Spina BifidaIRRICONCT02361450

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

A study testing Retrograde Colonic Irrigation in people with Spina Bifida, run by Rennes University Hospital at 6 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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… Read more about this study

Who is it for?: Ages 15 years and older
Conditions the study is for: Spina Bifida
What is being tested?: Retrograde Colonic Irrigation
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 34 participants
Where: 6 sitesFrance
Study dates: 16 Mar 2015to 31 Jul 2019
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 15 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

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).

Who cannot join

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)

Show all 9Show fewer

Person involved in another clinical trial
Pregnant women
Person with a measure of legal protection (guardianship)

Trial locations and contacts

6 sites in 1 country.

City, postcode or hospital

6 sites in 1 country

France6 sites

CHRU de Lille
Lille, 59037
CHU de Nantes
Nantes, 44093
CMRRF de Kerpape
Ploemeur, 56275
Rennes University Hospital
Rennes, 35000
CHU de Rouen
Rouen, 76031
CHRU de Nancy-Brabois
Vandœuvre-lès-Nancy, 54511

Other trials in France

About this study

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.

Read the 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.

Conditions: Spina Bifida
Being tested: Retrograde Colonic Irrigation, Usual Care
Keywords: Faecal incontinence, Spina Bifida, Enema, Constipation, Myelomeningocele, Human
Medical subject headings: Spinal Dysraphism, Encopresis, Constipation, Meningomyelocele

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Retrograde Colonic IrrigationDevice
Usual CareOther

Study groups in NCT02361450
Study group	Role	What they receive
Retrograde Colonic Irrigation with usual care	Experimental	In the experimental group, retrograde colonic irrigation sessions will be scheduled in addition to conventional treatment according to a progressive volume program. Receives: Device: Retrograde Colonic Irrigation; Other: Usual Care
Usual Care	Active comparator	In the comparator group, patients will receive conventional care, according to each clinical center habits. Receives: Other: Usual Care

What is being measured

The primary outcome is the main question the study is designed to answer.

Neurogenic Bowel Dysfunction (NBD) score
Measured: Ten weeks after inclusion

Secondary outcomes (22)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

16 Mar 201531 Jul 2019

First posted11 Feb 2015 (estimated)
Study start16 Mar 2015
Primary completion31 Jul 2019
Study completion31 Jul 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Spina BifidaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 34 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02361450
Sponsor's protocol ID: 2013-A01520-45
Acronym: IRRICO
Status last verified: May 2023
First submitted: 2 Feb 2015
Last updated: 24 May 2023
Results posted: No
Data monitoring committee: No

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 Jun;25(6):1267-1276. doi: 10.1111/codi.16518. Epub 2023 Mar 11.
PubMed 36799340

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Transcutaneous Spinal Stimulation for Children and Youth With Spina Bifida
Myelomeningocele, Spina Bifida
Not yet recruiting
Parenting Program for Young Children With Spina Bifida
Spina Bifida
Recruiting
EVALUATION OF THE SAFETY AND EFFICACY OF ADJUSTABLE CONTINENT THERAPY IN CHILDREN WITH SPINAL DYSRAPHISM.
Neurogenic Bladder Due to Spinal Dysraphism
Recruiting
Evaluating Long-term Use of a Pediatric Robotic Exoskeleton (P.REX/Agilik) to Improve Gait in Children With Movement Disorders
Cerebral Palsy, Muscular Dystrophy
Not yet recruiting
Motor Imagery-Supported Thoracic Expansion in Children With Spina Bifida
Spina Bifida

