Introduction

Faecal incontinence (FI) is a prevalent issue which can have a detrimental impact on the patient’s quality of life. Current international guidelines lack strong treatment recommendations due to few studies in the field, in combination with the heterogeneity in outcome reporting. To address this, a Core Outcome Set (COS) is proposed to standardize outcome reporting in FI studies, facilitating meta-analyses and enhancing therapeutic recommendations. This systematic review aims to identify which outcomes have been used in FI intervention studies so far in adult patients as a starting phase for the development of a future COS for FI.

Aims & Methods

Medline, Embase and the Cochrane library were searched to identify all outcomes reported in comparative effectiveness trials assessing one or more treatment option in adult patients suffering from FI. The outcomes were categorized according to the Core Outcome Measurement in Effectiveness Trials (COMET) taxonomy to standardize outcome terminology, assess completeness, and inform subsequent steps in COS development.

Results

A total of 109 studies were included, which revealed 51 unique outcomes which were classified into 38 domains within four core areas. On average four outcomes were reported per study (range 1-11). The most commonly reported outcomes were ‘Severity of FI’ (83%), ‘Quality of life’ (64%), ‘Number of FI episodes’ (40%), ‘Anorectal motor function’ (39%), and ‘Frequency of bowel movements’ (16%).

Conclusion

This systematic review offers an overview of outcomes reported in FI studies, highlighting the heterogeneity between studies. This heterogeneity emphasises the need for standardising outcome reporting which can be established through the creation of a COS. Outcomes identified through this study will be combined with other outcomes identified through patients interviews, forming a comprehensive list for a Delphi survey with relevant stakeholders to establish a consensus on a final list of outcomes for a COS for FI.

Disclosure

DK and SB have received grant support from UEG and ESCP for the development of a guideline for faecal incontinence. DK has received a grant from ZonMw for the study of the clinical efficacy of anal plugs in faecal incontinence. DK has received research funding from Rome Foundation, MLDS, Horizon 2020, Horizon Europe, Allergan, Grunenthal, and speaker’s free from Dr Falk (paid to host institute), all outside of submitted work. The other authors declare that they have no conflict of interest.

Introduction

Faecal incontinence (FI) is a prevalent and debilitating anorectal problem which can cause embarrassment, anxiety, social isolation and diminishes quality of life (QoL). Currently, there is no optimal treatment option for FI, consequently, treatments primarily focus on symptom reduction and improving QoL. In order to gain a clearer understanding of the challenge’s patients encounter, it is essential to actively listen to patients’ perspectives and experiences, as well as the specific outcomes they aim to achieve from treatment.
This study aims to explore how FI impacts patients’ lives and identify important treatment outcomes as part of the development of a Core Outcome Set (COS).

Aims & Methods

Patients with FI were recruited from surgery and gastroenterology outpatient clinics in the Netherlands. Semi-structured interviews were performed, audio recorded, transcribed per verbatim and coded. Thematic analysis was performed to identify (sub)themes and categories relevant to the patients.

Results

Twelve interviews were conducted before saturation was reached (75% female, 25% male, mean age 63, range 39-83 year). Four main themes emerged ‘Physical symptoms’, ‘Impact on daily life’, ‘Emotional impact’ and ‘Coping’. Patients expressed how FI severely limits daily activities and emotional wellbeing. Patients' treatment priorities centred on resuming normal activities rather than solely on (physical) symptom reduction.

Conclusion

The impact of FI extends far beyond uncontrolled loss of faeces, affecting psychological, emotional, and social wellbeing. Patients prioritise outcomes focussed on reclaiming normalcy and independence rather than focusing on physical symptoms alone. Integrating these patient-centered outcomes in future studies could enhance treatment satisfaction and patient-perceived treatment success. Furthermore, outcomes identified through this study will be combined with other outcomes identified through literature review, forming a comprehensive list for a Delphi survey with relevant stakeholders to establish a consensus on a final list of outcomes for a COS for FI.

Introduction

Faecal incontinence (FI) affects up to 8.3% of the population and may have physical, psychological and social consequences (1). Sadly, patient experiences remain under-explored, and most symptom measures are based on clinical outcomes rather than key priorities or concerns of affected individuals (2).

Aims & Methods

This study aimed to describe the lived experience of FI through review of published qualitative studies. A systematic literature search of studies of patients with FI published between 2003-2023 was conducted across Medline, Embase, CINAHL and PsycINFO. Studies were included if they provided qualitative data on patient experiences of living with FI. Studies in children and those principally focused on experiences following stoma formation were excluded. Methodological quality was described using the Critical Appraisal Skills Programme (CASP) tool for qualitative studies. An inductive approach by 2 reviewers enabled identification of key concepts. Collaboration with a third reviewer then generated higher-order interpretations. Finally, a meta- ethnographic method was utilized to construct a comprehensive thematic framework of lived experiences of FI.

