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Fecal Incontinence clinical trials

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NCT ID: NCT04766138 Completed - Fecal Incontinence Clinical Trials

Trial to Evaluate Fecobionics in Healthy Subjects and Patients

NORMAL
Start date: January 1, 2021
Phase: N/A
Study type: Interventional

Fecobionics combines several existing tests to provide novel insight into anorectal function. The purpose for the development was to overcome the technological controversies and disagreement between various tests and unphysiological test conditions. The aim was to imitate defecation as much as possible to the natural process. Fecobionics was developed to simulate stool and to provide the driving pressure and resulting deformations of stool along with a measure of an objective anorectal angle during defecation in a single examination. Fecobionics makes it possible to describe objectively, without disturbing the defecation process, the opening characteristics and pressure signatures during initial entry into the relaxing anal canal. The overall goal is to provide mechanistic understanding of defecation in health and defecatory disorders. It exceeds previous attempts to make artificial stool for evaluation of defecation and integrates other technologies as well. It was designed to have a consistency and deformability of Type 4 (range type 3-5) on the Bristol stool form scale. The range from types 3-5 is found in 70% of healthy subjects. A major novelty is that Fecobionics measures pressures in axial direction; i.e., in the flow direction. It is anticipated that Fecobionics will shed light on the neurophysiology of defecation in health and disease, including understanding the effect of biofeedback and neuromodulatory effect of SNS. It will be of great value to provide endpoints in normal subjects that in future studies can be objective measures for monitoring treatment efficacy. The present protocol is on normal subjects only.

NCT ID: NCT04749316 Completed - Faecal Incontinence Clinical Trials

Acs-Tens Treatment for Faecal Incontinence: a RCT With Sham-controls

Start date: August 1, 2017
Phase: N/A
Study type: Interventional

This study assess the effectiveness on AcuTENS on the treatment of faecal incontinence

NCT ID: NCT04741893 Completed - Faecal Incontinence Clinical Trials

Anal Canal Functional Assessment Using EndoFLIP

Start date: August 14, 2017
Phase: N/A
Study type: Interventional

Faecal incontinence (FI) is characterized by involuntary loss of rectal content through the anal canal. FI is psychologically and socially debilitating problem that can dramatically affect patient's quality of life, often in otherwise healthy individual. FI can occur as a result of obstetric sphincter injury, surgery, irradiation, anorectal malformations as well as neurological, connective tissue or endocrine disorders. Currently management options for these patients are limited, partly due to the fact that control of defaecation and continence is multifactorial but also due to the fact that FI is difficult to identify the exact cause of patients' incontinence. Current assessment of patients with FI include endoscopic assessment to rule out intraluminal organic cause for patients' symptoms, endoanal ultrasound scan / MRI to assess their pelvic floor anatomy and anorectal manometry to assess anorectal function. Anorectal manometry is a simple test to perform but Anorectal manometry is susceptible to measurement artifacts, with a high inter-individual variation with significant overlap between healthy asymptomatic and symptomatic patients with FI. Harris et al in 1966 suggested that the anal sphincter's resistance to distension that may be of importance for sphincter competence, not how tight anal sphincter can squeeze. Endoluminal Functional Lumen Imaging Probe (EndoFLIP©) is a novel technology used to measure the dimensions and function of a hollow organ. Limited publication so far has shown that EndoFLIP© provides a new way of assessing anal sphincter competence. The study is to assess the use of EndoFLIP© to assess anal sphincter function in Hong Kong population. Firstly to evaluate whether age has an effect on the distensibility of the anal sphincter and its function and secondly to compare between symptomatic patients with faecal incontinence and asymptomatic healthy subjects.

