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Utility of an Animated Bowel Biofeedback Training Routine to Improve Bowel Function in Individuals With SCI

Bowel Biofeedback Training to Improve Bowel Function in Individuals With SCI

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02406859
Enrollment
50
Registered
2015-04-02
Start date
2013-07-01
Completion date
2017-12-29
Last updated
2021-09-17

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

Conditions

Spinal Cord Injury, Constipation, Fecal Incontinence, Neurogenic Bowel

Keywords

Spinal Cord Injury, Constipation, Fecal Incontinence, Neurogenic Bowel, Bowel Biofeedback, Manometry

Brief summary

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.

Detailed description

Neurogenic bowel characteristics differ among spinal cord injured (SCI) individuals, and appear to depend primarily on the level and completeness of injury. It is thought that upper motor neuron lesions in the spinal cord above L1-2 results in a hyperreflexive bowel with increased colonic wall tone and loss of cortical control over the relaxation of the external anal sphincter (EAS). These changes result in chronic high sphincter tone and dyssynergic defecation. The main symptoms in these patients are constipation and fecal retention, or difficulty with evacuation (DWE). In many of these individuals, some nerve connections between the spinal cord and the colon may be preserved, and stool propulsion and reflex coordination may remain intact and under control of the central nervous system. Furthermore, individuals with spinal lesions above T7 experience loss of voluntary control over abdominal muscles and an inability to increase intra-abdominal pressure, which results in more DWE and constipation. Lower motor neuron (LMN) lesions in the spinal cord below L1-2 result in the interruption of the centrally mediated innervation to the bowel, which causes slowing of peristalsis, a flaccid EAS, and atonic levator ani muscles. This is also called an areflexic bowel. The main symptoms in these patients are constipation from slowed peristalsis and fecal incontinence (FI) from atonic EAS and levator ani muscles. While the symptoms of bowel dysfunction in persons with SCI are known, function and motility of the anal canal have not been documented in this population. Anorectal manometry can provide valuable information about sphincter strength, defecation dynamics and reflex mechanisms. New high-resolution anorectal manometric systems (Given Imaging, Duluth, GA), simultaneously captures pressure data from the rectum, IAS, EAS and atmosphere. High resolution manometry also allows for much clearer display of pressure events compared to line tracing series, and direction of contractions are much easier to discern. To date, anorectal high resolution topographical studies have not been conducted in a SCI population. Modalities in which the patient can be trained to control the internal anal sphincter (IAS) and EAS are promising solutions to FI, and have been shown to be useful in able bodied (AB) populations. For example, anorectal biofeedback methods teach patients to recognize sensations of a distended rectum while also teaching abdominal or pelvic muscles to voluntarily contract for short periods of time in order to improve continence. Such biofeedback modalities have also been shown to decrease constipation in AB populations by teaching proper external sphincter relaxation and rectal muscle contraction. The concept of biofeedback is based on principles of operant conditioning, in which information concerning a normally subconscious physiological function in relayed to patients and that become actively engaged in learning to consciously control this function. During bowel (re)training programs, patients are provided with visual feedback on voluntary and reflex sphincter and rectal muscle contractions, so that they can learn to recognize diffuse sensations and gradually regain control.

Interventions

BEHAVIORALBowel Biofeedback

Subjects will complete 2 sessions twice a week for 6 weeks of bowel biofeedback training. Subjects will be asked to squeeze and bear down for a period of 5 seconds followed by rest for 10seconds. Following the training, each subject will complete similar training at home for 6 weeks.

Subjects will undergo an anorectal manometry to establish baseline pressure characteristics. If subjects qualify for biofeedback training, they will complete two additional manometries to track the changes occuring during training.

Sponsors

James J. Peters Veterans Affairs Medical Center
CollaboratorFED
VA Office of Research and Development
Lead SponsorFED

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

* Chronic SCI (duration over 1 year) * Able-bodied (no SCI)

Exclusion criteria

* Contraindication to bowel biofeedback * Currently pregnant or trying to become pregnant * Inability to provide informed consent

Design outcomes

Primary

MeasureTime frameDescription
Baseline Motility (Anorectal Sensation and Strength) Characteristics1 Session (Baseline Anorectal Manometry Assessment)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.

Secondary

MeasureTime frameDescription
Change in Rectal and Sphincter Pressure Due to Bowel Biofeedback Training in Individuals With Incomplete SCI.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.
Changes in Recto-anal Inhibitory Reflex (RAIR) Due to Bowel Biofeedback Training in Individuals With Incomplete SCI.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)
Change in Subjective Bowel Care Due to Guided and Self-Guided Biofeedback Training in Individuals With Incomplete SCIBaseline, 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.

