Evaluation of the efficacy of sacral neuromodulation in the treatment of voiding dysfunction after endometriosis surgery.

Pelvic surgery for endometriosis is associated with a risk of bladder and digestive sequelae. Sacral neuromodulation (SNM) has been shown to be effective in the treatment of overactive bladder (OAB) and voiding dysfunction (VD). This study aimed to evaluate the efficacy of sacral neuromodulation (SNM) in treating voiding dysfunction (VD) following endometriosis surgery. A retrospective analysis was conducted on data from women who underwent SNM testing for persistent VD after endometriosis surgery. The study included 21 patients from a French tertiary referral center. Patient characteristics, lower urinary tract symptoms, urodynamic findings, SNM procedures, and outcomes were assessed. The primary outcome was the success of SNM treatment for VD. After a median follow-up of 55 months, 60% of patients achieved successful outcomes, with significant improvements of VD and quality of life. Moreover, more than half of patients who required clean intermittent self-catheterization (CISC) before SNM were able to wean off CISC. Complications such as infections and paraesthesia were observed, but overall, SNM was found to be effective and well tolerated. Age and the interval between endometriosis surgery and SNM testing were associated with treatment success. This study adds to the limited existing literature on SNM for VD after endometriosis surgery and suggests that SNM can be a valuable therapeutic option for these patients. Further research is needed to identify predictive factors and mechanisms underlying the effectiveness of SNM in this context. MRI-compatible and rechargeable devices, has improved the feasibility of SNM for these patients. In conclusion, SNM offers promise as a treatment option for persistent VD after endometriosis surgery, warranting further investigation. LEVEL OF EVIDENCE: 4.

Is sacral nerve modulation reprogramming effective after permanent implantation for faecal incontinence?

AIM: Sacral nerve modulation (SNM) is recommended as a first-line surgical therapy for patients with faecal incontinence (FI). During patient follow-up, it is recommended that stimulation settings be reprogrammed to optimize patient outcomes. The aim of the present study was to evaluate the efficacy of stimulator reprogramming in patients with an implanted SNM device to treat FI. METHOD: The data from patients who received a permanent SNM implant in a single centre from January 2008 to December 2019 were retrospectively analysed. Symptoms that occurred after implantation, the stimulator settings of the SNM device and changes made at each follow-up visit were noted. The efficacy of reprogramming was determined by assessing patient satisfaction. RESULTS: Of the 117 patients (male/female 4/113; mean age 59.5 ± 11.8 years) with a SNM implant for FI, 84 (72%) had at least one symptom requiring reprogramming of the stimulator, most often during the first year after implantation (p = 0.05). The most frequently reported symptoms were loss of efficacy (68.5%; p = 1 × 10-3 ) and pain (20.5%; p = 1 × 10-3 ). Reprogramming was effective 53% of the time when treating loss of efficacy and 76% of the time when treating pain. When the stimulation parameters were reprogrammed at least four consecutive times to correct a symptom, the reprogramming was less effective in treating the symptom (p = 0.02). CONCLUSION: Regular follow-up of patients with SNM device implants associated with reprogramming of stimulation parameters to improve the treatment of reported symptoms would optimize the efficacy of SNM.

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.

Sacral neuromodulation with the InterStim™ system for faecal incontinence: results from a prospective French multicentre observational study.

AIM: The aim of this work was to evaluate the effectiveness, patient satisfaction and quality of life (QoL) and the safety of sacral neuromodulation (SNM) with the InterStimTM system for the treatment of faecal incontinence (FI) and establish whether results published predominantly by expert sites are generalisable. METHOD: This is a prospective, multicentre, observational study that invited all French sites treating FI with the InterStim™ system to enrol subjects indicated for an SNM therapy evaluation. Data were collected at three follow-up visits within 1 and 15 months. Therapeutic effectiveness was evaluated by the reduction in leakages per week and improvements over time in the ability to defer defaecation and QoL (as measured with the Faecal Incontinence Quality of Life score). Safety was assessed through reported adverse events. RESULTS: A total of 221 subjects with a mean age of 62.1 years were tested (184 women) and 178 received a permanent implant. For all implanted subjects with diary data at baseline and follow-up, a reduction in leakage of more than 50% was observed in 80%, 76% and 83% at 1-3, 4-8 and 9-15 months, respectively. The mean number of leakage episodes and urgency improved significantly compared with the baseline (p < 0.0001). Subjects showed improvements in QoL and time to defer defaecation and were generally satisfied with their therapy. The main device-related adverse event was the requirement to undertake reprogramming (in 52% of subjects with actions following an event). The rates of infection (in 6% of subjects) and surgical revision (in 10% of subjects) were in agreement with literature reports. CONCLUSION: This study confirms the clinical effectiveness, safety and positive effect of SNM on QoL as well as high patient satisfaction for the treatment of FI in real-life.

