Long-term results of sacral neuromodulation for the treatment of anorectal diseases.

INTRODUCTION: Sacral neuromodulation (SNM) aims to improve anorectal function in patients with disorders of anal continence and rectal emptying. The mechanism of action of SNM is not well known, and its indications are still under evaluation. We report the functional results and morbidity of a prospective cohort treated between 2002 and 2019. RESULTS: A total of 284 patients (of 423 tested) had implantation of a SNM. Five patients (1.8%) were lost to follow-up. Among those who had implantation, the indications for SNM were anal incontinence (n=376), refractory constipation (n=17), anterior resection syndrome (n=13), solitary rectal ulcer syndrome (n=7), and chronic inflammatory bowel disease (IBD) (n=10). The morbidity rate was 2.7% (Dindo-Clavien>2), 33 patients (11%) required explantation for infection (n=5), pain (n=2), inefficacy (n=24) or other reasons (rectal cancer) (n=3). It was necessary to change the stimulator in 68 patients (24%) during the follow-up period. Regarding the group of patients with anal incontinence, functional results showed improvement of the incontinence score in 40% and of quality of life in 25% after a mean follow-up of 55months. CONCLUSION: SNM constitutes a mini-invasive treatment associated with low morbidity. Its' efficacy in anal incontinence makes it a priority approach. Other indications are still under evaluation; while results are promising, they are highly variable.

Sacral nerve modulation for faecal incontinence: influence of age on outcomes and complications. A multicentre study.

AIM: Faecal incontinence is frequent in the elderly. Little is currently known about the efficacy of sacral nerve modulation (SNM) in the elderly. The present study aimed to assess the impact of age on the outcome of SNM and on the surgical revision and explantation rates by comparing the results of a large data set of patients. METHOD: Prospectively collected data from patients who underwent an implant procedure between January 2010 and December 2015 in seven French centres were retrospectively evaluated. In total, 352 patients [321 women; median age (range): 63 (24-86) years] were included. Clinically favourable and unfavourable outcomes, and surgical revision and explantation rates, were compared according to the age of the patients. RESULTS: A similar outcome was observed when comparing patients < 70 years and ≥ 70 years (a favourable outcome in 79.2% and 76.2%, respectively, P = 0.89). The probability of a successful treatment as a function of time was similar for the two age groups (< 70 years and ≥ 70 years, P = 0.54). The explantation and revision rates were not influenced by age (explantation rate: 17% in patients < 70 years vs 14% in patients ≥ 70 years, P = 0.89; and revision rate: 42% in patients < 70 years vs 40% in patients ≥ 70 years, P = 0.89). The probability of explantation as a function of time was similar for the two age groups (P = 0.82). The limitations of this study were its retrospective status, the rate of loss at follow-up and different durations of patient follow-up. CONCLUSIONS: Our results suggest that patients ≥ 70 years suffering from faecal incontinence benefit from SNM with a similar risk as a younger population.

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

BACKGROUND: The aim was to assess the effects of percutaneous tibial nerve stimulation (PTNS) in the treatment of faecal incontinence (FI) by means of an RCT. METHODS: Patients aged over 18 years with FI were included in a multicentre, single-blinded RCT. The primary endpoint was reduction in the median or mean number of FI episodes per week. Secondary endpoints were changes in measures of FI severity, and disease-specific and generic quality of life. Outcomes were compared between PTNS and sham stimulation after 9 weeks of treatment. RESULTS: A higher proportion of patients in the PTNS (13 of 29) than in the sham (6 of 30) group showed a reduction of at least 50 per cent in the median number of FI episodes/week (incidence rate ratio (IRR) 2·40, 95 per cent c.i. 1·10 to 5·24; P = 0·028), but not in the mean number of episodes/week (10 of 29 versus 8 of 30; IRR 1·42, 0·69 to 2·92; P = 0·347). The absolute median number of FI episodes per week decreased in the PTNS but not in the sham group (IRR 0·66, 0·44 to 0·98; P = 0·041), as did the mean number (IRR 0·65 (0·45 to 0·97); P = 0·034). Scores on the Cleveland Clinic Florida faecal incontinence scale decreased significantly in both groups, but more steeply in the PTNS group (mean difference -1·3, 95 per cent c.i. -2·6 to 0·0; P = 0·049). The aggregated mental component score of Short Form 36 improved in the PTNS but not in the sham group (mean difference 5·1, 0·5 to 9·6; P = 0·028). CONCLUSION: PTNS may offer a small advantage in the clinical management of FI that is insufficiently responsive to conservative treatment. The key challenge will be to identify patients who may benefit most from this minimally invasive surgical procedure. Registration number: NCT00974909 (http://www.clinicaltrials.gov).

