Bowel Irrigation Techniques for Chronic Constipation and Faecal Incontinence

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a post-market, exploratory randomized trial comparing two transanal irrigation devices approved for use in the UK/CE-marked system. Participants with faecal incontinence and/or chronic constipation of heterogeneous origin are randomized to one of the two devices and receive a four-week training by nurse specialists. After training, they irrigate daily or at least three times per week and are followed for up to 52 weeks with calls or in-person visits to monitor outcomes in a real-world setting. The study aims to observe routine clinical practice while maintaining randomization, with more frequent contact than typical care to capture data on safety and effectiveness. Inclusion requires adults 18+ with Rome IV criteria for FI and/or functional constipation, and the ability to consent and communicate in English; exclusions include prior transanal irrigation use and certain bowel dysfunctions.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Faecal incontinence (FI), chronic constipation (CC) or co-existing FI/CC, all of heterogenous origin
* Positive Rome IV criteria for functional constipation and/or positive Rome IV criteria for faecal incontinence
* 18 years or older
* Ability to understand written and spoken English (due to questionnaire validity)
* Ability to understand and provide written, informed consent prior to any investigation-specific procedures

Exclusion Criteria:

* Prior use of transanal irrigation
* Neurogenic bowel dysfunction
* Low anterior resection syndrome (this group will be excluded due to the possibility of being randomised to a balloon catheter).
* Previous rectal and/or anal surgery (except minor rectal or anal surgery such as haemorrhoid procedures, anal fissure surgery, drainage of a perianal/rectal abscess, or other rectal or anal surgeries deemed minor by the investigator)
* Physical disability that affects the ability to independently use the irrigation device
* Intermittent use of opioids inducing chronic constipation
* Patulous anus
* Participation in research conflicting with the current investigation
* Physical or mental conditions affecting the ability to comply with the clinical investigation plan
* Pregnancy or plans to become pregnant during the investigation period

Where it's running

• University Hospital Southampton
  Southampton, United Kingdom Recruiting

Study contacts

• Study coordinator: Haya N.H. Pedersen
• Email: hap@qufora.com
• Phone: +45 31394941

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Tailored treatment approaches for low anterior resection syndrome

  This study will see if advanced physiological and imaging tests can identify different subtypes of LARS in people after rectal cancer surgery to help match them to better treatments.

  Recruiting at 2 sites Aalborg University Hospital · Aalborg and 2 other locations · NCT07573371

• Fecal microbiota transplant with prebiotic nutrition for functional constipation

  This will try fecal microbiota transplantation combined with a prebiotic nutrition plan to see if it helps adults aged 18–70 with chronic functional constipation that hasn’t improved with diet or laxatives.

  Recruiting Peking Union Medical College Hospital · Beijing · NCT07387952

• Radiation-free imaging to measure intestinal transit time in children

  This project will try a radiation-free imaging method (MSOT) with an oral dye plus MRI to measure how quickly stool moves through the intestines in children and teenagers with chronic bowel emptying disorders.

  Recruiting Friedrich-Alexander-Universität Erlangen-Nürnberg · Erlangen, Bavaria · NCT06911749

• Evaluating the effects of probiotic yogurt on chronic constipation

  This study tests if eating a special probiotic yogurt can help people with chronic constipation feel better over three weeks.

  Recruiting Wecare Probiotics Co., Ltd. · Suzhou, Jiangsu · NCT06847919

• Care pathways for women with obstetric anal sphincter injury-related incontinence

  This study looks at how women with incontinence from childbirth-related injuries are currently cared for to see if better support can be provided.

  Recruiting London North West Healthcare NHS Trust · London · NCT06143072

• Database of factors related to faecal and double incontinence

  This study is trying to gather information about what causes faecal and double incontinence in people to see how it affects their lives and compare it with those who don’t have these issues.

  Recruiting Universitair Ziekenhuis Brussel · Brussels, Brussels Capital · NCT05550675

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.