Magnetic stimulation dramatically improves fecal incontinence

Date:
August 25, 2020
Source:
Medical College of Georgia at Augusta University
Summary:
Painless magnetic stimulation of nerves that regulate muscles in the
anus and rectum appears to improve their function and dramatically
reduce episodes of fecal incontinence, a debilitating problem
affecting about 10% of the population, investigators report.



FULL STORY ========================================================================== Painless magnetic stimulation of nerves that regulate muscles in the anus
and rectum appears to improve their function and dramatically reduce
episodes of fecal incontinence, a debilitating problem affecting about
10% of the population, investigators report.


==========================================================================
They have early evidence that TNT, or translumbosacral neuromodulation
therapy, is a promising, novel, safe, low-cost treatment for strengthening
key nerves and reducing or even eliminating episodes of stool leakage,
Medical College of Georgia investigators report in the American Journal
of Gastroenterology.

"We have identified that nerve damage is an important mechanism
in the pathogenesis of stool leakage, and we have identified a
noninvasive and targeted treatment to correct the nerve damage and
address this pervasive problem," says Dr. Satish S.C. Rao, director of neurogastroenterology/motility and the Digestive Health Clinical Research Center at the Medical College of Georgia at Augusta University.

"We found there was significant improvement in fecal incontinence across
the board," says Rao, after six sessions of weekly TNT treatment to key
nerves, "which told us something is happening with this treatment. There
is an effect on nerve function which, in turn, is leading to improvement
of symptoms." The rectum is the connector between the colon and the
anus, where stool exits, and the muscles directly involved in moving
feces along then holding it in place until we are ready to go to the
bathroom, have been a focal point for treating fecal incontinence. However current strategies are largely unsatisfactory for at least half of
patients because they do not directly address the causes, including
nerve dysfunction in the anus and rectum, the investigators say.

Rao and his team decided to take a step back and look at the function of
the nerves controlling those muscles. He developed a relatively benign
test, called TAMS, or translumbosacral anorectal magnetic stimulation,
to look at nerve activity by placing a probe in the rectum and a coil
on the back to deliver magnetic stimulation to nerves in the anus and
rectum and watch the response.

When they found that nerve function was an issue in 80-90% of patients
they assessed, they began exploring a similar approach using external, repetitive magnetic stimulation to help heal those nerves.



==========================================================================
This first study was in 33 participants, including 23 women, who tend
to have more problems with fecal incontinence, and, who were an average
of about 60 years old. Age also is a risk factor. They used the same
four sites on the upper and lower back they used to test the function
of the relevant lumbar and sacral nerves, which are about two inches
below the skin, after some surface mapping to find an exact location in
each individual.

Patients lie comfortably face down and the machine makes a steady 'tock,
tock' sound. Treatment lasts 15 minutes to an hour depending on the
frequency. The 15-minute version meant, for example, 15 stimulations
per second, or 15 hertz, clearly the quickest but, surprisingly, not
the most effective frequency for this purpose.

Rather, while all participants derived some benefit, it was those
receiving the lowest frequency, one hertz, over an hour who benefited
most.

The investigators defined responders as those with at least a 50%
reduction in the number of episodes of stool leakage per week. The
one-hertz group experienced about a 90% reduction in weekly episodes
as well as significantly improved ability to sense a need to defecate
and in their ability to hold more stool. Those in the one hertz and
midrange five-hertz group also reported the most improvement in quality
of life issues.

"We measured several parameters including their leakage events,
we measured their nerve and muscle function, quality of life, all of
those were measured," Rao says. Participants also kept stool diaries,
with some reporting zero incontinence episodes following TNT.



========================================================================== "It's still in the early stage, but it's quite remarkable what we are
seeing," he says.

Like the patients he sees in his practice, study participants had
a variety of issues that likely contributed to their lack of fecal
control including diabetes, back injuries, hysterectomies and bladder
and hemorrhoid surgeries.

Childbirth is a common cause of both fecal and urinary incontinence. One
of the females in the study had never had a baby, 18 others had vaginal deliveries and three of those also had a C-section, and four others only
had a C-section.

Eleven of the women with a vaginal delivery had vaginal tears and six
had a forceps-assisted delivery.