Countries

United States

Participant flow

Pre-assignment details

American Spinal Cord Injury Association (ASIA) exams were administered to all subjects with spinal cord injury to determine severity of injury and whether the participant meets the criteria to participate in bowel biofeedback training portion.

Participants by arm

ArmCount
Able Bodied Participants
The representation of this group are those participants with no known spinal cord injury and full motor function.
12
Complete Spinal Cord Injury (ASIA A)
The representation of this group are those participants with known spinal cord injury and medically diagnosed with an American spinal cord injury rating of A. This exam will delineate that the individual has a complete lack of motor and sensory function below the level of injury.
13
Incomplete Spinal Cord Injury (ASIA B, C, D)
The representation of this group are those participants with known spinal cord injury and medically diagnosed with an American spinal cord injury rating of B,C or D. This exam will delineate that the individual falls within the range of having some sensation below the level of injury to most motor function and sensation being preserved below the level of injury.
17
Total42

Baseline characteristics

CharacteristicAble Bodied ParticipantsComplete Spinal Cord Injury (ASIA A)Incomplete Spinal Cord Injury (ASIA B, C, D)Total
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants2 Participants3 Participants5 Participants
Age, Categorical
Between 18 and 65 years
12 Participants11 Participants14 Participants37 Participants
Mean Sphincteric Pressure (mm Hg)77.9 mmHg
STANDARD_DEVIATION 21.9
67.1 mmHg
STANDARD_DEVIATION 31.8
65.2 mmHg
STANDARD_DEVIATION 21.4
72.0 mmHg
STANDARD_DEVIATION 26.2
Race and Ethnicity Not Collected0 Participants
Region of Enrollment
United States
12 Participants13 Participants17 Participants42 Participants
Sex: Female, Male
Female
0 Participants0 Participants2 Participants2 Participants
Sex: Female, Male
Male
12 Participants13 Participants15 Participants40 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
0 / 150 / 140 / 21
other
Total, other adverse events
0 / 150 / 140 / 21
serious
Total, serious adverse events
0 / 150 / 140 / 21

Outcome results

Primary

Baseline Motility (Anorectal Sensation and Strength) Characteristics

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.

Time frame: 1 Session (Baseline Anorectal Manometry Assessment)

ArmMeasureGroupValue (MEAN)Dispersion
Able Bodied ParticipantsBaseline Motility (Anorectal Sensation and Strength) CharacteristicsResidual anal Pressure169.3 mmHgStandard Deviation 55
Able Bodied ParticipantsBaseline Motility (Anorectal Sensation and Strength) CharacteristicsMax Sphincter Pressure253 mmHgStandard Deviation 101
Able Bodied ParticipantsBaseline Motility (Anorectal Sensation and Strength) CharacteristicsIntra-rectal Pressure105 mmHgStandard Deviation 35
Able Bodied ParticipantsBaseline Motility (Anorectal Sensation and Strength) CharacteristicsMean Sphincter Pressure77.9 mmHgStandard Deviation 21.9
Able Bodied ParticipantsBaseline Motility (Anorectal Sensation and Strength) CharacteristicsRecto-anal Pressure Differential-63 mmHgStandard Deviation 31
Complete Spinal Cord Injury (ASIA A)Baseline Motility (Anorectal Sensation and Strength) CharacteristicsMax Sphincter Pressure81.1 mmHgStandard Deviation 12.3
Complete Spinal Cord Injury (ASIA A)Baseline Motility (Anorectal Sensation and Strength) CharacteristicsIntra-rectal Pressure34.4 mmHgStandard Deviation 29
Complete Spinal Cord Injury (ASIA A)Baseline Motility (Anorectal Sensation and Strength) CharacteristicsMean Sphincter Pressure67.1 mmHgStandard Deviation 31.8
Complete Spinal Cord Injury (ASIA A)Baseline Motility (Anorectal Sensation and Strength) CharacteristicsResidual anal Pressure61.4 mmHgStandard Deviation 42
Complete Spinal Cord Injury (ASIA A)Baseline Motility (Anorectal Sensation and Strength) CharacteristicsRecto-anal Pressure Differential-27 mmHgStandard Deviation 7
Incomplete Spinal Cord Injury (ASIA B, C, D)Baseline Motility (Anorectal Sensation and Strength) CharacteristicsRecto-anal Pressure Differential-44 mmHgStandard Deviation 20
Incomplete Spinal Cord Injury (ASIA B, C, D)Baseline Motility (Anorectal Sensation and Strength) CharacteristicsResidual anal Pressure73.8 mmHgStandard Deviation 30
Incomplete Spinal Cord Injury (ASIA B, C, D)Baseline Motility (Anorectal Sensation and Strength) CharacteristicsIntra-rectal Pressure30 mmHgStandard Deviation 19
Incomplete Spinal Cord Injury (ASIA B, C, D)Baseline Motility (Anorectal Sensation and Strength) CharacteristicsMax Sphincter Pressure108.9 mmHgStandard Deviation 64
Incomplete Spinal Cord Injury (ASIA B, C, D)Baseline Motility (Anorectal Sensation and Strength) CharacteristicsMean Sphincter Pressure65.2 mmHgStandard Deviation 21.4
Secondary

