Guideline for the diagnosis and treatment of Faecal IncontinenceA UEG/ESCP/ESNM/ESPCG collaboration

This is an open access article under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non-commercial and no modifications or adaptations are made.AbstractIntroduction: The goal of this project was to create an up-to-date joint European clinical practice guideline for the diagnosis and treatment of faecal incontinence (FI), using the best available evidence. These guidelines are intended to help guide all medical professionals treating adult patients with FI (e.g., general practitioners, surgeons, gastroenterologists, other healthcare workers) and any patients who are interested in information regarding the diagnosis and management of FI.Methods: These guidelines have been created in cooperation with members from the United European Gastroenterology (UEG), European Society of Coloproctology (ESCP), European Society of Neurogastroenterology and Motility (ESNM) and the European Society for Primary Care Gastroenterology (ESPCG). These members made up the guideline development group (GDG). Additionally, a patient advisory board (PAB) was created to reflect and comment on the draft guidelines from a patient perspective. Relevant review questions were established by the GDG along with a set of outcomes most important for decision making. A systematic literature search was performed using these review questions and outcomes as a framework. For each predefined review question, the study or studies with the highest level of study design were included. If evidence of a higher-level study design was available, no lower level of evidence was sought or included. Data from the studies were extracted by two reviewers for each predefined important outcome within each review question. Where possible, forest plots were created. After summarising the results for each review question, a systematic quality assessment using the GRADE (Grading of Recommendations, Assessment, Development and Evaluations) approach was performed. For each review question, we assessed the quality of evidence for every predetermined important outcome. After evidence review and quality assessment were completed, recommendations could be formulated. The wording used for each recommendation was dependent on the level of quality of evidence. Lower levels of evidence resulted in weaker recommendations and higher levels of evidence resulted in stronger recommendations. Recommendations were discussed within the GDG to reach consensus. Results: These guidelines contain 45 recommendations on the classification, diagnosis and management of FI in adult patients. Conclusion: These multidisciplinary European guidelines provide an up-to-date comprehensive evidence-based framework with recommendations on the diagnosis and management of adult patients who suffer from FI. K E Y W O R D S clinical guidelines, diagnosis, faecal incontinence, fecal incontinence, GRADE, guidelines, ptns, treatment, Sacral neuromodulation, unwanted loss of feces The Guideline Development Group had full control over the wording of the guideline without any influence from the funding body.The full method can be found in Appendix 1.Key summaryCurrent knowledge Faecal incontinence is debilitating anorectal problem with an estimated prevalence of 7.7%. There is a lack of up-to-date, evidence based guidance according to international standards for clinicians for the diagnosis and treatment of adult patients with faecal incontinence.What is new here These guidelines contain 45 up-to-date recommendations on the classification, diagnosis and management of faecal incontinence in adult patients. A patient advisory board was involved in this project from start to finish to provide their invaluable perspectives and to ensure issues important to this patient group were covered.

# Introduction
The most recent guideline for management of faecal incontinence in adults was published in 2007.Since then, a large number of studies have been published related to the treatment and diagnosis of faecal incontinence. As such, the goal of this project was to create an up-to-date joint This guideline is intended for use for all healthcare professionals treating patients with FI (e.g., general practitioners, gastroenterologists, colorectal surgeons, nurses etc.) and for any patients with FI who are interested in further information regarding the diagnosis and management of FI.
To summarise the results of this current guideline, an evidencebased treatment algorithm [fig_ref] 1: What are the effects of using an additional diagnostic tool compared to... [/fig_ref] has been created which presents the most important recommendations formulated in this guideline. We suggest using this algorithm as a guide in combination with the main body of text to determine which possible steps can be taken when treating a patient with FI. This guideline was funded by the UEG and the ESCP.

# Introduction
When a patient with complaints related to faecal incontinence (FI) visits a health care professional for the first time, the health care professional should establish clarity of the exact complaint the patient has, including any associated symptoms. After making a diagnosis, the physician should aim to manage the patient's expectations regarding FI and regarding the different available treatment options. This chapter discusses definition, classification/subdivision, diagnosis and patients' expectations of FI prognosis.

