Do resistance exercises during biofeedback therapy enhance the anal sphincter and pelvic floor muscles in anal incontinence?

AIM: To determine if a biofeedback therapy that includes concentric resistance exercise for the anal sphincter muscles can improve muscle strength/function and improve AI symptoms compared to the traditional/non-resistance biofeedback therapy. BACKGROUND: Biofeedback therapy is the current gold standard treatment for patients with anal incontinence (AI). Lack of resistance exercise biofeedback programs is a limitation in current practice. METHODS: Thirty-three women with AI (mean age 60 years) were randomly assigned to concentric (resistance) or isometric (non-resistance) biofeedback training. Concentric training utilized the Functional Luminal Imaging Probe to provide progressive resistance exercises based on the patient's ability to collapse the anal canal lumen. Isometric training utilized a non-collapsible 10 mm diameter probe. Both groups performed a biofeedback protocol once per week in the clinic for 12 weeks and at home daily. High definition anal manometry was used to assess anal sphincter strength; symptoms were measured using FISI and UDI-6. 3D transperineal ultrasound imaging was used to assess the anal sphincter muscle integrity. RESULTS: Concentric and isometric groups improved FISI and UDI-6 scores to a similar degree. Both the concentric and isometric groups showed small improvement in the anal high-pressure zone; however, there was no difference between the two groups. Ultrasound image analysis revealed significant damage to the anal sphincter muscles in both patient groups. CONCLUSIONS: Concentric resistance biofeedback training did not improve the anal sphincter muscle function or AI symptoms beyond traditional biofeedback training. Anal sphincter muscle damage may be an important factor that limits the success of biofeedback training.

Randomized controlled trial of home biofeedback therapy versus office biofeedback therapy for fecal incontinence.

BACKGROUND: Biofeedback therapy is useful for treatment of fecal incontinence (FI), but is not widely available and labor intensive. We investigated if home biofeedback therapy (HBT) is non-inferior to office biofeedback therapy (OBT). METHODS: Patients with FI (≥1 episode/week) were randomized to HBT or OBT for 6 weeks. HBT was performed daily using novel device that provided resistance training and electrical stimulation with voice-guided instructions. OBT consisted of six weekly sessions. Both methods involved anal strength, endurance, and coordination training. Primary outcome was change in weekly FI episodes. FI improvement was assessed with stool diaries, validated instruments (FISI, FISS, and ICIQ-B), and anorectal manometry using intention-to-treat analysis. KEY RESULTS: Thirty (F/M = 26/4) FI patients (20 in HBT, 10 in OBT) participated. Weekly FI episodes decreased significantly after HBT (Δ ± 95% confidence interval: 4.7 ± 1.8, compared with baseline, p = 0.003) and OBT (3.7 ± 1.6, p = 0.0003) and HBT was non-inferior to OBT (p = 0.2). The FISI and FISS scores improved significantly in HBT group (p < 0.02). Bowel pattern, bowel control, and quality of life (QOL) domains (ICIQ-B) improved significantly in HBT arm (p < 0.023). Resting and maximum squeeze sphincter pressures significantly improved in both HBT and OBT groups and sustained squeeze pressure in HBT, without group differences. CONCLUSIONS & INFERENCES: Home biofeedback therapy is non-inferior to OBT for FI treatment. Home biofeedback is safe, effective, improves QOL, and through increased access could facilitate improved management of FI.

Effectiveness of Biofeedback Therapy on Quality of Life in Patients with Dyssynergic Defecation Disorder.

