Functional outcomes and satisfaction rates of sacral nerve stimulation in the treatment of one and multiples pelvic floor dysfunctions

Objective: Few studies have addressed the use of sacral nerve stimulation (SNS) in the treatment of patients with multiple pelvic floor dysfunctions (PFD). So, we evaluated the functional outcomes and level of satisfaction with SNS in selected patients with one or multiples PFD. Methods: A prospective database was used to collect information on eligible patients treated for PFD with SNS, and severity of symptoms was assessed with scores and satisfaction rates by visual analogue scale (VAS) at baseline and by the end of follow-up. Results: We recruited 70 patients, 98.6% of whom responded positively during the evaluation period (Global Response Assessment ≥ 50% for at least one type of PFD), resulting in the implantation of a permanent SNS device. Additionally, 49 of the patients (71%) had a single PFD (fecal incontinence [FI] = 38; constipation/obstructed defecation syndrome [C/ODS] = 11), while 20 (29%) had more than one PFD (double incontinence/n = 12; double incontinence + C/ODS/n = 8). All scores improved significantly between baseline (pre-SNS) and the end of follow-up (post-SNS), as did VAS in all groups (single and multiple PFD). The pre-SNS scores were higher in patients with a single PFD, including FI (Cleveland clinic Florida incontinence score [CCF-FI]) and C/ODS (Cleveland clinic constipation score [C-CCF] and the Renzi ODS score). The pre-SNS impact of VAS scores was similar in all groups (single and multiple PFD), but the VAS (post-SNS) was significantly lower (better response) for FI alone compared with multiple PFD. Conclusion: The SNS technique is an effective and safe option for patients with one or more PFD refractory to conservative measures. Response was positive for at least two PFD, based on reduced correspondent scores and satisfaction rate. (AU)

Vaginal distention rodent model for fecal incontinence: a pilot study on the effect on defecation behavior

Objectives: Vaginal balloon inflation simulates the compressive forces on the pelvic floor during the second phase of natural delivery. The foremost use of this animal model of vaginal distention (VD) is to study the mechanisms underlying urinary incontinence. As damage to the pelvic floor during natural birth is a common cause of fecal incontinence, the present paper aimed to investigate the effect of VD on defecation behavior in adult rats. Methods: Vaginal distention was performed in 8 rats for 2 hours, and in 3 rats for 4 hours, and sham inflation was performed in 4 rats. With the use of a latrine box in the rat home-cage and 24/7 video tracking, the defecation behavior was examined. The time spent in and outside the latrine was monitored for two weeks preoperatively and three weeks postoperatively, and a defecation behavior index (DBI; range: 0 [continent] to 1 [incontinent]) was defined. Pelvic floor tissue was collected postmortem and stained with hematoxylin and eosin. Results: Vaginal balloon inflation for 2 hours resulted in fecal incontinence in 29% of the animals (responders) whereas the DBI scores of non-responders (71%) and control animals did not change in the postoperative phase compared with the baseline score. A 4-hour balloon inflation resulted in fecal incontinence in 1 animal and caused a humane endpoint in 2 animals with markedly more tissue damage in the 4-hour responder compared with the 2-hour responders. Conclusions: Vaginal balloon inflation, with an optimum duration between 2 and 4 hours, can be used as a model to study changes in defecation behavior in rats induced by pelvic floor damage. (AU)

Analysis of Characteristics of Clinical Researches on Sacral Nerve Stimulation Based on PubMed Database / 中国康复理论与实践

