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Fecal Incontinence clinical trials

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NCT ID: NCT06423222 Recruiting - Anal Incontinence Clinical Trials

Anal Incontinence and Its Impact on Quality of Life and Physical Activity Among Hungarian Women and the Hungarian Language Validation of the International Consultation on Incontinence Modular Questionnaire-Bowels (ICIQ-B)

Start date: April 22, 2024
Phase:
Study type: Observational

The aim of the study is to assess the prevalence of anal incontinence among Hungarian women who have given birth at least once before, and to examine the impact of anal incontinence on the quality of life and physical activity of these women. A further aim of our study is to adapt the Hungarian version of the International Consultation on Incontinence Modular Questionnaire - Bowels (ICIQ-B) and to assess its validity and reliability.

NCT ID: NCT06368284 Recruiting - Anal Incontinence Clinical Trials

Perineal Trauma After Jet Ski Accidents and Long-term Functional Outcomes Results

TP-JET
Start date: January 1, 2023
Phase:
Study type: Observational

French multicentric retrospective cohort study including patients who underwent an ano-perineal trauma following a personal watercraft/jet-ski accident and that were treated in France from January 2017 to December 2023. Aims of the study were to describe the initial management of the patients and to evaluate the digestive, urological and sexual functional outcomes as well as the quality of life, using validated questionnaires commonly employed in clinical practice.

NCT ID: NCT06351852 Recruiting - Clinical trials for Spinal Cord Injuries

Transdermal Administration by a Novel Wireless Iontophoresis Device

Start date: March 22, 2022
Phase: Early Phase 1
Study type: Interventional

Persons with spinal cord injury (SCI) have neurogenic bowel disorders which is associated with significant morbidity. The negative impact of bowel complications is often at the top of the list of problems reported by persons with SCI. Despite the magnitude of the problem of bowel dysfunction in persons with SCI, and the associated reduction in quality of life, this condition has yet to be effectively treated. The investigators have developed a novel dual drug combination to elicit a safe and predictable bowel evacuation (BE). The ability to move the bowel contents along to the rectum was severely impaired primary because of poor gut contractions on the left side of the colon, as shown by our team of investigators. To address this problem, a dual medication combination (neostigmine and glycopyrrolate) was developed that safely and predictably caused the bowel to empty after delivering these drugs into a vein (intravenously) or into the muscle bed (intramuscularly). Because no one likes needles, and because of the practical limits of administering medications on a routine basis by the use of needles, especially in persons with SCI because of their other health considerations, the investigators have devised a new approach: driving these medications across the skin and into the circulation of the body by applying an electrical current that is too small to feel (iontophoresis). The proposed research project to determine the safety of positively charged compounds (e.g., vitamin B12, NEO, and GLY) administered transcutaneously by the prototype wireless ION device and to compare the pharmacokinetic profiles of transcutaneous administration of NEO and GLY by the wireless ION device to a commercially available wired ION device. The potential administration of any number of other positively charged agents by this wireless prototype may be a clinically relevant outcome of this work. The ability to use a wireless ION device is far more practical for patients to use, especially those with SCI, which will permit the self-administration of these agents in the home setting to induce a bowel evacuation.

NCT ID: NCT06273046 Recruiting - Fecal Incontinence Clinical Trials

Treatment of Fecal Incontinence and Functional Defecation Disorders Using Non-instrumental Biofeedback

Start date: April 19, 2024
Phase: N/A
Study type: Interventional

Background. Rehabilitation and re-education using instrumental anorectal biofeedback are the main treatment of anorectal functional disorders producing incontinence and outlet obstructed defecation. These treatments imply intubation of patient and several sessions of treatment leading to high consumption of resources and costs. Hypothesis. A cognitive intervention based on original audiovisual programs developed specifically for the management of anorectal functional disorders is effective in correcting anorectal function disorders that cause fecal incontinence and evacuation disorders. Aim. To prove in two different protocols (fecal incontinence and dyssinergic defecation) the efficacy of specifically developed non-instrumental biofeedback techniques. Selection criteria. Patients with fecal incontinence and altered sphincter function and patients with outlet obstructed evacuation referred for biofeedback treatment. Intervention. In separate studies (incontinence and dyssynergic defecation) patients will be randomized into biofeedback and placebo groups. One session of either biofeedback or placebo intervention will be performed at the beginning of the intervention period and patients will be instructed to performed the assigned daily treatment at home. A visit for outcome assessment will be performed at 3 months in incontinence study and at 4 weeks in the dyssinergic defecation study. In addition, in the incontinence study a phone call will be performed after 6 months of the beginning of the study to evaluate treatment outcome. Biofeedback: patients will be taught to control anal and abdominal muscular activity by providing instructions using original video supports. Patients will be instructed to perform the same exercises daily at home in scheduled times. Placebo: a pill of placebo containing 0.3 g glucose will be administered every day at home.