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## United european gastroenterology journal

## Review questions
We considered the following questions for our evidence review: For the purpose of these guidelines, the following definition for FI as defined by the Rome IV criteria will be utilised: "The recurrent uncontrolled passage of faecal material for at least 3 months".This definition excludes secretion of clear mucus and flatus incontinence.

## Classification/subdivision of fi
Although classification systems for FI based on underlying cause, on severity scales or on character of leakage (i.e., urge, passive, combined) do currently exist, there is no established and universally accepted classification system. We aimed to find literature which examines whether classifying/subdividing FI into any of these systems could be clinically meaningful.
Analysis of the literature revealed one study by from 2020 which assessed whether categorizing FI into urgency or passive FI is clinically meaningful. [bib_ref] Comparison of patient impact and clinical characteristics between urgency and passive fecal..., Pahwa [/bib_ref] Patients with urgency FI are able to feel the presence of faeces in the rectum but are not able to hold the faeces in for a prolonged period of time, resulting in unwanted loss of faeces. Patients with passive FI are not able to feel the presences of faeces in the rectum, resulting in unwanted loss of faeces which can leak out of the rectum without the patient's knowledge.The study by functional differences between women with urgeny FI compared to women with passive FI.
Whilst in women with urgency FI, a weaker squeeze pressure was found during digital rectal examination (DRE) and an earlier rectal sensation during anorectal manometry compared to patients with passive FI, patients with passive FI had a lower resting tone during DRE and a lower resting pressure on anorectal manometry compared to women with urge FI. [bib_ref] Comparison of patient impact and clinical characteristics between urgency and passive fecal..., Pahwa [/bib_ref] Previous studies have shown that certain treatments such as percutaneous tibial nerve stimulation (PTNS) and biofeedback are more effective in patients with urge incontinence than in patients with passive incontinence. [bib_ref] Outcome of biofeedback for faecal incontinence, Norton [/bib_ref] [bib_ref] Short-term outcome following percutaneous tibial nerve stimulation for faecal incontinence: a single-centre..., Hotouras [/bib_ref] These findings may help physicians to make a treatment decision based on FI subdivision into type of leakage.
We did not find any evidence favouring one classification system over another.

## Diagnosis

## History taking
Patients who suffer from FI often feel ashamed to talk about their problem and may find it difficult to describe their complaints. Many people who suffer from FI delay seeking help or never discuss their problem with a healthcare professional at all. [bib_ref] If we don't ask, they won't tell: screening for urinary and fecal..., Brown [/bib_ref] A patient may come in with a complaint related to FI (e.g., abdominal pain), rather than telling the health care professional they suffer from FI in a straightforward fashion due to shame surrounding the subject. When FI is suspected, health care professionals should take it upon themselves to ask the patient whether they suffer from FI, rather than waiting for the patient to mention this problem. Direct Any associated FI complaints should be identified, including the effects on social and psychological well-being. It should be ASSMANN ET AL.
-259 determined whether the patient has tried any treatment options before and if so, whether any of these options were successful. The patient's preferences and daily schedule as well as their ability or their carers ability to administer a certain treatment should be determined. Appendix 2 can be consulted for guiding questions.

## Physical examination
Physical examination of a patient with FI starts with the general appearance of the patient, including any signs of mental distress.
A general abdominal examination should be conducted, taking into account any signs or characteristics of possible gastrointestinal disease. Inspection and physical examination of the anorectal region should be performed to exclude other anorectal pathology, to assess for previous perianal surgery/trauma and faecal impaction and to evaluate anal state/tone at rest and during voluntary effort. It should also be observed whether the patient is using any incontinence material.Digital rectal examination (DRE) should be performed in a position that facilitates reliable diagnosis and comfort for the patient and physician, for example, the left lateral position. Lithotomy and kneechest position may be alternatives. 

