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Neurogenic Bowel clinical trials

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NCT ID: NCT04815226 Enrolling by invitation - Clinical trials for Urinary Incontinence

The Role of Active Administration of Peristeen Bowel Evacuation for the Management of Urinary Tract Infection

Start date: April 14, 2021
Phase: N/A
Study type: Interventional

This study investigates whether active use of transanal irrigation (Peristeen®) effectively manages urinary tract infection among patients with the diagnosis of neurogenic bladder.

NCT ID: NCT04726059 Recruiting - Clinical trials for Spinal Cord Injuries

Motor & Autonomic Concomitant Health Improvements With Neuromodulation & Exercise Training: An SCI RCT

MACHINE
Start date: July 22, 2022
Phase: N/A
Study type: Interventional

Spinal cord injury (SCI) disrupts many aspects of life, including the loss of volitional movement and involuntary control of bodily functions; both crucial functional recovery priorities for this population. Mobility impairments and secondary complications limit an individual's ability to exercise, a behavior known to have wide-ranging functional and health benefits. This trial will investigate whether activity-based therapy (ABT), using body-weight-supported treadmill training (BWSTT), can change the strength of signals from the brain that control volitional movement, leading to improvements in seated balance as well as other important involuntary bodily (i.e. cardiovascular, urinary tract, bowel and sexual) functions. The investigators aim to determine whether these improvements can be augmented with the addition of non-invasive transcutaneous spinal cord stimulation (TSCS). This therapy has been shown to re-awaken dormant spinal circuits. In this randomized controlled trial, TSCS with ABT, using BWSTT (three sessions/week for twelve weeks), will be compared to ABT+SHAM in individuals with chronic motor-complete spinal cord injury (SCI). Those in the ABT+SHAM group will be given the option to complete an ABT+TSCS open-label follow-up. Before and after training, the following outcomes will be assessed by validated methods: corticospinal excitability, motor function, and seated balance (Hypothesis 1 - Motor Function); severity and frequency of blood pressure instability, urinary tract, bowel, and sexual dysfunctions (Hypothesis 2 - Autonomic Functions); and general health (Hypothesis 3 - Quality of Life). This collaborative project is between consumers with SCI and clinicians/scientists with expertise in SCI care (kinesiologists, physiotherapists, physiatrists, sexual health clinicians). Compared to ABT alone, the investigators anticipate that ABT+TSCS will result in superior improvements in motor and autonomic functions in individuals with SCI.

NCT ID: NCT04707976 Recruiting - Multiple Sclerosis Clinical Trials

Comparing Transanal Irrigation With Navina Smart vs. Standard Bowel Care in Patients With Multiple Sclerosis

Start date: December 1, 2020
Phase: N/A
Study type: Interventional

A randomized, superiority, controlled, interventional, prospective, multicentre, post-market study of TAI with Navina™ Smart versus Standard Bowel Care performed in a population of 92 subjects suffering from Multiple Sclerosis and confirmed Neurogenic Bowel Dysfunction. The study is expected to last for a total of 8 weeks per subject with two scheduled site visits.

NCT ID: NCT04671030 Completed - Clinical trials for Spinal Cord Injuries

Use of a Prokinetic Agent as an Adjunct to Thrice Weekly Bowel Care After SCI

TWBC
Start date: January 15, 2018
Phase: Phase 1
Study type: Interventional

To measure a baseline for each subject, an abdominal x-ray (KUB) was performed, the SCI Bowel Survey and Treatment Satisfaction Questionnaire (TSQM) were administered and the subject's weight determined. After all the baseline measurements were acquired, the subjects underwent transdermal screening with hair epilation to test their response to transdermal administration of NEO (0.07mg/kg) and GLY (0.014mg/kg). All subjects had a positive response (bowel movement within 60 minutes of drug administration) and received five more cycles of bowel care for two weeks. All subjects reported bowel evacuation during each session and some reported side effects like slight dry mouth, eye twitching, and cramping. These side effects lasted approximately 20-30 minutes in duration and there were no clinically significant changes in cardiopulmonary vital signs. Six subjects after completing two weeks of bowel care had an abdominal x-ray (KUB) done. Also, they were weighted and reassessed using the TSQM and bowel survey.

NCT ID: NCT04604951 Recruiting - Clinical trials for Spinal Cord Injuries

Below the Belt: Non-invasive Neuromodulation to Treat Bladder, Bowel, and Sexual Dysfunction Following Spinal Cord Injury

Start date: May 2, 2022
Phase: N/A
Study type: Interventional

Recent findings have demonstrated that electrical stimulation to the spinal cord (i.e. implanted electrodes) can significantly recover bladder, bowel, and sexual function after injury. While promising, a major drawback is that individuals must undergo a highly invasive and expensive surgical procedure to implant the stimulator on top of the spinal cord. Moreover, the inability to re-position the implanted stimulator considerably limits the flexibility of this procedure. In this project, the investigators propose a comprehensive clinical study examining the effects of TCSCS in promoting recovery of these crucial functions in individuals with spinal cord injury (SCI). This non-invasive therapeutic modality uses electrodes applied over the skin to deliver electrical stimulation. It is based on the same principles of ground-breaking work from the investigator's group and others, showing that stimulation of the spinal cord can promote motor and autonomic (cardiovascular, bladder, bowel) recovery in individuals with chronic SCI.

NCT ID: NCT04367571 Completed - Clinical trials for Spinal Cord Injuries

Osteopathic Manipulative Treatments and Neurogenic Bowel Dysfunction in Patients With Spinal Cord Injuries.

