A randomised trial of rectal stimulants for neurogenic bowel management after spinal cord injury - Rectal stimulant trial

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-006855-10-GB

Enrollment

120

Registered

2007-01-01

Start date

2007-02-23

Completion date

Unknown

Last updated

2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Response of the neurogenic bowel after spinal cord injury to pharmacological rectal stimulants

Interventions

Trade Name: Lecicarbon E Product Name: Lecicarbon E Pharmaceutical Form: Suppository Trade Name: Glycerin suppository Product Name: Glycerin suppository Pharmaceutical Form: Suppository Trade Name

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria: Pregnancy Current or past bowel disease Colostomy or history of other bowel surgery (not including fissurectomy or haemorrhoidectomy)

Design outcomes

Primary

Measure	Time frame
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) ;Secondary Objective: To determine whether individual rectal stimulants impact on the frequency of use of digital ano-rectal stimulation and manual evacuation of stool ;Primary end point(s): Total duration of bowel management not including ‘clean up’ time Time to flatus Time to first stool Frequency of use of digital ano-rectal stimulation Frequency of use of manual evacuation of stool	—

Measure

Time frame

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) ;Secondary Objective: To determine whether individual rectal stimulants impact on the frequency of use of digital ano-rectal stimulation and manual evacuation of stool ;Primary end point(s): Total duration of bowel management not including ‘clean up’ time Time to flatus Time to first stool Frequency of use of digital ano-rectal stimulation Frequency of use of manual evacuation of stool

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Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026