Impact of Gastric Electrical Stimulation on Economic Burden of Refractory Vomiting: A French Nationwide Multicentre Study.

BACKGROUND & AIMS: Medico-economic data of patients suffering from chronic nausea and vomiting are lacking. In these patients, gastric electrical stimulation (GES) is an effective, but costly treatment. The aim of this study was to assess the efficacy, safety and medico-economic impact of Enterra therapy in patients with chronic medically refractory nausea and vomiting. METHODS: Data were collected prospectively from patients with medically refractory nausea and/or vomiting, implanted with an Enterra device and followed for two years. Gastrointestinal quality of life index (GIQLI) score, vomiting frequency, nutritional status and safety were evaluated. Direct and indirect expenditure data were prospectively collected in diaries. RESULTS: Complete clinical data were available for142 patients (60 diabetic, 82 non-diabetic) and medico-economic data were available for 96 patients (36 diabetic, 60 non-diabetic), 24 months after implantation. GIQLI score increased by 12.1 ± 25.0 points (p < .001), with a more significant improvement in non-diabetic than in diabetic patients (+15.8 ± 25.0 points, p < .001 versus 7.3 ± 24.5 points, p = .027, respectively). The proportion of patients vomiting less than once per month increased by 25.5% (p < .001). Hospitalisations, time off work and transport were the main sources of costs. Enterra therapy decreased mean overall healthcare costs from 8873 US$ to 5525 US$ /patient/year (p = .001), representing a saving of 3348 US$ per patient and per year. Savings were greater for diabetic patients (4096 US$ /patient/year) than for non-diabetic patients (2900 US$ /patient/year). CONCLUSIONS: Enterra therapy is an effective, safe and cost-effective option for patients with refractory nausea and vomiting. CLINICALTRIALS: gov Identifier: NCT00903799.

Ten-year Evaluation of a Large Retrospective Cohort Treated by Sacral Nerve Modulation for Fecal Incontinence: Results of a French Multicenter Study.

OBJECTIVE: The aim of this study was to assess the effectiveness of sacral nerve modulation (SNM) in a large cohort of patients implanted for at least 10 years, quantify adverse event rates, and identify predictive factors of long-term success. SUMMARY BACKGROUND DATA: Few studies have evaluated the long-term success of SNM. METHODS: Data collected prospectively from patients implanted for fecal incontinence (FI) in 7 French centers between January 1998 and December 2008 were retrospectively analyzed. Patient FI severity scores were assessed before and 10 years after implantation. The main evaluation criterion was the success of SNM defined by the continuation of the treatment without additional therapies. The secondary evaluation criteria were the rate of device revisions and explantations. Preoperative predictors of success at 10 years were sought. RESULTS: Of the 360 patients (27 males, mean age: 59 ± 12 years) implanted for FI, 162 (45%) had a favorable outcome 10 years post-implantation, 115 (31.9%) failed, and 83 (23.1%) were lost to follow-up. The favorable outcome derived from the time-to-event Kaplan-Meier curve at 10 years was 0.64 (95% CI 0.58-0.69). FI severity scores were significantly better 10 years post-implantation compared to preimplantation (7.4 ± 4.3 vs 14.0 ± 3.2; P < 0.0001). During the 10-year follow-up, 233 patients (64.7%) had a surgical revision and 94 (26.1%) were explanted. A history of surgery for FI and sex (male) were associated with an increased risk of an unfavorable outcome. CONCLUSIONS: Long-term efficacy was maintained in approximately half of the FI patients treated by SNM at least 10 years post-implantation.

Effectiveness of Non-Pharmacological Interventions for Irritable Bowel Syndrome: A Systematic Review.

