Outcomes and efficacy of magnetic resonance imaging-compatible sacral nerve stimulator for management of fecal incontinence: A multi-institutional study

BACKGROUND Fecal incontinence(FI)is an involuntary passage of fecal matter which can have a significant impact on a patient’s quality of life.Many modalities of treatment exist for FI.Sacral nerve stimulation is a well-established treatment for FI.Given the increased need of magnetic resonance imaging(MRI)for diagnostics,the In-terStim which was previously used in sacral nerve stimulation was limited by MRI incompatibility.Medtronic MRI-compatible InterStim was approved by the United States Food and Drug Administration in August 2020 and has been widely used.AIM To evaluate the efficacy,outcomes and complications of the MRI-compatible InterStim.METHODS Data of patients who underwent MRI-compatible Medtronic InterStim placement at UPMC Williamsport,University of Minnesota,Advocate Lutheran General Hospital,and University of Wisconsin-Madison was pooled and analyzed.Patient demographics,clinical features,surgical techniques,complications,and outcomes were analyzed.Strengthening the Reporting of Observational studies in Epidemiology(STROBE)cross-sectional reporting guidelines were used.RESULTS Seventy-three patients had the InterStim implanted.The mean age was 63.29±12.2 years.Fifty-seven(78.1%)patients were females and forty-two(57.5%)patients had diabetes.In addition to incontinence,overlapping symptoms included diarrhea(23.3%),fecal urgency(58.9%),and urinary incontinence(28.8%).Fifteen(20.5%)patients underwent Peripheral Nerve Evaluation before proceeding to definite implant placement.Thirty-two(43.8%)patients underwent rechargeable InterStim placement.Three(4.1%)patients needed removal of the implant.Migration of the external lead connection was observed in 7(9.6%)patients after the stage I procedure.The explanation for one patient was due to infection.Seven(9.6%)patients had other complications like nerve pain,hematoma,infection,lead fracture,and bleeding.The mean follow-up was 6.62±3.5 mo.Sixty-eight(93.2%)patients reported significant improvement of symptoms on follow-up evaluation.CONCLUSION This study shows promising results with significant symptom improvement,good efficacy and good patient outcomes with low complication rates while using MRI compatible InterStim for FI.Further long-term follow-up and future studies with a larger patient population is recommended.

Garg incontinence scores: New scoring system on the horizon to evaluate fecal incontinence. Will it make a difference?

The main aim of this opinion review is to comment on the recent article published by Garg et al in the World Journal of Gastroenterology 2023;29:4593–4603.The authors in the published article developed a new scoring system,Garg incon-tinence scores(GIS),for fecal incontinence(FI).FI is a chronic debilitating disease that has a severe negative impact on the quality of life of the patients.Rome IV criteria define FI as multiple episodes of solid or liquid stool passed into the clothes at least twice a month.The associated social stigmatization often leads to significant under-reporting of the condition,which further impairs management.An important point is that the complexity and vagueness of the disease make it difficult for the patients to properly define and report the magnitude of the problem to their physicians.Due to this,the management becomes even more difficult.This issue is resolved up to a considerable extent by a scoring ques-tionnaire.There were several scoring systems in use for the last three decades.The prominent of them were the Cleveland Clinic scoring system or the Wexner scoring system,St.Marks Hospital or Vaizey’s scores,and the FI severity index.However,there were several shortcomings in these scoring systems.In the opinion review,we tried to analyze the strength of GIS and compare it to the existing scoring systems.The main pitfalls in the existing scoring systems were that most of them gave equal weightage to different types of FI(solid,liquid,flatus,etc.),were not comprehensive,and took only the surgeon’s perception of FI into view.In GIS,almost all shortcomings of previous scoring systems had been addressed:different weights were assigned to different types of FI by a robust statistical methodology;the scoring system was made comprehensive by including all types of FI that were previously omitted(urge,stress and mucus FI)and gave priority to patients’rather than the physicians’perceptions while developing the scoring system.Due to this,GIS indeed looked like a paradigm shift in the evaluation of FI.However,it is too early to conclude this,as GIS needs to be validated for accuracy and simplicity in future studies.