BACKGROUND: The first option to be considered in the treatment of functional defecation disorder is to correct the dyssynergia. However, limited studies exist to show the effectiveness of biofeedback. OBJECTIVE: We evaluated the effect of biofeedback on the severity of constipation, quality of life, and anorectal manometry in patients with dyssynergic defecation in which the biofeedback method was applied. METHODS: Effectiveness of biofeedback method on the quality of life of 24 dyssynergic defecation patients according to Rome III criteria after clinical and balloon expulsion tests (BETs) and colonic transit time was measured. Data were collected with patient identification form, Bristol Stool Chart, Constipation Quality of Life Scale forms, Visual Analogue Scale, diaphragmatic breathing exercises form, constipation diary, and constipation biofeedback monitoring form. Dyssnergic defecation cases received 6-week biofeedback training. For the same timeframe, the control group had a catheter into the rectum without any intervention. RESULTS: Constipation severity was reduced in both groups before biofeedback to post-biofeedback (P < .05). Anal canal pressure, BET, colonic transit time, and quality of life significantly improved in biofeedback patients compared with controls. CONCLUSIONS: Biofeedback has a favorable effect on therapy and quality of life in dyssynergic defecation cases.

Translumbosacral Neuromodulation Therapy for Fecal Incontinence: A Randomized Frequency Response Trial.

INTRODUCTION: Treatments for fecal incontinence (FI) remain unsatisfactory because they do not remedy the underlying multifactorial dysfunction(s) including anorectal neuropathy. The aim of this study was to investigate the optimal dose frequency, clinical effects, and safety of a novel treatment, translumbosacral neuromodulation therapy (TNT), aimed at improving neuropathy. METHODS: Patients with FI were randomized to receive 6 sessions of weekly TNT treatments consisting of 600 repetitive magnetic stimulations over each of 2 lumbar and 2 sacral sites with either 1, 5, or 15 Hz frequency. Stool diaries, FI severity indices, anorectal neurophysiology and sensorimotor function, and quality of life were compared. Primary outcome measure was the change in FI episodes/week. Responders were patients with ≥50% decrease in weekly FI episodes. RESULTS: Thirty-three patients with FI participated. FI episodes decreased significantly (∆ ±95% confidence interval, 4.2 ± 2.8 (1 Hz); 2 ± 1.7 (5 Hz); 3.4 ± 2.5 (15 Hz); P < 0.02) in all 3 groups when compared with baseline. The 1 Hz group showed a significantly higher (P = 0.04) responder rate (91 ± 9.1%) when compared with the 5 Hz group (36 ± 18.2%) or 15 Hz (55 ± 18.2%); no difference was found between the 5 and 15 Hz groups (P = 0.667). Anal neuropathy, squeeze pressure, and rectal capacity improved significantly only in the 1 Hz (P < 0.05) group compared with baseline, but not in other groups. Quality of life domains improved significantly (P < 0.05) with 1 and 5 Hz groups. No device-related serious adverse events were noted. DISCUSSION: TNT significantly improves FI symptoms in the short term, and the 1 Hz frequency was overall better than 5 and 15 Hz. Both anorectal neuropathy and physiology significantly improved, demonstrating mechanistic improvement. TNT is a promising, novel, safe, efficacious, and noninvasive treatment for FI (see Visual Abstract, Supplementary Digital Content 3, http://links.lww.com/AJG/B598).

The not-so-rare absent RAIR: Internal anal sphincter achalasia in a review of 1072 children with constipation undergoing high-resolution anorectal manometry.

BACKGROUND: Our objective is to describe the prevalence of patients with internal anal sphincter achalasia (IASA) without Hirschsprung disease (HD) among children undergoing anorectal manometry (ARM) and their clinical characteristics. METHODS: We performed a retrospective review of high-resolution ARM studies performed at our institution and identified patients with an absent rectoanal inhibitory reflex (RAIR). Clinical presentation, medical history, treatment outcomes, and results of ARM and other diagnostic tests were collected. We compared data between IASA patients, HD patients, and a matched control group of patients with functional constipation (FC). KEY RESULTS: We reviewed 1,072 ARMs and identified 109 patients with an absent RAIR, of whom 28 were diagnosed with IASA. Compared to patients with FC, patients with IASA had an earlier onset of symptoms and were more likely to have abnormal contrast enema studies. Compared to patients with HD, patients with IASA were more likely to have had a normal timing of meconium passage, a later onset of symptoms, and were diagnosed at an older age. At the latest follow-up, the majority of patients diagnosed with IASA (54%) were only using oral laxatives. Over half of patients with IASA had been treated with anal sphincter botulinum toxin injection, and 55% reported a positive response. CONCLUSIONS AND INFERENCES: Patients diagnosed with IASA may represent a more severe patient population compared to patients with FC, but have a later onset of symptoms compared to patients with HD. They may require different treatments for their constipation and deserve further study.