While they didn't selectively pick people with nerve damage for the
study, the investigators again found that whatever the cause, those with significant stool leakage had problems with delayed and weakened nerve conduction compared to healthy controls.

TNT dramatically shortened the time it takes those nerves to activate the muscle by several important milliseconds, particularly in the one-hertz
group, where the response time consistently returned to normal.

"We have always tended to blame the anal muscle as the problem," Rao
says of key controls needed to keep stool contained until we are in the bathroom. But they also know from women who experience muscle tears during childbirth, which is common, that repairing the muscle does not guarantee
the woman will not have problems with leakage, he says. Sometimes muscle
repair works temporarily, but when you follow up five years later,
about half are incontinent, and nearly 90% are incontinent in 10 years,
he says. "Ideally you want to treat all the mechanisms that are not
working. We have not really approached it like that," Rao says.

His team suspected their repeated stimulation of the nerves would induce
their innate ability to adapt in response to a variety of stimulations,
called neuroplasticity, a skill that exists in nerves throughout the
brain and body that enables both learning as well as recovery from injury
or disease. They had preliminary evidence of this including studies
indicating that magnetic stimulation improves neuropathy and pain in
a condition called levator ani syndrome, in which patients experience
burning pain in the rectal or perianal region.

They suspected high frequency stimulation, like 15 hertz, already used
in the brain to treat problems like depression and stroke recovery,
would work best, which is why they were surprised to find that the
relevant nerves in this case were most responsive to longer periods of
low frequency 1 hertz. Rao surmises one reason may be that the nerves
that help control defecation are not as active as typical brain cells,
although laboratory studies are needed to confirm that theory, he says. He
also wants to learn more about underlying mechanisms for how the nerve
changes occur with magnetic stimulation and, along with colleague Dr. Amol Sharma, MCG gastroenterologist and a study coauthor, look at its potential
in other gastrointestinal motility problems caused by conditions like Parkinson's disease and the stomach-paralyzing problem gastroparesis.

How long benefits of TNT hold, and how often follow-up sessions may be
needed are already being pursued in a larger study of 132 participants
now underway at MCG and AU Health System and Harvard University's
Massachusetts General Hospital in Boston, on which Rao is also the
project director and principal investigator.

Participants for the published study were recruited from MCG's
adult teaching hospital, AU Medical Center, and from the University
of Manchester's Manchester Academic Health Sciences Centre in the
United Kingdom, under the supervision of Dr. Shaheen Hamdy, professor
of neurogastroenterology, although all participants were ultimately
enrolled at the Augusta facility.

They went through extensive screening to ensure there weren't other
medical problems, like severe diarrhea or inflammatory bowel disease,
that could contribute to their incontinence, as well as a host of other
serious medical conditions. To qualify, individuals had to have a history
of recurrent fecal incontinence for six months that did not respond
to approaches like diet modifications and diarrhea medication, and a
two-week diary that reported at least one episode of fecal incontinence
per week. As part of the study, investigators performed several tests to
assess nerve and muscle function, including Rao's TAMS test, at the start
and finish of the trial. They also used TAMS to ensure the participant's
nerves were responding to the stimulation.

The only reported side effect of TNT was some temporary tingling in the treatment area, probably prompted by rejuvenating nerves, Rao says. He
notes penetrability of the magnetic stimulations can be problematic with obesity or in patients with significant scarring from problems like back
injury and/or surgeries. He also notes poor nerve conduction likely is
a factor in some patients with constipation.

The published research was supported by the National Institutes of Health.


========================================================================== Story Source: Materials provided by Medical_College_of_Georgia_at_Augusta_University.

Original written by Toni Baker. Note: Content may be edited for style
and length.


========================================================================== Journal Reference:
1. Satish S.C. Rao, Xuelian Xiang, Amol Sharma, Tanisa Patcharatrakul,
Yun
Yan, Rachael Parr, Deepak Ayyala, Shaheen Hamdy. Translumbosacral
Neuromodulation Therapy for Fecal Incontinence. American Journal
of Gastroenterology, 2020; Publish Ahead of Print DOI: 10.14309/
ajg.0000000000000766 ==========================================================================

Link to news story: https://www.sciencedaily.com/releases/2020/08/200825110658.htm

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