Sacral Nerve Modulation Research Articles

Efficacy and tolerance of botulinum toxin injections after sacral nerve stimulation failure for idiopathic overactive bladder.

Management of idiopathic overactive bladder (iOAB) after the failure of sacral nerve modulation (SNM) is very challenging. To the best of our knowledge, no study has evaluated the use of botulinum toxin A (BoNT-A) after SNM failure for iOAB. The aim of this study is to evaluate the tolerance and efficacy of BoNT-A injection after the failure of SNM for iOAB. We conducted a retrospective multicentric analysis of all patients who had received either onabotulinumtoxinA or abobotulinumtoxinA intradetrusor injection for iOAB after SNM failure, between January 2004 and December 2017. The primary outcome was the percentage of success of first BoNT-A injection (either resolution of their urinary incontinence or their frequency or more than 50% reduction in frequency). Secondary outcomes were results of urodynamic studies, complications, total number of injections, causes of withdrawal, and subsequent treatment. Seventy-six patients (62 female) were included. The percentage of success of first BoNT-A injection was 43.4% (n = 33). All overactive bladder symptoms were significantly improved on the 3-day bladder diary. Twenty-eight patients (36.8%) were put under clean intermittent self-catheterization transitory. After a mean follow-up of 57.7 (±38.5) months, median number of injections was 2 (1-15). Overall, 42 patients (55.2%) stopped injections during follow-up. The estimated 36-months discontinuation-free rate was 48.1%. Mean cause of discontinuation was a primary failure (n = 32; 42.1%). BoNT-A can be used in SNM nonresponders with a success rate of 43.4% but is associated with a high long-term discontinuation rate.

Sphincter repair or Sacral Nerve Modulation: Still debatable?

Fecal incontinence (FI) is a debilitating condition with negative consequences to patients. It is recognized as a “quality of life” illness. Sphincter tears resulting often from difficult childbirth or from surgical trauma, are well-identified causes of FI. When conservative measures fail to resolve FI symptoms, a surgical treatment is recommended on the basis of a comprehensive pelvic floor work-up. A sphincter tear is frequently found on endoanal ultrasonography. The best way to surgically approach a patient with FI related/associated with a sphincter lesion is still debatable. International guidelines are inconsistent regarding the role of either sacral neuromodulation (SNM) or anal sphincteroplasty (anal sphincter repair) (AS) in patients with anal sphincter defect. Decision making for an individual patient often relies on expert opinion and personal experience due to the poor quality of the few published studies. Currently the presence of a sphincter defect is no longer considered a contraindication for sacral nerve modulation (SNM) which has several advantages. SNM is a minimally invasive procedure with very low morbidity, its results can be accurately predicted with a test phase, and are sustained with long-term placement of the implant. Nevertheless, AS has clearly a role to play, for instance in young female patients reluctant to get an implanted nerve stimulator early in life and/or in case of a cloacae-like deformity as a sequela of a post-obstetrical 4th degree tear. While waiting for prospective studies directly comparing SNM and AS for various types of FI, we propose in this paper a pragmatic treatment algorithm based on the most recently published studies and recommendations for the management of sphincter defect related/associated FI.

Sacral nerve modulation in older patients with faecal incontinence, Mege et al.

Sacral nerve modulation in older patients with faecal incontinence, Mege <i>et al</i>.

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

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. 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. 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). 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.

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

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. 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. A similar outcome was observed when comparing patients <70years and ≥70years (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 (<70years and ≥70years, P=0.54). The explantation and revision rates were not influenced by age (explantation rate: 17% in patients <70years vs 14% in patients ≥70years, P=0.89; and revision rate: 42% in patients <70years vs 40% in patients ≥70years, 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. Our results suggest that patients ≥70years suffering from faecal incontinence benefit from SNM with a similar risk as a younger population.

Sacral nerve modulation for irritable bowel syndrome: A randomized, double-blinded, placebo-controlled crossover study.

