary pouch operation and in 25 (30%) a secondary pouch procedure was attempted. This was abandoned, in one case, leaving 24 patients who had a successful secondary restorative proctocolectomy. The median (range) follow-up was 123 (0-359) months. There were no intra-operative difficulties in the 59 primary operations, but intra-operative difficulties were reported in nine of 25 secondary operations (P < 0.001). Complications within 1 month of surgery occurred in six of 59 primary operations and in none of 24 secondary operations (P < 0.001); and late surgical complications occurred in eight of 55 primary operations and in eight of 24 secondary operations (P = 0.13). The only difference in bowel function was a lower frequency of nocturnal defaecation after secondary pouch formation (P = 0.02). CONCLUSION: Reoperation with proctectomy after a previous ileorectal anastomosis and conversion to restorative proctocolectomy is feasible in polyposis patients, with morbidity and functional results similar to those seen after a primary pouch operation.

Distensibility of the anal canal in patients with systemic sclerosis: a study with the functional lumen imaging probe.

AIM: Systemic sclerosis (SSc) is a generalized connective tissue disease that affects smooth muscle cells. Patients with SSc often have faecal incontinence caused by fibrotic degeneration of the internal anal sphincter (IAS). The functional lumen imaging probe (FLIP) is a novel method that allows the segmental biomechanical properties of the anal canal to be dynamically evaluated. The aim of the present study was to compare the segmental biomechanical properties of the anal canal in incontinent SSc patients and healthy controls. We hypothesized that the FLIP would reveal weaknesses of the IAS in the SSc patients. METHOD: We performed FLIP distensions, endoanal ultrasonography and standard anal manometry on 14 incontinent SSc patients [11 women, median age 60 years (range 35-80)] and 15 healthy volunteers [12 women, median age 54 years (range 33-67)]. The anal canal was divided into three parts for the biomechanical analysis: upper (surrounded by the IAS and the puborectalis), middle (IAS and external anal sphincter) and lower (external sphincter only). RESULTS: The middle anal canal was the segment most resistant to distension in all of the subjects, but it was less resistant in the SSc patients than in the controls (P < 0.01). Correspondingly, the endoanal ultrasonography showed that the IAS of the SSc patients was thinner than normal (P < 0.05), and the anal resting and squeeze pressures were lower (P < 0.05). Only minor distensibility differences were found in the upper anal canal. No changes were found in the lower anal canal. CONCLUSION: Faecal incontinence in SSc patients is associated with poor IAS function, causing increased distensibility of the middle anal canal.

Randomized double-blind crossover study of alternative stimulator settings in sacral nerve stimulation for faecal incontinence.

BACKGROUND: Sacral nerve stimulation is an established treatment for faecal incontinence. Nearly half of all patients experience loss of efficacy at some point. Standard reprogramming restores efficacy for some, but not all, patients. This study aimed to determine whether alternative stimulator settings would increase treatment efficacy. METHODS: Patients with sustained loss of efficacy were recruited from two international specialist centres. A number of alternative stimulation parameters were tested using a double-blind randomized crossover study design. Stimulation settings tested were pulse frequencies of 6.9 and 31 Hz, and pulse widths of 90 and 330 µs, compared with one standard setting of 14 Hz/210 µs. Treatment efficacy was evaluated using a disease-specific quality-of-life score (Fecal Incontinence Quality of Life Scale, FIQLS) and a bowel habit diary completed before randomization, during the study period and after 3 months of follow-up with one preferred setting. RESULTS: Fifteen patients were analysed. With one preferred setting, three of four subdomains in the FIQLS improved significantly. The mean(s.d.) total number of incontinence episodes dropped from 11.7(10.8) to 4.8(4.5) per 3 weeks (P = 0.011) and improvements were maintained after 3 months of follow-up. Optimal pacemaker settings were individual, but a trend towards highest patient satisfaction and improved treatment outcome was evident for high-frequency stimulation (31 Hz/210 µs), which was preferred by eight of the 15 patients. CONCLUSION: Patients experiencing loss of efficacy can experience improvement if alternative pacemaker settings are tested. High-frequency stimulation (31 Hz/210 µs) was preferred by more than half of the patients, and improved treatment outcome was sustained at 3 months.

Functional results and patient satisfaction with sacral nerve stimulation for idiopathic faecal incontinence.

AIM: Sacral nerve stimulation (SNS) is an established treatment for faecal incontinence (FI) when conservative modalities have failed to restore continence. This two-centre study aimed to document functional outcome and its relationship to patient satisfaction. METHOD: Patients treated with SNS for idiopathic FI in Aarhus (Denmark) and Maastricht (The Netherlands) were included. At the most recent follow-up appointment, 127 patients (80%) were identified as receiving active SNS therapy. A questionnaire considering bowel habits, quality of life, and self-reported satisfaction and a 3-week bowel-habit diary were mailed to these patients, and 85% responded. RESULTS: Patient satisfaction was clearly related to the number of FI episodes. Patients experiencing full continence were all satisfied, and although the satisfaction rate decreased as the number of FI episodes increased, 46% of the patients with more FI episodes at follow-up than at baseline were still satisfied. Per-protocol analysis resulted in a satisfaction rate of 57.3%. In total, 74.7% of the patients receiving active SNS therapy reported a reduction of ≥ 50% in FI episodes, 10.3% of whom were dissatisfied after a median of 46 months of follow-up. CONCLUSION: There is a clear relationship between patient satisfaction and improved continence. A total of 57.3% of the patients offered SNS therapy were satisfied at follow-up. However, 46% of the patients with more FI episodes at follow-up than at baseline were also satisfied. Therefore, functional outcome of SNS therapy cannot be based only on bowel-habit diaries and bowel scores.