Objective:To analyze the clinical studies on sacral nerve stimulation based on PubMed database and summarize its research status and clinical characteristics. Methods:Literatures about sacral nerve stimulation were collected from PubMed database before December 31, 2019. HistCite software was used to analyze the published year, published periodicals, published country and research institutions. Pajek software principal path analysis was used to identify the evolution direction of hot topics. The spectrum of diseases, therapeutic outcomes, stimulation methods and stimulation parameters were summarized. Results:A total of 96 articles were included. The number of publications increased significantly since 2000 and reached its peak in 2014 to 2015. The literatures with most influence were published in 2000 to 2001. All the literatures published in 32 journals, the top two were Urology and Diseases of the Colon & Rectum, which published 17 and 22 articles, respectively. The literatures came from 16 countries, and the top three were the United State (17 articles), the Netherlands (13) and the United Kingdom (13). Among the 211 institutes involved, Aarhus University Hospital (Denmark, twelve articles) and St. Marks Hospital (United Kingdom, nine) were the top two. The study involved 16 diseases, mainly about fecal incontinence, urinary incontinence and urination, shifted from urinary system diseases to digestive system diseases. 91.67% of the study corroborated the benefit of sacral nerve stimulation. Implanted stimulation (77 articles) was the most used, and transdermal stimulation (10 articles) was the second. The parameters were depending on the disease and the mode of stimulation. Conclusion:Sacral nerve stimulation can effectively improve the function of pelvic floor, which may be focused for a long time. Non-implantable sacral nerve stimulation would become the new research topic.

Mid-term efficacy of sacral nerve stimulation for the treatment of chronic constipation / 中华胃肠外科杂志

Objective: To investigate the mid-term efficacy of sacral nerve stimulation (SNS) for chronic constipation. Methods: A descriptive case series study was conducted. Patients with chronic constipation were treated in Xijing Hospital of Digestive Disease from February 2013 to December 2018 were retrospectively enrolled. The types of constipation were confirmed based on colon slow transit test, anorectal manometry and defecography in Xi'an Mayinglong Coloproctological Hospital. This study has been registered in China clinical trial registry (Registration No.: ChiCTR-ROC-16008945). Case inclusion criteria: (1) constipation was diagnosed according to Rome III criteria; (2) traditional treatment, including education, diet adjustment, laxative, biofeedback treatment, failed for at least 1 year; (3) there were no constipation-related organic diseases. After excluding neurogenic diseases, including spinal cord injury and multiple sclerosis, 21 patients were included in this study. There were 10 males and 11 females, with an average age of 50.9 (14-76) years. After the relevant examination and evaluation of patients, they underwent percutaneous nerve evaluation (PNE). If patient experienced a good response to PNE after 2 or 3 weeks (≥50%), permanent SNS implantation was performed. The improvement of clinical symptoms and quality of life between the baseline, PNE, and latest follow-up time points were compared. Improvement of clinical symptoms, including autonomic stool frequency per week, autonomic stool days per week, defecation time, visual analogue scale (VAS, lower score indicates more serious symptoms) score and Cleveland clinic constipation score (CCCS, higher score indacates more serious symptoms) criteria. The change of quality of life was scored by SF-36 questionnaires (the higher score indicates better quality of life). Results: Of 21 patients, 18 (85.7%) experienced significant improvement in symptoms with PNE, and 2 patients discontinued treatment due to their dissatisfaction. Sixteen patients (76.2%) received permanent SNS implantation, two of whom underwent bilateral PNE implantation. These patients were followed-up for mean 56 (34-72) months. The treatment was continuously effective in 13 patients (61.9%), including 3 of ODS, 1 of STC and 9 of mixed constipation. Compared with baseline, the score of constipation patients receiving permanent SNS implantation at latest follow-up was shown. The median autonomic stool frequency per week increased from 1.0 (0-7) to 7.5 (0-10) (P<0.001), the median autonomic stool days per week increased from 1.0 (0-7) d to 4.5 (0-7) d (P<0.001), the median defecation time decreased from 19.0 (8-40) minutes to 4.0 (3-31) minutes (P<0.001), the median CCCS decreased from 20.0 (13-30) to 9.0 (6-30) (P<0.001), and the median VAS score increased from 9.0 (7-40) to 80.0 (15-90) (P<0.001). The values of the 8 parts of the SF-36 questionnaire increased (all P<0.05). Conclusion: SNS implantation is safe and has obvious effects on severe constipation with stable mid-term efficacy.