Efficacy of gastric electrical stimulation in intractable nausea and vomiting at 10 years: A retrospective analysis of prospectively collected data.

BACKGROUND: Gastric electrical simulation has been shown to relieve nausea and vomiting in medically refractory patients. Efficacy of gastric electrical stimulation has been reported mostly in short-term studies, but none has evaluated its efficacy beyond 10 years after implantation. METHODS: Patients implanted at our center for medically refractory severe and chronic nausea and/or vomiting were evaluated before and over 10 years after implantation using symptomatic scale and quality of life (GIQLI) score. Improvement was defined as a reduction of more than 50% in vomiting frequency. KEY RESULTS: A total of 50 patients were implanted from January 1998 to December 2009. Among them, 7 were explanted due to a lack of efficacy and/or side effects, 2 died, and 4 were lost to follow-up. Mean follow-up was 10.5 ± 3.7 years. In intention-to-treat analysis, 27/50 (54%) patients reported an improvement. Beyond 10 years, an improvement in early satiety (3.05 vs 1.76, <0.001), bloating (2.51 vs 1.70, P = .012), nausea (2.46 vs 1.35, P = .001), and vomiting (3.35 vs 1.49 P < .001) scores were observed. Quality of life improved over 10 years (GIQLI score: 69.7 vs. 86.4, P = .005) and body mass index (BMI: 23.4 vs. 26.2 kg/m2 ; P = .048). CONCLUSIONS AND INFERENCES: Gastric electrical simulation is effective in the long-term in patients with medically refractory nausea and vomiting, with an efficacy of 54% at 10 years on an intention-to-treat analysis. Other long-term observational studies are warranted to confirm these results.

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.

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.

Development of a Remote-Controlled Implantable Rat Sacral Nerve Stimulation System.

OBJECTIVES: Sacral nerve stimulation (SNS) is a surgical treatment of urinary and fecal incontinence. Despite its clinical efficacy, the mechanisms of action of SNS are still poorly known. This may be related to the use of acute stimulation models. Up to date, no rodent model of chronic SNS implants has been developed. Therefore, the aim of this study was to create a fully implantable and remotely controllable stimulating device to establish an animal model of chronic SNS. MATERIALS AND METHODS: The stimulating device consisted of an implantable pulse generator linked to a platinum electrode. The communication with the device was made through an inductive link which allowed to adjust the stimulation parameters; that is, to turn the device on and off or check the battery status remotely. Rats underwent two surgical procedures. In the first procedure, we achieved chronic sacral stimulation but the implanted electrode was not fixated. In the second procedure, the electrode was fixated in the sacral foramen using dental resin. In both cases, the correct positioning of the electrode was evaluated by computed tomography (CT) imaging and the presence of tail tremor in response to high intensity stimulation. We only tested the function of implanted electrode with fixation using micturition frequency assessment following bipolar or unipolar SNS for three days after recovery. RESULTS: CT imaging showed that implantation of the electrode required fixation as we found that the second surgical procedure yielded a more precise placement of the implanted electrode. The correct placement of implanted electrode observed with imaging was always correlated with a successful tail tremor response in rats, therefore we pursued our next experiments with the second surgical procedure and only assessed the tail tremor response. We found that both bipolar and unipolar SNS reduced micturition frequency. CONCLUSION: This stimulating device provides an efficient method to perform chronic SNS studies in rats.

Clinical practice guidelines from the French National Society of Coloproctology in treating chronic constipation.