INTRODUCTION: Given the complexity of the therapeutic management of irritable bowel syndrome (IBS), alternative non-pharmacological therapies are frequently offered to patients. The aim of this study was to conduct a systematic review in order to establish the current evidence base for non-pharmacological interventions (body-directed and mind-body therapies) in the management of IBS. MATERIALS AND METHODS: The literature was searched in several electronic databases (PubMed (including Medline), Web of Science (Clarivate Analytics), Scopus (Elsevier), ScienceDirect (Elsevier), Cochrane Library (Wiley), and Wiley Online Library (Wiley)) for randomized controlled trials (RCTs) published in the English language from 1990 to 2020. Effectiveness outcomes were examined through the change in overall IBS symptoms or abdominal pain up to 12 months after treatment. RESULTS: 11 studies (parallel-group RCTs) were identified that enrolled 1590 participants in total. Body-directed therapies (acupuncture and osteopathic medicine) showed a beneficial effect compared with standard medical treatment for overall IBS symptoms at 6 months follow-up, while no study found any difference between body-directed and sham therapies for abdominal pain or overall IBS symptoms. It was not possible to conclude whether hypnotherapy was superior to standard medical treatment or supportive therapy for overall IBS symptoms or abdominal pain due to discordant results. CONCLUSIONS: Although body-directed therapies such as acupuncture and osteopathic medicine may be beneficial for overall IBS symptoms, higher-quality RCTs are needed to establish the clinical benefit of non-pharmacological interventions for IBS. An important challenge will be the definition of the optimal control groups to be used in non-pharmacological trials.

Efficacy and safety of sacral nerve modulation for faecal incontinence after pelvic radiotherapy.

OBJECTIVE: To assess the efficacy and safety of sacral nerve modulation (SNM) in patients with faecal incontinence (FI) after pelvic radiotherapy in comparison with results of SNM for FI related to other conditions. METHODS: Prospectively collected data from patients who underwent SNM therapy between January 2010 and December 2015 at 7 tertiary colorectal units were reviewed retrospectively. Patients with FI following pelvic radiotherapy were identified and matched (1:2) for age and sex with 38 patients implanted over the same period for FI without previous radiotherapy. The treatment was considered favourable if the patient reported any therapeutic benefit from SNM, had no further complaints or interventions and did not consider stopping the treatment. Long-term results, surgical revision and definitive explantation rates were compared. RESULTS: Among 352 patients who received a permanent SNM implant, 19 (5.4%) had FI following pelvic radiotherapy. After a mean follow-up of 3.5 ± 1.9 years, the cumulative successful treatment rates were similar between the groups (p = 0.60). For patients with FI following pelvic radiotherapy, the cumulative success rates were 99.4% [85.4-99.8], 96.7% [78.1-99.6], 91.7% [70.4-98.1] and 74.6% [48.4-94.8] at 1, 2, 3 and 5 years respectively. The revision and definitive explantation rates for infection did not differ significantly. CONCLUSION: The long-term success rate of SNM for FI after pelvic radiotherapy is similar to that of SNM for FI related to other more frequent conditions. Our study suggests that FI after pelvic radiotherapy could be improved with SNM without an increased risk of complication.

Gastric Electrical Stimulation Reduces Refractory Vomiting in a Randomized Crossover Trial.

BACKGROUND & AIMS: There have been conflicting results from trials of gastric electrical stimulation (GES) for treatment of refractory vomiting, associated or not with gastroparesis. We performed a large, multicenter, randomized, double-blind trial with crossover to study the efficacy of GES in patients with refractory vomiting, with or without gastroparesis. METHODS: For 4 months, we assessed symptoms in 172 patients (66% women; mean age ± standard deviation, 45 ± 12 years; 133 with gastroparesis) with chronic (>12 months) of refractory vomiting (idiopathic, associated with a type 1 or 2 diabetes, or postsurgical). A GES device was implanted and left unactivated until patients were randomly assigned, in a double-blind manner, to groups that received 4 months of stimulation parameters (14 Hz, 5 mA, pulses of 330 µs) or no stimulation (control); 149 patients then crossed over to the other group for 4 months. Patients were examined at the end of each 4-month period (at 5 and 9 months after implantation). Primary endpoints were vomiting score, ranging from 0 (daily vomiting) to 4 (no vomiting), and the quality of life, assessed by the Gastrointestinal Quality of Life Index scoring system. Secondary endpoints were changes in other digestive symptoms, nutritional status, gastric emptying, and control of diabetes. RESULTS: During both phases of the crossover study, vomiting scores were higher in the group with the device on (median score, 2) than the control group (median score, 1; P < .001), in diabetic and nondiabetic patients. Vomiting scores increased significantly when the device was ON in patients with delayed (P < .01) or normal gastric emptying (P = .05). Gastric emptying was not accelerated during the ON period compared with the OFF period. Having the GES turned on was not associated with increased quality of life. CONCLUSIONS: In a randomized crossover study, we found that GES reduced the frequency of refractory vomiting in patients with and without diabetes, although it did not accelerate gastric emptying or increase of quality of life. Clinicaltrials.gov, Number: NCT00903799.