Success and Complication Rates After Sacral Neuromodulation for Fecal Incontinence and Constipation: A Single-center Follow-up Study

BACKGROUND/AIMS: The aim of this study was to evaluate the sustainability of sacral neuromodulation (SNM) success in patients with fecal incontinence (FI) and/or constipation. METHODS: This is a retrospective analysis of a prospective database of patients who received SNM therapy for FI and/or constipation between 2006 and 2015. Success rates, complications and reintervention rates were assessed after up to 10 years of follow-up. RESULTS: Electrodes for test stimulation were implanted in 101 patients, of whom 79 (78.2%) received permanent stimulation. The mean follow-up was 4.4 ± 3.0 years. At the end of follow-up, 57 patients (72.2%) were still receiving SNM. The 5-year success rate for FI and isolated constipation was 88.2% (95% confidence interval [CI], 80.1–97.0%) and 31.2% (95% CI, 10.2–95.5%), respectively (P 50% in 76.1% of patients (95% CI, 67.6–86.2%) after 5 years. A lead position at S3 was associated with an improved outcome (P = 0.04). Battery exchange was necessary in 23 patients (29.1%), with a median battery life of 6.2 years. Reinterventions due to complications were necessary in 24 patients (30.4%). For these patients, the 5-year success rate was 89.0% (95% CI, 75.3–100.0%) compared to 78.4% (95% CI, 67.2–91.4%) for patients without reintervention. CONCLUSIONS: SNM offers an effective sustainable treatment for FI. For constipation, lasting success of SNM is limited and is thus not recommended. Reinterventions are necessary but do not impede treatment success.

Requirements of Technical Review for Clinical Trial for Implantable Sacral Nerve Stimulation System / 中国康复理论与实践

The technical review for clinical trials of implantable sacral nerve stimulation system needs to focus on the basic principles of trials, clinical institutition and design elements of clinical trial protocols.

Fecal incontinence in adults:diagnose and treatment / 临床外科杂志

This paper delineate the definition,etiology and treatment of fecal incontinence,Initial management of fecal incontinence consists of supportive care and medical therapy.If patients fail to re-spond to initial management,such patients should undergo additional evaluation(such as anorectal manom-etry,endorectal ultrasound and magnetic resonance imaging)to detect functional and structural abnormali-ties causing fecal incontinence and to guide subsequent management.For patients who fail to respond to initial management,options include biofeedback,injectable anal bulking agent,sacral nerve stimulation, and anal sphincteroplasty.Dynamic graciloplasty and artificial anal sphincter devices are associated with significant morbidity and should therefore only be used to treat refractory fecal incontinence.Fecal diver-sion with a colostomy should be reserved for patients with intractable symptoms who are not candidates for any other therapy,or in whom other treatments have failed.

Sacral nerve stimulation for existence of c-kit positive cells of interstitial cells of Cajal in the subserosal layer of the STC rat / 中国现代普通外科进展

Objective:To evaluate the effect of sacral nerve stimulation (SNS) for STC by receptor tyrosine kinase c-kit.Methods:Wistar rats were fed with diphenoxylate to make slow transit constipation(STC) rat model.Sacral nerve stimulation(SNS) for the SNS Rat Group.The studied animals were allocated into three experimental groups:STC Rat Group;SNS Rat Group;Normal Rat Group;Every group included 10 rats.The c-kit of ICC in the subserosal layer of rats were analyzed by immunohistochemistry,western blot and RT-PCR.Results:The morphological characteristics of STC Rat Group were not comparable to those of the multipolar c-Kit positive ICC seen in the subserosa of colon of normal rat.In the colon of rat,c-kit protein and c-kit gene in SNS rat group and Normal rat group was significantly higher than STC rat group detecting by western blot.Statistical differences between STC Group and SNS Rat Group were found (P＜0.05);statistical differences between STC Group and Normal Rat Group were also found (P＜0.05).There was not statistical differences between SNS rat group and Normal Rat Group.Conclusion:SNS has effective treatment for the STC rat.