Chronic constipation is a common symptom that regularly affects the quality of life of adult patients. Its treatment is mainly based on dietary rules, laxative drugs, perineal rehabilitation and surgical treatment. The French National Society of Coloproctology offers clinical practice recommendations on the basis of the data in the current literature, including those on recently developed treatments. Most are noninvasive, and the main concepts include the following: stimulant laxatives are now considered safe drugs and can be more easily prescribed as a second-line treatment; biofeedback therapy remains the gold standard for the treatment of anorectal dyssynergia that is resistant to medical treatment; transanal irrigation is the second-line treatment of choice in patients with neurological diseases, but it may also be proposed for patients without neurological diseases; and although interferential therapy may be a new promising treatment, it needs further evaluation.

Effect of submental sensitive transcutaneous electrical stimulation on virtual lesions of the oropharyngeal cortex.

OBJECTIVE: The aim of this study was to assess the effect of submental sensitive transcutaneous electrical stimulation (SSTES) on pharyngeal cortical representation after the creation of an oropharyngeal cortical virtual lesion in healthy subjects. METHODS: Motor-evoked potential amplitude of the mylohyoid muscles was measured with transcranial magnetic stimulation (TMS), the oropharyngeal cortex was mapped by cartography, and videofluoroscopic parameters of swallowing function were measured before and after SSTES (at the end of SSTES [0 min] and at 30 and 60 min), after the creation of a cortical virtual lesion (repetitive TMS, 1 Hz, 20 min on the dominant swallowing hemisphere). RESULTS: Nine subjects completed the study. After 20 min of SSTES, motor-evoked potential amplitude increased (P<0.05), as did swallow reaction time after repetitive TMS, as seen on videofluoroscopy, which was reversed after electrical stimulation. On cortical mapping, the number of points with a cortical response increased in the dominant lesioned hemisphere (P<0.05), remaining constant at 60 min (P<0.05). CONCLUSION: SSTES may be effective for producing cortical plasticity for mylohyoid muscles and reverses oropharyngeal cortical inhibition in healthy subjects. It could be a simple non-invasive way to treat post-stroke dysphagia.

Predictive factors for successful sacral nerve stimulation in the treatment of fecal incontinence: lessons from a comprehensive treatment assessment.

BACKGROUND: Sacral nerve stimulation has a place in the treatment algorithm for fecal incontinence, but the predictive factors of its midterm and long-term success are unknown. OBJECTIVE: The purpose of this study was to investigate the effect of a 3-year sacral nerve stimulation treatment of fecal continence and to identify specific predictive factors from the pretreatment and per-treatment assessments for the midterm success of sacral nerve stimulation. DESIGN: A cohort analysis of consecutive patients treated with sacral nerve stimulation for fecal incontinence over a period of 3 years was performed. SETTINGS: This study was conducted at an academic colorectal unit in a tertiary care center. PATIENTS: Sixty patients were available for the assessment of 3-year outcomes. MAIN OUTCOME MEASURES: Clinical outcome (including Cleveland Clinic score) and anorectal physiological data were collected prospectively before and after treatment. RESULTS: At the 3-year follow-up, 33 of the 60 implanted patients had an improved outcome as defined by a ≥30% improvement in the Cleveland Clinic score from baseline (37.1% on intention to treat and 55.0% per protocol), whereas 22 had an unsuccessful outcome as defined by a <30% improvement in the Cleveland Clinic score from baseline (24.7% on intention to treat and 36.7% per protocol), of whom 7 had their device explanted or switched off permanently before the 3-year assessment, and 3 were lost at follow-up. At 3 years, we failed to identify any factors that could predict the 3-year clinical outcome of sacral nerve stimulation based on preimplantation and postimplantation assessments. LIMITATIONS: This study involved a relatively small number of patients. There was a lack of consistency in the tool used to evaluate the efficacy of the test and permanent stimulations. CONCLUSIONS: Based on per-protocol assessments, 55% of the patients had improved outcomes at the 3-year follow-up. No predictor was identified by the pretreatment and posttreatment assessments (see Video, Supplemental Digital Content 1, http://links.lww.com/DCR/A133).