Functional luminal imaging probe: a new technique for dynamic evaluation of mechanical properties of the anal canal.

BACKGROUND: The muscle structures surrounding the anal canal are of major importance in maintaining continence but their anatomy and function vary along its length. Standard manometry does not provide detailed information about mechanical properties of the anal canal. A new functional luminal imaging probe (FLIP) has been developed for this purpose. The aim of our study was to investigate whether FLIP allows detailed evaluation of dynamic biomechanical properties along the length of the anal canal. METHODS: The in vitro validity and reproducibility of the FLIP system were tested. Fifteen healthy volunteers (age 32-65 years, mean 51 years), of whom 12 were females, were investigated. The integrity and dimensions of the anal sphincter apparatus were evaluated with endoanal ultrasonography and standard anal manometry. During standardized distensions with the FLIP, 16 cross-sectional areas of the anal canal were measured at 5-mm intervals. Distensibility of the following three segments was evaluated: upper anal canal (surrounded by the internal anal sphincter and the puborectalis muscle), mid-anal canal (surrounded by the internal anal sphincter and the external anal sphincter) and lower anal canal (surrounded by the external anal sphincter). Color contour plots were generated from the FLIP-based dynamic recordings of serial cross-sections. RESULTS: In vitro tests confirmed the validity and reproducibility of the FLIP system. The luminal geometry during distension and the biomechanical properties of the anal canal differed at the three levels. Both at rest and during squeeze the mid-anal canal was significantly less distensible than the upper (p < 0.01) and the lower (p < 0.05) anal canal. CONCLUSIONS: FLIP is a promising method for evaluation of the nonhomogeneous biomechanical properties along the length of the anal canal.

Suboptimal outcome following sacral nerve stimulation for faecal incontinence.

BACKGROUND: The aim of the study was to identify the incidence of suboptimal therapeutic responses and adverse events associated with sacral nerve stimulation (SNS) for faecal incontinence, and to determine their influence on treatment outcome. METHODS: Prospectively collected data from 176 patients who underwent SNS were reviewed retrospectively. Patient variables and reportable events were analysed by binary regression to identify the predictors of treatment outcome. RESULTS: Overall, 592 reportable events were recorded from 150 patients (85·2 per cent) at a median of 11 (interquartile range (i.q.r.) 4-26) months. Loss of efficacy (212 events, 87 patients), lack of efficacy (186 events, 68 patients) and pain/discomfort (126 events, 67 patients) accounted for 88·5 per cent of reportable events. Loss of efficacy (odds ratio (OR) 2·52, 95 per cent confidence interval 1·33 to 4·79; P = 0·007), lack of efficacy (OR 2·80, 1·46 to 5·36; P = 0·002) and pain in the leg (OR 4·07, 1·34 to 12·33; P = 0·013) were predictors of unfavourable outcome in the medium to long term. At a median follow-up of 33 (i.q.r. 20-52) months, 31 patients (17·6 per cent) had explantation of the device or discontinued treatment. CONCLUSION: Suboptimal therapeutic responses and adverse events are not uncommon when SNS is employed for faecal incontinence. They have a negative impact on treatment outcome.

Poor outcome of sphincter repair: an evacuation problem?

INTRODUCTION: Colorectal transport in idiopathic fecal incontinence has scarcely been studied, and it remains to be investigated in patients with fecal incontinence and anal sphincter lesion. The aim of the present study was to compare colorectal transport during defecation in patients with idiopathic fecal incontinence and patients with fecal incontinence due to anal sphincter lesions with transport in healthy volunteers. METHOD: Five women with idiopathic fecal incontinence (median age 72 years, range: 58-78 years) and five women with an obstetric sphincter lesion (median age 42 years, range: 28-63 years), four of whom had had previous anal sphincter repair, were compared with nine healthy female volunteers (median age 53 years, range 32-57 years). Colorectal scintigraphy was performed to assess colorectal emptying at defecation as well as segmental antegrade and retrograde transport during defecation. Segmental colorectal transit times were determined using radio-opaque markers. RESULTS: Median colorectal emptying time at defecation was significantly lower in the sphincter lesion group compared with the healthy volunteers (P = 0.009). At defecation, median antegrade transport time from the ascending colon was significantly lower in the sphincter lesion group than in the healthy group (P = 0.02). The median segmental transit time from the rectosigmoid colon was higher in the group with a sphincter lesion than in the healthy group (P = 0.05). There were no statistically significant differences between the group with idiopathic fecal incontinence and the healthy volunteers. CONCLUSION: Patients with fecal incontinence due to sphincter lesions, but not those with idiopathic fecal incontinence, have reduced transport from the cecum/ascending colon and from the rectosigmoid colon at defecation.