Randomized clinical trial of sacral nerve stimulation for refractory constipation.

BACKGROUND: Open studies have reported favourable results for sacral nerve stimulation in the treatment of refractory constipation. Here, its efficacy was assessed in a double-blind crossover RCT. METHODS: Patients with at least two of the following criteria were included: fewer than three bowel movements per week; straining to evacuate on more than 25 per cent of attempts; or sensation of incomplete evacuation on more than 25 per cent of occasions. Response to therapy was defined as at least three bowel movements per week and/or more than 50 per cent improvement in symptoms. Responders to an initial 3-week peripheral nerve evaluation were offered permanent implantation of a pulse generator and were assigned randomly in a crossover design to two 8-week intervals of active or sham stimulation. At the end of the two trial periods, the patients received active stimulation until the final evaluation at 1 year. RESULTS: Thirty-six patients (34 women; mean(s.d.) age 45(14) years) underwent peripheral nerve evaluation. Twenty responded and received a permanent stimulator. A positive response was observed in 12 of 20 and 11 of 20 patients after active and sham stimulation periods respectively (P = 0·746). Pain related to the device occurred in five patients and wound infection or haematoma in three, leading to definitive removal of the pulse generator in two patients. At 1 year, 11 of the 20 patients with an implanted device continued to respond. Stimulation had no significant effect on colonic transit time. CONCLUSION: These results do not support the recommendation of permanent implantation of a pulse generator in patients with refractory constipation who initially responded to temporary nerve stimulation. Registration number: NCT01629303 (http://www.clinicaltrials.gov).

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.

Sacral nerve stimulation for faecal incontinence and constipation: a European consensus statement.

AIM: In Europe during the last decade sacral nerve stimulation (SNS) or sacral neuromodulation (SNM) has been used to treat faecal incontinence (FI) and constipation. Despite this, there is little consensus on baseline investigations, patient selection and operative technique. A modified Delphi process was conducted to seek consensus on the current practice of SNS/SNM for FI and constipation. METHOD: A systematic literature search of SNS for FI and constipation was conducted using PubMed. A set of questions derived from the search and expert opinion were answered on-line on two occasions by an international panel of specialists from Europe. A 1-day face-to-face meeting of the experts finalized the discussion. RESULTS: Three hundred and ninety-three articles were identified from the literature search, of which 147 fulfilled the inclusion criteria. Twenty-two specialists in FI and constipation from Europe participated. Agreement was achieved on 43 (86%) of 50 domains including the set-up of service, patient selection, baseline investigations, operative technique and programming of the device. The median of agreement was 95% (35-100%). CONCLUSION: Consensus was achieved on the majority of domains of SNS/SNM for FI and constipation. This should serve as a benchmark for safe and quality practice of SNS/SNM in Europe.

Percutaneous tibial nerve stimulation vs sacral nerve stimulation for faecal incontinence: a comparative case-matched study.