Improvement of Patient Satisfaction and Anorectal Manometry Parameters After Biofeedback Therapy in Patients with Different Types of Dyssynergic Defecation.

Biofeedback is a well-known and effective treatment for patients with fecal evacuation disorder (FED). The main purpose of this study was to investigate the outcome and the effects of biofeedback therapy on physiological parameters as assessed by manometry in patients with FED. Data from 114 consecutive patients with FED who underwent biofeedback therapy in Sara Gastrointestinal clinic in Tehran, Iran during 2015-2018 were retrospectively reviewed and analyzed. All participants underwent a comprehensive evaluation of anorectal function that included anorectal manometry and a balloon expulsion test at the baseline and after biofeedback therapy. Maximum anal squeeze pressure and sustained anal squeeze pressure were improved up to 100% and 94.7% of normal values in the patients after biofeedback, respectively (P < 0.001). First rectal sensation, was significantly decreased (25 ± 18.5 vs. 15.5 ± 5.2) while the maximum tolerable volume was significantly increased (233.6 ± 89.7 vs. 182.4 ± 23.1) after biofeedback therapy (P < 0.001). Type I dyssynergia was the most common type, effecting 82 cases (71.9%) of our patients. Dyssynergia parameters were improved 50-80% in 34 (41.5%) and 10 (31.3%) type I and non-type I patients, respectively. Over 80% improvement of dyssynergia parameters occurred in 48 (58.5%) and 22 (68.8%) type I and non-type I patients, respectively. These differences were not statistically significant between the two groups (P = 0.3). In addition, the ability to reject the balloon was significantly better in post intervention measurements (P < 0.001). Biofeedback not only improves the symptoms in patients of FED but also reverses more than 80% the dyssynergic parameters of defecation. However, due to the general effectiveness of biofeedback treatment in different types of DD, there were no significant differences between their improvement scores.

Secondary sphincter repair for anal incontinence following obstetric sphincter injury: functional outcome and quality of life at 18 years of follow-up.

AIM: Secondary sphincter repair has been the conventional management of anal incontinence (AI) when a structural defect in the sphincter is recognized. However, disappointing long-term results have contributed to a tendency towards an increasing use of alternative treatment methods. This study aimed to assess the long-term functional outcomes following a secondary sphincter repair in women with AI after obstetric sphincter injury. METHOD: This is a questionnaire study of women who underwent a secondary sphincter repair in Denmark between January 1990 and December 2005. Patients were identified through the Danish National Patient Registry. Functional outcomes were assessed by a self-administered questionnaire in 2010 and 2018. Primary outcomes were Wexner and St. Mark's scores. Impact on quality of life was assessed using the Fecal Incontinence Quality of Life Scale. RESULTS: Functional outcome was assessed in 370 women in 2010 and 255 women in 2018. At 18.3 [interquartile range (IQR 15.0-22.0)] years of follow-up, the mean ± SD Wexner score was 8.8 ± 4.8 and the mean St. Mark's score was 11.7 ± 5.0. Flatus incontinence was the most frequent symptom, reported by 97%. Incontinence for liquid and solid stools was reported by 75% and 54%, respectively. There were no significant changes in incontinence frequencies over time. Women with a Wexner score of ≥ 9 had a significantly lower quality of life score in all domains than did women with a Wexner score of < 9 (P < 0.001). CONCLUSION: At long-term follow-up, few patients are fully continent following a secondary sphincter repair. However, it appears that the functional results remain stable at very long-term follow-up.

