Retrograde Colonic Irrigation to Manage Spina Bifida Functional Digestive Sequelae: a Multicenter, Prospective, Randomized Controlled Trial (IRRICO)

Spina Bifida is a developmental congenital disorder caused by the incomplete closing of the embryonic neural tube, leading to serious malformations of the nervous system. Caudal neuropore malformations almost always lead to sensory-motor deficits (including complete paraplegia) with orthopedic deformations, pressure sores, and pelvic/perineal neurological dysfunctions (affecting the bladder-sphincter, anorectal, and genital sphere).

The purpose of the study is to assess the efficacy of retrograde colonic irrigation associated with usual care (medical treatments, patient education) on anorectal dysfunction (incontinence and/or constipation), compared to usual care only.

Study Overview

• Status: Completed
• Conditions: Spina Bifida
• Intervention / Treatment: Other: Usual Care; Device: Retrograde Colonic Irrigation

Detailed Description

Sphincter dysfunctions impair the quality of life and patients' self-esteem. However, defecation disorders are important issues the Spina Bifida National Reference Center has to deal with. Indeed, more than half of patients are concerned. These disorders are mainly due to fecal stasis. Treatments include laxatives and hygiene recommendations. Colonic irrigation can also be useful, especially to achieve colonic vacuity and improve continence. The use of intra-rectal balloon inflation probes and the control of instillation flow improved retrograde colonic irrigation efficacy. Nevertheless, this technique is currently not evaluated in young adults suffering from Spina Bifida functional digestive sequelae, who are mainly concerned by Malone enema.

The purpose of the study is to assess the efficacy of retrograde colonic irrigation associated with usual care (medical treatments, patient education) on anorectal dysfunction (incontinence and/or constipation), compared to usual care only.

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Lille, France, 59037
    • CHRU de Lille
  • Nantes, France, 44093
    • CHU de Nantes
  • Ploemeur, France, 56275
    • CMRRF de Kerpape
  • Rennes, France, 35000
    • Rennes University Hospital
  • Rouen, France, 76031
    • CHU de Rouen
  • Vandoeuvre les Nancy, France, 54511
    • CHRU de Nancy-Brabois

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients aging at least 15 years old with Spina Bifida neurological pelvi-perineal sequelae, objected by neurologic exam , functional urinary and/or anorectal and/or neurophysiological data,
• Patients with NBD score above 9,
• Written and informed consent (Minor children may be included with the consent of the two parents).

Exclusion Criteria:

