Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT05946967 |
| Other study ID # |
2023-128-DM-131 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
July 20, 2023 |
| Est. completion date |
December 31, 2023 |
Study information
| Verified date |
July 2023 |
| Source |
Sanjay Gandhi Postgraduate Institute of Medical Sciences |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
One of the most challenging functional gastrointestinal illnesses (FGID) to manage is
constipation, which is a widespread issue. The fact that constipation can be caused by a
variety of conditions, including slow colon transit, faecal evacuation disorder, or a
combination of both slow colon transit and faecal evacuation disorder, is one of the main
reasons it is challenging to treat. Treatment options vary based on the pathogenetic
mechanism; for instance, biofeedback, botulinum toxin injections in the puborectal sling, or
transcutaneous electrical nerve stimulation (TENS) are required to treat faecal evacuation
problem. On the other hand, prucalopride and other colokinetic drugs as well as drugs that
promote high amplitude propagating contractions, including bisacodyl and sodium pyrosulphate,
are used to treat slow transit constipation. Sometimes faecal evacuation disorders that
inhibit the evacuation of the transit markers can cause slow colon transit times; these
secondary sluggish colon transit times have been shown to improve with biofeedback therapy
alone. Even though the causes of faecal evacuation disorders are not fully understood, it is
known that abnormal neuromuscular function is the result. A few workers have stimulated the
posterior tibial nerve, another sacral plexus branch, non-invasively with TENS. Studies on
the use of biofeedback in the treatment of patients with faecal evacuation problems are
lacking. Accordingly, we wish to undertake a prospective study with following aims: (i) To
assess safety and efficacy of colon transit study by an indigenous radio opaque marker to
identify the mechanism of constipation and to assess outcome of treatment (improvement of
transit time). (ii) To assess the efficacy of pathogenesisdirected therapy such as
biofeedback with or without TENS for posterior tibial nerve to treat fecal evacuation
disorder. (iii) To assess colon transit following treatment of fecal evacuation disorder with
either biofeedback alone or biofeedback with TENS for posterior tibial nerve.
Description:
Introduction Constipation is a common problem and one of the most difficult functional
gastrointestinal diseases (FGID) to treat. An Asian survey showed that among patients with
FGID, constipation patients are most dissatisfied with treatment . One of the major reasons
why constipation is difficult to treat is because of the fact that constipation may result
from multiple factors like slow colon transit, fecal evacuation disorder, or a combination of
both slow colon transit and fecal evacuation disorder . Until and unless the exact cause is
identified, the empirical treatment with laxatives does not work. Treatment varies depending
upon the pathogenetic mechanism, for example, fecal evacuation disorder needs to be treated
with biofeedback , botulinum toxin injection in the puborectal sling, or transcutaneous
electrical nerve stimulation (TENS) . On the other hand, slow transit constipation is treated
with colokinetic agents such as prucalopride and agents stimulating high amplitude propagated
contractions such as bisacodyl and sodium pyrosulphate. Sometimes colon transit time may be
slow secondary to fecal evacuation disorder mitigating evacuation of the transit markers;
such secondary slow colon transit has been shown to improve with biofeedback therapy alone.
Fecal evacuation disorders are diagnosed with anorectal manometry, balloon expulsion test,
and barium or magnetic resonance imaging defecography. On the other hand, slow transit
constipation is diagnosed by radio-nuclide colon transit study, a colon transit study using
radio-opaque markers and smart pills, etc. Since these investigations are not widely
available, it becomes difficult to detect the mechanism of constipation in practice by many
physicians and gastroenterologists. Two tests that can be easily performed in office practice
by most physicians and gastroenterologists include: (i) balloon expulsion test, (ii) colon
transit time (CTT) by opaque markers. Detecting these pathophysiological mechanisms of
chronic constipation is expected to provide personalized therapy for these patients.
Though mechanisms of fecal evacuation disorders are poorly understood, yet it is known that
it results from abnormal neuromuscular function resulting in lack of increase in intra-rectal
pressure during attempted defecation and failure of relaxation of pelvic floor muscles. This
led to some workers to treat these patients with sacral nerve stimulation, which is primarily
used to treat fecal incontinence. However, sacral nerve stimulation is quite invasive,
requires major surgical procedure and is associated with multiple complications, including
infection. A few workers have used non-invasive TENS to stimulate posterior tibial nerve,
which is also a branch of sacral plexus. However, there is lack of studies to treat patients
with fecal evacuation disorders with or without biofeedback, which is considered, the
first-line therapy for fecal evacuation disorder. Accordingly, we hypothesized that, (i) the
office-based investigation such as colon transit study using radio-opaque markers will be
useful to diagnose fecal evacuation disorder, which will be able to direct further therapy,
(ii) biofeedback with TENS for posterior tibial nerve will be superior to biofeedback alone
to treat fecal evacuation disorder, and (iii) successful treatment of fecal evacuation
disorder with either biofeedback alone or biofeedback with TENS for posterior tibial nerve
will improve colon transit as assessed by radio-opaque marker study.
Accordingly, we wish to undertake a prospective study with following aims:
(i) To assess safety and efficacy of colon transit study by an indigenous radio opaque marker
to identify the mechanism of constipation and to assess outcome of treatment (improvement of
transit time).
(ii) To assess the efficacy of pathogenesis-directed therapy such as biofeedback with or
without TENS for posterior tibial nerve to treat fecal evacuation disorder.
(iii) To assess colon transit following treatment of fecal evacuation disorder with either
biofeedback alone or biofeedback with TENS for posterior tibial nerve.
Methodology
Inclusion criteria:
i) Patient with refractory chronic constipation ii) >18 years of age Exclusion criteria i)
Patient with uncontrolled diabetes/ untreated thyroid/ organic disease ii) No lower limb iii)
<18 years of age
Fifty patients with chronic constipation will undergo the below-mentioned tests as per
standardized protocol. It is important to mention here that all these tests are standard of
care for these patients. The tests are: (i) anorectal manometry, (ii) balloon expulsion,
(iii) colon transit study by an indigenous radio-opaque marker according to the standard of
care, and (iv) defecography (either barium or magnetic resonance imaging).
The diagnostic criteria for fecal evacuation disorder will be as follows: positive result in
2 of the following tests - a) anorectal manometry with defecation index of <1.4, b) abnormal
balloon expulsion test, c) abnormal defecography.
The ability of CTT to diagnose fecal evacuation disorder and slow transit constipation among
these subjects will be assessed. Patients with fecal evacuation disorders diagnosed as above
will be subjected to daily biofeedback with one group receiving TENS daily and the other
group receiving sham stimulations. These treatments will be given for 10 days. The treatment
group shall be decided based upon the understanding with patients and mutual decision of the
doctor and the patient. Standard treatment of stimulative laxatives will be given to patients
with bloating and ispaghula husk to patients without bloating.
No patient will have to pay for biofeedback and TENS. The other tests (anorectal manometry,
balloon expulsion, colon transit study, and defecography) are standard of care for patients
with constipation. Follow up will be done at 1 month and 3 months as described in figure 2.
Outcome measures i) Constipation severity questionnaire will be used to assess the
Constipation Scoring System.
ii) Number of spontaneous bowel movements, time spent in the toilet, stool form (according to
Bristol stool chart) will be assessed with a stool diary.
iii) Dose of laxatives used. iv) After the end of treatment, colon transit study will be
repeated to assess its improvement.
