Characteristics of INTESTINAL DYSFUNCTION in Patients With MULTIPLE SCLEROSIS

CompletedOBSERVATIONAL
Enrollment

100

Participants

Timeline

Start Date

June 7, 2018

Primary Completion Date

April 10, 2020

Study Completion Date

April 10, 2020

Conditions
Multiple SclerosisIntestinal DysfunctionAnal IncontinenceMicrobiota
Interventions
DEVICE

Peristeen (Coloplast)

"Patients with severe intestinal dysfunction impairment (PAC QoL score ≥ 32) will be offered the adoption of the TAI (Transanal Irrigation) with Peristeen Device as a way to manage their own evacuation, replacing any other measure used until that moment (suppositoires, clisms exceptionally cc) with the exception of the possible intake of macrogols and/or prebiotics and/or probiotics which instead patients can continue. This treatment will be proposed to all patients with severe impairment of intestinal function.~The TAI training with Peristeen will be carried out at the surgical clinic of the Surgical Department of the Ferrara University Hospital, Italy, by the health personnel involved in the study, usually in a single session, but more sessions may be necessary, with the continuation of the TAI for 4 weeks or with patient's exclusion from the study if the guarantees of appropriate use of the device will not be reached."

Trial Locations (1)

44121

Simona Ascanelli, Ferrara

All Listed Sponsors
lead

University Hospital of Ferrara

OTHER

NCT04599595 - Characteristics of INTESTINAL DYSFUNCTION in Patients With MULTIPLE SCLEROSIS | Biotech Hunter | Biotech Hunter