Is Sacral Nerve Modulation a Good Option for Fecal Incontinence in Men?

OBJECTIVE: The objective was to assess the efficacy and the safety of sacral nerve modulation (SNM) in men with fecal incontinence (FI) compared with those of SNM in women. METHOD: Prospectively collected data from patients from seven tertiary colorectal units who underwent an implant procedure between January 2010 and December 2015 were reviewed retrospectively. Outcomes and surgical revision and definitive explantation rates were compared between men and women. RESULTS: A total of 469 patients (60 men [12.8%]; mean age = 61.4 ± 12.0 years) were included in the study, 352 (78.1%) (31 men [8.8%]) of whom received a permanent implant. The ratio of implanted/tested men was significantly lower than the ratio of implanted/tested women (p = 0.0004). After a mean follow-up of 3.4 ± 1.9 years, the cumulative successful treatment rates tended to be less favorable in men than in women (p = 0.0514): 88.6% (75.6-95.1), 75.9% (60.9-86.4), 63.9% (48.0-77.3), and 43.9% (26.7-62.7) at one, two, three, and five years, respectively, in men; 92.0% (89.1-94.2), 84.2% (80.3-87.4), 76.8% (72.3-80.7), and 63.6% (57.5-69.3) at one, two, three, and five years, respectively, in women. The revision rate for infection and the definitive explantation rate for infection were higher in men than in women (p = 0.0001 and p = 0.0024, respectively). CONCLUSION: Both short- and long-term success rates of SNM for FI were lower in men than in women. The revision and definitive explantation for long-term infection rates were significantly higher in men.

Refractory GERD, beyond proton pump inhibitors.

Pharmacologic therapy, surgery, minimally invasive therapies, and alternative therapies are different options available for the management of refractory GERD. The choice may depend on the cause of refractoriness. Increased gastric acid suppression therapy might be useful in the rare patients with persistent elevated esophageal acid exposure on proton pump inhibitors (PPI). Potassium-competitive acid blockers (P-CAB) might induce a more important acid inhibition than PPI. Baclofen might act as a reflux inhibitor and demonstrates a significant efficacy in rumination syndrome. The role of topical antacid-alginate in refractory GERD might be limited. Surgery might be a valid option in case of persistent pathological acid esophageal exposure despite PPI. Further evaluation of minimally invasive procedures is necessary. Finally diet, diaphragmatic breathing and transcutaneous electrical acustimulation might be of interest in patients with esophageal hypersensivity or functional symptoms.

Perineal retraining improves conservative treatment for faecal incontinence: a multicentre randomized study.

BACKGROUND: Anal incontinence is a frequent complaint that profoundly affects quality of life. Our aim was to determine whether perineal retraining gives additional benefits to standard medical treatment. METHODS: Patients with anal incontinence and a Wexner score >4 were randomly assigned to standard conservative treatment (control) or perineal retraining, including biofeedback, in addition to standard treatments (biofeedback). Diaries, self-administered questionnaires and satisfaction scores quantified the benefits. Self-evaluated improvement was the primary outcome measure. A score ≥3 (in an improvement scale from -5 to +5) defined success. RESULTS: Overall, 157 patients were included; 80 in the control group (75% females, mean age 60.1 ± 13.2 years) and 77 in the biofeedback group (79% females, mean age 61.9 ± 10.2 years). After a 4-month follow-up, the success rate was significantly higher in the biofeedback group (57% versus 37%; p<0.021). In the biofeedback group, daily stool frequency, leakage, and faecal urgency significantly decreased, and daily non-urgent perception of stool increased. Conversely, symptomatic scores and quality of life scales did not significantly differ between groups. In a multivariate model, the adjusted odds ratio showed that perineal retraining was significantly associated with a higher chance of self-rated improvement (adjusted Odd Ratio [95%CI]: 2.34 [1.14-4.80]; p=0.021). CONCLUSIONS: Perineal retraining offers a moderate but significant benefit for patients suffering from anal incontinence.

