Spina Bifida
Conditions
Keywords
Faecal incontinence, Spina Bifida, Enema, Constipation, Myelomeningocele, Human
Brief 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 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
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.
Interventions
DEVICERetrograde Colonic Irrigation
OTHERUsual Care
Sponsors
Rennes University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
15 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Neurogenic Bowel Dysfunction (NBD) score | Ten weeks after inclusion |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life | Ten weeks after inclusion | Quality of life will be assess by semi-quantified scales |
| Self esteem (Rosenberg scale) | Ten weeks after inclusion | — |
| Functional digestive score (NBD) | Twenty-four weeks after inclusion | — |
| Cumulative time spent using restrooms | Ten weeks after inclusion | Cumulative time spent using restrooms will be collected with a patient reported outcome questionnaire |
| Number of accidents of incontinence | Ten weeks after inclusion | Number of accidents of incontinence will be collected with a patient reported outcome questionnaire |
| Questionnaire data of incontinence and constipation (Cleveland scores) | Ten weeks after inclusion | — |
| Type of incontinence guards used | Ten weeks after inclusion | Type of incontinence guards (panty liner, pad, nappy) used will be collected with a patient reported outcome questionnaire |
| Number of stools | Ten weeks after inclusion | Number of stools will be collected with a patient reported outcome questionnaire |
| Stools consistency | Ten weeks after inclusion | Stools consistency will be collected with a patient reported outcome questionnaire |
| Symptoms experienced during defecation | Ten weeks after inclusion | Symptoms experienced during defecation will be collected with a patient reported outcome questionnaire |
| Frequency of digital help during defecation | Ten weeks after inclusion | The frequency of digital stimulation will be collected with a patient reported outcome questionnaire |
| Number of incontinence guards used | Ten weeks after inclusion | Number of incontinence guards used will be collected with a patient reported outcome questionnaire |
Countries
France
Outcome results
None listed