Start date: April 1, 2020
Phase: N/A
Study type: Interventional

Studies based on the relationship between Osteopathic Manipulative Treatment (OMT) and the gastrointestinal system have been conducted in patients with constipation with Irritable Bowel Syndrome (IBS), and in children with infantile cerebral palsy. For IBS patients, OMT can facilitate visceral vascularization and restore the physiological elasticity and motility of the viscera, and of the peritoneal structures around the viscera. The study also focused on the effects of OMT on women and constipated children, indicating an improvement in the stool consistency, reduction in the symptoms of constipation, the severity of the constipation, and in the use of laxative drugs. In patients with Spinal Cord Injury (SCI), the secondary health disorders include the alteration of gastric acid secretion, abnormal colonic myenteric activity, and neurogenic bowel dysfunction (NBD). Patients with NBD present loss or absence of normal bowel function. About 80% of SCI is accompanied by NBD resulting in a lower quality of life caused by loss of independence, sense of embarrassment, mental disorder, social isolation. Conservative treatments for NBD after SCI include oral laxatives, enemas, retroanal trans-grade irrigation and digital anorectal stimulation. These treatments are mainly focused on promoting intestinal faecal evacuation and on strengthening the anal sphincter to improve bowel function. There are no studies that investigate the effects of OMT on patients with SCI, however, several studies have already showed the effects of OMT on the nervous system, on the hemodynamic system, and on visceral motility. Therefore, the starting hypothesis of this study is to use OMT in order to improve the symptoms of NBD in subjects with SCI, through a global OMT

NCT ID: NCT04307303 Recruiting - Neurogenic Bowel Clinical Trials

Electrical Stimulation of Abdominal Muscles for Bowel Management in People With Spinal Cord Injury

BOWMAN
Start date: July 7, 2021
Phase: N/A
Study type: Interventional

A well-managed bowel program is an essential part of daily life for many people with a SCI. Nevertheless, constipation is frequently reported (42-95%). Constipation embraces a spectrum of harms including both physical & psychological distress. Initial exploratory studies suggest abdominal FES may be useful for decreasing overall bowel management time, decreasing colonic transit time and reducing discomfort. The current study will seek to reproduce previous findings in a 12 week study, using overall bowel management time as a benchmark for establishing proof of principle. The study will include 36 people with a spinal cord injury aged 18 and over with an above T12 injury, a complete or incomplete lesion in a medically stable condition, one year or more after injury. Participants will be randomised into two groups. One group will receive abdominal electrical stimulation and the other group low dose abdominal electrical stimulation. Participants will be asked to keep a bowel diary and complete questionnaires examining quality of life and bowel management.

NCT ID: NCT04127617 Recruiting - Clinical trials for Central Nervous System Injury

Effects of Osteopathic Manipulative Treatment in People With Neurogenic Bowel Dysfunction

Start date: October 28, 2019
Phase: N/A
Study type: Interventional

People affected central nervous system (CNS) diseases often suffer from neurogenic bowel dysfunction (NBD) that causes a reduction in the quality of life and participation in social life. Although some conservative approaches exist to treat NBD, none has shown to be effective in managing this complex condition. Osteopathic manipulative treatment (OMT) has shown to be efficient in CNS diseases such as epilepsy and migraine. This randomised trial aims at evaluating the efficacy of osteopathic manipulative treatment (OMT) in supporting the management of NBD. The research will be conducted at the outpatient service of Neuro-Urology / Spinal Unit of the Città della Salute e della Scienza Hospital of Torino. A sample of 62 participants will be divided into two groups: standard (nursing intervention) and experimental (nursing intervention and OMT). A neuro-urologist will determine the eligibility for the study. The outcomes will include self-reported and instrumental measures that will be evaluated in 3 times (before, at the end of the intervention and the follow- up three months). The protocol has been approved by the Ethics Committee of the Città della Salute e della Scienza Hospital of Torino on 15.04.2019, protocol number 0040534. The standard intervention has been scheduled for 28.10.2019.

NCT ID: NCT04027972 Active, not recruiting - Clinical trials for Spinal Cord Injuries

Pharmacokinetics of Neostigmine and Glycopyrrolate

Start date: March 9, 2020
Phase: Early Phase 1
Study type: Interventional

A group of 6 able-bodied healthy volunteers will receive Neostigmine (NEO) and Glycopyrrolate (GLY) intravenously and via 2 methods of Iontophoresis (ION): one-patch and two-patch administration, with subsequent blood draws over 1 hour in order to measure the pharmacokinetic behavior of the drugs in-vivo.

NCT ID: NCT03987126 Completed - Clinical trials for Spinal Cord Injuries

Prebiotics for Spinal Cord Injury Patients With Bowel and Bladder Dysfunction

Start date: January 27, 2021
Phase: Phase 3
Study type: Interventional

An investigator initiated pilot study: two arm, double blind, placebo controlled, randomized, group of approximately 60 patients with spinal cord injury, and who have evidence of neurogenic bladder. Patients will be treated with human milk oligosaccharide (HMO) versus placebo over 12 weeks from start of the investigational medication date (approximately 3 months) to test whether HMO can improve bowel motility in neurogenic bowel and bladder patients. Patients in the placebo arm of the study will be offered participation in the open label portion of the study immediately after their part in the control group is completed, they will receive HMO for 12 weeks. HMO sachets will be administered to determine the safety and efficacy of HMO relative to placebo in improving quality of life of neurogenic bowel and bladder patients by improving bowel motility and function.