Irritable bowel syndrome (IBS) is among the most common gastrointestinal disorders, and a substantial proportion of patients have an insufficient response to treatment. In a single-blinded study, sacral nerve modulation (SNM) significantly reduced symptoms of IBS. The aim of the present double-blinded, randomized, placebo-controlled study was to evaluate the effect of SNM for IBS. We included patients with diarrhea-predominant or mixed IBS and a minimum baseline IBS-specific symptom score of 40 points (Gastrointestinal Symptom Rating Scale-IBS version). Patients underwent a 6-week period of SNM. In the first 4weeks, the patients were randomized 1:1 to have the neurostimulator set subsensory or OFF for 2weeks and then the opposite for another 2weeks. Patients and investigators were blinded to settings. In the remaining 2weeks, the stimulation was set suprasensory. IBS-specific symptoms and quality of life were assessed with validated questionnaires and bowel diaries. Twenty-one patients were randomized and eligible for analysis. The IBS-specific symptom score was reduced with borderline significance during stimulation (subsensory-OFF median change -1 (-26, 9), OFF-subsensory median change 8 (-11, 36); P=0.0572). Pain was significantly reduced during stimulation (subsensory-OFF median change -1.5 (-4, 1), OFF-subsensory median change 1 (-4, 3); P=0.0188), along with the number of daily bowel movements (subsensory-OFF median change 0 (-1.8, 0.2), OFF-subsensory median change 0.2 (-0.5, 1.1); P=0.0373). The median placebo effect was 14% (0, 55). Sacral nerve modulation for IBS seems promising but should be considered experimental until larger multicenter studies have been performed.

Current State of Neuromodulation for Constipation and Fecal Incontinence in Children: A Systematic Review.

Neuromodulation is the application of electrical stimulation on nerve fibers to modulate the neuronal activity. Its use for chronic constipation and fecal incontinence has increased in popularity over the past few years. Invasive and noninvasive techniques are currently available. We reviewed the current literature on the application of the neuromodulation techniques in the management of chronic constipation and fecal incontinence in children. A search of Healthcare Database Advanced Search, Embase, Medline, and Cochrane database was performed in accordance with PRISMA guideline. Terms used in the search included neuromodulation, nerve stimulation, fecal/fecal incontinence, incontinence, constipation, children, and pediatric/pediatric. Two-hundred forty-one papers were screened. Fourteen papers were included for the systematic review: seven were selected for the ISNM (implantable sacral nerve modulation) technique, one for the transcutaneous tibial nerve stimulation), one for the transcutaneous sacral nerve modulation), and five for the transcutaneous interferential sacral nerve stimulation. Results showed an overall improvement in constipation symptoms in 79 to 85.7% of patients, resolution of symptoms in 40%, reduced use of ACE stoma/transanal irrigation system in 12.5 to 38.4%, and improvement in incontinence symptoms in 75%. High complication rate was reported (17-50%) in the ISNM group. No complications were reported in the non-invasive group. Neuromodulation is a promising tool in the management of constipation refractory to medical treatment and fecal incontinence in children. Noninvasive techniques provide good results with no complications. A longer term follow-up will provide more information regarding patient compliance and sustainability of benefits of these new techniques.

Long-Term Outcome Following Implanted Pulse Generator Change in Patients Treated With Sacral Nerve Modulation for Fecal Incontinence

Long-term outcome of sacral nerve modulation (SNM) patients after implanted pulse generator (IPG) change for fecal incontinence (FI) is unknown. This study reported the outcome and long-term satisfaction after a change of an exhausted IPG, questioning the need to concurrently change the electrode and looking for factors involved in the maintenance of treatment efficiency. Patients with fecal incontinence and with a Medtronic IPG implanted in a single center (2001-2016) were prospectively followed up. Satisfaction was graded according to a patient-reported outcome measure from 0 to 10. A pre- and postreplacement FI severity score (Cleveland Clinic Fecal Incontinence Score) and Fecal Incontinence Quality of Life questionnaire were also collected. In 170 patients with SNM, 39 had an IPG replacement. At a median of 29 month after replacement, 32 and 7 patients reported respectively a similar and reduced satisfaction (7.6 ± 1.62 vs. 5.5 ± 0.87), p < .001. Satisfied patients were younger (65 years vs. 76 years, p < .001). Cleveland Clinic Fecal Incontinence Scores were not significantly different, but the satisfied group had a significantly better Fecal Incontinence Quality of Life score (p = .047). Only 5 patients needed an electrode change at the time of the IPG replacement or later. Patient satisfaction and efficiency remain high after IPG replacement. Older age has a negative impact on the outcome. Electrode replacement is rarely required and does not need to be performed routinely when an IPG is exhausted. Paul-Antoine Lehur has a consulting agreement with Medtronic SA. This had no impact with the results of the study. The other authors have no conflict of interests to declare.