NCT ID: NCT04727463 Completed - Fecal Incontinence Clinical Trials

Obstetric Fecal Incontinence Treatment Registry

Start date: December 16, 2020
Phase:
Study type: Observational [Patient Registry]

INTRODUCTION Anal Incontinence (AI) is a loose of voluntary control for bowel movements, with recurrent leaking of flatus, liquid or solid stools. AI is a frecuent pathology. Prevalence is similar among men and women. AI´s ethiology is quite variable. Nevertheless, the most frecuent one is sphinteric injuries, obstetric, traumatic or secondary to anal surgery. Conservative measures have to be iniciated and they are essential for every patient. If a sphincteric injury exists, several choices of surgical treatment exist. The long term results obtained with sphincteroplasty, with a uniform surgical technique, follow up and complementing with other therapeutic options, has been considered interesting to analyze. HYPOTHESIS Sphincteroplasty with the adoption of the appropriate complementary treatments, provides satisfactory results in the very long term, and should be considered as the procedure of choice in patients with Anal Incontinence. OBJECTIVES - Analyze the very long term results obtained with Sphincteroplasty as surgical technique for treatment of severe anal incontinence. - Evaluate the results of the different types of surgical repair performed, according to the CCIS Score (Wexner Score). - Evaluate the importance of patient follow-up and incorporation of complementary treatments. - Establish patient´s satisfaction with the procedure after a long term follow up period after the intervention.

NCT ID: NCT04664868 Completed - Faecal Incontinence Clinical Trials

SphinkeeperTM Procedure for Treating Severe Faecal Incontinence

Start date: August 1, 2018
Phase:
Study type: Observational

Patients, aged 18 - 90 years, undergoing sphinkeeper operation at the Department of General Surgery at the Medical University of Vienna are enrolled into our study. Primary endpoints is the functional outcome as well as movement, migration and extrusion of sphinkeeper prostheses after implantation by endoluminal ultrasound and manometrical examination.

NCT ID: NCT04652024 Completed - Fecal Incontinence Clinical Trials

Effect of Anorectal Biofeedback on Encopresis in School Aged Girls After Sexual Assault

Start date: November 1, 2020
Phase: N/A
Study type: Interventional

Females who have been sexually abused anally, have a disturbed anorectal motility. They have an increased resting pressure at the lower part of the anal canal. When their rectum is suddenly distended, they tend not to have an initially increased pressure in the anal canal, and the recto-anal inhibitory reflex is markedly decreased amplitude which is caused by reflex contraction of the pelvic floor during the relaxation of the internal anal sphincter.

NCT ID: NCT04599595 Completed - Multiple Sclerosis Clinical Trials

Characteristics of INTESTINAL DYSFUNCTION in Patients With MULTIPLE SCLEROSIS

Start date: June 7, 2018
Phase:
Study type: Observational

MS (Multiple Sclerosis) is the most common neurological disease involving disabilities in young adults, with bowel symptoms, in particular constipation and fecal incontinence. The main objectives of the study are to assess the prevalence, characteristics, severity and impact on the Quality of Life of intestinal disorders in this population, to correlate the severity and characteristics of constipation and fecal incontinence with Intestinal Transit Time and the time dedicated to the evacuation, and how these items change in relation to the use of transanal irrigation (TAI). Another objective is to identify the composition of the intestinal microbiota in MS patients in relation to the type of bowel characteristics, comparing it with microbiota profile of the healthy population of the same region of origin, Emilia-Romagna, Italy.

NCT ID: NCT04478799 Completed - Fecal Incontinence Clinical Trials

Transcutaneous Posterior Nerve Stimulation inTreatment of Fecal Incontience

Start date: September 1, 2017
Phase: N/A
Study type: Interventional

Shafik and colleagues were the first to report the use of posterior tibial nerve stimulation (PTNS) for FI, and they documented improved continence after 4 weeks course. Subsequent studies documented percutaneous and transcutaneous PTNS as effective methods for treatment of FI, with a short term reduction in incontinence episode by 50-80 %. Percutaneous PTNS (PPTNS) showed a greater effect than transcutaneous PTNS (TPTNS) and this may be assumed due to the presence of the stimulating electrode very close to the posterior tibial nerve. However, TPTNS is more preferable to percutaneous PTNS because of the concern about the insertion of a needle may result in stimulation that is sufficient to produce a neuromodulatory effect.