Change in Rectal and Sphincter Pressure Due to Bowel Biofeedback Training in Individuals With Incomplete SCI.

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.

Time frame: Baseline, post- 6 week guided biofeedback training (weeks 1-6), post- 6 week self-guided biofeedback training (weeks 7-12).

Population: Participants with Incomplete Spinal Cord Injury (ASIA B, C, D). 17 participants with SCI (incomplete) completed baseline procedures; of those 17, 13 participants completed bowel biofeedback training part 1 (guided) and part 2 (self-guided).

ArmMeasureGroupValue (MEAN)Dispersion
Able Bodied ParticipantsChange in Rectal and Sphincter Pressure Due to Bowel Biofeedback Training in Individuals With Incomplete SCI.Squeeze Max Pressure109.54 mmHgStandard Deviation 63.57
Able Bodied ParticipantsChange in Rectal and Sphincter Pressure Due to Bowel Biofeedback Training in Individuals With Incomplete SCI.Mean Sphincter Pressure65.23 mmHgStandard Deviation 21.49
Able Bodied ParticipantsChange in Rectal and Sphincter Pressure Due to Bowel Biofeedback Training in Individuals With Incomplete SCI.Intrarectal Pressure29.75 mmHgStandard Deviation 19.98
Able Bodied ParticipantsChange in Rectal and Sphincter Pressure Due to Bowel Biofeedback Training in Individuals With Incomplete SCI.Max Sphincter Pressure71.39 mmHgStandard Deviation 24.32
Able Bodied ParticipantsChange in Rectal and Sphincter Pressure Due to Bowel Biofeedback Training in Individuals With Incomplete SCI.Residual Anal Pressure73.79 mmHgStandard Deviation 30.38
Complete Spinal Cord Injury (ASIA A)Change in Rectal and Sphincter Pressure Due to Bowel Biofeedback Training in Individuals With Incomplete SCI.Intrarectal Pressure38.53 mmHgStandard Deviation 30.17
Complete Spinal Cord Injury (ASIA A)Change in Rectal and Sphincter Pressure Due to Bowel Biofeedback Training in Individuals With Incomplete SCI.Max Sphincter Pressure61.21 mmHgStandard Deviation 23.36
Complete Spinal Cord Injury (ASIA A)Change in Rectal and Sphincter Pressure Due to Bowel Biofeedback Training in Individuals With Incomplete SCI.Mean Sphincter Pressure55.58 mmHgStandard Deviation 21.29
Complete Spinal Cord Injury (ASIA A)Change in Rectal and Sphincter Pressure Due to Bowel Biofeedback Training in Individuals With Incomplete SCI.Squeeze Max Pressure105.96 mmHgStandard Deviation 63.2
Complete Spinal Cord Injury (ASIA A)Change in Rectal and Sphincter Pressure Due to Bowel Biofeedback Training in Individuals With Incomplete SCI.Residual Anal Pressure80.09 mmHgStandard Deviation 34.36
Incomplete Spinal Cord Injury (ASIA B, C, D)Change in Rectal and Sphincter Pressure Due to Bowel Biofeedback Training in Individuals With Incomplete SCI.Intrarectal Pressure37.48 mmHgStandard Deviation 37.52
Incomplete Spinal Cord Injury (ASIA B, C, D)Change in Rectal and Sphincter Pressure Due to Bowel Biofeedback Training in Individuals With Incomplete SCI.Squeeze Max Pressure106.69 mmHgStandard Deviation 52.06
Incomplete Spinal Cord Injury (ASIA B, C, D)Change in Rectal and Sphincter Pressure Due to Bowel Biofeedback Training in Individuals With Incomplete SCI.Residual Anal Pressure84.35 mmHgStandard Deviation 32.83
Incomplete Spinal Cord Injury (ASIA B, C, D)Change in Rectal and Sphincter Pressure Due to Bowel Biofeedback Training in Individuals With Incomplete SCI.Mean Sphincter Pressure56.05 mmHgStandard Deviation 19.69
Incomplete Spinal Cord Injury (ASIA B, C, D)Change in Rectal and Sphincter Pressure Due to Bowel Biofeedback Training in Individuals With Incomplete SCI.Max Sphincter Pressure61.41 mmHgStandard Deviation 20.6
Secondary

