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Fecal Incontinence clinical trials

View clinical trials related to Fecal Incontinence.

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NCT ID: NCT06370637 Not yet recruiting - Clinical trials for Incontinence-associated Dermatitis

Efficacy of Cream for Moisture Associated Skin Damage From Fecal Incontinence and/or Diarrhea

Survey
Start date: May 2024
Phase: N/A
Study type: Interventional

Scotiaderm Inc. has developed a cream formulation to be used in the treatment of MASD caused diarrhea or fecal incontinence. This study aims to evaluate the efficacy and safety of a plant extract incorporated into a standard barrier in the treatment of MASD from diarrhea and/or fecal incontinence. The goal of this research is to conduct an open-label outpatient study of this novel cream in a population with MASD secondary to diarrhea and/or fecal incontinence.

NCT ID: NCT06166615 Not yet recruiting - Fecal Incontinence Clinical Trials

The Safety and Efficacy of 5-HT3 Receptor Antagonist (Ramosetron) for the Treatment of Fecal Incontinence

SERAFI
Start date: December 15, 2023
Phase: Phase 2/Phase 3
Study type: Interventional

This clinical trial aims to assess the effectiveness of Ramosetron compared to Psyllium, a gold standard therapy, in patients with fecal incontinence. The primary questions it seeks to answer are: 1. Does Ramosetron improve the symptoms of fecal incontinence? 2. Is Ramosetron superior to Psyllium in terms of symptom improvement and its impact on quality of life? Participants will be randomly assigned to one of two groups, either taking Ramosetron or Psyllium for one month. They will be asked to complete a questionnaire. Researchers will then compare the Fecal Incontinence Severity Index between the Ramosetron and Psyllium groups to determine whether Ramosetron provides superior symptom relief compared to Psyllium.

NCT ID: NCT05998187 Not yet recruiting - Fecal Incontinence Clinical Trials

Mechanisms of Action on Rectal Motricity of Intrarectal Botulinum Toxin Injections

MECA-TOX
Start date: December 1, 2023
Phase: Phase 3
Study type: Interventional

Previous studies have demonstrated the efficacy of this treatment in certain patients suffering from fecal incontinence, but it is not yet reimbursed in this indication as it is still in the evaluation phase. Indeed, little is known about botulinum toxin mechanisms of action. The aim of this study is to better understand the mechanisms of action of intra-rectal botulinum toxin injections, so that the investigators can identify the patients most likely to benefit from this treatment in the future.

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: NCT05530681 Not yet recruiting - Clinical trials for Urinary Incontinence

Correlation Pelvic Floor Function and Ultrasound Findings One Year After Childbirth

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

This is a single-center prospective cohort study sponsored by the University Hospitals Leuven (UZ). Women will undergo a pelvic floor ultrasound and will be asked to fill out a questionnaire at the time of their admission into the labour suite, at the postpartum check-up and 12 months postpartum. The primary objective is to correlate self-reported symptoms of Pelvic Floor Dysfunction (PFD) (binary outcome) at one year after delivery with structural changes to the Pelvic Floor Muscles (PFM) and postpartum evidence of levator avulsion (binary indicator) as measured by TransPerineal UltraSound (TPUS). Secondary objectives are to compare demographical and obstetrical variables between patients suffering from PFD symptoms or pelvic floor injury (documented one year after delivery) and those who do not; to record how patients manage and cope with PFD including recovery and compliance with Pelvic Floor Muscle Training (PFMT) as prescribed in the standard pathway of peripartum care; and to use of TPUS images for the development of artificial intelligence tools for automated image analysis. Primary outcomes are PFD symptoms one year after delivery and injury to the PFM evidenced by POP-Q and TPUS. The demographic variables and information about the pregnancy and the delivery will be obtained from the medical records. The presence and severity of PFD will be measured using standardized self-reporting tools: Pelvic Organ Prolapse Distress Index (POP-DI), Patient Assessment Constipation-SYMptoms (PAC-SYM), International Consultation on Incontinence Questionnaire - Urinary Incontinence - Short Form (ICIQ-SF), St. Mark's Incontinence Score (SMIS), Female Sexual Function Index (FSFI), Female Sexual Distress Scale - Revised (FSDS-R). FSFI is a widely used generic tool with sufficient granularity and validated in a large number of languages. FSDS-R assesses the construct "personal distress", which has been considered as an additional important aspect contributing to sexual dysfunction of women. PFD, as a clustered outcome, being the presence of any kind of pelvic floor dysfunction symptoms, will be defined as POP-DI score of ≥11 OR ICIQ-SF score of ≥1 OR SMIS score of ≥1 OR FSFI score ≤ 26.55 OR FSDS-R score ≥11.

