Constipation - Functional, Faecal Incontinence
Conditions
Keywords
trans anal irrigation
Brief summary
The goal of this exploratory clinical investigation is to understand the clinical benefits of Peristeen Light in adult patients with faecal incontinence, chronic constipation and/or time-consuming bowel management procedures. The primary objective is to evaluate changes in bowel-function when using Peristeen Light. Participants will use Peristeen Light for 12 weeks test period.
Detailed description
The goal of this exploratory clinical investigation is to understand the clinical benefits of Peristeen Light in adult patients with faecal incontinence, chronic constipation and/or time-consuming bowel management procedures. The primary endpoint is bowel function measured on a 10 cm Visual Analog Scale (VAS) at Baseline Visit and end of Clinical Investigation visit. Participants will use Peristeen Light for 12 weeks test period.
Interventions
DEVICEPeristeen Light - trans anal irrigation system
Subjects naive to TAI will use Peristeen Light trans anal irrigation
Sponsors
Coloplast A/S
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Has given written informed consent * Is at least 18 years old * Has full legal capacity * Is able (assessed by investigator) and willing to adhere to clinical investigational procedures during clinical investigation-al duration * Has access to and is able to use a smartphone * Has constipation and/or faecal incontinence based on one or more of the following symptoms during the last 3 month: Straining in more than 25% of defecations, lumpy stools (Bristol Stool Type 1 and 2) in more than 25% of defecations, sensation of incomplete evacuation in more than 25% of defecations, sensation of anorectal obstruction/blockage in more than 25% of defecations, need to use manual maneuvers to facilitate defecation in more than 25% of defecations, fewer than three spontaneous bowel movements per week, loose stools are rarely present without use of laxatives, recurrent uncontrolled passage of faecal material (other words to describe this could be: Soiling, leak-age, passive faecal incontinence of flatus, mucus and/or stool) * Is assessed (by investigator) to have a need for low-volume TAI minimum every other day
Exclusion criteria
* Is participating in any other clinical investigation during this investigation * Has previously completed this investigation * Is former or current user of transanal irrigation (low- and high volume) * Has known hypersensitivity towards the device used in the investigation * Is pregnant * Has known anal stenosis * Has active/recurrent colorectal cancer * Has had anastomotic colorectal surgery within the last 3 months * Has ischaemic colitis * Has active inflammatory bowel disease * Has acute diverticulitis or diverticular abscess * Has medicine induced constipation (e.g. due to opioids) * Has chronic diarrhea * Has bowel dysfunction due to neurogenic disorder(s) * Is in need of high-volume TAI (as estimated by investigator)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bowel function measured on a 10 cm Visual Analog Scale (VAS) at Baseline Visit (V1) and End of Clinical Investigation Visit (V7). | From enrollment to the end of treatment at week 12. | 0 cm = worst possible bowel function and 10 cm = best possible bowel function. |
Countries
Denmark, Italy
Contacts
CONTACTMichel Briand de Crevecoeur
Outcome results
None listed