## Patient expectations

## First line treatment for faecal incontinence introduction
After a diagnosis of faecal incontinence is made, the first management steps which should be considered, are compiled as "first line treatment". First line treatment options aim to reduce FI complaints and to give patients a greater sense of security. First line treatment includes lifestyle adjustments, dietary advice (fibre and water intake, possibly reduction of caffeine and FODMAP intake), basic behavioural advice (toilet routine/bowel training), stool bulking agents and/ or anti-diarrheal medication, pelvic floor muscle exercises, absorbent products for containment and possibly skin care products to treat irritation of the skin around the anus.
In addition, it is important to manage the patients' expectations regarding symptom reduction.

## Review questions
We considered the following questions for our evidence review plus the comparison between any two of the below mentioned treatment options:

## Lifestyle adjustments
No studies were found regarding the effects of lifestyle adjustments (i.e., weight-loss and smoking cessation) on FI.
Skin care products Analysis of the literature revealed two systematic reviews which examined the effects of skin care products to prevent and/or reduce incontinence associated dermatitis (IAD). [bib_ref] Interventions for preventing and treating incontinence-associated dermatitis in adults, Beeckman [/bib_ref] [bib_ref] Effectiveness of topical skin products in the treatment and prevention of incontinenceassociated..., Pather [/bib_ref] The first review by Beeckman et al. from 2016 included a total of 6 (quasi)
RCT's with a total of 450 patients which answered our research question. [bib_ref] Interventions for preventing and treating incontinence-associated dermatitis in adults, Beeckman [/bib_ref] Seven of the studies from this review were excluded due to assessing effect of timing of application or due to lack of data in combination with a lack of up-to-date contact details. The second review by Pather et al. from 2017 did not include any additional studies which were not already included in the first review to answer our research question. Both reviews included patients with urinary incontinence, faecal incontinence, or both and did not differentiate between the types of incontinence within their analysis.
Both reviews were narrative synthesis. Meta-analyses of the results was not possible for either review due to heterogeneity of the interventions, measurement outcomes and tools.

## Skin care products versus control (water and soap)
Prevention of Incontinence associated dermatitis (IAD). One of the RCT's which compared no rinse skin cleanser (ClinisanTM) showed that significantly less patients in the no rinse skin cleanser group Reduction of Incontinence associated dermatitis (IAD) severity. One RCT days, compared to 7 out of 73 (9.6%) of the participants in the Desitin group. No significant difference was found between the two groups (RR 0.44, 95% CI 0.19, 1.02). [bib_ref] Topical zinc oxide based creams in a structured care regimen for the..., Buckley [/bib_ref] For a further breakdown of the results of these reviews, see Appendices: Appraisal Beeckman et al. and appraisal Pather et al.

# Conclusion:
Skin care products such as moisturisers, skin protectant or a combination of the two have beneficial effects on preventing and treating incontinence associated dermatitis compared to soap and water. No significant difference was found between different types of skin care products. A definitive conclusion cannot be drawn on which product may be the best option.

## Absorbent products
No systematic reviews, RCT's or observational studies with control groups were found which answered our PICO question comparing absorbent products to a control group. However, a systematic review which examined the effects of different types of absorbent products to each other was available. This systematic review by Fader et al.

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UNITED EUROPEAN GASTROENTEROLOGY JOURNAL from 2008 concluded that there was not enough evidence on use of absorbent products in faecal incontinence to draw definitive conclusions on which products are superior. [bib_ref] Absorbent products for urinary/faecal incontinence: a comparative evaluation of key product designs, Fader [/bib_ref] The results from this review should be interpreted with caution due to indirectness, as the included studies assess patients with urinary incontinence and/or faecal incontinence. [bib_ref] Absorbent products for urinary/faecal incontinence: a comparative evaluation of key product designs, Fader [/bib_ref] As this systematic review did not answer our predefined question, the results will not be discussed any further and we would like to refer you to the systematic review for further information.

