Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT02556151 · ClinicalTrials.gov registry record · NA
Neuromodulation Therapy for Fecal Incontinence
A NA study, sponsored by Augusta University.
- Completed
- Registry status
- NA
- Development phase
- 44
- Enrollment target
NCT02556151 is a NA study that has completed, run by Augusta University. The registered enrollment target is 44 participants.
The verdict
NCT02556151, a NA study, has completed, sponsored by Augusta University.
- COMPLETED
- Registry status
- NA
- Development phase
- 44 participants
- Enrollment target
Study Summary
Fecal Incontinence (FI) affects 8-15 % of the US population, predominantly women and elderly, and 45% of nursing home residents. It significantly impairs quality of life and poses a major health care burden. FI is characterized by significant neuromuscular dysfunction of the pelvic floor that includes bilateral lumbo-anorectal and sacro-anorectal neuropathy and sensori-motor dysfunction. This multifactorial etiology suggests that maladaptive neuroplastic changes in the neural innervation of lower gastrointestinal tract could play a significant role in the pathogenesis of FI. A critical barrier to progress in the treatment of FI is the lack of understanding of how treatments affect the core pathophysiological mechanisms of FI, and the absence of mechanistically based non-invasive therapies. Our goal is to address the problem of FI by developing therapies that modulate peripheral and central neuronal perturbations and thereby improve visceromotor control and sensori-motor dysfunctions, and to understand the neurobiologic basis of these treatments. Our central hypothesis is that a novel non-invasive treatment consisting of repetitive translumbar magnetic stimulation (rTLMS) and repetitive transsacral magnetic stimulation (rTSMS) will significantly improve FI by enhancing peripheral and central neural excitability and will provide a multidimensional therapeutic benefit- enhance anal muscle strength, improve stool perception and improve rectal capacity. Our approach is based on our preliminary studies which suggest that repetitive translumbar magnetic stimulation (rTLMS) and transsacral magnetic stimulation (rTSMS) improve anorectal pain and neuropathy and induce central neuroplastic changes. Our objectives are to: 1. address the significant gap in our knowledge regarding the peripheral and central neuroenteric axis and how perturbations in the afferent and efferent neural signaling can affect FI; 2. develop a new treatment for FI with repetitive magnetic stimulation a
Interventions
- PROCEDURE Repetitive lumbosacral magnetic stimulation (rTLSMS)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 44 participants |
| Start Date | 2015-04 |
| Est. Completion | 2018-12-31 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02556151
The ClinicalTrials.gov registry entry for NCT02556151 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 44 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Augusta University, which has 106 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Repetitive lumbosacral magnetic stimulation (rTLSMS) is the first listed.
NCT02556151 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02556151 about?
NCT02556151 is a clinical study titled "Neuromodulation Therapy for Fecal Incontinence". Fecal Incontinence (FI) affects 8-15 % of the US population, predominantly women and elderly, and 45% of nursing home residents. It significantly impairs quality of life and poses a major health care burden. FI is characterized by significant neuromuscular dysfunction of the pelvic floor that includ...
What is the current status of trial NCT02556151?
This trial is currently completed. It is a NA study. The enrollment target is 44 participants. The study started on 2015-04. Estimated completion is 2018-12-31.
What interventions are being tested in trial NCT02556151?
The interventions under investigation include: Repetitive lumbosacral magnetic stimulation (rTLSMS) (PROCEDURE).
Who is sponsoring clinical trial NCT02556151?
This trial is sponsored by Augusta University, which has 106 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.