Neuromodulation Therapy for Fecal Incontinence
1 other identifier
interventional
44
2 countries
2
Brief 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 and determine the feasibility, safety and optimal frequency setting of rTLMS and rTSMS;
- 3.determine the mechanistic basis for this neuromodulation therapy;
- 4.identify if the locus for improvement lies in the afferent or efferent signaling or both.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2015
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2015
CompletedFirst Submitted
Initial submission to the registry
September 17, 2015
CompletedFirst Posted
Study publicly available on registry
September 22, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2018
CompletedFebruary 20, 2019
February 1, 2019
3 years
September 17, 2015
February 19, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
The reduction in number of episodes of Fecal Incontinence
The primary outcome measure will be the reduction in number of episodes of Fecal incontinence from baseline to post treatment.
12 weeks
Secondary Outcomes (4)
Bowel symptoms
12 weeks
Fecal incontinence Quality of life
12 weeks
Psychosocial function
12 weeks
Anal and rectal sensations
12 weeks
Study Arms (3)
1 Hz
ACTIVE COMPARATORSix sessions of weekly therapy with 1 Hz magnetic stimulations of the lumbar and sacral regions.
5 Hz
ACTIVE COMPARATORSix sessions of weekly therapy with 5 Hz magnetic stimulations of the lumbar and sacral regions.
15 Hz
ACTIVE COMPARATORSix sessions of weekly therapy with 15 Hz magnetic stimulations of the lumbar and sacral regions.
Interventions
Patients randomized to Six sessions of weekly therapy with either 1 HZ or 5 Hz or 15 Hz magnetic stimulations of the lumbar and sacral regions.
Eligibility Criteria
You may qualify if:
- Recurrent episodes of FI for 6 months;
- No mucosal disease (colonoscopy + biopsy); and
- On a 2-week stool diary patients reported at least one episode of solid or liquid FI/week.
You may not qualify if:
- severe diarrhea (\>6 liquid stools/day, Bristol scale \>6);
- on opioids, tricyclics (except on stable doses \> 3months);
- active depression;
- comorbid illnesses, severe cardiac disease, chronic renal failure or previous gastrointestinal surgery except cholecystectomy and appendectomy;
- neurologic diseases (e.g. head injury, epilepsy, multiple sclerosis, strokes, spinal cord injury);
- impaired cognizance (mini mental score of \< 15/25) and/or legally blind;
- metal implants, pacemakers;
- previous pelvic surgery, bladder repair, radical hysterectomy;
- ulcerative and Crohn's colitis;
- rectal prolapse, anal fissure, anal surgery or inflamed hemorrhoids;
- pregnant women
- nursing mothers.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Augusta University
Augusta, Georgia, 30912, United States
University of Manchester
Manchester, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Satish Rao, MD, PhD
Augusta University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 17, 2015
First Posted
September 22, 2015
Study Start
April 1, 2015
Primary Completion
March 31, 2018
Study Completion
December 31, 2018
Last Updated
February 20, 2019
Record last verified: 2019-02