NCT ID: NCT05253196 Not yet recruiting - Fecal Incontinence Clinical Trials

Enema Device for Children With Spina Bifida

Start date: January 2024
Phase: N/A
Study type: Interventional

The International Center for Colorectal and Urogenital Care at Children's Hospital Colorado treats patients who suffer from many different colorectal issues such as anorectal malformation, Hirschsprung disease, and severe constipation. Many of these patients suffer from fecal incontinence. The investigators have developed a week long bowel management program (BMP) that is offered every month to help these kids stay clean of stool in the underwear, by finding the perfect enema recipe to clean the colon for 24 hours. This allows one to perform an enema once every day, clean their colon, and remain free of 'accidents'. Many spina bifida patients also suffer from fecal incontinence and are referred to this BMP. The overall success rate for all patients who suffer from fecal incontinence is 95%, however the success rate for spina bifida patients is only 77%. The reason for this decrease in success is due to the lack of anal sphincter tone in spina bifida patients, which leads to inadvertent leakage and spillage of enema fluid and bowel content during enema administration. The purpose of this study is to create and test an enema administration device that improves upon current methods.

NCT ID: NCT05196620 Not yet recruiting - Fecal Incontinence Clinical Trials

Prevalence of Anal Sphincter Defects After Childbirth

PRADA
Start date: June 1, 2024
Phase:
Study type: Observational [Patient Registry]

The incidence of obstetric sphincter tears has risen to 15-30% and the prevalence of anal incontinence (AI) symptoms after childbirth may be as high as 40%. The present study aims to evaluate the prevalence of anal sphincter defects after childbirth in primiparous women-

NCT ID: NCT04940494 Not yet recruiting - Anal Incontinence Clinical Trials

Anal Incontinence After Obstetrical Anal Sphincter Injury

INCONT-LOSA
Start date: June 24, 2021
Phase:
Study type: Observational

Obstetrical Anal Sphincter Injury is an identified risk factor for anal incontinence. The mechanisms and the risk factors for anal incontinence in Obstetrical Anal Sphincter Injury women are not well known. Anal incontinence in such women is not well documented and probably underestimated. Cohort studies estimated that up to 53% of Obstetrical Anal Sphincter Injury women are incontinent but that most of them does not complain their doctor.

NCT ID: NCT03813251 Not yet recruiting - Fecal Incontinence Clinical Trials

Safety and Effectiveness Evaluation of the ForConti Contix Fecal Incontinence Management System (FIMS)

Start date: February 2019
Phase: N/A
Study type: Interventional

The ForConti Contix Fecal Incontinence Management System (FIMS) is indicated for the management of accidental bowel leakage due to bowel incontinence. The ForConti Contix FIMS is designed to seal and help prevent the involuntary leakage of stool, liquids and gases from the rectum. ForConti Contix FIMS is for an individual with fecal incontinence that has impaired quality of life, is responsive and mentally capable to participate in their own treatment. This study is designed to evaluate the safety and effectiveness of the ForConti Contix FIMS for its intended use utilizing a baseline period of 2 weeks followed by an on-device period of using the device for 4 weeks and completed with a followup period of 2 weeks.

NCT ID: NCT03052946 Not yet recruiting - Fecal Incontinence Clinical Trials

Bulking Agent Versus Electrostimulation Therapy in Anal Incontinence

Bulking
Start date: February 28, 2018
Phase: Phase 2/Phase 3
Study type: Interventional

Randomized trial with a estimated number of 60 patients with mild or moderate anal incontinence at the clinic Physiology of the Hospital das Clínicas of the Medical School of the University of São Paulo (HC-FMUSP). - Exclusion criteria: symptoms of anal incontinence for less than six months, with severe anal incontinence, associated external anal sphincter damage, past pelvic radiotherapy, evidence of perineal sepsis, rectal prolapse, anorectal cancer, inflammatory bowel disease, malignant disease Congenital formation, scleroderma, Parkinson's disease, immunosuppression and ongoing gestation. In addition, those patients who do not agree to participate in the survey will be excluded. - The study will have 4 phases: preoperative, surgical, recent postoperative and later postoperative