A prospective multicenter clinical research of transanal irrigation in patients with faecal incontinence or chronic constipation resistant to conservative bowel management

A prospective multicenter clinical research of transanal irrigation in patients with faecal incontinence or chronic constipation resistant to conservative bowel management - A prospective multicenter clinical research of transanal irrigation in patients with faecal incontinence or chronic constipation resistant to conservative bowel management

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000024950

Enrollment

Registered

2016-11-24

Start date

2017-01-20

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

chronic faecal incontinence and constipation

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Faecal incontinence and/or constipation resistant to conservative bowel management (medicinal treatment, suppositories, enemas, bio feedback etc.) Transanal irrigation naive Post-surgical patients: a valid endoscopy or barium enema must be available to exclude rectal conditions contraindicating irrigation Be at least 20 years of age and have full legal capacity Be willing and able to comply with investigation procedures Have given written informed consent

Exclusion criteria

Exclusion criteria: Known anal or colorectal stenosis Known colorectal cancer Acute inflammatory bowel disease Acute diverticulitis Within 3 months of anal or colorectal surgery Within 4 weeks of endoscopic polypectomy Ischaemic colitis Current or planned pregnancy or nursing women, in the investigational period Currently performs transanal irrigation using a device other than Peristeen Anal Irrigation System Depending on the condition each patient, the patient who the physician judged that it is not aplicable in this clinical research

Design outcomes

Primary

Measure	Time frame
Using a VAS (Visual Analogue Scale), patients are asked to evaluate their satisfaction with current bowel management	—

Secondary

Measure	Time frame
Number and ratio of patients who wish to continue using transanal irrigation after end of clinical research Quality of Life improvement as measured by EQ-5D instrument Need for and frequency of use of bowel medications Need for digital evacuation Daily time required for bowel management Need for use if diapers/pads, number of diapers/pads used weekly Number of new urinary tract infections(UTI) Transanal irrigation-specific items NBD Score CCFIS Score CSS Score LARS Score	—

Measure

Time frame

Number and ratio of patients who wish to continue using transanal irrigation after end of clinical research Quality of Life improvement as measured by EQ-5D instrument Need for and frequency of use of bowel medications Need for digital evacuation Daily time required for bowel management Need for use if diapers/pads, number of diapers/pads used weekly Number of new urinary tract infections(UTI) Transanal irrigation-specific items NBD Score CCFIS Score CSS Score LARS Score

—

Countries

Japan

Contacts

Public ContactKoutaro Maeda

Fujita Health University, School of Medicine Department of Surgery

kmaeda@fujita-hu.ac.jp0562-93-2111

Outcome results