Change in Subjective Bowel Care Due to Guided and Self-Guided Biofeedback Training in Individuals With Incomplete SCI

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.

Time frame: Baseline, post- 6 week guided biofeedback training (weeks 1-6), post- 6 week self-guided biofeedback training (weeks 7-12).

Population: Subjects with Incomplete SCI, pre (baseline) and post guided and self-guided biofeedback training.

ArmMeasureGroupValue (MEAN)Dispersion
Able Bodied ParticipantsChange in Subjective Bowel Care Due to Guided and Self-Guided Biofeedback Training in Individuals With Incomplete SCIOral Medications (per week): Range: 1 (none used) to 5 (used every time)2.33 Score on scaleStandard Deviation 1.84
Able Bodied ParticipantsChange in Subjective Bowel Care Due to Guided and Self-Guided Biofeedback Training in Individuals With Incomplete SCIFrequency of Bowel Movement Scale:10Question Bowel Survey (QBS) Range:1 (≥7 times/week) to 5(None)2.53 Score on scaleStandard Deviation 1.25
Able Bodied ParticipantsChange in Subjective Bowel Care Due to Guided and Self-Guided Biofeedback Training in Individuals With Incomplete SCIBowel Evacuation Time: Scale: 10 QBS Range: 1 (5-15min/day) to 5 (≥3hrs/day)2.20 Score on scaleStandard Deviation 1.32
Able Bodied ParticipantsChange in Subjective Bowel Care Due to Guided and Self-Guided Biofeedback Training in Individuals With Incomplete SCIDigital Stimulation (per week): Range: 1 (none) to 5 (every time)1.80 Score on scaleStandard Deviation 1.42
Able Bodied ParticipantsChange in Subjective Bowel Care Due to Guided and Self-Guided Biofeedback Training in Individuals With Incomplete SCIEnemas (per week): Range: 1 (none used) to 5 (used every time)2.13 Score on scaleStandard Deviation 1.64
Able Bodied ParticipantsChange in Subjective Bowel Care Due to Guided and Self-Guided Biofeedback Training in Individuals With Incomplete SCILeakage (per week): Range: 1 (leakage 0 times) to 5 (leakage ≥7 times)1.13 Score on scaleStandard Deviation 0.35
Complete Spinal Cord Injury (ASIA A)Change in Subjective Bowel Care Due to Guided and Self-Guided Biofeedback Training in Individuals With Incomplete SCIEnemas (per week): Range: 1 (none used) to 5 (used every time)2.08 Score on scaleStandard Deviation 1.71
Complete Spinal Cord Injury (ASIA A)Change in Subjective Bowel Care Due to Guided and Self-Guided Biofeedback Training in Individuals With Incomplete SCIOral Medications (per week): Range: 1 (none used) to 5 (used every time)2.00 Score on scaleStandard Deviation 1.73
Complete Spinal Cord Injury (ASIA A)Change in Subjective Bowel Care Due to Guided and Self-Guided Biofeedback Training in Individuals With Incomplete SCIBowel Evacuation Time: Scale: 10 QBS Range: 1 (5-15min/day) to 5 (≥3hrs/day)1.69 Score on scaleStandard Deviation 1.03
Complete Spinal Cord Injury (ASIA A)Change in Subjective Bowel Care Due to Guided and Self-Guided Biofeedback Training in Individuals With Incomplete SCILeakage (per week): Range: 1 (leakage 0 times) to 5 (leakage ≥7 times)1.23 Score on scaleStandard Deviation 0.44
Complete Spinal Cord Injury (ASIA A)Change in Subjective Bowel Care Due to Guided and Self-Guided Biofeedback Training in Individuals With Incomplete SCIFrequency of Bowel Movement Scale:10Question Bowel Survey (QBS) Range:1 (≥7 times/week) to 5(None)2.54 Score on scaleStandard Deviation 0.97
Complete Spinal Cord Injury (ASIA A)Change in Subjective Bowel Care Due to Guided and Self-Guided Biofeedback Training in Individuals With Incomplete SCIDigital Stimulation (per week): Range: 1 (none) to 5 (every time)1.69 Score on scaleStandard Deviation 1.49
Incomplete Spinal Cord Injury (ASIA B, C, D)Change in Subjective Bowel Care Due to Guided and Self-Guided Biofeedback Training in Individuals With Incomplete SCIDigital Stimulation (per week): Range: 1 (none) to 5 (every time)2.38 Score on scaleStandard Deviation 1.85
Incomplete Spinal Cord Injury (ASIA B, C, D)Change in Subjective Bowel Care Due to Guided and Self-Guided Biofeedback Training in Individuals With Incomplete SCIFrequency of Bowel Movement Scale:10Question Bowel Survey (QBS) Range:1 (≥7 times/week) to 5(None)2.38 Score on scaleStandard Deviation 1.33
Incomplete Spinal Cord Injury (ASIA B, C, D)Change in Subjective Bowel Care Due to Guided and Self-Guided Biofeedback Training in Individuals With Incomplete SCIBowel Evacuation Time: Scale: 10 QBS Range: 1 (5-15min/day) to 5 (≥3hrs/day)2.00 Score on scaleStandard Deviation 1.15
Incomplete Spinal Cord Injury (ASIA B, C, D)Change in Subjective Bowel Care Due to Guided and Self-Guided Biofeedback Training in Individuals With Incomplete SCILeakage (per week): Range: 1 (leakage 0 times) to 5 (leakage ≥7 times)1.31 Score on scaleStandard Deviation 0.48
Incomplete Spinal Cord Injury (ASIA B, C, D)Change in Subjective Bowel Care Due to Guided and Self-Guided Biofeedback Training in Individuals With Incomplete SCIEnemas (per week): Range: 1 (none used) to 5 (used every time)2.23 Score on scaleStandard Deviation 1.79
Incomplete Spinal Cord Injury (ASIA B, C, D)Change in Subjective Bowel Care Due to Guided and Self-Guided Biofeedback Training in Individuals With Incomplete SCIOral Medications (per week): Range: 1 (none used) to 5 (used every time)2.54 Score on scaleStandard Deviation 2.03
Secondary