## Biofeedback + education versus education alone
Analysis of the literature revealed one RCT which examined the effects of biofeedback + education versus education alone. [bib_ref] A randomized-controlled trial comparing an educational intervention alone vs education and biofeedback..., Ilnyckyj [/bib_ref] 

## Stool bulking agents
Analysis of the literature revealed one systematic review which examined the effects of fibre on FI complaints. [bib_ref] Role of diet in fecal incontinence: a systematic review of the literature, Colavita [/bib_ref] Only two of the [bib_ref] Drug treatment for faecal incontinence in adults, Omar [/bib_ref] However, these study populations consisted of patients who suffered from ulcerative colitis or chronic diarrhoea with or without FI, rather than the general FI population we intended to assess. [bib_ref] Drug treatment for faecal incontinence in adults, Omar [/bib_ref] As this systematic review did not assess our predefined population, the results will not be discussed any further and we would like to refer you to the systematic review for further information. 34

## Diagnostic tests prior to second line treatment introduction
In patients where initial first line treatment has not resulted in acceptable symptom reduction additional diagnostic test could be considered prior to starting second line treatment. This chapter focuses on whether the outcomes of any of the additional diagnostic tests could have an impact on treatment decisions and whether these diagnostic tests have any added value.

## Review questions
We considered the following questions for our evidence review: Group for Disorders of Gastrointestinal Motility and Function. [bib_ref] International Anorectal Physiology Working Group and the International Working Group for Disorders..., Carrington [/bib_ref] We would like to refer you to this consensus paper as a useful guide in determining which additional diagnostic test (including anorectal manometry, neurophysiological tests, endo-anal ultrasound, defecography, endoanal or pelvic MRI, balloon distention and balloon expulsion) may be of use (https://www.ncbi.nlm.nih.gov/pmc/ articles/PMC6028941/). [bib_ref] International Anorectal Physiology Working Group and the International Working Group for Disorders..., Carrington [/bib_ref] The table below has been extracted from this article and shows a concise summary of the clinical utility of each diagnostic test [fig_ref] 1: What are the effects of basic behavioural advice/education versus no behavioural advice/education... [/fig_ref].

## Recommendations for diagnostic tests prior to second line treatment second line: non-surgical interventions for faecal incontinence introduction
In patients where first line treatment has not resulted in acceptable symptom reduction, further procedures should be considered. We propose that in general, health care professionals should first consider second line non-surgical procedures prior to moving on to more invasive and/or more expensive treatments and/or treatments with a higher risk of (serious) complications such as surgical procedures.

## Review questions
We considered the following questions for our evidence review and the comparison between any two of the below mentioned treatment

## Evidence in the literature

## Posterior tibial nerve stimulation (ptns)
Analysis of the literature revealed six systematic reviews which examined the effects of PTNS on FI complaints. [bib_ref] Posterior tibial nerve stimulation for the treatment of fecal incontinence: a systematic..., Edenfield [/bib_ref] [bib_ref] Posterior tibial nerve stimulation in the treatment of fecal incontinence: a systematic..., Arroyo-Fernandez [/bib_ref] [bib_ref] Posterior tibial nerve stimulation in fecal incontinence: a systematic review and meta-analysis, Sarveazad [/bib_ref] [bib_ref] Systematic review of tibial nerve stimulation to treat faecal incontinence, Horrocks [/bib_ref] [bib_ref] Posterior tibial nerve stimulation and faecal incontinence: a review, Findlay [/bib_ref] The four most recent reviews which included additional RCT's not included in the older systematic reviews, examined the effectiveness of tibial nerve stimulation on FI without distinguishing between trans-and percutaneous stimulation. [bib_ref] Posterior tibial nerve stimulation for the treatment of fecal incontinence: a systematic..., Edenfield [/bib_ref] [bib_ref] Posterior tibial nerve stimulation in the treatment of fecal incontinence: a systematic..., Arroyo-Fernandez [/bib_ref] [bib_ref] Posterior tibial nerve stimulation in fecal incontinence: a systematic review and meta-analysis, Sarveazad [/bib_ref] Therefore, we performed our own

