We aim to assess the following baseline motility characteristics: maximum sphincter pressure (resting and squeezing pressure), mean sphincter pressure, residual anal and intrarectal pressure (high pressure zone), and recto-anal pressure differential (difference of intrarectal and residual anal pressures) in persons with chronic spinal cord injury (SCI) and able bodied (AB) subjects.
Intra-rectal Pressure
Group
Value
95% CI
Able Bodied Participants
105
± 35
Complete Spinal Cord Injury (ASIA A)
34.4
± 29
Incomplete Spinal Cord Injury (ASIA B, C, D)
30
± 19
Mean Sphincter Pressure
Group
Value
95% CI
Able Bodied Participants
77.9
± 21.9
Complete Spinal Cord Injury (ASIA A)
67.1
± 31.8
Incomplete Spinal Cord Injury (ASIA B, C, D)
65.2
± 21.4
Max Sphincter Pressure
Group
Value
95% CI
Able Bodied Participants
253
± 101
Complete Spinal Cord Injury (ASIA A)
81.1
± 12.3
Incomplete Spinal Cord Injury (ASIA B, C, D)
108.9
± 64
Residual anal Pressure
Group
Value
95% CI
Able Bodied Participants
169.3
± 55
Complete Spinal Cord Injury (ASIA A)
61.4
± 42
Incomplete Spinal Cord Injury (ASIA B, C, D)
73.8
± 30
Recto-anal Pressure Differential
Group
Value
95% CI
Able Bodied Participants
-63
± 31
Complete Spinal Cord Injury (ASIA A)
-27
± 7
Incomplete Spinal Cord Injury (ASIA B, C, D)
-44
± 20
Change in Rectal and Sphincter Pressure Due to Bowel Biofeedback Training in Individuals With Incomplete SCI.Secondary· Baseline, post- 6 week guided biofeedback training (weeks 1-6), post- 6 week self-guided biofeedback training (weeks 7-12).
Changes in maximum rectal and sphincter pressures generated during "squeeze" and "bear down" maneuvers performed during anorectal manometric studies pre-biofeedback training (baseline) and post-guided (part 1) and self-guided (part 2) biofeedback training.
Incomplete Spinal Cord Injury (ASIA B, C, D); Bowel Biofeedback Training Part 1 (Guided)
38.53
± 30.17
Incomplete Spinal Cord Injury (ASIA B, C, D); Bowel Biofeedback Training Part 2 (Self Guided)
37.48
± 37.52
Changes in Recto-anal Inhibitory Reflex (RAIR) Due to Bowel Biofeedback Training in Individuals With Incomplete SCI.Secondary· Baseline, post- 6 week guided biofeedback training (weeks 1-6), post- 6 week self-guided biofeedback training (weeks 7-12).
Changes to the sensitivity and strength of response of the recto-anal inhibitory reflex (RAIR) in response to rectal distension.
Outcome measure clarification: Minimal balloon volume, in cc, which was the threshold at which anorectal sensation was perceived by subjects with incomplete SCI, as assessed through High Resolution Manometry (HRM)
Incomplete Spinal Cord Injury (ASIA B, C, D); Bowel Biofeedback Training Part 1 (Guided)
59.17
± 25.39
Incomplete Spinal Cord Injury (ASIA B, C, D); Bowel Biofeedback Training Part 2 (Self Guided)
67.00
± 29.83
Change in Subjective Bowel Care Due to Guided and Self-Guided Biofeedback Training in Individuals With Incomplete SCISecondary· Baseline, post- 6 week guided biofeedback training (weeks 1-6), post- 6 week self-guided biofeedback training (weeks 7-12).
Constipation and fecal Incontinence was assessed in participants with incomplete SCI by the Ten Question Bowel Survey. This survey is based on a scale 1-5; a lower score represents fewer bowel management difficulties (better functioning). Survey was administered at baseline (pre-training), and post- guided (part 1) and self-guided (part 2) bowel biofeedback training.
Frequency of Bowel Movement Scale:10Question Bowel Survey (QBS) Range:1 (≥7 times/week) to 5(None)
Incomplete Spinal Cord Injury (ASIA B, C, D); Bowel Biofeedback Training Part 1 (Guided)
1.69
± 1.49
Incomplete Spinal Cord Injury (ASIA B, C, D); Bowel Biofeedback Training Part 2 (Self Guided)
2.38
± 1.85
Sponsor's own description
An injury to the spinal cord results in a number of secondary medical problems, including the inability to voluntarily control the bowels. Depending on the severity and location of the injury, remaining bowel function differs, and can include any combination of the following: constipation (prolonged stool retention), difficulty with evacuation (difficultly moving bowels), fecal incontinence (problems retaining stool until it is appropriate to move the bowels). Most of the current medications and treatment options address problems of constipation and difficulty with evacuation, but there are few options for individuals who suffer from incontinency. In this study, the investigators propose to study, in detail, anorectal muscle function in individuals with spinal injury - the investigators will do so using new technology called high resolution manometry - which will present the investigator with a 3 dimensional representation of the pressure profile of the anorectal muscles as the subject attempts different maneuvers. A subgroup with representatives of all levels and completeness of injury and anorectal muscle function will be enrolled to participate in six weeks of biofeedback training to see if their bowel function can be improved. During these six weeks, the subjects will be asked to visit the laboratory twice a week in order to be trained by the research team on how to improve their anorectal strength and function in response to visual cues. After the six weeks, another manometry study will be performed. Subjects will then be sent home and asked to perform a series of home exercises for another 6 weeks, after which they will asked to return for a third and final manometry study.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
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Sponsor: as reported to ClinicalTrials.gov by VA Office of Research and Development
Last refreshed: 17 September 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02406859.