Fecal incontinence - Challenges and solutions

Fecal incontinence is not a diagnosis but a frequent and debilitating common final pathway symptom resulting from numerous different causes. Incontinence not only impacts the patient’s self-esteem and quality of life but may result in significant secondary morbidity, disability, and cost. Treatment is difficult without any panacea and an individualized approach should be chosen that frequently combines different modalities. Several new technologies have been developed and their specific roles will have to be defined. The scope of this review is outline the evaluation and treatment of patients with fecal incontinence.

Impact of fecal incontinence on quality of life

AIM:To explore the impact of fecal incontinence (FI) on quality of life (QOL) of patients attending urogynecology and colorectal clinics (CCs).METHODS:Cross-sectional study of 154 patients (27 male) with FI,who attended the clinics at a regional hospital in North Queensland,Australia in 2003 and 2004,and completed the Fecal Incontinence Quality of Life Scale (FIQL:1=very affected;4=not affected).RESULTS:More than 22% of patients had their QOL affected severely by FI.Patients reported that they had not previously been asked about FI by a medical practitioner nor did they voluntarily disclose its presence.The median FIQL scores for all participants were:lifestyle=3.24;coping=2.23;depression=2.42;and embarrassment=2.33.Increasing frequency of soiling had a negative effect on all four FIQL scales (P < 0.001) as did the quantity of soiling (P < 0.01).Female CC patients had poorer FIQL scores than urogynecology clinic patients for lifestyle (P=0.015),coping (P=0.004) and embarrassment (P=0.009),but not depression (P=0.062),despite having experienced FI for a shorter period.CONCLUSION:Failure to seek treatment for FI degrades the quality of patients' lives over time.FI assessment tools should incorporate the quantity of fecal loss.

Treatment strategies in obstructed defecation and fecal incontinence

Obstructed defecation （OD） and fecal incontinence （FI） are challenging clinical problems, which are commonly encountered in the practice of colorectal surgeons and gastroenterologists. These disorders sodally and psychologically distress patients and greatly impair their quality of life. The underlying anatomical and pathophysiological changes are complex, often incompletely understood and cannot always be determined. As a consequence, many medical, surgical, and behavioral approaches have been described, with no panacea. Over the past decade, advances in an understanding of these disorders together with rational and similar methods of evaluation in anorectal physiology laboratories （ARP）, radiology studies, and new surgical techniques have led to promising results. In this brief review, we discuss treatment strategies and recent updates on clinical and therapeutic aspects of obstructed defecation and fecal incontinence.

Anal plugs and retrograde colonic irrigation are helpful in fecal incontinence or constipation

AIM： To evaluate the feasibility, clinical effect and predicting factors for favorable outcome of treatment with anal plugs in fecal incontinence and retrograde colonic irrigation （RCI） in patients with fecal incontinence or constipation.METHODS： Patients who received treatment with an anal plug or RCI between 1980 and 2005 were investigated with a questionnaire.RESULTS： Of the 201 patients （93 adults, 108 children）, 101 （50%） responded. Adults： anal plugs （8）, five stopped immediately, one stopped after 20 mo and two used it for 12-15 too. RCl （40, 28 fecal incontinence, 12 constipation）, 63% are still using it （mean 8.5 years）, 88% was satisfied. Younger adults （〈 40 years） were more satisfied with RCI （94 % vs 65%, P = 0.05）. Children： anal plugs （7）, 5 used it on demand for an average of 2.5 years with satisfactory results, one stopped immediately and one after 5 years. RCI （26 fecal incontinence, 22 constipation）, 90% are still using it （mean time 6.8 years） and felt satisfied. Children tend to be more satisfied （P = 0.001）. Besides age, no predictive factors for success were found. There was no difference in the outcome between patients with fecal incontinence or constipation.CONCLUSION： RCI is more often applied than anal plugs and is helpful in patients with fecal incontinence or constipation, especially for younger patients. Anal plugs can be used incidentally for fecal incontinence, especially in children.