• Patients with psychiatric disorders, cognitive or intellectual disabilities compromising the assessment of primary outcome measure,
• Patients using currently irrigation colonic technique,
• Patients with functional colostomy, known anal or colorectal stenosis, colorectal cancer, acute or chronic inflammatory disease, recent anal or colorectal surgery for less than 3 months, polyp removal for less than 4 weeks, ischemic colitis.
• Patients with urinary trophic or orthopedic disease with planned surgery during inclusion or follow-up periods,
• Patients with progressive anal disease (suppuration, hemorrhoid or rectal prolapse)
• Patient with a hard follow-up ( judged by the investigator)
• Person involved in another clinical trial
• Pregnant women
• Person with a measure of legal protection (guardianship)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Retrograde Colonic Irrigation with usual care; In the experimental group, retrograde colonic irrigation sessions will be scheduled in addition to conventional treatment according to a progressive volume program.	Other: Usual Care; Device: Retrograde Colonic Irrigation
Active Comparator: Usual Care; In the comparator group, patients will receive conventional care, according to each clinical center habits.	Other: Usual Care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Neurogenic Bowel Dysfunction (NBD) score	Ten weeks after inclusion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Questionnaire data of incontinence and constipation (Cleveland scores)		Ten weeks after inclusion
Questionnaire data of incontinence and constipation (Cleveland scores)		Twenty-four weeks after inclusion
Quality of life	Quality of life will be assess by semi-quantified scales	Ten weeks after inclusion
Quality of life	Quality of life will be assess by semi-quantified scales	Twenty-four weeks after inclusion
Self esteem (Rosenberg scale)		Ten weeks after inclusion
Functional digestive score (NBD)		Twenty-four weeks after inclusion
Cumulative time spent using restrooms	Cumulative time spent using restrooms will be collected with a patient reported outcome questionnaire	Ten weeks after inclusion
Cumulative time spent using restrooms	Cumulative time spent using restrooms will be collected with a patient reported outcome questionnaire	Twenty-four weeks after inclusion
Number of accidents of incontinence	Number of accidents of incontinence will be collected with a patient reported outcome questionnaire	Ten weeks after inclusion
Number of accidents of incontinence	Number of accidents of incontinence will be collected with a patient reported outcome questionnaire	Twenty-four weeks after inclusion
Number of incontinence guards used	Number of incontinence guards used will be collected with a patient reported outcome questionnaire	Ten weeks after inclusion
Number of incontinence guards used	Number of incontinence guards used will be collected with a patient reported outcome questionnaire	Twenty-four weeks after inclusion
Type of incontinence guards used	Type of incontinence guards (panty liner, pad, nappy) used will be collected with a patient reported outcome questionnaire	Ten weeks after inclusion
Type of incontinence guards used	Type of incontinence guards (panty liner, pad, nappy) used will be collected with a patient reported outcome questionnaire	Twenty-four weeks after inclusion
Number of stools	Number of stools will be collected with a patient reported outcome questionnaire	Ten weeks after inclusion
Number of stools	Number of stools will be collected with a patient reported outcome questionnaire	Twenty-four weeks after inclusion
Stools consistency	Stools consistency will be collected with a patient reported outcome questionnaire	Ten weeks after inclusion
Stools consistency	Stools consistency will be collected with a patient reported outcome questionnaire	Twenty-four weeks after inclusion
Symptoms experienced during defecation	Symptoms experienced during defecation will be collected with a patient reported outcome questionnaire	Ten weeks after inclusion
Symptoms experienced during defecation	Symptoms experienced during defecation will be collected with a patient reported outcome questionnaire	Twenty-four weeks after inclusion
Frequency of digital help during defecation	The frequency of digital stimulation will be collected with a patient reported outcome questionnaire	Ten weeks after inclusion
Frequency of digital help during defecation	The frequency of digital stimulation will be collected with a patient reported outcome questionnaire	Twenty-four weeks after inclusion

Collaborators and Investigators

• Sponsor: Rennes University Hospital
• Investigators: Principal Investigator: Laurent Siproudhis, Md, PhD, Rennes University Hospital

Publications and helpful links

General Publications

• Brochard C, Jezequel M, Blanchard-Dauphin A, Kerdraon J, Perrouin-Verbe B, Leroi AM, Reymann JM, Peyronnet B, Morcet J, Siproudhis L. Transanal irrigation is a better choice for bowel dysfunction in adults with Spina bifida: A randomised controlled trial. Colorectal Dis. 2023 Feb 17. doi: 10.1111/codi.16518. Online ahead of print.

Study record dates

Study Major Dates

• Study Start (Actual): March 16, 2015
• Primary Completion (Actual): July 31, 2019
• Study Completion (Actual): July 31, 2019

Study Registration Dates

• First Submitted: February 2, 2015
• First Submitted That Met QC Criteria: February 6, 2015
• First Posted (Estimate): February 11, 2015

Study Record Updates

• Last Update Posted (Actual): May 24, 2023
• Last Update Submitted That Met QC Criteria: May 22, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Constipation; Human; Myelomeningocele; Spina Bifida; Faecal incontinence; Enema
• Additional Relevant MeSH Terms: Nervous System Diseases; Congenital Abnormalities; Nervous System Malformations; Neural Tube Defects; Spinal Dysraphism
• Other Study ID Numbers: 2013-A01520-45