Changes in Recto-anal Inhibitory Reflex (RAIR) Due to Bowel Biofeedback Training in Individuals With Incomplete SCI.

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)

Time frame: Baseline, post- 6 week guided biofeedback training (weeks 1-6), post- 6 week self-guided biofeedback training (weeks 7-12).

Population: Subjects that reached the maximum set limit of balloon inflation with no sensation were set as a non-recordable value.

ArmMeasureGroupValue (MEAN)Dispersion
Able Bodied ParticipantsChanges in Recto-anal Inhibitory Reflex (RAIR) Due to Bowel Biofeedback Training in Individuals With Incomplete SCI.Balloon Volume - Urge to Defecate63.13 ccStandard Deviation 30.92
Able Bodied ParticipantsChanges in Recto-anal Inhibitory Reflex (RAIR) Due to Bowel Biofeedback Training in Individuals With Incomplete SCI.Balloon Volume - First Sensation41.87 ccStandard Deviation 17.21
Complete Spinal Cord Injury (ASIA A)Changes in Recto-anal Inhibitory Reflex (RAIR) Due to Bowel Biofeedback Training in Individuals With Incomplete SCI.Balloon Volume - First Sensation35.00 ccStandard Deviation 14.46
Complete Spinal Cord Injury (ASIA A)Changes in Recto-anal Inhibitory Reflex (RAIR) Due to Bowel Biofeedback Training in Individuals With Incomplete SCI.Balloon Volume - Urge to Defecate59.17 ccStandard Deviation 25.39
Incomplete Spinal Cord Injury (ASIA B, C, D)Changes in Recto-anal Inhibitory Reflex (RAIR) Due to Bowel Biofeedback Training in Individuals With Incomplete SCI.Balloon Volume - First Sensation51.82 ccStandard Deviation 30.27
Incomplete Spinal Cord Injury (ASIA B, C, D)Changes in Recto-anal Inhibitory Reflex (RAIR) Due to Bowel Biofeedback Training in Individuals With Incomplete SCI.Balloon Volume - Urge to Defecate67.00 ccStandard Deviation 29.83

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026