AIM: The study assessed the initial experience with posterior tibial nerve stimulation (PTNS) for faecal incontinence and compared it with sacral nerve stimulation (SNS) performed in a single centre during the same timespan. METHOD: A retrospective review of a prospectively collected database was conducted at the colorectal unit, University Hospital, Nantes, France, from May 2009 to December 2010. Seventy-eight patients diagnosed with chronic severe faecal incontinence underwent neurostimulation including PTNS in 21 and SNS in 57. The main outcome measures were faecal incontinence (Wexner score) and quality of life (Fecal Incontinence Quality of Life, FIQL) scores in a short-term follow-up. RESULTS: No significant differences were observed in patients' characteristics. Of 57 patients having SNS, 18 (32%) failed peripheral nerve evaluation and 39 (68%) received a permanent implant. Two (5%) developed a wound infection. No adverse effects were recorded in the PTNS group. There was no significant difference in the mean Wexner and FIQL scores between patients having PTNS and SNS at 6 (P = 0.39 and 0.09) and 12 months (P = 0.79 and 0.37). A 50% or more improvement in Wexner score was seen at 6 and 12 months in 47% and 30% of PTNS patients and in 50% and 58% of SNS patients with no significant difference between the groups. CONCLUSION: Posterior tibial nerve stimulation is a valid method of treating faecal incontinence in the short term when conservative treatment has failed. It is easier, simpler, cheaper and less invasive than SNS with a similar short-term outcome.

Surgical approaches to fecal incontinence in the adult.

Surgical treatment of anal incontinence is indicated only for patients who have failed medical treatment. Sphincterorraphy is suitable in case of external sphincter rupture. In the last decade, sacral nerve stimulation has proven to be a scientifically validated solution when no sphincter lesion has been identified and more recently has also been proposed as an alternative in cases of limited sphincter defect. Anal reconstruction using artificial sphincters is still under evaluation in the literature, while indications for dynamic graciloplasty are decreasing due to its complexity and high morbidity. Less risky techniques involving intra-sphincteric injections are being developed, with encouraging preliminary results that need to be confirmed especially in the medium- and long-term. Antegrade colonic enemas instilled via cecostomy (Malone) can be an alternative to permanent stoma in patients who are well instructed in the techniques of colonic lavage. Stomal diversion is a solution of last resort.

Does the magnetic anal sphincter device compare favourably with sacral nerve stimulation in the management of faecal incontinence?

AIM: The magnetic anal sphincter (MAS) is a recent surgical innovation for severe faecal incontinence (FI). With its place in the treatment algorithm of FI yet to be defined, we report a nonrandomized comparison between MAS and sacral nerve stimulation (SNS) in a single-centre cohort of patients with FI. METHOD: Data were reviewed from prospective databases. From December 2008 to December 2010, 12 women [median age 65 (42-76) years], having FI for a median of 6.5 years, were implanted with a MAS. Sixteen women, of similar age, preoperative function scores, aetiology and duration of incontinence, and implanted with a permanent SNS pulse generator during the same period, served as a reference group. The duration of hospital stay, complications, change in incontinence and quality of life scores and anal physiology were compared between the two groups. RESULTS: The duration of follow up was similar [MAS = 18 (8-30) months vs SNS = 22 (10-28) months; P = 0.318]. Four patients with MAS experienced a 30-day complication, and the device was removed from one patient in each group. A significant improvement in incontinence (P < 0.001) and quality-of-life scores (P < 0.04) occurred in both groups. Mean anal resting pressure increased significantly in patients implanted with a MAS (P = 0.027). CONCLUSION: In this single-centre nonrandomized cohort of FI patients, MAS was as effective as SNS in improving continence and quality of life, with similar morbidity. These results can now serve as a prelude to a randomized trial comparing the procedures.

Predictive factors for successful sacral nerve stimulation in the treatment of faecal incontinence: results of trial stimulation in 200 patients.