Three-dimensional high-resolution anorectal manometry can predict response to biofeedback therapy in defecation disorders.

PURPOSE: Biofeedback therapy (BT) is a simple and effective technique for managing outlet constipation and fecal incontinence. Several clinical factors are known to predict BT response, but a 50% failure rate persists. Better selection of BT responsive patients is required. We aimed to determine whether the defecation disorder type per high-resolution manometry (HRM) was predictive of BT response. METHODS: We analyzed clinical, manometric, and ultrasound endoscopic data from patients who underwent BT in our department between January 2015 and January 2016. Patients were classified into four groups per the following defecation disorder classification criteria: rectal pressure > 40 mmHg and anal paradoxical contraction (type I); rectal pressure < 40 mmHg and anal paradoxical contraction (type II); rectal pressure > 40 mmHg and incomplete anal relaxation (type III); and rectal pressure < 40 mmHg and incomplete anal relaxation (type IV). An experienced single operator conducted ten weekly 20-min sessions. Efficacy was evaluated with the visual analog scale. RESULTS: Of 92 patients, 47 (50.5%) responded to BT. Type IV and type II defecation disorders were predictive of success (p = 0.03) (OR = 5.03 [1.02; 24.92]) and failure (p = 0.05) (OR = 0.41 [0.17; 0.99]), respectively. The KESS score severity before BT (p = 0.03) (OR = 0.9 [0.81; 0.99]) was also predictive of failure. CONCLUSION: The manometry types identified according to the defecation disorder classification criteria were predictive of BT response. Our data confirm the role of three-dimensional HRM in the therapeutic management of anorectal functional disorders.

Laparoscopic sphincter reconstruction after abdominoperineal resection: feasibility and technical aspects.

BACKGROUND: Abdominal colostomy has been reported as an option with good quality of life for patients requiring abdominoperineal resection (APR) for very low rectal cancer. Some young, compliant patients, nevertheless, are very motivated to avoid abdominal colostomy following APR. Spiral smooth muscle cuff perineal colostomy as neosphincter reconstruction can be a reasonable alternative. We have published before the results of a series of sphincter reconstruction in the conventional technique following APR. As we developed our technique for colorectal resection sphincter reconstruction, we also changed to a laparoscopic approach. The aim of the present study was to evaluate the feasibility of laparoscopic neosphincteric reconstruction and outline the aspects of the technique. METHODS: This retrospective study was conducted on 15 patients treated at our institution during a 6 year period for low rectal cancer by laparoscopic APR and spiral smooth muscle cuff perineal colostomy as sphincter reconstruction. At follow-up at a median time of 3.7 years (range 3-9 years) after surgery, patients underwent functional evaluation which included the modified Holschneider continence score (0-16), assessing consistency of stool, frequency, impulse, discrimination, warning period, incontinence for formed or fluid feces, soiling, wearing pads, drugs, enema where a score of 13-16 is associated with normal continence, as well as neosphincter manometry. RESULTS: Laparoscopic sphincter reconstruction was feasible in all 15 patients. Two of the fifteen patients (13%) required secondary colostomy in the long term due to neosphincter malfunction and neosphincter perforation after enema. Four of the remaining thirteen patients (30%) were partially continent according to the Holschneider continence score (HCS) with a score of 7-12. The other 9 (70%) were continent (HCS: 13-16). Neosphincter manometry showed a median resting pressure of 33 cm H2O (range 30-41 cm H2O) and a median squeeze pressure of 95 cm H2O (range 84-150 cm H2O). CONCLUSIONS: Laparoscopic sphincter reconstruction following APR is a feasible option offering an alternative to abdominal colostomy for selected patients.

Cortico-anorectal, Spino-anorectal, and Cortico-spinal Nerve Conduction and Locus of Neuronal Injury in Patients With Fecal Incontinence.

