Patient Satisfaction With Long-term Sacral Neuromodulation for Fecal Incontinence: Experience from a Single Tertiary Center.

BACKGROUND: Sacral Neuromodulation is an effective treatment for faecal incontinence in the long-term. Efficacy is typically assessed using bowel diary, symptom severity, or quality of life questionnaires and 'success' defined as >50% improvement in these measures. Patient satisfaction may however be a more meaningful and individualised measure of treatment efficacy. OBJECTIVE: To assess patient reported satisfaction with long-term sacral neuromodulation and compare it to the frequently applied efficacy measures. DESIGN: An observational study of a prospectively maintained database. SETTING: A single tertiary pelvic floor referral unit. PATIENTS: Data from 70 (68 female, median age 69 [60 - 74]) patients were available. The median time since implantation was 11 (9 - 14) years. Nineteen patients reported inactive neuromodulation devices. MAIN OUTCOME MEASURES: Bowel diaries, the Manchester Health Questionnaire, and the St Marks Incontinence Score recorded at baseline, after percutaneous nerve evaluation, and at last follow-up. Patient reported satisfaction, using a 0%-100% visual analogue scale, with treatment since implantation (overall) and in the two-weeks preceding completion of the last outcome measures (current). RESULTS: Satisfaction was significantly higher in those with active sacral neuromodulation devices (75% vs 20%, p<0.001) at follow-up. No significant relationships exist between symptom improvement using conventional measures, and patient reported satisfaction. Current satisfaction was not associated with changes in bowel diary data following percutaneous nerve evaluation. Despite improvements in the St Mark's incontinence score and Manchester Health Questionnaire below the 50% improvement threshold used to define 'success', patients reported high (80%) satisfaction. LIMITATIONS: Retrospective with gaps in the available data. CONCLUSIONS: High patient satisfaction with sacral neuromodulation can be achieved, however the response to percutaneous nerve evaluation may not predict treatment satisfaction in long-term. The change in questionnaire results, which measure the use of compensatory behaviors and quality of life impact, may better correspond to treatment satisfaction.

A comparison of function lumen imaging probe measurements of anal sphincter function in fecal incontinence.

BACKGROUND: The functional lumen imaging probe (FLIP) is a test of anal sphincter distensibility under evaluation by specialist centers. Two measurement protocols termed "stepwise" and "ramp" are used, risking a lack of standardization. This study aims to compare the performance of these protocols to establish if there are differences between them. METHODS: Patients with fecal incontinence were recruited and underwent measurement with both protocols at a tertiary pelvic floor referral unit. Differences in minimum diameter, FLIP bag pressure, and distensibility index (DI) at rest and during squeeze were calculated at various FLIP bag volumes. KEY RESULTS: Twenty patients (19 female, mean age 61 [range: 38-78]) were included. The resting minimum diameter at 30 and 40 mL bag volumes were less in the stepwise protocol (mean bias: -0.55 mm and -1.18 mm, p < 0.05) along with the DI at the same bag volumes (mean bias: -0.37 mm2/mmHg and -0.55 mm2/mmHg, p < 0.05). There was also a trend towards greater bag pressures at 30 mL (mean bias: +2.08 mmHg, p = 0.114) and 40 mL (mean bias: +2.81 mmHg, p = 0.129) volumes in the stepwise protocol. There were no differences between protocols in measurements of minimum diameter, maximum bag pressure, or DI during voluntary squeeze (p > 0.05). CONCLUSION AND INFERENCES: There are differences between the two commonly described FLIP measurement protocols at rest, although there are no differences in the assessment of squeeze function. Consensus agreement is required to agree the most appropriate FLIP measurement protocol in assessing anal sphincter function.

Percutaneous tibial nerve stimulation versus sacral nerve stimulation for the treatment of faecal incontinence.

Introduction: Faecal incontinence (FI) is a common condition with a significant impact on quality of life (QoL). Neuromodulation treatments delivered by members of the multidisciplinary team including sacral nerve stimulation (SNS) and percutaneous tibial nerve stimulation (PTNS) are options for FI refractory to conservative management. The aim of this study was to assess whether a successful treatment with one neuromodulation modality corresponds with success in the other. Methods: A retrospective review of a prospectively managed neuromodulation database identified 15 patients who had undergone both PTNS and SNS. The definition of success of each treatment was a >50% improvement in any of The St. Mark's Incontinence Score, Manchester Health Questionnaire, or weekly faecal urgency or FI episodes. Results: Complete data from 12 patients was available for assessment and PTNS was delivered as the first treatment in nine patients. Overall, seven patients (58%) had successful PTNS treatment, with 10 (83%) having a successful SNS trials. Of the seven patients who had successful PTNS treatment, six patients (85.4%) went on to have success with SNS. Of the five patients who failed PTNS, four (80%) went on to have SNS success. Five (71%) of those who had positive PTNS outcomes had permanent SNS implantation as their final treatment decision. Conclusion: This study suggests that there is no clear relationship between successful PTNS treatment and an SNS trial period which may be explained by differing mechanisms of action or the potential placebo effect of PTNS. Further work is required to investigate any association in larger studies to inform clinical practice.

