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Fecal Incontinence clinical trials

View clinical trials related to Fecal Incontinence.

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NCT ID: NCT05783219 Completed - Overactive Bladder Clinical Trials

Lidocaine Patches Prior to Percutaneous Nerve Evaluation

Start date: May 1, 2023
Phase: Phase 2
Study type: Interventional

The study will be a double-blind randomized control trial comparing 4% lidocaine patch placed over the sacrum 3 minutes prior to a percutaneous nerve evaluation (PNE) procedure to a placebo patch in patients already scheduled to undergo a medically indicated percutaneous nerve evaluation (PNE). VAS pain score, The volume of injectable lidocaine used, Patient Satisfaction Score, rate of successful PNE (defined as successful placement of wire in the S3 spinal foramen), and the amplitude of perineal stimulation on a Likert scale will be collected immediately after the procedure. Patients will follow up in 1 week - as is standard of care with the PNE procedure. Adverse events such as pain or change in sensation will be recorded. Number of voids and incontinence episodes per day after the PNE procedure will be recorded. Overall satisfaction score will be recorded at that time. Rate of progression to Sacral nerve stimulator implantation will be collected. The investigators hypothesize that patients in the lidocaine patch group will experience significantly less pain at the time of PNE as measured by a lower change in VAS pain score when compared with the control group.

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: NCT05773742 Not yet recruiting - Constipation Clinical Trials

Treatment of Fecal Incontinence and Chronic Constipation With Low-volume Irrigation

Start date: April 11, 2023
Phase: N/A
Study type: Interventional

The aim of this study is to investigate the efficacy of low-volume irrigation on bowel function among patients with fecal incontinence and/or chronic constipation (of heterogenous origin).

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: NCT05755763 Completed - Fecal Incontinence Clinical Trials

Validity and Reliability of the Turkish St. Marks Incontinence Score

Start date: February 7, 2023
Phase:
Study type: Observational

For the Turkish validity and reliability study of St.Mark's (Vaizey) Incontinence Score, which consists of 7 questions, it will be applied to 65 people diagnosed with anal incontinence after it is translated by translation-retranslation method.

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: NCT05688644 Enrolling by invitation - Overactive Bladder Clinical Trials

Sacral Neuromodulation in Neurogenic Patients

Start date: December 19, 2021
Phase:
Study type: Observational

The goal of this observational study is to evaluate efficacy and safety of sacral neuromodulation in neurogenic patients compared to non-neurogenic (idiopathic) patients. [. The main question[s] it aims to answer are: - determine efficacy and safety of the therapy in neurogenic patients. - compare outcomes of the therapy to idiopathic patients. If there is a comparison group: Researchers will compare the outcomes of the therapy between the neurogenic and non-neurogenic subset of patients.

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: NCT05624060 Completed - Clinical trials for Urinary Incontinence

Perineal Massage and Pelvic Floor Exercise in the Antenatal Period

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

This study aimed to determine the effect of perineal massage and pelvic floor exercise in the antenatal period on sexuality and urinary and fecal incontinence in the postpartum period. This study will be conducted in a pregnant school at a state hospital in Turkey. An active control group will be formed as the control group. The control group will be given the "Pelvic Floor Dysfunction Prevention Training" booklet prepared by the researchers. Experimental 1 group will receive perineal massage training in addition to the "Pelvic Floor Dysfunction Prevention Training" booklet given to the control group. Experimental 2 group will receive pelvic floor exercises in addition to perineal massage training and the "Pelvic Floor Dysfunction Prevention Training" booklet given to the control group.

NCT ID: NCT05621629 Completed - Fecal Incontinence Clinical Trials

Management of FI After Surgery of ARM

Start date: September 1, 2022
Phase:
Study type: Observational

The posterior sagittal approach to anorectal malformation (ARM) has radically changed the outcome of these patients, improving the preservation of anal sphincters, owing to their anatomical identification. However, in long term follow-up, fecal incontinence and severe constipation remain the most frequent and disabling postoperative clinical problems, having a significant influence on quality of life. Current therapeutic measures for Fecal Incontinence include biofeedback, sacral nerve stimulation, radiofrequency energy delivery, surgical treatment and sphincter replacement. Biofeedback combined with SNS has achieved satisfactory results. However, not all patients have an improvement in their weakened anal sphincter and achieve acceptable continence. A detailed assessment of anorectal sphincter morphology and function can predict therapeutic outcome. Magnetic resonance imaging(MRI) can help to judge the anal atresia type, to display the presence and running of the fistula, and to show the nature of anal sphincter, such as the shape, thickness, directions and position of the anal sphincter complex and location in the pelvic floor and other systems malformations, finally to provide a reliable diagnostic basis for surgical program and prognostic assessment. High-resolution anorectal manometry (HR-ARM) is the latest internationally recognized examination for the evaluation of anorectal function. A standardised protocol of HR-ARM can characterise FI from dyssynergic or other neuromuscular and sensory problems. As a result, HR-ARM provides a more appropriate management in patients with FI. In order to assess whether patients with fecal incontinence should choose biofeedback therapy, our study included children with FI after anorectal malformation, and combined HR-ARM and MR to predict the efficacy of sacral nerve stimulation and pelvic floor rehabilitation.