BACKGROUND & AIMS: The neuropathophysiology of fecal incontinence (FI) is incompletely understood. We examined the efferent brain-anorectal and spino-anorectal motor-evoked potentials (MEP) to characterize the locus of neuronal injury in patients with FI. METHODS: We performed bilateral transcranial, translumbar, and transsacral magnetic stimulations in 27 patients with FI (19 female) and 31 healthy individuals (controls, 20 female) from 2015 through 2017. MEPs were recorded simultaneously from the rectum and anus using 4 ring electrodes. The difference in MEP latencies between the transcranial (TMS) and translumbar transsacral magnetic stimulations was calculated as cortico-spinal conduction time. MEP data were compared between patients with FI and controls. Patients filled out questionnaires that assessed the severity and effects of FI. RESULTS: The MEP latencies with TMS were significantly longer in patients with FI than controls at most sites, and on both sides (P < .05). Almost all translumbar and transsacral MEP latencies were significantly prolonged in patients with FI vs controls (P < .01). The cortico-spinal conduction time were similar, on both sides, between patients with FI and controls. Ninety-three percent of patients had 1 or more abnormal translumbar and transsacral latencies, but neuropathy was patchy and variable, and not associated with sex or anal sphincter function or defects. CONCLUSIONS: Patients with FI have significant neuropathy that affects the cortico-anorectal and spino-anorectal efferent pathways. The primary loci are the lumbo-rectal, lumbo-anal, sacro-rectal, and sacro-anal nerves; the cortico-spinal segment appears intact. Peripheral spino-anal and spino-rectal neuropathy might therefore contribute to the pathogenesis of FI.

Medium-term outcome of percutaneous tibial nerve stimulation in the treatment of fecal incontinence.

INTRODUCTION: Fecal incontinence (FI) is a multifactorial disease that affects patients' quality of life. The aim of this study was to evaluate the efficacy of posterior tibial nerve stimulation (PTNS) in the treatment of FI and to assess the medium-term results. METHODS: A prospective cohort of patients with FI treated with PTNS between 2012 and 2014 was analysed. Endoluminal ultrasound and anorectal physiologic studies were performed in all patients. The efficacy of PTNS was assessed using a validated questionnaire (Cleveland Clinic Incontinence Score) at baseline, after treatment, and 2 years later. The Vaizey score was also used at 2-year follow-up to assess urge incontinence. RESULTS: Fifty-six patients (38 females; mean age 59.7 years) with FI were treated. The causes of FI were mainly obstetric injury and previous colorectal surgery. A decrease of 50% from baseline CCIS was seen in 41.1% of patients after PTNS. One-third maintained a minimum of 50% decrease of their initial CCIS after 2 years. Comparing CCIS at baseline, after treatment, and at 2-year follow-up, a statistically significant difference was observed (p < 0.0001 and p < 0.0004 respectively). Medium-term improvement was not maintained in patients with passive and mixed FI, while it was maintained in those with urge incontinence. At 2 years, patients with mild incontinence maintained the greatest response. CONCLUSIONS: PTNS is a safe, effective, non-invasive treatment for FI with good results in almost half of the patients at the end of the treatment. There is also an acceptable maintained response at 2-year follow-up. It seems to be most successful in patients with mild incontinence and urge incontinence.