The Long-term Outcomes of Sacral Neuromodulation for Fecal Incontinence: A Single-Center Experience.

BACKGROUND: Sacral neuromodulation is an effective treatment for fecal incontinence. OBJECTIVE: To assess the long-term outcomes of sacral neuromodulation and establish the outcomes of patients with inactive devices. DESIGN: This is an observational study of patients treated for >5 years. A positive outcome was defined as a more than 50% reduction in fecal incontinence episodes or improvement in a symptom severity score. Data were reviewed from a prospectively managed database. SETTINGS: This study was conducted at a single tertiary referral center. PATIENTS: Data from 74 patients (72 women) were available at long-term follow-up. MAIN OUTCOME MEASURES: Bowel diary, St. Mark's incontinence score, and Manchester Health Questionnaire data were prospectively recorded at baseline, after percutaneous nerve evaluation, and at last follow-up. RESULTS: Patients were analyzed in cohorts based on time since sacral neuromodulation implantation: group 1: 5 to 10 years (n = 20), group 2: >10 years (n = 35), and group 3: inactive sacral neuromodulation devices (n = 19). Median St. Mark's incontinence score and Manchester Health Questionnaire improved from baseline to last follow-up in group 1 ( p ≤ 0.05) and group 2 ( p ≤ 0.05), but in group 3, results returned to baseline levels at the last follow-up. Similarly, weekly fecal incontinence episodes improved in both active device groups at the last follow-up. However, in group 3, incontinence episodes were no different from baseline ( p = 0.722). Despite active devices, fecal urgency episodes increased at the last follow-up after >10 years since percutaneous nerve evaluation ( p ≤ 0.05). Complete continence was reported by 44% of patients, and at least a 50% improvement was seen in 77% of patients with active devices. LIMITATIONS: This study is retrospective with some gaps in the available data at the last follow-up. CONCLUSIONS: Sacral neuromodulation is an effective treatment for fecal incontinence in the long term, but all outcomes are adversely affected by device inactivity. Therefore, ongoing stimulation is required for continued benefit. See Video Abstract. RESULTADOS A LARGO PLAZO DE LA NEUROMODULACIN SACRA PARA LA INCONTINENCIA FECAL EXPERIENCIA DE UN SOLO CENTRO: ANTECEDENTES:La neuromodulación sacra es un tratamiento eficaz para la incontinencia fecal.OBJETIVO:Este estudio tuvo como objetivo evaluar los resultados a largo plazo de la neuromodulación sacra y establecer los resultados de los pacientes con dispositivos inactivos.DISEÑO:Este es un estudio observacional de pacientes tratados durante más de 5 años. Un resultado positivo se definió como una reducción >50 % en los episodios de incontinencia fecal o una mejoría en la puntuación de gravedad de los síntomas. Los datos se revisaron a partir de una base de datos administrada prospectivamente.ENTERNO CLINICO:Este estudio se realizó en un solo centro de referencia terciario.PACIENTES:Los datos de 74 pacientes (72 mujeres) estaban disponibles en el seguimiento a largo plazo.PRINCIPALES MEDIDAS DE RESULTADO:Diario intestinal, puntuación de incontinencia de St. Mark y datos del Cuestionario de salud de Manchester se registraron prospectivamente al inicio, después de la evaluación de nervio periférico y en el último seguimiento.RESULTADOS:Los pacientes se analizaron en cohortes según el tiempo transcurrido desde la implantación de la neuromodulación sacra: Grupo 1: 5-10 años (n = 20), Grupo 2: >10 años (n = 35) y Grupo 3: dispositivos SNM inactivos (n = 19). La mediana de la puntuación de incontinencia de St. Mark y Questionnaire Cuestionario de salud de Manchester mejoraron desde el inicio hasta el último seguimiento en el Grupo 1 (p = < 0,05) y el Grupo 2 (p = < 0,05), pero en el Grupo 3 los resultados volvieron a los niveles iniciales en el último seguimiento. arriba. De manera similar, los episodios semanales de incontinencia fecal mejoraron en ambos grupos de dispositivos activos en el último seguimiento. Sin embargo, en el Grupo 3 los episodios de incontinencia no fueron diferentes de los basales (p = 0,722). A pesar de los dispositivos activos, los episodios de urgencia fecal aumentaron en el último seguimiento después de más de 10 años desde la evaluación del nervio periférico (p = < 0,05). Continencia completa se reportó en el 44 % de los pacientes, y al menos una mejora del 50 % en el 77 % con dispositivos activos.LIMITACIONES:Este estudio es retrospectivo con algunas vacíos en los datos disponibles en el último seguimiento.CONCLUSIONES:La neuromodulación sacra es un tratamiento eficaz para la incontinencia fecal a largo plazo, pero todos los resultados se ven afectados negativamente por la inactividad del dispositivo. Por lo tanto, se requiere estimulación continua para un beneficio continuo. (Traducción- Dr. Francisco M. Abarca-Rendon ).