Long term efficacy of gastric electrical stimulation in intractable nausea and vomiting.

BACKGROUND: Although the efficacy of gastric electrical stimulation has been reported in short-term studies, there is a lack of data on the long-term improvement of nausea and vomiting by gastric electrical stimulation in patients with delayed or normal gastric emptying. METHODS: Thirty-one patients were implanted at our centre for medically refractory severe and chronic nausea and/or vomiting. Patients were evaluated at baseline, 6 months then 5 years after implantation (mean follow-up 80±4 months) using a symptomatic and quality of life scores. KEY RESULTS: Amongst the 31 patients, 4 were lost to follow-up, 6 explanted due to lack of improvement, and 1 patient died. Out of the 20 patients evaluated over 5 years, the quality of life score showed 27% improvement (p<0.01), including nausea (62%; p<0.01), vomiting (111%; p=0.03), satiety (158%; p<0.01), bloating (67%; p<0.01) and epigastric pain (43%; p=0.03). Over 5 years, 15/20 patients reported a 50% improvement with a global satisfaction rated at 64±6%. Therefore, 15/27 patients (56%) were improved by gastric electrical stimulation over 5 years in intention to treat. Improvement of nausea 6 months after implantation was predictive of 5-year success of gastric electrical stimulation (p=0.04). Finally, patients with delayed gastric emptying or with normal gastric emptying rate before surgery were similarly improved over 5 years (60% versus 50% respectively). CONCLUSION: Gastric electrical stimulation is safe and effective in the long term in patients with medically refractory nausea and vomiting, with an efficacy over 50% beyond 5 years in intention to treat. Gastric emptying measured before implantation did not influence the response rate over 5 years.

Gastric electrical stimulation decreases gastric distension-induced central nociception response through direct action on primary afferents.

BACKGROUND & AIMS: Gastric electrical stimulation (GES) is an effective therapy to treat patients with chronic dyspepsia refractory to medical management. However, its mechanisms of action remain poorly understood. METHODS: Gastric pain was induced by performing gastric distension (GD) in anesthetized rats. Pain response was monitored by measuring the pseudo-affective reflex (e.g., blood pressure variation), while neuronal activation was determined using c-fos immunochemistry in the central nervous system. Involvement of primary afferents was assessed by measuring phosphorylation of ERK1/2 in dorsal root ganglia. RESULTS: GES decreased blood pressure variation induced by GD, and prevented GD-induced neuronal activation in the dorsal horn of the spinal cord (T9-T10), the nucleus of the solitary tract and in CRF neurons of the hypothalamic paraventricular nucleus. This effect remained unaltered within the spinal cord when sectioning the medulla at the T5 level. Furthermore, GES prevented GD-induced phosphorylation of ERK1/2 in dorsal root ganglia. CONCLUSIONS: GES decreases GD-induced pain and/or discomfort likely through a direct modulation of gastric spinal afferents reducing central processing of visceral nociception.

Can sacral neuromodulation improve minor incontinence symptoms in doubly incontinent patients successfully treated for major incontinence symptoms?

OBJECTIVE: To describe the effect of sacral nerve modulation (SNM) on less severe types of incontinence in patients who were successfully implanted for either urinary or fecal incontinence, and who presented with double incontinence. When conservative treatments fail, SNM is a first-line treatment for patients with urge urinary or fecal incontinence. METHODS: All patients who received SNM between 2005 and 2010 at 5 hospitals and who still had the implant were included in our survey. All received a urinary and fecal change and quality of life questionnaire by mail to complete. RESULTS: Of the 51 questionnaires sent out, 37 were returned, for a 72.5% response rate. The population was composed of 97.3% women, with a mean age of 56.8 years (SD 14). The main indication for SNM was urge urinary incontinence in 15 patients (40.5%) and fecal incontinence in 22 patients (59.5%). Eighteen patients (48.7%) had improvements in both urinary and fecal incontinence symptoms. The percentage increased to 53.3% (16/30) in the group of patients with urge urinary incontinence associated with fecal incontinence. Patients who reported an improvement in double incontinence symptoms complained more often of urge urinary incontinence than other patients (P=.04). CONCLUSIONS: Of the doubly incontinent patients who were successfully implanted for a predominant type of incontinence (ie, urinary or fecal incontinence), 48.7% had an improvement in the other type of incontinence. Patients with urge urinary incontinence associated with fecal incontinence were more likely to report an improvement in double incontinence than the other patients.