Anale Inkontinenz

Fecal incontinence Abstract. Fecal incontinence may be due to various pathologies and is underreported. The prevalence among females is age dependent, ranging from 16 % in younger women and up to 40 % in elderly women. Given this wide range, it is suspected there may be a high rate of undetected and / or underreported cases. The most common aetiology is pelvic floor disorders which is the focus of this article. First-line therapy for pelvic floor disorders is conservative, and may include professionally guided pelvic floor exercises supported by biofeedback training, dietary adjustments, fiber supplementation, and constipating agents. If this fails, additional treatment options include sacral nerve modulation which offers an effective, minimally invasive therapy for patients with insufficient improvement after conservative therapy.

Anterior resection syndrome: What should we tell practitioners and patients in 2018?

Multidisciplinary management of infra-peritoneal rectal cancer has pushed back the frontiers of sphincter preservation, without impairment of carcinological outcome. However, functional intestinal sequelae, grouping together several symptoms known under the name of anterior resection syndrome (ARS), have emerged and become an increasingly frequent concern for both patients and physicians. The pathophysiology is complex: ARS is a combination in various degrees of stool frequency, incontinence for flatus and/or stools, urgency, and disorders in discrimination and evacuation. The "Low Anterior Resection Score" (LARS), validated in 2012, is currently used to evaluate the severity of ARS and its impact on quality of life. While ARS can show improvement over the first two years, symptoms persist for longer than two years in nearly 60% of patients and in half of these patients, ARS is considered severe. The most frequently reported independent risk factors of severe ARS include neo-adjuvant radiation therapy, the extent of resection (total mesorectal excision that includes inter-sphincteric resection), absence of colonic pouch and anastomotic leak. In the absence of surgical complications and/or local recurrence, physicians can draw from a wide therapeutic armamentarium in order to improve the functional outcome of patients, including diet and lifestyle modifications, gut motility regulators, multimodal rehabilitation (biofeedback, electro-stimulation) and sacral nerve modulation. Permanent colostomy is an alternative of last resort, proposed only when all other solutions fail. A better understanding of the natural history of ARS, its risk factors as well as the array of therapeutic alternatives should provide better patient information and optimize management.

Sakrale Nervenmodulation in der Koloproktologie

Sacral nerve modulation and stimulation (SNM/SNS) is aminimally invasive treatment for fecal incontinence, which has become widely established in recent years. Modulation of sacral nerve roots occurs through an electrode which is placed in the sacral foramina S2-4. By complex spinal and supraspinal mechanisms, rectal compliance is improved and anal incontinence episodes are reduced. The use of SNM is asuitable therapeutic option for nearly all causes of fecal incontinence refractory to conservative treatment. In the majority of patients, asignificant reduction of incontinence episodes or acomplete relief of symptoms is achieved. These results are also observed in long-term follow-up. Although the efficacy of SNM in constipation is less well established, it may be considered in patients who fail to respond to conservative measures. The role of further potential indications for SNM/SNS in coloproctological disorders is discussed in the present review.

Management of device-related complications after sacral neuromodulation for lower urinary tract disorders in women: a single center experience.

This study is aimed at presenting and discussing the device-related complication management during a 5-year period, of the sacral nerve modulation (SNM), in a tertiary-care university unit. This is a retrospective chart review of all women, who received SNM in our department between May 2011 and May 2016. All two-stage procedures were performed by the same experienced surgeon and according to our strict protocol of patients' selection and follow-up. Data of perioperative and postoperative complications and their management were collected. The test stimulation was positive in 59 out of 64 patients (92%), who then received the permanent implantation after a mean test phase duration of 9 days. Mean overall follow-up was 16.5 (±10.9) months. We recorded 20 complications (31%) in 15 patients, after a mean follow-up time of 160 days. These comprise: lead migration (13.8%), infection (8.6%), pain (5.2%), wound healing disorders (5.2%) and lead fibrosis (10%). The event/patient ratio was significantly reduced from 0.6 in the beginning of our experience with SNM to 0.2 at the second period of the study (p = 0.005). All complications could be successfully resolved after surgical intervention without influence on the treatment effect. Complications after SNM are common and may require additional surgical intervention for full resolution but without affecting the treatment effect. Also, due to a learning curve, a lower events/patient ratio over time is to be expected.