## Percutaneous posterior tibial nerve stimulation (pptns) versus no (pptns)
Analysis of the literature revealed a total of three RCT's, two of which were also included in the systematic reviews which examined the effects of percutaneous PTNS (PPTNS) on mean number of FI episodes, FI severity and QoL.
Our meta-analysis which includes three RCT's from 2013, 2015
and 2017 by George et al. [bib_ref] Randomized controlled trial of percutaneous versus transcutaneous posterior tibial nerve stimulation in..., George [/bib_ref] Knowles et al. [bib_ref] Percutaneous tibial nerve stimulation versus sham electrical stimulation for the treatment of..., Knowles [/bib_ref] and van der Wilt et al. [bib_ref] Randomized clinical trial of percutaneous tibial nerve stimulation versus sham electrical stimulation..., Van Der Wilt [/bib_ref] respectively, examined the effects of PPTNS compared to sham in a total of 305 patients of which 155 were randomized into a PPTNS group and 150 were randomized into a sham group. [bib_ref] Randomized controlled trial of percutaneous versus transcutaneous posterior tibial nerve stimulation in..., George [/bib_ref] [bib_ref] Percutaneous tibial nerve stimulation versus sham electrical stimulation for the treatment of..., Knowles [/bib_ref] [bib_ref] Randomized clinical trial of percutaneous tibial nerve stimulation versus sham electrical stimulation..., Van Der Wilt [/bib_ref] The meta-analysis shows that participants in the PPTNS group had

## Anal inserts
Analysis of the literature revealed three systematic reviews which assessed the effectiveness of anal inserts on FI complaints. [bib_ref] Mechanical inserts for the treatment of faecal incontinence: a systematic review, Buono [/bib_ref] [bib_ref] Plugs for containing faecal incontinence, Deutekom [/bib_ref] [bib_ref] Insert devices for faecal incontinence, How [/bib_ref] The most up-to-date systematic review by How et al. from 2020
included an additional two studies which assessed the effectiveness of anal inserts in adult patients with FI, not assessed in the previous two reviews. [bib_ref] Insert devices for faecal incontinence, How [/bib_ref] The descriptive review from 2020 by One of 10 participants dropped out due to discomfort of the plug in the first study, 11 of 15 patients withdrew after a median of 7 days due to discomfort in the second study and 9 out of 20 patients dropped out due to discomfort in the third study.
The first study reported that no FI episodes took place 82% of the time the plug was in use, the second study reported that 64% of participants were continent with the plug in place and the third study reported that 50% of the participants were continent with the plug in place. It should be noted that these results include the PP-rather than the ITT population.
Only mild adverse events were reported but were frequent. In the first study, slippage of the plug was reported in 19%-20% of participants and discomfort in 10%-19% of participants. In the second study, occasional slippage of the plug was reported by 43% of participants and discomfort by 71% of participants. The third study reported discomfort in 70% of patients. frequent alarm activation of device due to sensitivity (n = 3). In the second study, 9 out of 17 patients dropped out before the end of the 14-day trial due to the frequent alarm activation of device due to sensitivity (n = 3), non-compliance and lack of motivation (n = 2), inability to follow study protocol (n = 1) and 3 unknown reasons.

## Renew anal insert
In the first study, five out of seven participants ( therefore not included. [bib_ref] Efficacy of sacral nerve stimulation for fecal incontinence: results of a multicenter..., Leroi [/bib_ref] Adverse events were reported in 3 out of 5 studies included in this review, which assessed a total of 96 patients. [bib_ref] Sacral nerve modulation for fecal incontinence: results of a prospective single-center randomized..., Kahlke [/bib_ref] Patients with postoperative anorectal dysfunction Any patient group with anorectal dysfunction after surgery to the anorectal region (e.g., ileoanal reconstruction and low anterior resection) were included in this section.

