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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Usual Care | Active Comparator | In the comparator group, patients will receive conventional care, according to each clinical center habits. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Retrograde Colonic Irrigation | Device |
| ||
| Usual Care |
| Measure | Description | Time Frame |
|---|---|---|
| Neurogenic Bowel Dysfunction (NBD) score | Ten weeks after inclusion |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Laurent Siproudhis, Md, PhD | Rennes University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHRU de Lille | Lille | 59037 | France | |||
| CHU de Nantes |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36799340 | Result | 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. |
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| Other |
|
| 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 |
| Nantes |
| 44093 |
| France |
| CMRRF de Kerpape | Ploemeur | 56275 | France |
| Rennes University Hospital | Rennes | 35000 | France |
| CHU de Rouen | Rouen | 76031 | France |
| CHRU de Nancy-Brabois | Vandœuvre-lès-Nancy | 54511 | France |
| ID | Term |
|---|---|
| D016135 | Spinal Dysraphism |
| D004688 | Encopresis |
| D003248 | Constipation |
| D008591 | Meningomyelocele |
| ID | Term |
|---|---|
| D009436 | Neural Tube Defects |
| D009421 | Nervous System Malformations |
| D009422 | Nervous System Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D019960 | Elimination Disorders |
| D001523 | Mental Disorders |
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