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.

Sensory transcutaneous electrical stimulation improves post-stroke dysphagic patients.

Oropharyngeal dysphagia is frequent in stroke patients and increases mortality, mainly because of pulmonary complications. We hypothesized that sensitive transcutaneous electrical stimulation applied submentally during swallowing could help rehabilitate post-stroke oropharyngeal dysphagia by improving cortical sensory motor circuits. Eleven patients were recruited for the study (5 females, 68 ± 11 years). They all suffered from recent oropharyngeal dysphagia (>eight weeks) induced by a hemispheric (n = 7) or brainstem (n = 4) stroke, with pharyngeal residue and/or laryngeal aspiration diagnosed by videofluoroscopy. Submental electrical stimulations were performed for 1 h every day for 5 days (electrical trains: 5 s every minute, 80 Hz, under motor threshold). During the electrical stimulations, the patients were asked to swallow one teaspoon of paste or liquid. Swallowing was evaluated before and after the week of stimulations using a dysphagia handicap index questionnaire, videofluoroscopy, and cortical mapping of pharyngeal muscles. The results of the questionnaire showed that oropharyngeal dysphagia symptoms had improved (p < 0.05), while the videofluoroscopy measurements showed that laryngeal aspiration (p < 0.05) and pharyngeal residue (p < 0.05) had decreased and that swallowing reaction time (p < 0.05) had improved. In addition, oropharyngeal transit time, pharyngeal transit time, laryngeal closure duration, and cortical pharyngeal muscle mapping after the task had not changed. These results indicated that sensitive submental electrical stimulations during swallowing tasks could help to rehabilitate post-stroke swallowing dysphagia by improving swallowing coordination. Plasticity of the sensory swallowing cortex is suspected.

Gastric electrical stimulation in intractable nausea and vomiting: assessment of predictive factors of favorable outcomes.

BACKGROUND: Gastric electrical stimulation (GES) represents a new therapy in patients with intractable vomiting and nausea. We aimed to determine preoperative factors associated with positive response during GES. Thirty-three consecutive patients received implants for medically refractory nausea or vomiting or both. STUDY DESIGN: Symptoms, Quality of Life (QOL), and gastric emptying (GE) were monitored before and 6 months after implantation. Compared with baseline, dyspeptic symptoms including nausea and vomiting, and QOL all improved at 6 months, yielding a significant weight gain while the GE rate remained unchanged. Twenty-four patients reported improvement; nine remained unimproved at 6 months. RESULTS: In multivariate analysis, baseline QOL and appetite alterations were predictive of improvement; previous history of gastric surgery was associated with failure. Surprisingly, patients with initial delayed GE (21 of 33) displayed similar improvement compared with patients with normal GE. Likewise, basal GE was not found to be predictive of positive outcomes, QOL, or symptoms improvement. CONCLUSIONS: Patients with severe symptoms and altered QOL at inclusion particularly benefit from GES; delay in GE is not predictive of positive outcomes. This suggests that indication for GES should be based on clinical settings rather than initial GE, and then possibly extended to patients with normal GE.

Gastric electrical stimulation in medically refractory nausea and vomiting.

