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Fecal Incontinence clinical trials

View clinical trials related to Fecal Incontinence.

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NCT ID: NCT05095077 Completed - Fecal Incontinence Clinical Trials

Effects of Single Dose Tadalafil on Urethral and Anal Closure Function

Start date: August 1, 2021
Phase: Phase 1
Study type: Interventional

The purpose of the trial is to assess the effect of tadalafil compared to placebo (inactive comparator) on the urethral - and anal pressure and on urine flow in healthy females. Further, the purpose of the trial is to evaluate the potential for going forward with studies of tadalafil in patients suffering from urine or fecal incontinence.

NCT ID: NCT05064384 Completed - Fecal Incontinence Clinical Trials

Axonics SacRal NeuromodulaTIon System RegisTRY Study

ARTISTRY
Start date: November 30, 2020
Phase:
Study type: Observational [Patient Registry]

To assess the post-market clinical outcomes with use of the Axonics Sacral Neuromodulation System(s).

NCT ID: NCT05058326 Completed - Fecal Incontinence Clinical Trials

Severity of Fecal Incontinence and Manometric Values Using the Anopress® Device in Women

MANOPRESS
Start date: September 20, 2020
Phase:
Study type: Observational [Patient Registry]

The purpose of this study is to stablish a correlation between fecal incontinence severity scales (Wexner & St. Mark's) and manometric values obtained using the Anopress® portable manometry and values obtained using endoanal ultrasound in women with fecal incontinence.

NCT ID: NCT05049486 Completed - Faecal Incontinence Clinical Trials

Computational Model of SNS (Sacral Nerve Stimulation) Induced Electrical Current Flow Using Tractography Imaging

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

This study aims to obtain finer details of tissues surrounding a lead in the pelvis using a combination of high-resolution anatomical MRI sequences and diffusion tensor imaging (DTI). DTI is a non-invasive technique sometimes described as fiber tractography that enables visualization of the pathways and integrity of nerves. In this feasibility study, we plan to use DTI to assess the sacral plexus and its peripheral nerves. A model will be constructed by superimposing SNS lead from a CT scan onto the DTI imaging to map out the electrode position. It is hoped that this study will lead to a better understanding of both therapeutic and adverse stimulation effects and enable patient-specific adjustments of stimulation parameters.

NCT ID: NCT05040139 Completed - Clinical trials for Fecal Incontinence With Fecal Urgency

A Comparison of Quality of Life Between MAlone Procedure and Percutaneaous Endoscopic Caecostomy in Patients With Antegrade Colonic Enema

MAPEC
Start date: November 13, 2018
Phase:
Study type: Observational [Patient Registry]

Background: Antegrade colonic enema (ACE) is a second intent treatment of severe constipation and/or fecal incontinence following the failure of medical treatment. ACE is classically administered through a percutaneous access to the caecum performed surgically according to the Malone procedure (MP). Recently, a novel endoscopic approach named Percutaneous Endoscopic Caecostomy (PEC) has been proposed to perform the percutaneous access to the caecum. PEC has never been compared to the traditional MP in terms of postoperative quality of life and functional outcomes. Objective: The aim of the study is to compare postoperative quality of life between MP and PEC in patients treated with ACE for severe constipation and/or fecal incontinence. Hypothesis: MP and PEC achieve similar quality of life outcomes. Methods: All patients from two prospective databases who underwent MP or PEC for severe constipation and/or fecal incontinence between 2006 and 2016 will be included. They will be contacted to answer questionnaires about quality of life (GIQLI) and functional outcomes including constipation, fecal incontinence and body image assessment (KESS, Wexner and BIQ scores respectively). The main measured outcome will be GIQLI score. Results: The results of this comparative study will determine if the endoscopic and the surgical approaches are similar in terms of quality of life, or if one of them is better than the other. This study will clarify the optimal protocol to perform a caecal percutaneous access before ACE administration in patients suffering from severe constipation and/or fecal incontinence.

NCT ID: NCT05032534 Completed - Fecal Incontinence Clinical Trials

Examination of a New Irrigation System for Transanal Irrigation in Children With Fecal Incontinence

Start date: September 20, 2021
Phase: N/A
Study type: Interventional

The aim of this study is to investigate if a new irrigation system for transanal irrigation (TAI) is effective and more tolerable than the currently used system at the Pediatric Ward at Aarhus University Hospital.

NCT ID: NCT05016453 Completed - Faecal Incontinence Clinical Trials

Long-term Efficacy of Percutaneous Tibial Nerve Stimulation Applied to Patients With Faecal Incontinence.

PTNSLONG
Start date: January 8, 2010
Phase:
Study type: Observational

Percutaneous tibial nerve stimulation (PTNS) is an ambulatory therapy validated for patients with Faecal Incontinence (FI) refractory to conservative treatment with proved short and mid-term efficacy. The investigators therefore aimed to evaluate the long-term efficacy of PTNS, considered 3 years of follow-up. The investigators also aimed to identify predictors of responses and suggest a new approach for partial responders.