Current and future perspectives on the utility of provocative tests of anal sphincter function: A state-of-the-art summary.

BACKGROUND: The maintenance of fecal continence depends upon coordinated interactions between the pelvic floor, anorectum, and anal sphincter complex orchestrated by central and peripheral neural activities. The current techniques to objectively measure anorectal function rely on fixed diameter catheters placed inside the anal canal with a rectal balloon to obtain measurements of anal resting and squeeze function, and rectal compliance. Until recently it had not been possible to measure the distensibility of the anal canal, or in other words its ability to resist opening against an increasing pressure, which has been proposed as the main determinant of a biological sphincter's function. Anal acoustic reflectometry (AAR) and the functional lumen imaging probe (FLIP) are two novel, provocative techniques that dynamically assess the anal sphincter complex under volume-controlled distension. In doing so, both provide information on the viscoelastic properties of the anal canal and offer new insights into its function. PURPOSE: This review details the current and potential future applications of AAR and FLIP and highlights the unanswered questions relevant to these new technologies.

Methodologic Validation of a Faster Pelvic Floor Test: Two Randomized Studies in Anal Acoustic Reflectometry.

BACKGROUND: Anal acoustic reflectometry investigates the opening and closing function of the anal canal using reflected sound waves to measure a cross-sectional area at different pressures. Anal acoustic reflectometry is reliable and repeatable, distinguishes between continence and incontinence and between subgroups of incontinence, correlates with symptom severity, and does not distort the anal canal during investigation. OBJECTIVE: The purpose of this study was to validate anal acoustic reflectometry methodology by asking 2 questions: can anal acoustic reflectometry be used alongside manometry (order study) and can anal acoustic reflectometry be performed faster (filling study). The secondary aim was to assess the response of the anal canal to stretch using anal acoustic reflectometry. DESIGN: This research included 2 prospective randomized studies. SETTINGS: The study was conducted at a tertiary referral center. PATIENTS: Patients undergoing investigation for fecal incontinence were included. INTERVENTION: For the order study, patients were prospectively randomized to anal acoustic reflectometry, manometry, 2-minute rest and then manometry, anal acoustic reflectometry, or vice versa. For the filling study, patients were prospectively randomized to fast rate anal acoustic reflectometry (5 cm H2O/1 s), manometry, 2-minute rest and then manometry, normal rate anal acoustic reflectometry (5 cm H2O/3 s), or vice versa. MAIN OUTCOME MEASURES: The primary outcome was no difference in anal acoustic reflectometry or manometry variables. Demographic and clinical data were recorded. RESULTS: The order study included 30 patients with a median age of 63 years (range, 30-84 y); 77% were women. No difference was found among all of the variables of anal acoustic reflectometry and manometry regardless of which test was performed first. The filling study included 50 patients with a median age of 62 years (range, 30-78 y); 80% were women. No difference was found between fast and normal rates of anal acoustic reflectometry and manometry in any order. LIMITATIONS: This study was limited by its comparison with water-perfused manometry. CONCLUSIONS: Anal acoustic reflectometry and manometry can be performed at the normal or fast rate of anal acoustic reflectometry in any order. A fast rate of anal acoustic reflectometry did not augment the response of the anal canal to stretch as measured by anal acoustic reflectometry and manometry. This study validates a faster anal acoustic reflectometry technique and vindicates previous data. See Video Abstract at http://links.lww.com/DCR/A821.

The short-term effects of posterior tibial nerve stimulation on anorectal physiology in patients with faecal incontinence: a single centre experience.