INTRODUCTION: High-frequency gastric electrical stimulation is a new therapeutic option to improve refractory nausea and vomiting, in gastroparetic patients. Its effects on gastric emptying are, however, inconstant and limited. Therefore, we have hypothesized that high-frequency gastric electrical stimulation could be also effective in patients suffering from refractory vomiting and nausea with normal gastric emptying, and we have compared the symptomatic efficacy of high-frequency gastric electrical stimulation between patients with delayed and normal gastric emptying. PATIENTS AND METHODS: Fifteen patients with chronic, severe and medically resistant nausea and vomiting were included in the study. Gastric emptying was delayed in eight patients (Group 1) and normal in seven patients (Group 2). At inclusion and at 6 months after the start of the stimulation, symptoms (nausea and vomiting, bloating, regurgitations, abdominal pain and appetite) and quality of life were prospectively evaluated using the Gastrointestinal Quality of Life Index score whereas gastric emptying was assessed by scintigraphy and/or octanoic acid breath test. RESULTS: Age, sex, symptoms and quality of life were not different at baseline between the two groups. At 6 months, Gastrointestinal Quality of Life Index and nausea/vomiting scores had significantly improved in both groups. Other symptoms (bloating, regurgitations, abdominal pain and appetite) had improved at 6 months in Group 1 but not in Group 2. Six months after the start of stimulation, gastric emptying was normal in 4/8 Group 1 patients and 5/7 Group 2 patients but was not significantly different from that calculated before the implantation of the stimulator. CONCLUSION: Our results suggest that high-frequency gastric electrical stimulation could be an effective therapy for treating chronic, severe vomiting and nausea whether gastric emptying is delayed or not.

Sacral nerve stimulation in fecal incontinence: are there factors associated with success?

PURPOSE: Sacral nerve stimulation has been used successfully in treating fecal incontinence. This study was designed to evaluate the proportion of patients with unsuccessful implantation despite positive test stimulation and to examine and compare factors associated with the success of the transitory and permanent sacral nerve stimulation. METHODS: A total of 61 patients (55 females; median age, 56 (range, 33-77) years) with refractory fecal incontinence underwent temporary stimulation. A 50 percent or greater improvement in the number of episodes of fecal incontinence or urgency was required to proceed to permanent implantation and was the criteria of success of permanent sacral nerve stimulation at the last follow-up visit in implanted patients. The factors compared between the success and the failure groups during temporary and permanent stimulation were patients' age and gender, diagnosis and characteristics of fecal incontinence, previous surgery, quality of life scores, anorectal manometry, endoanal ultrasound, and electrophysiologic tests performed before stimulation. RESULTS: Temporary stimulation was successful in 35 patients (57.4 percent). A permanent neurostimulation device was implanted in 33 patients. Age was the only factor related to success of the temporary stimulation (P=0.03). After permanent implantation, 31 percent of patients did not attain screening phase results for the number of episodes of fecal incontinence or urgency. A neurologic disorder was more frequently the origin of fecal incontinence in the success group compared with others (P=0.03). The left bulbocavernosus reflex was more frequently delayed in the success group than in the others (P=0.03), and a prolonged or absent bulbocavernosus reflex was more frequent in the success group than in the failure group (P=0.03). CONCLUSIONS: Patients with fecal incontinence from neurologic origins could be good candidates for sacral nerve stimulation.

Anal incontinence: the role of medical management.

BACKGROUND AND AIMS: Consensus recommendations suggest that patients with anal incontinence (AI) should be managed by medical treatment when indicated. Our aims were to prospectively evaluate from two different populations of patients: (1) the proportion of incontinent patients referred to a specialized center who were candidates for first line medical treatment (study 1); (2) the results of medical treatment in incontinent patients (study 2). METHODS: In study 1, standardized management of AI based on an algorithmic decision tree was applied to 287 incontinent patients (209 women, ranging from 16 to 84 years old). In study 2, 36 other incontinent patients with transit disorders (28 women, ranging from 29 to 86 years old) seen consecutively, were treated by a medical treatment of their transit disorders. The result of the medical treatment was objectively and subjectively evaluated after 2 months. RESULTS: Study 1: medical treatment was indicated in 126 of 287 patients (43.9%) (62 for diarrhea and 64 for constipation) while biofeedback was indicated in 52 patients (18.1%) and surgery specific for AI in 99 patients (34.5%). Eighty percent of the patients who were proposed conservative medical treatment were referred by their gastroenterologist or their general practitioner. Study 2: the continence score decreased from a median of 12 to 6.5 (P<0.001). 61% of patients regarded themselves as cured or improved after medical treatment. CONCLUSION: Conservative treatment can be proposed as a first line treatment in more than 50% of patients with anal incontinence referred to a specialized center. Medical treatment for anal incontinence associated with transit disorders improves continence.