All Spina Bifida trials

Study at a glance

From the registry record, last updated by the sponsor on 24 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Retrograde Colonic Irrigation to Manage Spina Bifida Functional Digestive Sequelae: a Multicenter, Prospective, Randomized Controlled Trial
ClinicalTrials.gov ID: NCT02361450
Acronym / sponsor ID: IRRICO / 2013-A01520-45
Conditions: Spina Bifida
Keywords: Faecal incontinence, Spina Bifida, Enema, Constipation, Myelomeningocele, Human
Study type: Interventional
Recruitment status: Completed
Enrolment: 34 participants (actual)
Lead sponsor: Rennes University HospitalUniversity, hospital or other
Study start: 16 Mar 2015 (actual)
Primary completion: 31 Jul 2019 (actual)
Study completion: 31 Jul 2019 (actual)
First posted: 11 Feb 2015 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Retrograde Colonic Irrigation with usual care	Experimental	Device: Retrograde Colonic Irrigation, Other: Usual CareIn the experimental group, retrograde colonic irrigation sessions will be scheduled in addition to conventional treatment according to a progressive volume program.
Usual Care	Active comparator	Other: Usual CareIn the comparator group, patients will receive conventional care, according to each clinical center habits.

Who may qualify

Ages: 15 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (3 listed)

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).

Key exclusion criteria (9 listed)

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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Retrograde Colonic Irrigation	Device	Retrograde Colonic Irrigation with usual care
Usual Care	Other	Retrograde Colonic Irrigation with usual care, Usual Care

Primary outcome

Neurogenic Bowel Dysfunction (NBD) score
Time frame: Ten weeks after inclusion

22 secondary outcomes

Questionnaire data of incontinence and constipation (Cleveland scores)
Time frame: Ten weeks after inclusion
Questionnaire data of incontinence and constipation (Cleveland scores)
Time frame: Twenty-four weeks after inclusion
Quality of life
Time frame: Ten weeks after inclusion
Quality of life
Time frame: Twenty-four weeks after inclusion
Self esteem (Rosenberg scale)
Time frame: Ten weeks after inclusion
Functional digestive score (NBD)
Time frame: Twenty-four weeks after inclusion
Cumulative time spent using restrooms
Time frame: Ten weeks after inclusion
Cumulative time spent using restrooms
Time frame: Twenty-four weeks after inclusion
Number of accidents of incontinence
Time frame: Ten weeks after inclusion
Number of accidents of incontinence
Time frame: Twenty-four weeks after inclusion
Number of incontinence guards used
Time frame: Ten weeks after inclusion
Number of incontinence guards used
Time frame: Twenty-four weeks after inclusion
Type of incontinence guards used
Time frame: Ten weeks after inclusion
Type of incontinence guards used
Time frame: Twenty-four weeks after inclusion
Number of stools
Time frame: Ten weeks after inclusion
Number of stools
Time frame: Twenty-four weeks after inclusion
Stools consistency
Time frame: Ten weeks after inclusion
Stools consistency
Time frame: Twenty-four weeks after inclusion
Symptoms experienced during defecation
Time frame: Ten weeks after inclusion
Symptoms experienced during defecation
Time frame: Twenty-four weeks after inclusion
Frequency of digital help during defecation
Time frame: Ten weeks after inclusion
Frequency of digital help during defecation
Time frame: Twenty-four weeks after inclusion

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2023.
Results publication: PubMed 36799340Brochard 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 Jun;25(6):1267-1276. doi: 10.1111/codi.16518. Epub 2023 Mar 11.

Related trials for Spina Bifida

Recruiting
Transcutaneous Spinal Stimulation for Children and Youth With Spina Bifida
Myelomeningocele, Spina Bifida
Not yet recruiting
Parenting Program for Young Children With Spina Bifida
Spina Bifida
Recruiting
EVALUATION OF THE SAFETY AND EFFICACY OF ADJUSTABLE CONTINENT THERAPY IN CHILDREN WITH SPINAL DYSRAPHISM.
Neurogenic Bladder Due to Spinal Dysraphism
Recruiting
Evaluating Long-term Use of a Pediatric Robotic Exoskeleton (P.REX/Agilik) to Improve Gait in Children With Movement Disorders
Cerebral Palsy, Muscular Dystrophy
Not yet recruiting
Motor Imagery-Supported Thoracic Expansion in Children With Spina Bifida
Spina Bifida

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Laurent Siproudhis, Md, PhD principal investigator

Rennes University Hospital

6 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Retrograde Colonic Irrigation in people with Spina Bifida, run by Rennes University Hospital at 6 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Neurogenic Bowel Dysfunction (NBD) score (time frame: Ten weeks after inclusion). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02361450, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2023.