Results

Of the 3394 studies identified, 29 studies were included in this synthesis. All studies were judged to be of good quality. Six major themes were identified (figure 1): quality of life, adaptation, protection, wider environment, perception and healthcare experiences. The theme ‘Quality of Life’ reflected the impact of FI on mental health, physical health, social well-being and functional ability. ‘Adaptation’ encompassed behavioural changes, dietary modification, and adjustments to daily routine to manage FI. The theme ‘Protection’ comprised risk management strategies and symptom concealment. ‘Wider Environment’ described navigation of the professional and public environment. ‘Perception’ reflected the impact of FI on self-perception, as well as the perception of other people’s attitudes towards FI. Finally, ‘Healthcare Experiences’ reflected patient experiences of accessing care and interactions with clinical care teams.

Conclusion

This qualitative synthesis offers a novel patient-centric framework of the lived experiences of FI and provides insight into the breadth of factors contributing to the burden of this condition. Many factors identified in this review are not represented in current outcome measures, highlighting the need for new ways of holistically assessing and measuring the impact of FI on patient wellbeing.

References

1.Mack I, Hahn H, Gödel C, Enck P, Bharucha AE. Global prevalence of fecal incontinence in community-dwelling adults: a systematic review and meta-analysis. Clinical Gastroenterology and Hepatology. 2023 Sep 19.
2. Bedard K, Heymen S, Palsson OS, Bharucha AE, Whitehead WE. Relationship between symptoms and quality of life in fecal incontinence. Neurogastroenterology & Motility. 2018 Mar;30(3):e13241.

Introduction

Faecal incontinence (FI) is prevalent, being associated with a high biopsychosocial burden and considerable health costs. The pathophysiology of FI is varied and often multifactorial, representing a diagnostic and therapeutic challenge. Anorectal manometry is the first recommended diagnostic method, although its utility is debatable due to overlapping findings between healthy individuals and patients.

Aims & Methods

The aim of this study is to establish a relationship between FI clinical presentation, manometric findings, and imaging.
We prospectively included all patients undergoing high-resolution anorectal manometry, according to the London protocol, at a tertiary centre, who agreed to respond to a questionnaire to characterize their FI, between August 2021 and March 2023. Clinical records were consulted, in order to access demographic data and past imaging reports. Statistical analysis was performed using IBM SPSS Statistics version 26®.

Results

Forty-seven patients were included with a mean age of 63.5±11.6 years, 87.2% women, of whom 73.2% had an obstetric history. Depressive/anxious symptoms were described in 59.6%, previous perineal surgery in 38.3%, and concomitant urinary incontinence in 40.0%. Mean FI duration was 5.4±5.2 years, with 51.1% reporting daily complaints and a bowel movement median of 2.0 (IQR 3.0). Males tended to have more bowel movements than females (3.5 (IQR 5.0) vs 2.0 (IQR 2.0); p-value 0.03). FI for flatus and faeces was present in 57.4%, for faeces alone in 34.0%, and for flatus alone in 8.5%. Urgency FI was verified in 37.0%, passive FI in 37.0%, and mixed FI in 26.1%. Mean Wexner score was 10±5. Rectal examination revealed hypotonicity in 15.9%. Mean resting pressure on anorectal manometry was 55.9±22.5 mmHg, dyssynergy was identified in 16.7% and altered balloon expulsion in 19.5%. The mean value of first sensation, first urge to defecate, and maximum tolerated volume were within the normal range. Imaging was performed in 19 patients (40.4%), with external anal sphincter injury in 15.8% and internal sphincter injury in 10.5%. Mean thickness of the internal anal sphincter (IAS) was 2.3±1.0 cm. Patients with hypotonicity in rectal examination had lower anal resting pressure (35.7±16.0 mmHg vs 60.3±22.4 mmHg; p-value 0.09) and lower IAS thickness (1.6±0.8 mm vs 2.6±0.9 mm; p-value 0.07), although not statistically significant. Patients with depressive/anxious symptoms showed lower maximum incremental pressure (56.6±34.0 mmHg vs 81.2±46.2 mmHg; p-value 0.045), as well as females when compared to males (60.0±34.9 mmHg vs 108.7±53.2 mmHg; p-value 0.005). No other statistically significant results were found, especially correlating clinical findings with manometry or imaging.

Conclusion

Our study showed, as previously replicated, that clinical, manometric and imaging findings have low correlation in the assessment of FI, reflecting its pathophysiological complexity.