BACKGROUND: Posterior tibial nerve stimulation (PTNS) is a novel treatment for patients with faecal incontinence (FI) and may be effective in selected patients; however, its mechanism of action is unknown. We sought to determine the effects of PTNS on anorectal physiological parameters. METHODS: Fifty patients with FI underwent 30 min of PTNS treatment, weekly for 12 weeks. High-resolution anorectal manometry, bowel diaries and Vaizey questionnaires were performed before and after treatment. Successful treatment was determined as a greater than 50% reduction in FI episodes. RESULTS: Fifty patients with FI were studied; 39 women, median age 62 years (range 30-82). Compared with pretreatment, there were reductions in episodes of urgency (16.0 versus 11.4, p = 0.006), overall FI (14.5 versus 9.1, p = 0.001), urge FI (5.4 versus 3.2, p = 0.016) and passive FI (9.1 versus 5.9, p = 0.008). Vaizey score was reduced (16.1 versus 14.5, p = 0.002). Rectal sensory volumes (ml) decreased (onset 40.3 versus 32.6, p = 0.014, call 75.7 versus 57.5, p < 0.001, urge 104.1 versus 87.4, p = 0.004). There was no significant change in anal canal pressures (mmHg) (maximum resting pressure 41.4 versus 44.2, p = 0.39, maximum squeeze pressure, 78.7 versus 88.2, p = 0.15, incremental squeeze pressure 37.2 versus 44.1, p = 0.22). Reduction in FI episodes did not correlate with changes in physiological parameters (p > 0.05). Treatment success of 44% was independent of changes in manometric parameters (p > 0.05). CONCLUSIONS: PTNS has a measureable physiological effect on rectal sensory volumes without an effect on anal canal pressures. It also reduces FI episodes; however, this effect is independent of changing physiology, suggesting that PTNS has a complex mechanism of action.

Use of Anal Acoustic Reflectometry in the Evaluation of Men With Passive Fecal Leakage.

BACKGROUND: Men with passive fecal leakage represent a distinct clinical entity in which the pathophysiology remains unclear. Standard anorectal investigations fail to demonstrate consistent abnormalities in this group. Anal acoustic reflectometry is a new test of anal sphincter function with greater sensitivity and discriminatory ability than conventional anal manometry. OBJECTIVE: The aim of this study was to determine whether men with fecal leakage have an abnormality in anal sphincter function that is detectable by anal acoustic reflectometry. DESIGN: This was an age-matched study of continent and incontinent men. SETTINGS: The study was conducted at a university teaching hospital. PATIENTS: Male patients with isolated symptoms of fecal leakage were recruited. Anal acoustic reflectometry, followed by conventional anal manometry, was performed. Results were then compared with those from an age-matched group of men with no symptoms of anal incontinence or anorectal pathology. MAIN OUTCOME MEASURES: Variables measured with anal acoustic reflectometry and anal manometry in the incontinent and continent men were compared. RESULTS: Thirty subjects were recruited, of whom 15 were men with fecal leakage and 15 were continent men. There was a significantly higher incidence of previous anorectal surgery in the men with leakage. The anal acoustic reflectometry variables of opening and closing pressure were significantly lower in leakers compared with continent subjects (p = 0.003 and p = 0.001). Hysteresis was significantly greater in the male leaker group (p = 0.026). No difference was seen in anal manometry. LIMITATIONS: With a larger sample size, the effect of previous anorectal surgery and the presence of an anal sphincter defect could be clarified. CONCLUSIONS: Anal acoustic reflectometry is a sensitive test of anal sphincter function and, unlike anal manometry, can discriminate male leakers from continent subjects. An identifiable abnormality has been detected using anal acoustic reflectometry, which may further our understanding of the pathogenesis in this group.

Viscoelastic assessment of anal canal function using acoustic reflectometry: a clinically useful technique.

