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 ).

A Suicide Prevention Intervention for Emerging Adult Sexual and Gender Minority Groups: Protocol for a Pilot Hybrid Effectiveness Randomized Controlled Trial.

BACKGROUND: Suicide attempts and suicide death disproportionately affect sexual and gender minority emerging adults (age 18-24 years). However, suicide prevention strategies tailored for emerging adult sexual and gender minority (EA-SGM) groups are not widely available. The Safety Planning Intervention (SPI) has strong evidence for reducing the risk for suicide in the general population, but it is unclear how best to support EA-SGM groups in their use of a safety plan. Our intervention (Supporting Transitions to Adulthood and Reducing Suicide [STARS]) builds on content from an existing life skills mobile app for adolescent men who have sex with men (iREACH) and seeks to target core risk factors for suicide among EA-SGM groups, namely, positive affect, discrimination, and social disconnection. The mobile app is delivered to participants randomized to STARS alongside 6 peer mentoring sessions to support the use of the safety plan and other life skills from the app to ultimately reduce suicide risk. OBJECTIVE: We will pilot-test the combination of peer mentoring alongside an app-based intervention (STARS) designed to reduce suicidal ideation and behaviors. STARS will include suicide prevention content and will target positive affect, discrimination, and social support. After an in-person SPI with a clinician, STARS users can access content and activities to increase their intention to use SPI and overcome obstacles to its use. EA-SGM groups will be randomized to receive either SPI alone or STARS and will be assessed for 6 months. METHODS: Guided by the RE-AIM (reach, efficacy, adoption, implementation, and maintenance) framework, we will recruit and enroll a racially and ethnically diverse sample of 60 EA-SGM individuals reporting past-month suicidal ideation. Using a type-1 effectiveness-implementation hybrid design, participants will be randomized to receive SPI (control arm) or to receive SPI alongside STARS (intervention arm). We will follow the participants for 6 months, with evaluations at 2, 4, and 6 months. Preliminary effectiveness outcomes (suicidal ideation and behavior) and hypothesized mechanisms of change (positive affect, coping with discrimination, and social support) will serve as our primary outcomes. Secondary outcomes include key implementation indicators, including participants' willingness and adoption of SPI and STARS and staff's experiences with delivering the program. RESULTS: Study activities began in September 2021 and are ongoing. The study was approved by the institutional review board of the University of Pennsylvania (protocol number 849500). Study recruitment began on October 14, 2022. CONCLUSIONS: This project will be among the first tailored, mobile-based interventions for EA-SGM groups at risk for suicide. This project is responsive to the documented gaps for this population: approaches that address chosen family, focus on a life-course perspective, web approaches, and focus on health equity and provision of additional services relevant to sexual and gender minority youth. TRIAL REGISTRATION: ClinicalTrials.gov NCT05018143; https://classic.clinicaltrials.gov/ct2/show/NCT05018143. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/48177.

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.

Do Stereotypic Images in Video Games Affect Attitudes and Behavior? Adolescents' Perspectives.

This study examined adolescents' attitudes about video games along with their self-reported play frequency. Ninth and eleventh grade students (N = 361), approximately evenly divided by grade and gender, were surveyed about whether video games have stereotypic images, involve harmful consequences or affect one's attitudes, whether game playing should be regulated by parents or the government, and whether game playing is a personal choice. Adolescents who played video games frequently showed decreased concern about the effects that games with negatively stereotyped images may have on the players' attitudes compared to adolescents who played games infrequently or not at all. With age, adolescents were more likely to view images as negative, but were also less likely to recognize stereotypic images of females as harmful and more likely to judge video-game playing as a personal choice. The paper discusses other findings in relation to research on adolescents' social cognitive judgments.

Social Evaluations of Stereotypic Images in Video Games: Unfair, Legitimate, or "Just Entertainment"?

The aim of this study was to assess adolescents' evaluations of, and reasoning about, gender stereotypes in video games. Female (N = 46) and male (N = 41), predominantly European-American, mean age = 19 years, were interviewed about their knowledge of game usage, awareness and evaluation of stereotypes, beliefs about the influences of games on the players, and authority jurisdiction over 3 different types of games: games with negative male stereotypes, and games with negative female stereotypes, and gender-neutral games. Gender differences were found for how participants evaluated these games. Males were more likely than females to find stereotypes acceptable. Results are discussed in terms of social reasoning, video game playing, and gender differences.