Sacral nerve stimulation for fecal incontinence improves symptoms, quality of life and patients' satisfaction: results of a monocentric series of 119 patients.

PURPOSE: Sacral nerve stimulation (SNS) is validated as an efficient treatment for fecal incontinence (FI). However, long-term results are scarce in the literature. The goal of this study was to assess the impact of SNS on FI symptoms and quality of life, based on a retrospective analysis of prospectively collected data. METHODS: From 2001 to 2009, 119 patients (six men, mean age 61 years) underwent SNS testing for FI after an extensive diagnostic workup. Permanent implantation was realized when FI symptoms improved during testing, and follow-up visits were performed every 12 months thereafter. This follow-up evaluated morbidity and efficacy, based on clinical data and self-administered questionnaires including Jorge and Wexner FI score, urinary incontinence score (urinary distress inventory-6, UDI-6), gastrointestinal quality of life index (GIQLI), and auto-evaluation scale. RESULTS: A permanent stimulator was implanted after a positive test in 102 patients (91 %). Ten patients were explanted during follow-up (pain in one case and absence of efficacy in nine), and 29 had the stimulator and/or the electrode changed. The mean follow-up was 48 months (range 12-84): there was a significant improvement of FI score (9 ± 1 vs 14 ± 3, p < 0.0001), UDI-6 score (8 ± 4 vs 11 ± 5, p < 0.05), and GIQLI index (p < 0.002). The improvement was present at 12 months follow-up and remained stable. Eighty percent of patients were satisfied with the treatment at the last point of follow-up. None of the pretreatment variables were predictive of SNS efficacy. CONCLUSIONS: SNS improved FI and quality of life, and this efficacy remained over time. Although a complete disappearance of FI was rare, most patients were satisfied.

Outcome and cost analysis of sacral nerve modulation for treating urinary and/or fecal incontinence.

BACKGROUND: Sacral nerve modulation (SNM) is an established treatment for urinary and fecal incontinence in patients for whom conservative management has failed. OBJECTIVE: This study assessed the outcome and cost analysis of SNM compared to alternative medical and surgical treatments. METHODS: Clinical outcome and cost-effectiveness analyses were performed in parallel with a prospective, multicenter cohort study that included 369 consecutive patients with urge urinary and/or fecal incontinence. The duration of follow-up was 24 months, and costs were estimated from the national health perspective. Cost-effectiveness outcomes were expressed as incremental costs per 50% of improved severity scores (incremental cost-effectiveness ratio). RESULTS: The SNM significantly improved the continence status (P < 0.005) and quality of life (P < 0.05) of patients with urge urinary and/or fecal incontinence compared to alternative treatments. The average cost of SNM for urge urinary incontinence was ∈8525 (95% confidence interval, ∈6686-∈10,364; P = 0.001) more for the first 2 years compared to alternative treatments. The corresponding increase in cost for subjects with fecal incontinence was ∈6581 (95% confidence interval, ∈2077-∈11,084; P = 0.006). When an improvement of more than 50% in the continence severity score was used as the unit of effectiveness, the incremental cost-effectiveness ratio for SNM was ∈94,204 and ∈185,160 at 24 months of follow-up for urinary and fecal incontinence, respectively. CONCLUSIONS: The SNM is a cost-effective treatment for urge urinary and/or fecal incontinence.

Transcutaneous electrical posterior tibial nerve stimulation for faecal incontinence: effects on symptoms and quality of life.