Electrophysiological Basis of Fecal Incontinence and Its Implications for Treatment

The majority of patients with neuropathic incontinence and other pelvic floor conditions associated with straining at stool have damage to the pudendal nerves distal to the ischial spine. Sacral nerve stimulation appears to be a promising innovation and has been widely adopted and currently considered the standard of care for adults with moderate to severe fecal incontinence and following failed sphincter repair. From a decision-to-treat perspective, the short-term efficacy is good (70%–80%), but the long-term efficacy of sacral nerve stimulation is around 50%. Newer electrophysiological tests and improved anal endosonography would more effectively guide clinical decision making.

Effects of Acute Sacral Neuromodulation at Different Frequencies on Bladder Overactivity in Pigs / 대한배뇨장애요실금학회지

PURPOSE: We investigated the effects of different stimulation frequencies on the inhibition of bladder overactivity by sacral neuromodulation (SNM) in pigs. METHODS: Implant-driven stimulators were used to stimulate the S3 spinal nerve in 13 pigs. Cystometry was performed by infusing normal saline (NS) or acetic acid (AA). SNM (pulse width, 210 µsec) at frequencies ranging from 5 to 50 Hz was conducted at the intensity threshold at which observable perianal and/or tail movement was induced. Multiple cystometrograms were performed to determine the effects of different frequencies on the micturition reflex. RESULTS: AA-induced bladder overactivity significantly reduced the bladder capacity (BC) to 34.4%±4.7% of the NS control level (354.4±35.9 mL) (P0.05), but SNM at 15, 30, and 50 Hz significantly increased the BC to 54.5%±7.1%, 55.2%±6.5%, and 57.2%±6.1% of the NS control level (P0.05). CONCLUSIONS: This study demonstrated that 15 Hz was an appropriate frequency for SNM and that frequencies higher than 15 Hz did not lead to better surgical outcomes.

Percutaneous Nerve Evaluation Test Versus Staged Test Trials for Sacral Neuromodulation: Sensitivity, Specificity, and Predictive Values of Each Technique / 대한배뇨장애요실금학회지

PURPOSE: InterStim device is an U.S. Food and Drug Administration approved minimal invasive therapy for sacral neuromodulation for lower urinary tract dysfunction. Before InterStim implantation, a trial with the appropriate screening tests is required to determine patient therapy eligibility. There are two different techniques for patient screening: percutaneous nerve evaluation (PNE) test and staged test. Few studies have reported success and failure rates for each technique. However, test sensitivity and predictive values of either test have not been studied. The aim of our study was to determine the sensitivity and specificity of each test and to establish a decision algorithm for the most appropriate testing method to be used as a screening test. METHODS: This cross-sectional study was conducted from August 2009 to February 2012 and included patients with lower urinary tract dysfunction who participated in the stimulation test trial. Patients underwent PNE as the first stimulation test, while those who encountered technical difficulty during PNE or electrode migration underwent staged testing. RESULTS: A total of 213 patients, including 172 female and 41 male subjects, underwent PNE. The patients’ diagnoses included refractory overactive bladder (47.9%), nonobstructive urinary retention (29.6%), and frequency urgency syndrome (22.1%). A total of 202 patients were screened with PNE and 10 patients with staged testing. Overall sensitivity of PNE was 87.3%, and it was 90% for staged test. PNE specificity was 98.5% as compared to 92.9% for staged test. Positive and negative predictive values for PNE were 99% and 82.1% and for staged test were 90% and 92.9%, respectively. CONCLUSIONS: PNE test has high specificity and positive predictive value. We recommend PNE, a simple office-based, less expensive procedure as the first option for screening.

