A randomised trial of rectal stimulants for neurogenic bowel management after spinal cord injury - Rectal stimulant trial
- Conditions
- Response of the neurogenic bowel after spinal cord injury to pharmacological rectal stimulants
- Registration Number
- EUCTR2006-006855-10-GB
- Lead Sponsor
- Buckinghamshire Hospitals NHS Trust
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 120
Inclusion Criteria
SCI individuals injured more than 1 year living in the community
Reflex bowel function (upper motor neurone injury)
Traumatic or non-traumatic spinal cord injury
Asia Grade A to D
18 years or older
Male or female
Current requirement for rectal stimulation for bowel evacuation
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
Pregnancy
Current or past bowel disease
Colostomy or history of other bowel surgery (not including fissurectomy or haemorrhoidectomy)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The main objectives of the trial are to identify the impact that currently available rectal stimulants have on the duration of bowel management in SCI individuals with reflex residual bowel function, and to identify the side effects, if any, induced by these products in short term use (i.e. frequency of episodes of faecal incontinence, pain associated with bowel care and autonomic dysreflexia associated with bowel care)<br>;Secondary Objective: To determine whether individual rectal stimulants impact on the frequency of use of digital ano-rectal stimulation and manual evacuation of stool<br>;Primary end point(s): Total duration of bowel management not including ‘clean up’ time<br>Time to flatus<br>Time to first stool<br>Frequency of use of digital ano-rectal stimulation<br>Frequency of use of manual evacuation of stool<br>
- Secondary Outcome Measures
Name Time Method