Delorme's operation plus sphincteroplasty for complete rectal prolapse associated with traumatic fecal incontinence

Rectal prolapse associated with traumatic fecal incontinence is a rare clinical combination. This study was designed to assess Delorme＇s operation with sphincteroplasty as a surgical management of this combination in terms of recurrence and improvement of fecal incontinence. In this prospective study, we enrolled patients suffering from short, full-thickness rectal prolapse associated with traumatic fecal incontinence who had been admitted to Alexandria Main University Hospital during the period of May 2010-January 2013. Preoperative data including cause of trauma, duration of symptoms, results of anal manometry, and degree of fecal incontinence using Wexner score were collected from all patients. Delorme＇s procedure with overlap sphincteroplasty was done in all patients. Recurrence of prolapse and improvement of fecal incontinence were assessed after 1, 3, 6 and 12 months. The study included 13 patients aged （32±8.7） years, 9 females and 4 males. Cause of sphincteric injury included previous anal surgery in 7 patients and normal labor in 6 patients. Duration between sphinctefic injury and operation was （8.08±2.47） months. Preoperative Wexner＇s mean score was 16.07±3.4. Early postoperative complications included superficial wound infection （69.2%）, minor wound dehiscence （61.5%）, and postoperative bleeding （7.6%）. Recurrence was detected in 1 patient at 6 month follow-up. Wexner＇s score showed significant improvement for all patients after 6 months （4.00±2.04）. In conclusion, combination of Delorme＇s procedure and sphincteroplasty for treatment of patients with short complete rectal prolapse associated with traumatic fecal incontinence is a safe, effective surgical management with satisfactory results regarding anatomical and functional outcomes.

Bio-feedback treatment of fecal incontinence: Where are we, and where are we going?

Fecal incontinence is a disabling disease, often observed in young subjects, that may have devastating psycho-social consequences. In the last years, numerous evidences have been reported on the efficacy of bio-feedback techniques for the treatment of this disorder. Overall, the literature data claim a success rate in more than 70% of cases in the short term. However, recent controlled trials have not confirmed this optimistic view, thus emphasizing the role of standard care. Nonetheless, many authors believe that this should be the first therapeutic approach for fecal incontinence due to the efficacy, lack of side-effects,and scarce invasiveness. Well-designed randomized,controlled trial are eagerly awaited to solve this therapeutic dilemma.

Sphincteroplasty for fecal incontinence in the era of sacral nerve modulation

The role of sphincteroplasty in the treatment of patients with fecal incontinence due to anal sphincter defects has been questioned because the success rate declines in the long-term.A new emerging treatment for fecal incontinence,sacral nerve stimulation,has been shown to be effective in these patients.However,the success rate of sphincteroplasty may depend of several patient-related and surgical-related factors and the outcome from sphincteroplasty has been evaluated differently(with qualitative data) from that after sacral nerve stimulation(quantitative data using scoring systems and quality of life).Furthermore,the data available so far on the longterm success rate after sacral nerve modulation do not differ substantially from those after sphincteroplasty.The actual data do not support the replacement of sphincteroplasty with sacral nerve stimulation in patients with fecal incontinence secondary to sphincter defects.

Fecal incontinence in men:Causes and clinical and manometric features

AIM:To determine the causes and characteristics of fecal incontinence in men and to compare these features with those presented by a group of women with the same problem.METHODS:We analyzed the medical history,clinical and manometric data from 119 men with fecal incontinence studied in our unit and compared these data with those obtained from 645 women studied for the same problem.Response to treatment was evaluated after 6 mo of follow-up.RESULTS:Fifteen percent of patients studied in our unit for fecal incontinence were male.Men took longer than women before asking for medical help.Anorectal surgery was the most common risk factor for men related to fecal incontinence.Chronic diarrhea was present in more than 40%of patients in both groups.Decreased resting and external anal sphincter pressures were more frequent in women.No significant differences existed between the sexes regarding rectal sensitivity and recto-anal inhibitory reflex.In 17.8%of men,all presenting soiling,manometric findings did not justify fecal incontinence.Response to treatment was good in both groups,as 80.4%of patients improved and fecal incontinence disappeared in 13.2%of them.CONCLUSION:In our series,it was common that men waited longer in seeking medical help for fecal incontinence.Ano-rectal surgery was the major cause of this problem.Chronic diarrhea was a predisposing factor in both sexes.Manometric differences between groups were limited to an increased frequency of hypotony of the external anal sphincter in women.Fecal incontinence was controllable in most patients.