## Evidence in the literature

## Patients in nursing homes
Analysis of the literature revealed three RCT's which examined treatment options for faecal incontinence in patients who reside in nursing homes. [bib_ref] Effects of a skin barrier cream on management of incontinence-associated dermatitis in..., Kon [/bib_ref] [bib_ref] Does treatment of constipation improve faecal incontinence in institutionalized elderly patients?, Chassagne [/bib_ref] [bib_ref] A controlled trial of an intervention to improve urinary and fecal incontinence..., Schnelle [/bib_ref] Toilet assistance + exercise + frequent food and drink offersThe study included 19 patients who predominantly suffer from nocturnal FI.
Participants were randomized into a phenylephrine (10%) group (n = 7) or placebo group (n = 5) and received treatment for 1 month. It should be taken into account that the quality of evidence was very low for both treatment options.

## Patients who underwent low anterior resection (lar)
Analysis studies with a total of 114 patients. [bib_ref] The efficacy of sacral neuromodulation in the treatment of low anterior resection..., Ram [/bib_ref] It should be noted that the studies included in this meta-analysis were heterogeneous and changes in FI outcomes were measured by 276 -UNITED EUROPEAN GASTROENTEROLOGY JOURNAL comparison of pre-and post-treatment rather than comparison to a control group.

## Pfpt
Analysis of the literature revealed a systematic review including one RCT and several uncontrolled studies which assessed the effects of pelvic floor physiotherapy (PFPT) on FI in patients after LAR. [bib_ref] Pelvic floor muscle training for bowel dysfunction following colorectal cancer surgery: a..., Lin [/bib_ref] [bib_ref] Effects of pelvic floor muscle exercise on faecal incontinence in rectal cancer..., Lin [/bib_ref] Due to the availability of higher evidence, the uncontrolled studies will not be discussed for purposes of these guidelines. The RCT by Lin et al. Cell therapy/regenerative medicine The analysis of literature reveals two systematic reviews and three additional RCT's which assessed the effects of cell therapy/ regenerative medicine in patients with sphincter defects who suffer from FI. [bib_ref] Regenerative medicine as a therapeutic option for fecal incontinence: a systematic review..., De Ligny [/bib_ref] [bib_ref] Regenerative medicine provides alternative strategies for the treatment of anal incontinence, Gras [/bib_ref] [bib_ref] Treatment of fecal incontinence with autologous expanded mesenchymal stem cells: results of..., De La Portilla [/bib_ref] [bib_ref] A new method for treating fecal incontinence by implanting stem cells derived..., Sarveazad [/bib_ref] Both of the systematic reviews included animal studies and no RCT's and will therefore not be included in this guideline. [bib_ref] Regenerative medicine as a therapeutic option for fecal incontinence: a systematic review..., De Ligny [/bib_ref] [bib_ref] Regenerative medicine provides alternative strategies for the treatment of anal incontinence, Gras [/bib_ref] The first RCT by Conclusion: Mean number of FI episodes per week was measured in one study, significantly less episodes were seen in the cell treatment group compared to the placebo group at 4 weeks, but no significant difference was seen at 48 weeks. A significantly greater reduction in FI severity was seen in the cell treatment groups in two studies in the short term, but only in one out of two studies in the longer term.

## Recommendations for special situations
QoL was measured in two studies, a significantly better QoL on the lifestyle domain was seen in one study, but no difference was seen between groups in any of the other domains in either study.