AIM: Sacral nerve stimulation (SNS) has a place in the treatment algorithm for faecal incontinence (FI). However, after implantation, 15-30% of patients with FI fail to respond for unknown reasons. We investigated the effect of SNS on continence and quality of life (QOL) and tried to identify specific predictive factors of the success of permanent SNS in the treatment of FI. METHOD: Two hundred consecutive patients (six men; median age = 60; range 16-81) underwent permanent implantation for FI. The severity of FI was evaluated by the Cleveland Clinic Score. Quality of life was evaluated by the French version of the American Society of Colon and Rectal Surgeons (ASCRS) quality of life questionnaire (FIQL). All patients underwent a preoperative evaluation. After permanent implantation, severity and QOL scores were reevaluated after six and 12 months and then once a year. RESULTS: The severity scores were significantly reduced during SNS (P = 0.001). QOL improved in all domains. At the 6-month follow-up, the clinical outcome of the permanent implant was not affected by age, gender, duration of symptoms, QOL, main causes of FI, anorectal manometry or endoanal ultrasound results. Only loose stool consistency (P = 0.01), persistent FI even though diarrhoea was controlled by medical treatment (P = 0.004), and low stimulation intensity (P = 0.02) were associated with improved short-term outcomes. Multivariate analysis confirmed that loose stool consistency and low stimulation intensity were related to a favourable outcome. CONCLUSION: Stool consistency and low stimulation intensity have been identified as predictive factors for the short-term outcome of SNS.

Long-term results of Malone's procedure with antegrade irrigation for severe chronic constipation.

AIM: The Malone antegrade colonic enema (MACE) procedure is a minimally invasive treatment for severe constipation, and the objective of the present study was to assess the long-term results and quality of life in patients undergoing such colonic irrigation. METHOD: Twenty-five adult patients underwent MACE between 1995 and 2002 for chronic constipation. After a mean follow-up duration of 55+/-36 months, the patients answered questionnaires to assess stoma usage, constipation score (KESS) and quality of life (GIQLI). RESULTS: The mean quality-of-life scores for these patients was 83+/-28 (normal: 125), while their mean constipation score was 19+/-9 (normal: <7). Twelve patients stopped the irrigations, and eight underwent further surgical procedures, specifically, total colectomy with ileostomy (n=2), ileorectal anastomosis (n=3) or segmental colectomy (n=3). Finally, five patients had permanent stoma. The 13 remaining patients continued to perform irrigations (4.6 per week). The patients' mean KESS score was 18.3+/-8 (normal: <7), and the mean GIQLI score was 98+/-20 (normal: 125). Continence status had no influence on success. CONCLUSION: In our series, MACE was successful in half the patients who were, thus, able to avoid more aggressive approaches. However, when MACE failed, other surgical procedures were often required.

Sacral nerve stimulation in faecal incontinence: position statement based on a collective experience.

OBJECTIVE: Since the first paper published by Matzel et al., in 1995, on the efficacy of sacral nerve stimulation (SNS) in patients with faecal incontinence, the indications, the contraindications, the stimulation technique and follow up of implanted patients have changed. The aim of this article was to provide a consensus opinion on the management of patients with faecal incontinence treated with SNS. METHOD: Recommendations were based on a critical review of the literature when available and on expert opinions in areas with insufficient evidence. RESULTS: We have reviewed the indications and contraindications, proposed an algorithm for patient management showing the place of SNS. The temporary test technique, the implantation technique, the patient follow up and the approach in case of treatment failure were discussed. CONCLUSION: We hope not only to provide a guide on patient management to clinical practitioners interested in SNS but also to harmonize our practices.

Value of sacral nerve stimulation in the treatment of severe faecal incontinence: a comparison to the artificial bowel sphincter.

OBJECTIVE: Sacral nerve stimulation (SNS) is a recent treatment option in the management of severe faecal incontinence (FI) that offers promising results. The aim of this study was to compare SNS to artificial bowel sphincter (ABS) implanted patients to assess the rationale of this approach in achieving satisfying functional results and improved quality of life (QoL). METHOD: Among 27 patients tested (December 2001 and April 2004), 15 patients were successfully managed with SNS. They were compared to 15 matched patients implanted with ABS in a previous period (control group). Assessment of continence level (Cleveland Clinic score), constipation score (Knowles, Eccersley, Scott Score) and QoL (Short-Form 36) were prospectively collected. RESULTS: Both groups were comparable for clinical parameters (age, gender, anal testing and aetiology of incontinence) and anal physiology. The mean postoperative continence score was significantly higher in the SNS group [9.4 (+/-3.3) vs 5.7 (+/-3.9), P < 0.01]; however, the mean constipation score was higher in the ABS group (6.3 +/- 6.3 vs 12.8 +/- 5.7, P < 0.01). The mean QoL score was similar in both groups. The mean follow-up after implantation was 15 (+/-9) months in the SNS group, and 43 (+/-33) months in the ABS group. CONCLUSION: In this study, SNS offers satisfying results in terms of QoL, similar to that of ABS. Although it seems to be less effective in restoring continence level, symptoms of outlet obstruction are more frequent after ABS. This SNS approach should be proposed as a first-line treatment of FI in selected patients. ABS should remain an option that can improve function.