Endoanal ultrasonography in fecal incontinence: Current and future perspectives

Fecal incontinence has a profound impact in a patient's life, impairing quality of life and carrying a substantial economic burden due to health costs. It is an underdiagnosed condition because many affected patients are reluctant to report it and also clinicians are usually not alert to it. Patient evaluation with a detailed clinical history and examination is very important to indicate the type of injury that is present. Endoanal ultrasonography is currently the gold standard for sphincter evaluation in fecal incontinence and is a simple, well-tolerated and non-expensive technique. Most studies revealed 100%sensitivity in identifying sphincter defect. It is better than endoanal magnetic resonance imaging for internal anal sphincter defects, equivalent for the diagnosis of external anal sphincter defects, but with a lower capacity for assessment of atrophy of this sphincter.The most common cause of fecal incontinence is anal sphincter injury related to obstetric trauma. Only a small percentage of women are diagnosed with sphincter tears immediately after vaginal delivery, but endoanal ultrasonography shows that one third of these women have occult sphincter defects. Furthermore, in patients submitted to primary repair of these tears, ultrasound revealed a high frequency of persistent sphincter defects after surgery. Three-dimensional endoanal ultrasonography is currently largely used and accepted for sphincter evaluation in fecal incontinence, improving diagnostic accuracy and our knowledge of physiologic and pathological sphincters alterations. Conversely,there is currently no evidence to support the use of elastography in fecal incontinence evaluation.

Advancing the predictive accuracy of PNTML in rectal prolapse:An ongoing quest

Fecal incontinence is a common symptom among patients with rectal prolapse.Pudendal nerve terminal motor latency(PNTML)testing can serve as a reference indicator for predicting the outcomes of rectal prolapse surgery,thereby assisting surgeons in formulating more appropriate surgical plans.The direct correlation between preoperative PNTML testing results and postoperative fecal incontinence in patients with rectal prolapse remains a contentious issue,necessitating further clarification.Thus,we analyze the existing publications from both clinical and statistical perspectives to comprehensively evaluate the accuracy of preoperative PNTML testing in rectal prolapse and provide some feasible statistical solutions.

Problems with repairing gut sphincters malfunctions

Correcting a gut sphincter malfunction is a difficult problem.Because each sphincter has two opposite functions,that of closure and opening,repairing one there is a risk of damaging the other.Indeed,widening a narrow sphincter,such as lower esophageal sphincter(LES)and anal sphincter,may cause gastroeso-phageal reflux and fecal incontinence,respectively,whereas narrowing a wide sphincter,may cause a difficult transit.All the corrective treatments for difficult or retrograde transit concerning LES and anal sphincter with their unwanted consequences have been analyzed and discussed.To overcome the drawbacks of sphincter surgical repairs,researchers have devised devices capable of closing and opening the gut lumen,named artificial sphincters(ASs).Their function is based on various mechanisms,e.g.,hydraulic,magnetic,mechanical etc,operating through many complicated components,such as plastic cuffs,balloons,micro-pumps,micromotors,connecting tubes and wires,electromechanical clamps,rechargeable batteries,magnetic devices,elastic bands,etc.Unfortunately,these structures may facilitate the onset of infections and induce a local fibrotic reaction,which may cause device malfunctioning,whereas the compression of the gut wall to occlude the lumen may give rise to ischemia with erosions and other lesions.Some ASs are already being used in clinical practice,despite their considerable limits,while others are still at the research stage.In view of the adverse events of the ASs mentioned above,we considered applying bioengineering methods to analyze and resolve biomechanical and biological interaction problems with the aim to conceive and build efficient and safe biomimetic ASs.