## Acupuncture
No systematic reviews, RCT's or observational studies with a control group were found regarding the effects of acupuncture on FI.
[fig] -: Value of digital rectal examination 5. In which position should physical examination be performed to exclude local malignancies and to assess quality of pelvic floor function? Definition Faecal Incontinence can be caused by multiple factors and is usually accompanied by numerous associated complaints which affect the patients' lives. The health aspects related to faecal incontinence are complex and multilayered. Predisposing factors, related complaints, pathophysiological mechanisms and the psychological and social impact faecal incontinence can have on a patient should all be given consideration when diagnosing and/or treating a patient with FI. [/fig]
[fig] 23 Conclusion: Absorbent products have a beneficial effect on reducing leakage of faeces, however, not enough evidence on use of absorbent products in faecal incontinence is available to draw definitive conclusions on which products are superior. Pelvic floor physiotherapy with or without biofeedback Analysis of the literature revealed five systematic reviews which examined the effects of pelvic floor physiotherapy (PFPT) and/or biofeedback on FI. 24-28 One of the RCT's included in the reviews answered our PICO question comparing PFPT to education only. 12 Two RCT's answered our PICO question regarding the effects of pelvic floor physiotherapy with biofeedback compared to the effects of pelvic floor physiotherapy without biofeedback. 12,29 Pelvic floor physiotherapy versus education See Section Basic behavioural advice for effects of PFPT versus education (Norton et al. 2003). 12 Pelvic floor physiotherapy versus pelvic floor physiotherapy + biofeedback Group 2 and 3 and group 2 and 4 from the above-mentioned study by Norton et al. were included for our comparison, as well as an RCT by Heymen et al. from 2009 which examined 108 patients who underwent either pelvic floor physiotherapy (PFPT) or PFPT with biofeedback. 12,29 In the RCT by Norton et al. no significant differences were found between any of the groups in mean number of FI episodes per week, continence score and quality of life, however all groups improved in all outcomes compared to baseline at 1 year follow-up. 12 In the RCT by Heymen et al. mean number of FI episodes per week was not measured, instead number of days per week with FI was assessed. 29 Mean number of days with FI per week was significantly lower after 3 months in the biofeedback group compared to the PFPT group MD 0.77 (95% CI 0.11, 1.43). Participants in the biofeedback group had significantly greater reductions in severity of FI (measured using the FISI score) compared to participants in the PFPT group after 3 months (estimated MD from baseline to 3-month follow-up from graph: 35 to 22.5 vs. 37 to 32, p = 0.01). No difference in QoL was found between groups (p = 0.64). It should be noted that in the RCT by Heymen et al. one of the inclusion criteria for participation was that the patient had to be a non-responder to conservative measures (i.e., medical management instructions for the use of fibre supplements and/or anti-diarrheal medication as well as education on anatomy and physiology of the pelvic floor muscles) during the 4-week run-in period. [/fig]
[fig] 1: What are the effects of using an additional diagnostic tool compared to using no additional diagnostic tool on therapeutic decisions and in improving outcomes (decreased frequency and symptoms) in patients with FI? 2. What are the effects of using endoscopy compared to not using endoscopy on therapeutic decisions and in improving outcomes (decreased frequency and symptoms) in patients with FI? 3. What are the effects of using anorectal manometry compared to not using anorectal manometry on therapeutic decisions and in improving outcomes (decreased frequency and symptoms) in patients with FI? 4. What are the effects of using pudendal nerve terminal motor latency (PNTML) to not using PNTML on therapeutic decisions and in improving outcomes (decreased frequency and symptoms) in patients with FI? 5. What are the effects of using defecography compared to not using defecography on therapeutic decisions and in improving outcomes (decreased frequency and symptoms) in patients with FI? 6. What are the effects of using endoanal ultrasound compared to not using endoanal ultrasound on therapeutic decisions and in improving outcomes (decreased frequency and symptoms) in patients with FI? 7. What are the effects of using rectal balloon expulsion compared to not using rectal balloon expulsion on therapeutic decisions and in improving outcomes (decreased frequency and symptoms) in patients with FI? 8. What are the effects of using rectal barostat compared to not using rectal barostat on therapeutic decisions and in improving outcomes (decreased frequency and symptoms) in patients with FI? Evidence in the literature Evidence in the literature regarding the effects of additional diagnostic tests on therapeutic decision making and in improving outcomes in patients with FI is low. Our literature search aimed to find articles which assessed the added value with regard to treatment decisions for the following diagnostic tools: Endoscopy, anorectal manometry, pudendal nerve terminal motor latency (PNTML), defecography, endoanal ultrasound, rectal balloon expulsion and rectal barostat. No systematic reviews, randomized controlled trials (RCT) ASSMANN ET AL. [/fig]