Complicaciones durante la neuromodulación de raíces sacras en el tratamiento de la incontinencia fecal grave / Complications during sacral nerve stimulation in the treatment of severe fecal incontinence

Objective: to evaluate the complications of sacral nerve stimulation for the treatment of fecal incontinence. Background: sacral nerve stimulation is considered to be nowadays an effective treatment for fecal incontinence in selected patients. Many authors have reported excellent results and indication for his use have increased. Nevertheless, even being a simple technique, not it exempts this from complications. Methods: fifty-two patients with severe faecal incontinence, treated with sacral nerve stimulation between january 2002 and december 2010, were analysed. All adverse events during follow-up were recorded. Results: there was not surgical complication during peripheral neural evaluation test. In our series, with an average follow-up to 55.52 +/- 31.84 months (range: 12-121), we had a rate of adverse effects of 14 percent, infection of surgical wound in two patients, break of electrode in two patients and the presence of pain in the place of the implant, with episodes of extremity pain and paresthesias in low members in 3 patients. Conclusions: sacral nerve stimulation in severe fecal incontinence is a safe treatment, with a low index of complications.

Objetivo: evaluar las complicaciones de la neuromodulación de raíces sacras en el tratamiento de la incontinencia fecal. Introducción: la neuromodulación de raíces sacras ha sido descrita como un tratamiento quirúrgico eficaz en pacientes con incontinencia fecal grave. Muchos autores han comunicado excelentes resultados y las indicaciones en su uso han aumentado. Sin embargo, a pesar de ser una técnica quirúrgica sencilla, no está exenta de complicaciones. Material y Método: 52 pacientes con incontinencia fecal grave, tratados mediante neuromodulación de raíces sacras entre enero de 2002 y diciembre de 2010, fueron analizados. Todas las complicaciones, tanto durante la implantación del dispositivo como durante el seguimiento, fueron registradas. Resultados: no se registraron complicaciones durante la prueba de estimulación. En nuestra serie, con un seguimiento de 55,52 +/- 31,84 meses, observamos un 14 por ciento de efectos adversos, infección de la herida quirúrgica en dos pacientes, rotura o movilización del electrodo en 2 pacientes y dolor y parestesias en 3 pacientes. Discusión: la neuroestimulación de raíces sacras en el tratamiento de la incontinencia fecal es un tratamiento seguro, con un bajo índice de complicaciones.

Sacral Nerve Stimulation Through the Sacral Hiatus

Sacral nerve stimulation through the retrograde approach has been used for peroneal or irritable bowel syndrome through the retrograde approach. However, several reasons, lead could not be advanced down ward. In this case, anterograde sacral nerve stimulation through the sacral hiatus could be used. The aim of this report is to present of technique of sacral nerve root stimulation through the sacral hiatus approach.

Treatment of fecal incontinence

Fecal incontinence is defined as either the involuntary passage of gas or stool or the inability to control the passage of fecal contents through the anus. Patients are reluctant to report fecal incontinence, resulting in underestimated prevalence. Studies have reported that its prevalence ranges from 2% to 20%. Diverse causes are involved in the generation of fecal incontinence. Fecal incontinence leads to a loss of self-esteem, social isolation, and a diminished quality of life. Antidiarrheals are useful for diarrhea with incontinence. Biofeedback therapy and exercise therapies may be helpful, particularly in patients with weak sphincters and/or impaired rectal sensation. Sacral nerve stimulation can be an option if other treatments have not been successful. Although some studies have shown the efficacy of injectable bulking agents, data on their long-term outcome and experience are lacking. Sphincteroplasty can be considered in selected patients who have failed nonsurgical measures or biofeedback therapy. A colostomy is a less preferable option. The various treatment options can be chosen with an individualized approach, depending on the causes of fecal incontinence, the action mechanism of treatment, comorbidities, general condition, and procedure-related risks.

Sacral Nerve Stimulation for Treatment of Chronic Intractable Anorectal Pain: A Case Report

Despite recent methodological advancement of the practical pain medicine, many cases of the chronic anorectal pain have been intractable. A 54-year-old female patient who had a month history of a constant severe anorectal pain was referred to our clinic for further management. No organic or functional pathology was found. In spite of several modalities of management, such as medications and nerve blocks had been applied, the efficacy of such treatments was not long-lasting. Eventually, she underwent temporary then subsequent permanent sacral nerve stimulation. Her sequential numerical rating scale for pain and pain disability index were markedly improved. We report a successful management of the chronic intractable anorectal pain via permanent sacral nerve stimulation. But further controlled studies may be needed.