NCT ID: NCT04996186 Completed - Multiple Sclerosis Clinical Trials

Symptoms and Treatment Assessment of Ano-Rectal Disorders in Multiple Sclerosis Patients : STAR-Q

STAR-Q
Start date: June 1, 2019
Phase:
Study type: Observational

Multiple sclerosis (MS) is known to cause urinary disorders, sexual and bowel dysfunction. Urinary symptoms due to MS are well known and profit of multiple questionnaire or tool developed in MS patients. Prevalence of bowel disorders in MS is difficult to assess. Some studies up to 70% bowel disorders in MS patients. Constipation and fecal incontinence are the two main symptoms in neurogenic bowel dysfunction and frequently coexist in this population, generally in association with urinary disorders. Because of the high prevalence of bowel disorders their and the major impact on the quality of life of patients with Multiple sclerosis (PwMS) , and the cross-talk bladder-rectum (persistence of anorectal dysfunction leading to poor neurogenic bladder control) assessment of bowel disorders in MS is necessary. But this evaluation is difficult as no specific score exist. The neurogenic Bowel Dysfunction score (NBD) is often used. The NBD was developed and validated for spinal cord injury (SCI) population but not for PwMS MS. Yet NBD is often used in research for all neurologic patients despite its lack of sensibility in various neurogenic population other than spinal cord injury patient. As recommended in a Cochrane revue in 2014, there is a need of a specific evaluation for bowel symptoms in neurogenic population, especially for PwMS. The aim of the study was to create and validate a new multidimensional questionnaire to assess bowel dysfunction and impact on quality of life in patients with MS. The investigators conducted a prospective multicenter study (8 centers) between June 2019 to April 2021. This study was developed in 3 steps. First step was literature review and qualitative interview. Then the second step was the feasibility study to evaluate comprehension, acceptability of the different items. The last part of the study was the validation study of the questionnaire. This part of the study was performed between June2020 and April 2021. Validation study allowed to determine the psychometric properties of the new tool. Patients aged over 18 years with multiple sclerosis diagnosed on the 2017 revised McDonald's criteria were included. Patients not able to read or understand the objectives and procedures for conducting the protocol and patient who had a recent relapse of MS were excluded.

NCT ID: NCT04992429 Completed - Fecal Incontinence Clinical Trials

Do Prostheses of SphinkeeperTM Migrate After Operation?

Start date: June 1, 2020
Phase:
Study type: Observational

32 patients who underwent sphinkeeper operation got enrolled in this study. The primary endoint is to explore the movement of the prostheses examined by manometry and ultrasound. The secondary endpoint is to find out about the functional outcome when migration of prostheses occurs and to examine differences in morphology of the sphincters after operation.

NCT ID: NCT04862299 Completed - Clinical trials for Obstetrical Perineal Injury and Anal Incontinence

Pelvic-perineal Disorders in Women With Sphincter Tears

PAPOASI
Start date: April 15, 2021
Phase:
Study type: Observational

According to INSEE, in 2016, in France, there were 785,000 births. According to the latest national perinatal survey in 2016, 80.4% of women gave birth by vaginal delivery. Of these, 52.1% had perineal tears and 0.8% had 3rd and 4th degree tears. Of these 3rd and 4th degree tears, 2.2% occurred during instrumental delivery and 0.5% during spontaneous delivery. In recent years, there has been an increase in the prevalence of obstetric anal sphincter injuries. Mc Pherson et al. found a prevalence of LOSA (Obstetric Anal Sphincter Injury) of 2% in 2004 versus 4.6% in 2008. Gurol-Urganci et al. also found an increase in prevalence from 1.8% in 2000 to 5.9% in 2012. This increase is probably due to improved diagnosis by obstetrical teams. Indeed, a large number of LOSAs remained undiagnosed at birth and these occult lesions were subsequently found by endoanal ultrasound. In the Andrews et al. study, when women were reexamined, the prevalence of LOSA increased from 11% to 24.5%. As practitioner training improved, the prevalence of LOSA at birth became increasingly accurate. Obstetric anal sphincter injuries are responsible for significant physical and psychological morbidity. These obstetrical lesions of the anal sphincter can generate functional consequences (including anal incontinence in the first rank), which will have harmful effects on the quality of life of the women, they can involve a social isolation passing by the limitation of displacements and physical and social activities. The daily life of these women can remain impacted by the consequences of LOSA until more than 10 years after delivery. In addition, a loss of self-esteem as well as feelings of guilt, shame and frustration are reported in these women. Thus, some will speak of a LOSA syndrome, which includes emotional, social and psychological consequences, including the ability to assume one's role as a mother. LOSA are perineal tears corresponding to the 3rd and 4th degree, formerly and respectively called complete perineum and complicated complete perineum. The Sultan classification for perineal tears proposed in 1999 was adopted by the Royal College of Obstretricians and Gynecologists (RCOG) and is the most widely used in the scientific literature worldwide. It defines the 3rd degree as a perineal injury involving the anal sphincter complex alone. Anal continence is a balance between several factors such as rectal sensitivity, stool quality, the smooth and striated muscles of the anal sphincter, the pubo-rectal muscle webbing and the innervation of these structures. Obstetrical trauma of the stretching and compression type affects all these structures. All of these lesions can contribute to the development of anal incontinence. However, these structures are not routinely evaluated in women who have had an obstetric anal sphincter injury. Pelvic-perineal pain was studied in 2 studies and involved 24.7% to 35% of women with obstetric anal sphincter injuries. Compared to women without LOSA, women with LOSA had a later return to sexual intercourse, with more severe anal incontinence during the first week after LOSA. Indeed, at 12 weeks postpartum, the rate of women who resumed sexual intercourse was lower in the group of women with LOSA than in the group without LOSA. The pelvic-perineal disorders faced by women with LOSA affect their quality of life, their sexuality, and their health. Thus, early identification of all pelvic-perineal disorders appears to be a priority in this population.