Clinical trial NCT02361450: Retrograde Colonic Irrigation to Manage Spina Bifida Functional Digestive Sequelae: a Multicenter, Prospective, Randomized Controlled Trial
Official title: Retrograde Colonic Irrigation to Manage Spina Bifida Functional Digestive Sequelae: a Multicenter, Prospective, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spina Bifida
Keywords: Faecal incontinence
Spina Bifida
Enema
Constipation
Myelomeningocele
Human
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
First posted: 2015-02-11
Enrollment: 34
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Neurogenic Bowel Dysfunction (NBD) score
timeFrame: Ten weeks after inclusion
Secondary outcomes:
measure: Questionnaire data of incontinence and constipation (Cleveland scores)
timeFrame: Ten weeks after inclusion
measure: Questionnaire data of incontinence and constipation (Cleveland scores)
timeFrame: Twenty-four weeks after inclusion
measure: Quality of life
timeFrame: Ten weeks after inclusion
measure: Quality of life
timeFrame: Twenty-four weeks after inclusion
measure: Self esteem (Rosenberg scale)
timeFrame: Ten weeks after inclusion
measure: Functional digestive score (NBD)
timeFrame: Twenty-four weeks after inclusion
measure: Cumulative time spent using restrooms
timeFrame: Ten weeks after inclusion
measure: Cumulative time spent using restrooms
timeFrame: Twenty-four weeks after inclusion
measure: Number of accidents of incontinence
timeFrame: Ten weeks after inclusion
measure: Number of accidents of incontinence
timeFrame: Twenty-four weeks after inclusion
measure: Number of incontinence guards used
timeFrame: Ten weeks after inclusion
measure: Number of incontinence guards used
timeFrame: Twenty-four weeks after inclusion
measure: Type of incontinence guards used
timeFrame: Ten weeks after inclusion
measure: Type of incontinence guards used
timeFrame: Twenty-four weeks after inclusion
measure: Number of stools
timeFrame: Ten weeks after inclusion
measure: Number of stools
timeFrame: Twenty-four weeks after inclusion
measure: Stools consistency
timeFrame: Ten weeks after inclusion
measure: Stools consistency
timeFrame: Twenty-four weeks after inclusion
measure: Symptoms experienced during defecation
timeFrame: Ten weeks after inclusion
measure: Symptoms experienced during defecation
timeFrame: Twenty-four weeks after inclusion
measure: Frequency of digital help during defecation
timeFrame: Ten weeks after inclusion
measure: Frequency of digital help during defecation
timeFrame: Twenty-four weeks after inclusion
Other outcomes:
Locations:
city: Lille
country: France
facility: CHRU de Lille
city: Nantes
country: France
facility: CHU de Nantes
city: Ploemeur
country: France
facility: CMRRF de Kerpape
city: Rennes
country: France
facility: Rennes University Hospital
city: Rouen
country: France
facility: CHU de Rouen
city: Vandoeuvre les Nancy
country: France
facility: CHRU de Nancy-Brabois
Study officials:
affiliation: Rennes University Hospital
name: Laurent Siproudhis, Md, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.