Neuromodulación sacra para el tratamiento de la incontinencia anal. Experiencia piloto prospectiva en Argentina / Sacral neuromodulation in fecal incontinence. A pilot prospective experience in Argentina

INTRODUCTION: Anal incontinence is a severe physical and emotional condition that affects quality of life. Its treatment with neuromodulation, that consists in sacral roots electrical stimulation, has became a therapeutic option. OBJECTIVE: This study was designed to present the surgical technique and the first prospective experience in neuromodulation for fecal incontinence in Argentina. PATIENTS AND METHODS: Four females with severe fecal incontinence (mean score 17/20) were included. Anorectal physiology testing and anal ultrasound were performed before surgery. Due to failed medical treatment and the presence of an intact anal sphincter, sacral neuromodulation was indicated. After temporary sacral nerve evaluation, definitive neuromodulator was implanted. RESULTS: After 13 months the incontinence score and the number of weekly escapes decrese from 17/20 to 1.7/20 (p = 0.059) and from 62 to 0.2 (p = 0.059). Quality of life scores also improves but not statiscally significative. CONCLUSIONS: Sacral neuromodulation in fecal incontinence is useful. It is effective in patients who had failed maximum conservative therapies with the advantage of testing before definitive.

Introducción: La incontinencia anal constituye un severo trastorno físico y emocional que altera y limita la calidad de vida de quienes la padecen. Su tratamiento mediante neuromodulación, que consiste en la estimulación eléctrica de las raíces sacras, se ha convertido en una opción terapéutica válida. Objetivo: Presentar la técnica y la primera experiencia piloto prospectiva realizada en Argentina con neuromodulación sacra para el tratamiento de la incontinencia anal. Pacientes y métodos: Se trataron 4 pacientes de sexo femenino con incontinencia anal severa (score promedio de 17/20). Fueron estudiadas mediante manometría anorrectal, ecografía esfintérica y evaluación neurofisiológica del piso pelviano. Debido a la refractariedad a los tratamientos convencionales y a la indemnidad anatómica muscular se indicó neuromodulación sacra mediante la colocación de un electrodo estimulador cuatripolar. Se llevó a cabo la prueba de estimulación nerviosa transitoria y habiendo obtenido resultados satisfactorios, se colocó el implante definitivo. Resultados: Luego de 13 meses de seguimiento promedio el score de incontinencia disminuyó de 17/20 a 1.7/20 (p= 0.059) y el número de escapes semanales de 6.2 a 0.2 (p=0.059). También se observó una mejoría en la calidad de vida que no se vio reflejada estadísticamente. Conclusiones: La neuromodulación sacra es un procedimiento útil para el tratamiento de la incontinencia anal. Ha demostrado ser efectiva en aquellos pacientes refractarios a tratamientos convencionales con la ventaja de poder evaluar su respuesta antes del implante definitivo. Presenta baja morbilidad y corta internación.

Present and Future in the Treatment of Fecal Incontinence

Treatment of fecal incontinence still remains a challenge to modern medicine due to many specific sides of this problem. The diversity of causes of fecal incontinence and different modes of action of the various treatment modalities mandate a tailored, individualized approach in each case. Surgery is the last treatment modality for patients suffering from severe fecal incontinence. Recent studies have shown poor late results after primary sphincter repair and low predictive value for most preoperative diagnostic tests. New surgical options such as artificial devices and electrically stimulated muscle transpositions are reported by acceptable success rates and unacceptably frequent complications. That is why current attention has focused on non- or minimally invasive therapies such as sacral nerve stimulation and temperature-controlled radio-frequency energy delivery to the anal canal. However, all these innovative techniques remain experimental untill enough high- evidence data are gathered for their objective evaluation.