Effects of biofeedback in the treatment of female fecal incontinence / Efeitos do biofeedback no tratamento da incontinência anal feminina

ABSTRACT Introduction: Fecal incontinence is the involuntary loss of stools and gases, characterized by the inability to keep physiological control of bowel contents. It can negatively affect patients' quality of life. Biofeedback is a therapeutic tool used in the treatment, through the training of the pelvic floor muscles from visual and sound stimuli. Objective: To evaluate the effects of biofeedback in the treatment of female fecal incontinence. Methods: Twenty-three patients with fecal incontinence, diagnosed by clinical evaluation and manometry, and referred for biofeedback treatment, participated responding to the Cleveland Clinic Incontinence Assessment scale, and the Fecal Incontinence Quality of Life Questionnaire to obtain personal data, clinical complaints and incontinence characteristics. Four biofeedback sessions were held once a week. After the protocol, they were reevaluated with anorectal manometry and questionnaires, and they were instructed to daily perform the sphincteric contraction exercises at home. Results: The comparison of the Cleveland Clinic Florida Scoring System and FIQL scores before and after the biofeedback protocol showed a significant decrease (p = 0.0001) in fecal incontinence. The mean anal pressure at rest was 33.3 mmHg before and 49.65 mmHg after biofeedback, while the mean anal pressure of maximal voluntary contraction was 85 mmHg before treatment and 136.65 mmHg after it. Conclusion: Biofeedback is an effective method for the treatment of fecal incontinence, with increased sphincter strength and improved quality of life.

RESUMO Introdução: A incontinência anal é a perda involuntária de fezes e gases, caracterizada pela incapacidade de manter o controle fisiológico do conteúdo intestinal. Pode interferir negativamente na qualidade de vida dos pacientes. Biofeedback é uma ferramenta terapêutica utilizada no tratamento, através do treinamento dos músculos do assoalho pélvico, a partir de estímulo visual e sonoro. Objetivo: Avaliar os efeitos do biofeedback no tratamento da incontinência anal feminina. Metódos: Participaram 23 pacientes portadoras de incontinência anal, diagnosticadas pela avaliação clínica, manométrica e encaminhadas para tratamento com biofeedback, responderam um questionário para obtenção dos dados pessoais, queixas clínicas e características da incontinência, a escala de Avaliação da Incontinência da Cleveland Clinic e o questionário Fecal Incontinence Quality of life. Foram realizadas quatro sessões de biofeedback, uma vez por semana. Após o protocolo foram novamente reavaliadas com exame de manometria anorretal e questionários, foram orientadas a realizar os exercícios de contração esfincteriana diariamente em casa. Resultados: Na comparação dos escores dos questionários Cleveland Clinic Florida Scoring System e FIQL antes e após o protocolo de biofeedback pode-se observar diminuição significativa (p = 0,0001) da incontinência anal. As medias de pressão anal de repouso foi de 33,3 mmHg antes e 49,65 mmHg após o biofeedback, enquanto que a média da pressão anal de contração voluntária máxima foi de 85 mmHg antes do tratamento e 136,65 mmHg após o mesmo. Conclusão: O biofeedback é um método efetivo no tratamento da Incontinência anal, com aumento da força esfincteriana e melhora da qualidade de vida.

Posterior Tibial Nerve Stimulation for the Treatment of Fecal Incontinence Following Obstetric Anal Sphincter Injury.

OBJECTIVES: Obstetric anal sphincter injuries (OASI) are a major risk factor for fecal incontinence (FI). Neuromodulation is often used as second-line therapy for FI, but evidence for its efficacy is conflicting. We aimed to evaluate the efficacy and predictive factors of posterior tibial nerve stimulation for obstetric anal sphincter injury-induced FI. MATERIALS AND METHODS: Consecutive females with FI related to past OASI who had not responded to first-line therapy and had received 8-12 weeks of posterior tibial nerve stimulation were included. Subjects aged more than 50 and/or having other causes of FI were excluded. Patients underwent anorectal physiology and endoanal ultrasound pretherapy. Symptom burden was evaluated pretherapy and posttherapy using Rockwood and Wexner scales. A Wexner score reduced to below 10 or halved was used to define responders. RESULTS: A total of 37 females (mean age 38 years, median parity 2) were included. About 17 (46%) had ultrasonographically visualized anal sphincter defects and 41% had a history of third or second-degree perineal tears. About 14 subjects (38%) were deemed responders. Compared with nonresponders, responders had lower baseline rectal distension thresholds and tended to have disrupted (59%) than intact sphincters (20%, p < 0.01). Responders demonstrated improvement in Rockwood score for depression and embarrassment, visual analogue score for bowel symptoms and stool consistency (median baseline Bristol score 5, to 3 posttherapy; p < 0.01). CONCLUSIONS: Of a well-defined cohort of females with FI secondary to OASI, 38% responded to posterior tibial nerve stimulation. Much of this improvement may relate to improvement in stool consistency.