BACKGROUND: Anal acoustic reflectometry is a new reproducible technique that allows a viscoelastic assessment of anal canal function. Five new variables reflecting anal canal function are measured: the opening and closing pressure, opening and closing elastance, and hysteresis. OBJECTIVE: The aim of this study was to assess whether the parameters measured in anal acoustic reflectometry are clinically valid between continent and fecally incontinent subjects. DESIGN: This was an age- and sex-matched study of continent and incontinent women. SETTING: The study was conducted at a university teaching hospital. PATIENTS: One hundred women (50 with fecal incontinence and 50 with normal bowel control) were included in the study. Subjects were age matched to within 5 years. MAIN OUTCOME MEASURES: Parameters measured with anal acoustic reflectometry and manometry were compared between incontinent and continent groups using a paired t test. Diagnostic accuracy was assessed by the use of receiver operator characteristic curves. RESULTS: Four of the 5 anal acoustic reflectometry parameters at rest were significantly different between continent and incontinent women (eg, opening pressure in fecally incontinent subjects was 31.6 vs 51.5 cm H2O in continent subjects, p = 0.0001). Both anal acoustic reflectometry parameters of squeeze opening pressure and squeeze opening elastance were significantly reduced in the incontinent women compared with continent women (50 vs 99.1 cm H2O, p = 0.0001 and 1.48 vs 1.83 cm H2O/mm, p = 0.012). In terms of diagnostic accuracy, opening pressure at rest measured by reflectometry was significantly superior in discriminating between continent and incontinent women in comparison with resting pressure measured with manometry (p = 0.009). CONCLUSIONS: Anal acoustic reflectometry is a new, clinically valid technique in the assessment of continent and incontinent subjects. This technique, which assesses the response of the anal canal to distension and relaxation, provides a detailed viscoelastic assessment of anal canal function. This technique may not only aid the investigation of fecally incontinent subjects, but it may also improve our understanding of anal canal physiology during both the process of defecation and maintenance of continence.

Anal acoustic reflectometry: a new reproducible technique providing physiological assessment of anal sphincter function.

BACKGROUND: Anal acoustic reflectometry is a new technique of assessing anal sphincter function. Five new variables reflecting anal canal function are measured: the opening and closing pressure, the opening and closing elastance, and hysteresis. OBJECTIVE: This study aimed to compare the reproducibility of this new technique, in terms of test-retest and interrater reliability, with manometry, the current standard test of sphincter function. DESIGN: This is a comparative study of reproducibility between anal acoustic reflectometry and manometry. SETTINGS: This study was conducted at a university hospital (outpatient clinic and endoscopy unit). PATIENTS: Twenty-six (21 female) subjects were assessed with both anal acoustic reflectometry and manometry on 2 separate occasions (test-retest reliability) and 22 (16 female) subjects were assessed with both methods by 2 separate investigators (interrater reliability). MAIN OUTCOME MEASURES: Reproducibility was assessed according to the Bland-Altman method. RESULTS: All of the measured novel anal acoustic reflectometry parameters had acceptable mean differences and repeatability coefficients. Comparison of the 2 methods of sphincter assessment (anal acoustic reflectometry vs manometry) was made for measurements taken at rest and during voluntary contraction. There was no significant difference in terms of test-retest reliability between the manometry maximum resting pressure vs the reflectometry opening pressure (P = .57) or manometry maximum squeeze pressure vs the reflectometry squeeze opening pressure (P = .68). No significant difference between methods was found in interrater reliability during assessments at rest (P = .62) and voluntary contraction (P = .96). LIMITATIONS: Anal acoustic reflectometry is limited, as with all tests of anorectal function, in that the device is placed within the anal canal, causing stimulation of sensory and stretch receptors. CONCLUSIONS: Anal acoustic reflectometry has a reproducibility comparable to manometry in terms of both test-retest and interrater reliability. Anal acoustic reflectometry is a promising technique that allows an assessment of anal canal physiology that is not available with manometry.

Anterior anal sphincter repair can be of long term benefit: a 12-year case cohort from a single surgeon.

BACKGROUND: Early surgical results of anterior sphincter repair for faecal incontinence can be good, but in the longer term are often disappointing. This study aimed to determine the short and long term outcomes from anterior sphincter repair and identify factors predictive of long term success. METHODS: Patients who underwent anterior sphincter repair between 1989 and 2001 in one institution were identified. Postal questionnaires were sent to patients, which included validated scoring systems for symptom severity and quality of life assessments for faecal incontinence. Patient demographics and risk factors were recorded as were the results of anorectal physiology studies and endoanal ultrasound. RESULTS: Eighty-five patients underwent repair by one consultant. The length of follow up ranged from 1 to 12 years. Most patients (96%) had early symptom improvement postoperatively. Of the 47 patients assessed long term (> or = 5 years), 28 (60%) maintained this success. Significant improvements in quality of life were observed (P < 0.001). Neither patient, surgical nor anorectal physiology study parameters were predictive of outcome. CONCLUSION: There were no predictive factors of outcome success and no changes in anal manometry identified, however anterior sphincter repair remains worthwhile. Changes in compliance of the anorectum may be responsible for symptom improvement.