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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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 Summary:

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.

Sponsor: Rennes University Hospital

Current Primary Outcome: Neurogenic Bowel Dysfunction (NBD) score [ Time Frame: Ten weeks after inclusion ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

• 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 will be assess by semi-quantified scales
• Quality of life [ Time Frame: Twenty-four weeks after inclusion ]
  Quality of life will be assess by semi-quantified scales
• 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 will be collected with a patient reported outcome questionnaire
• Cumulative time spent using restrooms [ Time Frame: Twenty-four weeks after inclusion ]
  Cumulative time spent using restrooms will be collected with a patient reported outcome questionnaire
• Number of accidents of incontinence [ Time Frame: Ten weeks after inclusion ]
  Number of accidents of incontinence will be collected with a patient reported outcome questionnaire
• Number of accidents of incontinence [ Time Frame: Twenty-four weeks after inclusion ]
  Number of accidents of incontinence will be collected with a patient reported outcome questionnaire
• Number of incontinence guards used [ Time Frame: Ten weeks after inclusion ]
  Number of incontinence guards used will be collected with a patient reported outcome questionnaire
• Number of incontinence guards used [ Time Frame: Twenty-four weeks after inclusion ]
  Number of incontinence guards used will be collected with a patient reported outcome questionnaire
• Type of incontinence guards used [ Time Frame: Ten weeks after inclusion ]
  Type of incontinence guards (panty liner, pad, nappy) used will be collected with a patient reported outcome questionnaire
• Type of incontinence guards used [ Time Frame: Twenty-four weeks after inclusion ]
  Type of incontinence guards (panty liner, pad, nappy) used will be collected with a patient reported outcome questionnaire
• Number of stools [ Time Frame: Ten weeks after inclusion ]
  Number of stools will be collected with a patient reported outcome questionnaire
• Number of stools [ Time Frame: Twenty-four weeks after inclusion ]
  Number of stools will be collected with a patient reported outcome questionnaire
• Stools consistency [ Time Frame: Ten weeks after inclusion ]
  Stools consistency will be collected with a patient reported outcome questionnaire
• Stools consistency [ Time Frame: Twenty-four weeks after inclusion ]
  Stools consistency will be collected with a patient reported outcome questionnaire
• Symptoms experienced during defecation [ Time Frame: Ten weeks after inclusion ]
  Symptoms experienced during defecation will be collected with a patient reported outcome questionnaire
• Symptoms experienced during defecation [ Time Frame: Twenty-four weeks after inclusion ]
  Symptoms experienced during defecation will be collected with a patient reported outcome questionnaire
• Frequency of digital help during defecation [ Time Frame: Ten weeks after inclusion ]
  The frequency of digital stimulation will be collected with a patient reported outcome questionnaire
• Frequency of digital help during defecation [ Time Frame: Twenty-four weeks after inclusion ]
  The frequency of digital stimulation will be collected with a patient reported outcome questionnaire

Original Secondary Outcome: Same as current

Information By: Rennes University Hospital

Dates:
Date Received: February 2, 2015
Date Started: February 2015
Date Completion: March 2018
Last Updated: October 3, 2016
Last Verified: October 2016