PURPOSE: Faecal incontinence is a disabling symptom which may be particularly difficult to treat. Recent studies showed that transcutaneous electrical posterior tibial nerve stimulation may improve faecal continence. In this study, we aimed to evaluate the effectiveness of this technique and tried to individualize predictive factors of success. METHODS: Twenty-four patients suffering from faecal incontinence were treated 20 min per day by applying transcutaneous electrical posterior tibial nerve stimulation for 3 months. A clinical evaluation was performed at the end of treatment, with Wexner's score and analogical scales for symptoms. After 3 months, if the treatment was successful, patients were proposed to continue on the treatment. Predictive factors such as age, symptom duration, proctologic history, obstetrical history, ano-rectal manometric data and quality-of-life score were also analysed. RESULTS: At 3 months, 13 patients (54%) reported a significant symptomatic improvement with a significant modification in the Wexner's score (14 vs 12, p < 0.025). At a median follow-up of 15 months, there were still 11 patients whose condition was improved. CONCLUSION: This study shows encouraging mid-term results, and even if further randomized studies are necessary, transcutaneous electrical posterior tibial nerve stimulation may be a new and easy-to-use therapeutic option to treat faecal incontinence.

Transcutaneous posterior tibial nerve stimulation for fecal incontinence in inflammatory bowel disease patients: a therapeutic option?

BACKGROUND: Fecal incontinence associated with inflammatory bowel disease (IBD) may be particularly difficult to treat. Two recent studies showed that transcutaneous posterior tibial nerve stimulation may improve fecal continence. In this pilot study, we tested the usefulness of this noninvasive technique to treat fecal incontinence in IBD. METHODS: Twelve patients with IBD (7 Crohn's disease, 2 undetermined colitis, 3 ulcerative colitis) were treated by applying transcutaneous posterior tibial nerve electrical stimulation daily for 3 months. A clinical evaluation was performed at the end of treatment, with Wexner's score and Harvey-Bradshaw index and analog scales to assess symptoms and quality of life. RESULTS: At 3 months, 5 patients (41.6%) reported a significant symptomatic and quality of life improvement, although only 1 reported a significant modification in the Wexner score. CONCLUSION: These preliminary results are encouraging, although further studies are necessary. Posterior tibial nerve electrical stimulation may represent a new therapeutic option to treat the difficult problem of fecal incontinence in patients with IBD.

Efficacy of sacral nerve stimulation for fecal incontinence: results of a multicenter double-blind crossover study.

BACKGROUND AND AIMS: This is the first double-blind multicenter study examining the effectiveness of sacral nerve stimulation in a significant number of fecally incontinent patients. METHODS: A total of 34 consecutive patients (31 women), median age 57 years (range, 33-73 years), underwent sacral nerve stimulation for fecal incontinence. After implantation, 27 of 34 patients were randomized in a double-blind crossover design to stimulation ON or OFF for 1-month periods. While still blinded, the patients chose the period of stimulation (ON or OFF) that they had preferred. The mode of stimulation corresponding to the selected period was continued for 3 months (final period). Outcome measures were frequency of fecal incontinence and urgency episodes, delay in postponing defecation, score severity, feeling of improvement, preference for ON or OFF, quality of life, and manometric measurements. RESULTS: In the crossover portion of the study, the self-reported frequency of fecal incontinence episodes was significantly reduced during the ON versus the OFF period (P = 0.03), and this symptomatic improvement was consistent: 1) with the patients feeling of greater improvement during the ON versus OFF period (P = 0.02); 2) with the significant preference of patients (P = 0.02) for the ON versus OFF period. In the final period of the study, the frequency of fecal incontinence episodes decreased significantly (P = 0.005) in patients with the stimulator ON. The ability to postpone defecation (P = 0.01), the score for symptom severity (P = 0.0004), and the quality of life (P < 0.05) as well as anal sphincter function significantly improved. CONCLUSIONS: The significant improvement in FI during the ON versus OFF period indicated that the clinical benefit of sacral nerve stimulation was not due to placebo.