Role of clinical pathway in improving the quality of care for patients with faecal incontinence:A randomised trial

AIMTo assess the development and implementation of the Integrated Rapid Assessment and Treatment (IRAT) pathway for the management of patients with fecal incontinence and measure its impact on patients’ care. METHODSPatients referred to the colorectal unit in our hospital for the management of faecal incontinence were randomised to either the Standard Care pathway or the newly developed IRAT pathway in this feasibility study. The IRAT pathway is designed to provide a seamless multidisciplinary care to patients with faecal incontinence in a timely fashion. On the other hand, patients in the Standard Pathway were managed in the general colorectal clinic. Percentage improvements in St. Marks Incontinence Score, Cleveland Clinic Incontinence Score and Rockwood Faecal Incontinence Quality of Life Scale after completion of treatment in both groups were the primary outcome measures. Secondary endpoints were the time required to complete the management and patients’ satisfaction score. χ2, Mann-Whitney-U and Kendall tau-c correlation coefficient tests were used for comparison of outcomes of the two study groups. A P value of 0.05 or less was considered significant. RESULTSThirty-nine patients, 34 females, consented to participate. Thirty-one (79.5%) patients completed the final assessment and were included in the outcome analysis. There was no significant difference in the quality of life scales and incontinence scores. Patients in the IRAT pathway were more satisfied with the time required to complete management (P = 0.033) and had stronger agreement that all aspects of their problem were covered (P = 0.006). CONCLUSIONDespite of the lack of significant difference in outcome measures, the new pathway has positively influenced patient’s mindset, which was reflected in a higher satisfaction score.

Current diagnostic tools and treatment modalities for rectal prolapse

Rectal prolapse is a circumferential,full-thickness protrusion of the rectum through the anus.It is a rare condition,and only affects 0.5%of the general population.Multiple treatment modalities have been described,which have changed significantly over time.Particularly in the last decade,laparoscopic and robotic surgical approaches with different mobilization techniques,combined with medical therapies,have been widely implemented.Because patients have presented with a wide range of complaints(ranging from abdominal discomfort to incomplete bowel evacuation,mucus discharge,constipation,diarrhea,and fecal incontinence),understanding the extent of complaints and ruling out differential diagnoses are essential for choosing a tailored surgical procedure.It is crucial to assess these additional symptoms and their severities using preoperative scoring systems.Additionally,radiological and physiological evaluations may explain some vague symptoms and reveal concomitant pelvic disorders.However,there is no consensus on or standardization of the optimal extent of dissection,type of procedure,and materials used for rectal fixation;this makes providing maximum benefits to patients with minimal complications difficult.Even recent publications and systematic reviews have not recommended the most appropriate treatment options.This review explains the appropriate diagnostic tools for different conditions and summarizes the current treatment approaches based on existing literature and expert opinions.

Gender influence on defecographic abnormalities in patients with posterior pelvic floor disorders

AIM:To compare defecographic abnormalities in symptomatic men and women and to analyze differences between men and age-and symptom-matched women.METHODS:Sixty-six men(mean age:55.4 years,range:20-81 years) who complained of constipation and/or fecal incontinence and/or pelvic pain underwent defecography after intake of a barium meal.Radiographs were analyzed for the diagnosis of rectocele,enterocele,intussusception and perineal descent.They were compared with age-and symptom-matched women(n = 198) who underwent defecography during the same period.RESULTS:Normal defecography was observed in 22.7% of men vs 5.5% of women(P < 0.001).Defecography in men compared with women showed 4.5%vs 44.4%(P < 0.001) rectocele,and 10.6% vs 29.8%(P < 0.001) enterocele,respectively.No difference was observed for the diagnosis of intussusception(57.6% vs 44.9%).Perineal descent at rest was more frequent in women(P < 0.005).CONCLUSION:For the same complaint,diagnosis of defecographic abnormalities was different in men than in women:rectocele,enterocele and perineal descent at rest were observed less frequently in men than in women.

Predictive factors for compliance with transanal irrigation for the treatment of defecation disorders

