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Fecal Incontinence clinical trials

View clinical trials related to Fecal Incontinence.

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NCT ID: NCT05864807 Recruiting - Faecal Incontinence Clinical Trials

UCon Treatment of the Symptoms of Faecal Incontinence (FI)

Start date: August 1, 2023
Phase: N/A
Study type: Interventional

UCon is a medical device for treatment of the symptoms of overactive bladder and fecal incontinence (FI). It electrically stimulates the DGN through the skin to obtain modulated behaviour of the bladder/bowel musculature e.g., suppress undesired bladder/bowel activity to relieve the symptoms of the patient. This clinical investigation is designed as a single-arm, prospective, single-centre, early feasibility study.

NCT ID: NCT05776277 Recruiting - Fecal Incontinence Clinical Trials

Iltamiocel Compared to Placebo for Chronic Fecal Incontinence in Females With Obstetric Injury

DigniFI
Start date: March 21, 2024
Phase: Phase 3
Study type: Interventional

This study evaluates the efficacy and safety of a single injection of iltamiocel (300 x 10^6 cells) compared to a placebo in the reduction of fecal incontinence episode frequency in adult female participants with chronic fecal incontinence and a history of obstetric anal sphincter injury. Half of the participants will receive iltamiocel (injections with cells) and the other half will receive placebo.

NCT ID: NCT05771597 Recruiting - Clinical trials for Urinary Incontinence

Home Biofeedback Therapy for Dyssynergic Defecation, Fecal Incontinence and Urinary Incontinence

Bioanatoner
Start date: March 27, 2023
Phase: N/A
Study type: Interventional

Biofeedback therapy is an effective treatment for the management of patients with dyssynergic defecation and constipation, urinary incontinence (UI), and fecal incontinence (FI). It is labor-intensive, costly, requires multiple office or hospital visits, is not easily available to the vast majority of patients in the community, and is not covered by many insurance companies. The purpose of this study is to 1. Evaluate home biofeedback therapy for patients with either constipation and dyssynergic defecation or urinary leakage or stool leakage by assessing the efficacy and safety of a wireless anorectal biofeedback device, and a cellphone app-based and voice guided home biofeedback training system 2. To compare the efficacy and safety of home biofeedback therapy system with the standard of care, office biofeedback therapy 3. To assess the cost-effectiveness of home biofeedback therapy.

NCT ID: NCT05708612 Recruiting - Fecal Incontinence Clinical Trials

Safety and Performance of a Silicone Implant for Fecal Incontinence Treatment (SimplyFI)

Start date: April 1, 2023
Phase: N/A
Study type: Interventional

The purpose of the clinical investigation is to verify that the device under investigation (SimplyFI) is appropriate to significantly improve fecal incontinence in patients in whom its use is indicated.

NCT ID: NCT05626816 Recruiting - Fecal Incontinence Clinical Trials

Acute Genital Nerve Stimulation for Neurogenic Bowel Dysfunction in Individuals Living With Spinal Cord Injury

Start date: March 21, 2023
Phase: N/A
Study type: Interventional

Bowel issues occur in nearly all people after spinal cord injury (SCI) and one major complication is fecal incontinence (accidents). This complication has been repeatedly highlighted by people living with SCI as particularly life-limiting and in need of more options for interventions. This study will test the effect of genital nerve stimulation (GNS), with non-invasive electrodes, on the activity of the anus and rectum of persons after SCI. Recording anorectal manometry (ARM) endpoints tells us the function of those tissues and our study design (ARM without stim, ARM with stim, ARM without stim) will allow us to conclude the GNS effect and whether it is likely to reduce fecal incontinence. The study will also collect medical, demographic, and bowel related functional information. The combination of all of these data should help predict who will respond to stimulation, what will happen when stimulation is applied, and if that stimulation is likely to provide an improvement in fecal continence for people living with SCI.

NCT ID: NCT05616208 Recruiting - Fecal Incontinence Clinical Trials

Implantation of BioSphincter TM for Treatment of Severe Passive Fecal Incontinence

Start date: November 2, 2022
Phase: Phase 1
Study type: Interventional

This is first-in-human prospective Phase I study of the immediate and long-term safety of an implanted internal anal sphincter (IAS) bioengineered from autologous cells to treat subjects with severe passive FI who have failed standard treatments.

NCT ID: NCT05570318 Recruiting - Clinical trials for Functional Constipation

Effect of MiniGo as add-on to Oral Laxatives for Children With Constipation and Fecal Incontinence

Start date: November 1, 2022
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to compare combination therapy with low volume trans anal irrigation (TAI) and oral laxatives to monotherapy with oral laxatives in children with functional constipation and fecal incontinence. The main questions it aims to answer are: - Can more efficient treatment be achieved with aforementioned combination therapy? - Does the well-being of the children change, when they are well treated for their symptoms? - Is low-volume trans anal irrigation a tolerable treatment method for children? Participants will be randomized into 2 groups, where one group is treated with current standard treatment of PEG (oral laxatives), and the other group is treated with PEG + daily low volume TAI.

NCT ID: NCT05550675 Recruiting - Clinical trials for Urinary Incontinence

Prospective Database of Factors Associated With Faecal vs. Double Incontinence in Patients Referred for High Resolution Anorectal Manometry.

Start date: June 8, 2022
Phase:
Study type: Observational

This study aims to verify the results from our previous retrospective cohort analysis by establishing a database of well-characterised patients prospectively. The different prevalence of neurological disorders, abdominal, urological and obstetrical surgery, diarrhoea and other potential associated factors as well as the importance of abnormalities identified by 3D high resolution anorectal manometry (HARM) will be compared between subjects with feacal incontinence (FI), double incontinence (DI) and controls. Presence and severity of both FI and urinary incontinence (UI) will be evaluated by disease specific questionnaires. Measuring both disease severity and Quality of Life (QoL) is needed to determine the true impact of incontinence. Finally, the impact on quality of life will be compared between both groups.

NCT ID: NCT05412069 Recruiting - Fecal Incontinence Clinical Trials

Trial to Evaluate Fecobionics in Fecal Incontinence (FI) (NORMAL and ABNORMAL-FI)

Start date: February 15, 2023
Phase: N/A
Study type: Interventional

The objective is to determine the length-tension properties of the anal sphincters using Fecobionics in normal subjects and FI patients during anal distension and during simulated evacuation. Fecobionics has the consistency and shape of normal stool and can record pressures, cross-sectional area, orientation and viscoelastic properties of the anorectum and can map the geometric profiles during evacuation, and thereby provides multi-dimensional measurements of pressures, deformability, and topographic changes. 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 (BET and FECOM) 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 normal subjects. A major novelty is that Fecobionics measures pressures in axial direction; i.e., in the flow direction.

NCT ID: NCT05396456 Recruiting - Fecal Incontinence Clinical Trials

Autologous Muscle Fiber Fragment Injections

Start date: January 12, 2023
Phase: N/A
Study type: Interventional

To regenerate functional anal sphincter muscle using muscle fiber fragments that contain muscle precursor cells (MPCs)