NCT ID: NCT06186765 Recruiting - Clinical trials for Urinary Frequency (UF)

F15 Recharge Free Axonics SNM System Clinical Study

Start date: December 8, 2023
Phase: N/A
Study type: Interventional

Multicenter, prospective, non randomized, single arm evaluation of patients with overactive bladder (OAB) and/or fecal incontinence (FI) employing the Axonics recharge free SNM System.

NCT ID: NCT06162312 Recruiting - Clinical trials for Urinary Incontinence

Efficacy of Antenatal Perineal Massage in Reducing Postpartum Morbidities

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

A randomized controlled trial was undertaken at Rajavithi Hospital, Bangkok, Thailand, encompassing 106 primigravidae within the period of December 2023 to June 2024. The intervention group underwent antepartum perineal massage, starting at the 34th - 35th week of gestation and extending until delivery, while the control group did not receive such intervention. The primary outcome evaluated was the incidence of anal incontinence at the 3-month postpartum. Secondary outcomes included the duration of each labor stage, perineal tears and their degrees, episiotomy occurrences, Apgar scores at 1 and 5 minutes, postpartum pain within 24 hours, dyspareunia, and urinary incontinence at the 3-month postpartum.

NCT ID: NCT06152224 Recruiting - Fecal Incontinence Clinical Trials

Use of the LEVA® Pelvic Health System for Fecal Incontinence

Start date: January 17, 2024
Phase: Phase 4
Study type: Interventional

The goal of this clinical trial is to learn about how the duration of use of The Leva Pelvic Health System® affects treatment of fecal incontinence in women. The main question it aims to answer is to test whether use of the The Leva Pelvic Health System® for 8 weeks is as good as using it for 16 weeks. Participants will complete surveys, and use the Leva device.

NCT ID: NCT06143072 Recruiting - Faecal Incontinence Clinical Trials

CArE for OAsI Study: Care Pathways and Anorectal Evaluation for OASI Associated Incontinence

CArE for OAsI
Start date: January 1, 2024
Phase:
Study type: Observational

The aim of this study is to ascertain which pathways currently exist in relation to the follow up of patients with obstetric anal sphincter injury related incontinence. This is particularly important as afflicted individuals may not readily volunteer information about their symptoms and struggles and need to be safeguarded by the presence of robust care pathways that ensure adequate follow up and care provision. As obstetric anal sphincter injuries have been associated with increased litigation rates over the years, positive interventions towards patient care will help ameliorate the financial burden that litigation carries on the National Health Service. It is noteworthy of mention that perineal injury, in itself, may not be suggestive of negligent care and is a recognized complication of vaginal delivery. However, a failure to adequately manage the injury may carry medicolegal implications.

NCT ID: NCT06091566 Recruiting - Clinical trials for Urinary Incontinence

Safety and Performance of UCon Bar Electrode for the Treatment of Overactive Bladder (OAB) and Bowel Dysfunction (BD)

Start date: January 12, 2024
Phase: N/A
Study type: Interventional

UCon is a medical device for treatment of the symptoms of overactive bladder (OAB) and bowel dysfunction (BD). 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, multi-centre, and early feasibility study.

NCT ID: NCT05900726 Recruiting - Faecal Incontinence Clinical Trials

Pelvipower for Faecal Incontinence

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

Faecal incontinence (FI) is a common condition which drastically reduces patient's quality of life and for which there are few effective treatments. The causes of FI are multiple and include disturbances in neuromuscular function (and structure) of the anal canal, rectum and pelvic floor. Treatment options include antidiarrheals, laxatives, biofeedback, surgery, SNS and PTNS. This study will test the Pelvipower extracorporeal magnetic stimulation device as a treatment for faecal incontinence.