Successful sacral nerve modulation despite migration of tined lead

Background: Sacral nerve modulation (SNM) is a minimally invasive treatment for chronic constipation or incontinence when conservative treatment is insufficient to provide relieve of symptoms. Case description: A 74-year-old patient with an implanted sacral nerve lead is presented in this case report with a dislodged lead without an adverse change in her incontinence treatment. This phenomenon has never been described before and raises the debate on sacral lead positioning in sacral nerve stimulation. Discussion: There are a lot of conflicting data regarding ideal lead positioning, such as S3 versus S2 or S4 implantation. The lead position in our case doesn’t correspond to previously described locations and pathways which corroborate the legitimacy of new developments in this area such as percutaneous tibial nerve stimulation, transcutaneous tibial nerve stimulation and transcutaneous abdominal electrical stimulation (TEN). Conclusions: The implantation of SNM seems standardized but leaves voids in the technique where further research is needed to refine it.

CT evaluation of acupuncture needles inserted into sacral foramina.

To use CT scanning to evaluate the precision with which acupuncture needles can be inserted into sacral foramina to establish sacral nerve modulation by electroacupuncture. The subjects were five adult women (mean age 71.6 years). These five cases were divided into two groups. In the first three subjects (group A) the intention was to insert acupuncture needles in the S3 and S4 foramina; in the remaining two subjects (group B) the intention was to insert acupuncture needles in the S2 and S3 foramina. CT scanning showed that in subject 1 of group A, the acupuncture needle intended for insertion in S3 was actually in the S4 foramen, and the acupuncture needle intended for insertion in S4 was actually distal to the sacral body. In subjects 2 and 3, the acupuncture needles were inserted accurately in the S3 and S4 foramina. In the three subjects who had acupuncture needles inserted in the S4 foramen, the tip of the acupuncture needle was an average distance of 6.0 mm from the rectum. The acupuncture needles inserted in subjects 4 and 5 of group B were inserted accurately into the S2 and S3 foramina. Inserting acupuncture needles into the sacral foramina of S2 and S3 at an angle of about 60° has the potential to be used for sacral nerve modulation by repeated electroacupuncture stimulation. Needling may be less accurate in subjects with higher body mass index. Because of the potential risk of perforating the rectum with the needle, this technique must be used by specialists only. 2013-026.

Faecal incontinence: Current knowledges and perspectives.

Faecal incontinence (FI) is a disabling and frequent symptom since its prevalence can vary between 5% and 15% of the general population. It has a particular negative impact on quality of life. Many tools are currently available for the treatment of FI, from conservative measures to invasive surgical treatments. The conservative treatment may be dietetic measures, various pharmacological agents, anorectal rehabilitation, posterior tibial nerve stimulation, and transanal irrigation. If needed, patients may have miniinvasive approaches such as sacral nerve modulation or antegrade irrigation. In some cases, a surgical treatment is proposed, mainly external anal sphincter repair. Although these different therapeutic options are available, new techniques are arriving allowing new hopes for the patients. Moreover, most of them are non-invasive such as local application of an α1-adrenoceptor agonist, stem cell injections, rectal injection of botulinum toxin, acupuncture. New more invasive techniques with promising results are also coming such as anal magnetic sphincter and antropylorus transposition. This review reports the main current available treatments of FI and the developing therapeutics tools.

Risk Factors for Surgical Site Infection in Patients Undergoing Sacral Nerve Modulation Therapy

The aim of this study was to identify risk factors for surgical site infection in patients undergoing sacral nerve modulation (SNM) surgery. We conducted a retrospective cohort analysis of 290 patients undergoing a total of 669 SNM procedures between 2002 and 2012 by 2 fellowship-trained female pelvic medicine and reconstructive surgery attending physicians at the University of California-Irvine Medical Center. Infection was defined as a charted abnormal examination finding at the implantation site (erythema, induration, purulent discharge) resulting in prescription of antibiotics, hospitalization, or explantation. We extracted information from the medical record regarding possible risk factors for infection including age, body mass index, immunosuppression (diabetes mellitus, chronic steroid use, smoker, chemotherapy), number of procedures per patient, and number of days between stages 1 and 2. In addition, we compared infection rates before and after 2008 when a clinical practice change was made with the implementation of home chlorhexidine washing (CHW) prior to SNM surgery. Thirty infections occurred, 25 of which were managed with oral antibiotics. Nine required intravenous antibiotics, and 11 required removal of the implanted device. Three patients experienced infection on 2 separate occasions. Seventeen infections had culture data available. Nine of the patients who underwent explantation had wound cultures positive for methicillin-resistant Staphylococcus aureus.Thirteen of the 26 patients who developed infection had medical histories significant for immunosuppression. Three patients developed late-onset abscess formation at 234, 257, and 687 days after stage 2, respectively. The median time between the most recent SNM procedure and development of infection was 14 days (range, 6-88 days).Body mass index and immunosuppression were significant predictors of infection, whereas age, parity, indication for procedure, and number of days between stages 1 and 2 were not found to be independent predictors. Three hundred twenty-three procedures were performed prior to and 346 procedures were performed after institution of home CHW. Twenty-four (80%) of the 30 reported infections were prior to CHW, whereas only 6 infections (20%) occurred after this change in practice. Prior to institution of CHW, the infection rate was 7.4%, and after institution of CHW, it was 1.7% (P = 0.002). Of the 83 patients with compliance data available for CHW use, 71 reported using CHW, whereas 12 reported not using CHW. Surgical site infection is a significant risk of SNM surgery, although our infection rate is lower than previously reported. Chlorhexidine washing appears to reduce the risk of infection in this population. Because the majority of infections requiring explantation were methicillin-resistant S. aureus positive, prophylactic treatment for this organism should be considered as an additional strategy to reduce infection. Body mass index and immunosuppression appear to be independent risk factors for infection.

