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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Spina Bifida

Intervention / Treatment
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* Device: Retrograde Colonic Irrigation
* Other: Usual Care


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Enema, Faecal incontinence, Spina Bifida, Constipation, Myelomeningocele, Human