Poor symptomatic relief and quality of life in patients treated for "solitary rectal ulcer syndrome without external rectal prolapse".

BACKGROUND: Solitary rectal ulcer syndrome (SRUS) is a chronic disabling condition. Several therapeutic options have been advocated including conservative approaches and surgery, bringing into question their functional outcomes. This study aimed to assess treatment procedures on both anorectal complaints and quality of life (QoL) using standardised self-administered questionnaires. MATERIALS AND METHODS: Forty-one patients who underwent treatments for SRUS in two referral centres were reviewed. A standardised self-administered questionnaire including incontinence (Cleveland Clinic), constipation (Knowles-Eccersley-Scott symptom, KESS) and gastrointestinal quality of life index validated scoring systems was mailed to each patient (median follow-up, 36 months). Correlation between treatment options, functional results and quality of life was analysed. RESULTS: The mean Cleveland Clinic and KESS scores were respectively 5.3+/-5.8 (normal 0) and 19.1+/-8 (normal<9). The mean QoL score reached 89+/-28.8 (normal 125). A linear correlation between the QoL score and functional results was observed. There was no influence of treatment options on QoL results. A multivariate analysis identified five parameters predictive of a better QoL: presence of paradoxical puborectalis contraction, absence of descending perineum, absence of procidentia, age<40 and treatment exclusively based on laxatives. CONCLUSION: Despite several therapeutic options including surgery, patients with SRUS still frequently complain of disturbed anorectal function and significant alteration of their QoL.

Clinical spectrum and surgical approach of adult intussusceptions: a multicentric study.

BACKGROUND: The preoperative diagnosis of adult intussusceptions (AIs) remains difficult, and the assessment of the radiological methods has been evaluated very little in the literature. The aim of this study was to evaluate the interest of the different imaging modalities for the preoperative diagnosis of AI and describe causes of AI. PATIENTS AND METHODS: Consecutive patients of 15 years and older with the postoperative diagnosis of intussusception from 1979 to 2004 were reviewed retrospectively for this multicentric study. Data concerning clinical considerations, morphological examinations, surgical procedure, histological conclusions, mortality rate and recurrence were analysed. RESULTS: Forty-four patients with documented intussusception were included. The mean age was 51 years (15-93 years). The preoperative diagnosis of intussusception was made in 52% of the cases. The sensitivities of the different radiological methods were abdominal ultrasounds (35%), upper gastrointestinal barium study (33%), abdominal computed tomography (CT) (58%) and barium enema (73%). An organic lesion was identified in 95% of the cases. There was 29 enteric and 15 colonic (including appendicular) intussusceptions. Thirty-seven percent of the enteric lesions were malignant, and a bit less than 50% of them were metastatic melanomas. The benign enteric lesions were Meckel's diverticulum and Peutz-Jeghers syndrome in half of the cases. Fifty-eight percent of the pure colonic lesions (excluding appendix) were malignant, and 85% of them were primary adenocarcinomas. The benign colonic lesions were lipomas in 80% of the cases. All patients, except one, had a surgical treatment, and 13 of them had a complete reduction of the intussusception before resection. The mortality rate was 16% and recurrence occurred in three patients; two of them had a Peutz-Jeghers syndrome. CONCLUSION: Intussusception rarely occurs in adults, but nearly half of their causes are malignant. The CT scan is a helpful examination for enteric intussusceptions whether barium enema seems to be the most performing method for colonic lesions. Surgery is the recommended treatment, with or without a primary reduction of the intussusception. During the surgical procedure, this reduction can lead to a more limited bowel resection.