The technique of sacral nerve modulation.

The aim of this review was to summarize current knowledge and recommendations regarding the technique of implantation of the electrode in performing sacroneuromodulation (SNM) and the available information on programming parameters and implantation algorithms. All English-language articles published from January 1985 to December 2013 that reported the SNM surgical technique and results were considered for inclusion. Data were considered useful for the present review only if related to: (i) peripheral nerve evaluation; (ii) temporary nerve stimulation; (iii) definitive impulse generator placement; and (iv) parameters programming. The literature search revealed 193 potentially relevant studies from initial electronic search terms and eligibility criteria, and these studies were evaluated in detail. In total, 41 studies were included in the final analysis. Of the studies reviewed, the majority (n=37) were prospective or retrospective case series. Only three randomized clinical trials were eligible for inclusion. Although the technique seems to be standardized, several steps still need to be clarified in order to define the best way to perform the procedure and then to maximize the outcome.

Sacral Nerve Modulation for Fecal Incontinence

Although sacral nerve modulation has become an important tool for the treatment of fecal incontinence, prospective, randomized data are still rare. To determine the effectiveness of sacral nerve modulation in a prospective randomized crossover study : Prospective randomized crossover study : Proctological Office and Department of Surgical Proctology at a private hospital. A total of 31 consecutive patients (31 women) aged 55 ± 12 years (median ± SD) with fecal incontinence were enrolled between February 2012 and December 2012. All patients underwent sacral nerve modulation through a staged implantation procedure between 2009-2011. After a median of 26.8 months following implantation, 16 of the 31 patients agreed to be randomized in a crossover design to stimulation ON or OFF, each for a 3-week period. After the two periods (ie, 6 weeks), while still blinded to the stimulator status, the patients chose which stimulation period (first or second) they preferred. The mode of stimulation corresponding to the selected period was then continued for 3 months (final period). Frequency of bowel movements, frequency of fecal incontinence and urgency episodes, severity scores, preference for ON or OFF. The frequency of fecal incontinence episodes and Cleveland Clinic Incontinence Score (CCIS) were both significantly lower in the ON period than the OFF period (p < 0.005) during the crossover phase of the study. All patients decided to stay in the ON mode for the final period and have continued in the ON mode until now. Small patient numbers. The significant improvement in fecal incontinence during the ON period, as compared to the OFF period, makes it unlikely that the observed benefits of sacral nerve modulation are due to a placebo effect.

The Shifting Paradigm of Treating Neurogenic Bladder Patients After the Introduction of Neuromodulation

Over the last 10 years, there have been an increasing number of treatment options for patients with neurogenic bladder. We conducted a literature review of the most current research on mirabegron, onabotulinumtoxin A, sacral nerve modulation (SNM), and posterior tibial nerve stimulation (PTNS) as it pertains to neurogenic bladder. In addition to discussing these treatments, we also discuss how these treatments pertain to the most common etiologies of neurogenic bladder: multiple sclerosis (MS), spinal cord injury (SCI) and Parkinson’s Disease. Each of the above treatment modalities has been shown to be effective in these populations, with the most research behind onabotulinumtoxin A. While SNM and PTNS appear promising, more research is needed with bigger populations to fully elucidate the benefits of these treatments. The decision on which treatment is best for each patient should be individualized based on a patient’s symptoms, disease, and his or her unique preferences.

VII．本邦における便失禁に対する仙骨神経刺激療法の位置づけ

VII．本邦における便失禁に対する仙骨神経刺激療法の位置づけ