AIM To investigate compliance with transanal irrigation(TAI) one year after a training session and to identify predictive factors for compliance.METHODS The compliance of one hundred eight patients [87 women and 21 men; median age 55 years(range 18-83)] suffering from constipation or fecal incontinence(FI) was retrospectively assessed. The patients were trained in TAI over a four-year period at a single institution. They were classified as adopters if they continued using TAI for at least one year after beginning the treatment or as non-adopters if they stopped. Predictive factors of compliance with TAI were based on pretreatment assessments and trainingprogress. The outcomes of the entire cohort of patients who had been recruited for the TAI treatment were expressed in terms of intention-to-treat.RESULTS Forty-six of the 108(43%) trained patients continued to use TAI one year after their training session. The patients with FI had the best results, with 54.5% remaining compliant with TAI. Only one-third of the patients who complained of slow transit constipation or obstructed defecation syndrome continued TAI. There was an overall discontinuation rate of 57%. The most common reason for discontinuing TAI was the lack of efficacy(41%). However, 36% of the patients who discontinued TAI gave reasons independent of the efficacy of the treatment such as technical problems(catheter expulsion, rectal balloon bursting, instilled water leakage or retention, pain during irrigation, anal bleeding, anal fissure) while 23% said that there were too many constraints. Of the patients who reported discontinuing TAI, the only predictive factor was the progress of the training(OR = 4.9, 1.3-18.9, P = 0.02).CONCLUSION The progress of the training session was the only factor that predicted patient compliance with TAI.

Current applications of transperineal ultrasound in gastroenterology

Transperineal ultrasound is an inexpensive,safe and painless technique that dynamically and non-invasively evaluates the anorectal area.It has multiple indications,mainly in urology,gynaecology,surgery and gastroenterology,with increased use in the last decade.It is performed with conventional probes,positioned directly above the anus,and may capture images of the anal canal,rectum,puborectalis muscle(posterior compartment),vagina,uterus,(central compartment),urethra and urinary bladder(anterior compartment).Evacuatory disorders and pelvic floor dysfunction,like rectoceles,enteroceles,rectoanal intussusception,pelvic floor dyssynergy can be diagnosed using this technique.It makes a dynamic evaluation of the interaction between pelvic viscera and pelvic floor musculature,with images obtained at rest,straining and sustained squeezing.This technique is an accurate examination for detecting,classifying and following of perianal inflammatory disease.It can also be used to sonographically guide drainage of deep pelvic abscesses,mainly in patients who cannot undergo conventional drainage.Transperineal ultrasound correctly evaluates sphincters in patients with fecal incontinence,postpartum and also following surgical repair of obstetric tears.There are also some studies referring to its role in anal stenosis,for the measurement of the anal cushions in haemorrhoids and in chronic anal pain.

Management of fistula-in-ano: An introduction

Peri-anal fistulae are a worldwide health problem that can affect any person anywhere.Surgical management of these fistulae is not free from risks.Recurrence and fecal incontinence are the most common complications after surgery.The cumulative personal surgical experience in managing cases with anal fistulae is significantly considered as necessary for obtaining better results with minimal adverse effects after surgery.The purpose for conducting this survey is to facilitate better outcome after surgical interventions in idiopathic anal fistulae’ cases.

Referral for anorectal function evaluation is indicated in 65% and beneficial in 92% of patients

AIM: To determine the indicated referrals to a tertiary centre for patients with anorectal symptoms, the effect of the advised treatment and the discomfort of the tests.METHODS: In a retrospective study, patients referred for anorectal function evaluation (AFE) between May 2004 and October 2006 were sent a questionnaire, as were the doctors who referred them. AFE consisted of anal manometry, rectal compliance measurement and anal endosonography. An indicated referral was defined as needing AFE to establish a diagnosis with clinical consequence (fecal incontinence without diarrhea, 3rd degree anal sphincter rupture, congenital anorectal disorder, inflammatory bowel disease with anorectal complaints and preoperative in patients for re-anastomosis or enterostoma, anal fissure, fistula or constipation). Anal ultrasound is always indicated in patients with fistula, anal manometry and rectal compliance when impaired continence reserve is suspected. The therapeutic effect was noted as improvement, no improvement but reassurance, and deterioration.RESULTS: From the 216 patients referred, 167 (78%) returned the questionnaire. The referrals were indicated in 65%. Of these, 80% followed the proposed advice. Improvement was achieved in 35% and a reassurance in 57% of the patients, no difference existed between patient groups. On a VAS scale (1 to 10) symptoms improved from 4.0 to 7.2. Most patients reported no or little discomfort with AFE. CONCLUSION: Referral for AFE was indicated in 65%. Beneficial effect was seen in 92%: 35% improved and 57% was reassured. Advice was followed in 80%. Better instruction about indication for AFE referral is warranted.