ICS Educational Module: Electromyography in the assessment and therapy of lower urinary tract dysfunction in adults.

AIM: To present the teaching module "Electromyography in the assessment and therapy of lower urinary tract dysfunction in adults." This teaching module embodies a presentation, in combination with this manuscript. This manuscript serves as a scientific background review; the evidence base made available on ICS website to summarize current knowledge and recommendations. METHODS: This review has been prepared by a Working Group of The ICS Urodynamics Committee. The methodology used included comprehensive literature review, consensus formation by the members of the Working Group, and review by members of the ICS Urodynamics Committee core panel. RESULTS: Electromyography (EMG) is a method to record spontaneous or artificially induced electrical activity of the nerve-muscle unit or to test nerve conductivity. EMG of the anal sphincter using surface electrode is most widely used screening technique to detect detrusor-sphincter dyssynergia in urology. It is non-invasive and easy to perform. EMG methods using needle electrodes are reserved for diagnostics in well selected group of mainly neurogenic patients. These methods require expertise in the field of general EMG and are usually performed by neurologist and neuro-physiologist. The evidence in many aspects of use of EMG in urology remains sparse. CONCLUSIONS: Currently EMG methods rarely play a decision making role in selecting proper treatment of lower urinary tract dysfunction. With the current efforts to improve phenotyping of these patients in order to provide individualized treatment, the role of EMG could increase.

The assessment and management of defecatory dysfunction: a critical appraisal.

PURPOSE OF REVIEW: To summarize the advances in diagnostic modalities and management options for defecatory dysfunction and highlight the areas in need of further research. RECENT FINDINGS: The diagnostic utility of high-resolution anorectal manometry (ARM), which has emerged as a promising tool for the diagnosis of defecatory dysfunction, appears to be questionable in differentiating disease from normal physiology. There also seems to be discrepancy between results of various tests of anorectal function in the diagnosis of defecatory dysfunction. New revisions in diagnostic criteria for defecatory dysfunction by Rome IV consortium, may enhance its diagnostic yield. Biofeedback remains to be the most effective evidence-based treatment option for patients with defecatory dysfunction. Anorectal pressure profile cannot predict or mediate the success of biofeedback. Biofeedback may improve the symptoms through central effects. SUMMARY: Despite the advances in the ARM and defecography techniques, no one test has been able to be considered as the 'gold standard' for diagnosis of defecatory dysfunction. The mechanism of action of biofeedback in defecatory dysfunction remains poorly understood.

Two-stage Turnbull-Cutait pull-through coloanal anastomosis versus coloanal anastomosis with protective loop ileostomy for low rectal cancer. Protocol for a randomized controlled trial (Turnbull-BCN).

PURPOSE: The aim of this study was to determine whether patients that underwent ultra-low rectal resection for cancer can benefit from the recently reintroduced two-stage Turnbull-Cutait abdominoperineal pull-through procedure. METHODS: Patients with low rectal tumors undergoing radical sphincter-sparing resection are eligible for inclusion in a randomized multicenter study. Whether two-stage Turnbull-Cutait coloanal anastomosis provides significant benefits over hand-sewn coloanal anastomosis and associated lateral ileostomy in terms of postoperative morbidity is the primary endpoint. In addition, the study aims to assess secondary endpoints such as quality of life, fecal incontinence, and locoregional recurrence of the neoplasm. Patients with adenocarcinoma of the lower rectum diagnosed by rigid proctoscopy, with histological confirmation of malignancy, and who are candidates of rectal removal and coloanal anastomosis will be included in a randomized controlled and multicenter trial. Postoperative morbidity is defined as complications that occur within 30 days of the data of the second surgical procedure of the last patient included in the trial. Patients will be followed for a minimum period of 3 years. CONCLUSIONS: The two-stage Turnbull-Cutait coloanal anastomosis may constitute an effective surgical alternative in the current approach to the treatment of low rectal cancer without the need of a temporary loop colostomy, preventing the wide range of complications related to stoma surgery. TRIAL REGISTRATION: This trial is registered at clinicaltrials.gov (trial number: NCT01766661). This trial is registered in January 10, 2013.