NCT ID: NCT04472923 Completed - Clinical trials for Fecal Incontinence in Children

Biofeedback Training Fecal Incontinence in Children

Start date: May 5, 2018
Phase: N/A
Study type: Interventional

Fecal incontinence (FI) is the inability to control bowel movements, causing stool to leak from rectum it ranges from an occasional leakage of stool while passing gas to a complete loss of bowel control after the age of 4 years1. Functional non-retentive fecal incontinence (FNRFI) is fecal incontinence in a child with a mental age of more than 4 years with no evidence of metabolic, inflammatory, or anatomical cause2. The long-term result of biofeedback therapy is one of the most important subjects of controversy, and few studies have extended to 2 years of follow-up 11. So, the purpose of this study was to evaluate quantitatively the short-term and long-term efficacy of biofeedback training as a treatment tool designed to control functional non-retentive fecal incontinence in children and its long term impact on the quality of life.

NCT ID: NCT04410822 Completed - Faecal Incontinence Clinical Trials

Fecal Incontinence Type Assessment Scale

Start date: December 1, 2019
Phase:
Study type: Observational

Urge faecal incontinence (FI) and passive FI are the two subgroups of FI described by the International Continence Society. Urge FI is described as "the inability to defer defecation once the urge is perceived for long enough to reach a toilet" and passive FI as "the involuntary leakage of faeces without forewarning". If several validated questionnaires are available for FI, all of these questionnaires were developed to assess FI severity. In literature, there is only a small number of studies that investigated clinical and paraclinical characteristics of the different phenotype of FI. Moreover, there is an heterogenicity in the definitions used for both urge and passive FI among these studies. Lastly, patients with mixed FI were commonly excluded from these studies. It can be established that there is a lack of validate tools to distinguish patients between subgroups of FI. The aim of the present study was to develop and to validate a new tool in order to investigate and classify patients among the different subgroups of FI (active, passive and mixed) defined by Rome IV criteria. A monocentric prospective study was conducted in the Neuro-urology Department of a University Hospital. All consecutive patients presenting in the Department with FI between December 2019 and June 2020 were screened for inclusion in the present study. Criteria of inclusion were an age older than 18 years old and symptoms of FI according to Rome IV criteria. Exclusion criteria were anorectal fistula, active inflammatory bowel disease, anorectal malignant tumor not treated, rectal or hemorrhoidal prolapses and specific inability regarding the questionnaire (i.e. cognitive disorders, inability to read and to understand questions). Phase 1: review of literature and qualitative interviews: To determine the dimensions of the different subgroups of faecal incontinence, a literature review was performed using Pubmed without date limitation until February 2020. The key words used were "active faecal incontinence", "active fecal incontinence", "passive faecal incontinence", "passive fecal incontinence", "urge faecal incontinence", "urge fecal incontinence", "questionnaire", "scale", "score" and "tool". In parallel to this literature review, semi-structured interviews were performed on 20 patients from December 2019 to February 2020. During this phase, a panel expert of 9 neuro-urologists and gastroenterologists was composed. At the term of all interviews, dimensions that were both the most used by patients and the most discriminative among subgroups of FI were included in the questionnaire. Redaction of questions was then performed by the panel expert. Phase 2: feasibility study: The feasibility study was conducted from February to April 2020 on 30 patients. Each patient was asked to rate each version of the 2 questions with a four-point Likert scale (A: very good, B: good, C: difficult, D: very difficult) regarding acceptance and comprehension of the questions. Phase 3: validation study: To investigate the psychometric properties of the questionnaire, a validation study was performed from April to June 2020 on 100 consecutive patients. In order to evaluate the FITAS' test reproducibility, patients were asked to answer a second time the questionnaire by mail with a second evaluation from 7 days to 10 days after the first one. The "intra-class correlation coefficient" (ICC) was used to determine if these evaluations could lead to similar results for each question. An ICC > 0.70 was necessary to define reproducibility.