Colon Transit Study for Chronic Constipation Assessment and Therapy by Biofeedback With and Without TENS - Trial NCT05946967

Timeline & Enrollment

Primary Outcome

Constipation severity,Bowel movement assessment,Treatment effect

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.

ICD-10 Classifications