Percutaneous tibial nerve stimulation (pTNS): success rate and the role of rectal capacity.

PURPOSE: Percutaneous tibial nerve stimulation (pTNS) was originally developed to treat urinary incontinence. Recently, some case series have also documented its success in the treatment of fecal incontinence. Nevertheless, the mechanism underlying this effect remains unknown but may be related to changes in rectal capacity. The aim of this study was to investigate the success of pTNS for the treatment of fecal urge incontinence and assess the influence of rectal capacity on treatment efficacy. METHODS: All patients undergoing pTNS for fecal incontinence between July 2009 and March 2014 were enrolled in a prospective, observational study consisting of a therapeutic regimen that lasted 9 months. Therapy success was defined as a reduction in the CCI (Cleveland Clinic incontinence) score of ≥50% and patient-reported success. Furthermore, quality of life (Rockwood's scale) and changes in anorectal physiology were recorded. RESULTS: Fifty-seven patients with fecal urge incontinence were eligible, nine of whom were excluded. The success rate was 72.5%. Incontinence events and urge symptoms were significantly reduced after 3 months and at the end of therapy. The median CCI score decreased from 12 to 4 (P < 0.0001), and the quality of life was significantly improved. However, rectal capacity was not significantly related to treatment success before or after therapy. No adverse events were observed. CONCLUSIONS: These results demonstrate that pTNS can improve the symptoms and quality of life of patients with fecal urge incontinence. However, the study fails to demonstrate a correlation between treatment success and changes in rectal capacity.

Efficacy of nitroglycerine ointment in the treatment of pediatric anal fissure.

BACKGROUND: Anal fissure is the most common anal disease in children. In the past few decades, the understanding of its pathophysiology has led to a progressive reduction in invasive procedures in favor of conservative treatment based on stool softeners and the relaxation of the anal sphincter. This randomized controlled study assessed the safety and efficacy of nitroglycerine (NTG) ointment in the treatment of pediatric anal fissure, which had not yet been proved. PATIENTS AND METHODS: An unequal randomized controlled study included 105 pediatric patients with anal fissure who had presented to the private and outpatient clinics of the Central Teaching Hospital of Pediatrics during the period from February 2015 to May 2016. The control group consisted of 70 patients. Both groups were treated with classical conservative therapy of sitz bath, stool softener, and local anesthetic. In the second group, chemical sphincterotomy with 0.2% NTG ointment was used in 35 patients, and was applied at the anal canal twice daily for 8weeks. The primary outcomes of symptomatic improvement and healed fissure, as well as side effects, were analyzed. RESULTS: The average age of patients was 2years (range, 4months to 5years). Patients in the NTG group had 77% symptomatic relief and 60% healed fissure compared to the control group, which had 54% and 32.8% respectively. All were statistically significant. No serious adverse effects were noticed during the treatment period. CONCLUSION: The use of 0.2% NTG ointment is an effective therapy for anal fissure in children in terms of good healing rate and rapid symptom relief, but it has the drawback of a long treatment period, making patient compliance more difficult, in addition to the problems of tolerance and recurrence. TYPE OF STUDY: Prospective randomized controlled study (treatment study). LEVEL OF EVIDENCE: Type 2.