MOWOOT Device to Treat Constipation in Adults (NCT04262752) | Clinical Trial Compass
CompletedNot Applicable
MOWOOT Device to Treat Constipation in Adults
Spain, United Kingdom100 participantsStarted 2018-01-11
Plain-language summary
The aim was to assess the safety and effectiveness of the automatic colon-specific massage with the MOWOOT device for patients suffering from chronic constipation due to Multiple Sclerosis, Parkinson Disease (NBD) or other unknown causes (Idiopathic).The hypothesis is that this treatment administered daily in home-use settings could ameliorate constipation in chronically affected people.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Fulfil Rome III criteria for functional constipation: include any two of the six symptoms of straining, lumpy or hard stools, sensation of incomplete evacuation, sensation of anorectal obstruction or blockage, digital manoeuvres and less than 3 defecations per week. These should be present during at least 25% of defecations for the last 3 months with symptom onset at least 6 months before the diagnosis;
* Failed routine management of constipation (lack of response to non-stimulant laxatives), or subjects responding to laxative treatment but with secondary diarrhoea and faecal incontinence.
* Duration of constipation more than 6 months.
* If subjects have a diagnosis of multiple sclerosis (MS) or Parkinson disease (PD), it is in a stable phase (no major change in medication for 1 month).
* Subject that have had no abdominal massage for at least 2 months.
* Subjects bothered by their constipation.
* Ability to understand the study
* Ability to come to the outpatient clinic during the study
* Subjects whose constipation aetiology is not only pelvic floor dyssynergia.
* Ability to use MOWOOT or have someone to apply it.
* Subjects that consent to participate in an informed way
Exclusion Criteria:
* Pregnancy or attempt to become pregnant in the next 6 months.
* Subjects alternating constipation and diarrhoea (not due to laxative use)
* Previous large bowel surgery
* The presence of a stoma
* External rectal prolapse
* Active anorexia or bulimia
* Mental i…