Trial Outcomes & Findings for Utility of an Animated Bowel Biofeedback Training Routine to Improve Bowel Function in Individuals With SCI (NCT NCT02406859)
NCT ID: NCT02406859
Last Updated: 2021-09-17
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
50 participants
Primary outcome timeframe
1 Session (Baseline Anorectal Manometry Assessment)
Results posted on
2021-09-17
Participant Flow
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.
Participant milestones
| Measure |
Able Body Participants
Anorectal Manometry: Able bodied subjects will undergo anorectal manometry and a baseline assessment of level of constipation or frequency of fecal incontinence (FI). Subjects will undergo an anorectal manometry to establish baseline pressure characteristics.
|
Complete Spinal Cord Injury (ASIA A)
Anorectal Manometry: Subjects with ASIA A spinal cord injury will undergo anorectal manometry and a baseline assessment of level of constipation or frequency of fecal incontinence (FI). The 10 Question Bowel Survey and Incontinence Scale will be administered. Subjects will undergo an anorectal manometry to establish baseline pressure characteristics.
|
Incomplete Spinal Cord Injury (ASIA B,C,D)
Part 1 Anorectal Manometry and 10 Question Bowel Survey
Part 2 \[Bowel Biofeedback\]: A subgroup of subjects who participated in the first arm of the study (Anorectal Motility) and report either constipation or fecal incontinence will be asked to participate in 12 weeks of twice weekly, biofeedback training. The biofeedback training will consist of in-lab exercises that are paired with a visual feedback. Anorectal manometry and bowel surveys will be repeated after the training session to assess the effects of bowel biofeedback on anorectal function.
Bowel 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.
|
|---|---|---|---|
|
Part 1 - Manometric Parameters
STARTED
|
15
|
14
|
21
|
|
Part 1 - Manometric Parameters
COMPLETED
|
12
|
13
|
17
|
|
Part 1 - Manometric Parameters
NOT COMPLETED
|
3
|
1
|
4
|
|
Part 2 - Biofeedback Training
STARTED
|
12
|
13
|
17
|
|
Part 2 - Biofeedback Training
COMPLETED
|
12
|
13
|
17
|
|
Part 2 - Biofeedback Training
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Able Bodied Participants
n=12 Participants
The representation of this group are those participants with no known spinal cord injury and full motor function.
|
Complete Spinal Cord Injury (ASIA A)
n=13 Participants
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.
|
Incomplete Spinal Cord Injury (ASIA B, C, D)
n=17 Participants
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.
|
Total
n=42 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=12 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=42 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
12 Participants
n=12 Participants
|
11 Participants
n=13 Participants
|
14 Participants
n=17 Participants
|
37 Participants
n=42 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=12 Participants
|
2 Participants
n=13 Participants
|
3 Participants
n=17 Participants
|
5 Participants
n=42 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=12 Participants
|
0 Participants
n=13 Participants
|
2 Participants
n=17 Participants
|
2 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=12 Participants
|
13 Participants
n=13 Participants
|
15 Participants
n=17 Participants
|
40 Participants
n=42 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
12 Participants
n=12 Participants
|
13 Participants
n=13 Participants
|
17 Participants
n=17 Participants
|
42 Participants
n=42 Participants
|
|
Mean Sphincteric Pressure (mm Hg)
|
77.9 mmHg
STANDARD_DEVIATION 21.9 • n=12 Participants
|
67.1 mmHg
STANDARD_DEVIATION 31.8 • n=13 Participants
|
65.2 mmHg
STANDARD_DEVIATION 21.4 • n=17 Participants
|
72.0 mmHg
STANDARD_DEVIATION 26.2 • n=42 Participants
|
PRIMARY outcome
Timeframe: 1 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.
Outcome measures
| Measure |
Able Bodied Participants
n=12 Participants
Part 1 \[Anorectal Manometry\]: Able bodied subjects will undergo an anorectal manometry to establish baseline pressure characteristics to serve as a comparison group for the SCI complete and incomplete baseline groups.
|
Complete Spinal Cord Injury (ASIA A)
n=12 Participants
Part 1 \[Anorectal Manometry\]: Subjects with complete spinal cord injury will undergo an anorectal manometry to establish baseline pressure characteristics, to compare with the incomplete spinal cord injury group.
|
Incomplete Spinal Cord Injury (ASIA B, C, D)
n=20 Participants
Part 1 \[Anorectal Manometry\]: Subjects with incomplete spinal cord injury 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 occurring due to training.
|
|---|---|---|---|
|
Baseline Motility (Anorectal Sensation and Strength) Characteristics
Intra-rectal Pressure
|
105 mmHg
Standard Deviation 35
|
34.4 mmHg
Standard Deviation 29
|
30 mmHg
Standard Deviation 19
|
|
Baseline Motility (Anorectal Sensation and Strength) Characteristics
Mean Sphincter Pressure
|
77.9 mmHg
Standard Deviation 21.9
|
67.1 mmHg
Standard Deviation 31.8
|
65.2 mmHg
Standard Deviation 21.4
|
|
Baseline Motility (Anorectal Sensation and Strength) Characteristics
Max Sphincter Pressure
|
253 mmHg
Standard Deviation 101
|
81.1 mmHg
Standard Deviation 12.3
|
108.9 mmHg
Standard Deviation 64
|
|
Baseline Motility (Anorectal Sensation and Strength) Characteristics
Residual anal Pressure
|
169.3 mmHg
Standard Deviation 55
|
61.4 mmHg
Standard Deviation 42
|
73.8 mmHg
Standard Deviation 30
|
|
Baseline Motility (Anorectal Sensation and Strength) Characteristics
Recto-anal Pressure Differential
|
-63 mmHg
Standard Deviation 31
|
-27 mmHg
Standard Deviation 7
|
-44 mmHg
Standard Deviation 20
|
SECONDARY outcome
Timeframe: 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).
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.
Outcome measures
| Measure |
Able Bodied Participants
n=17 Participants
Part 1 \[Anorectal Manometry\]: Able bodied subjects will undergo an anorectal manometry to establish baseline pressure characteristics to serve as a comparison group for the SCI complete and incomplete baseline groups.
|
Complete Spinal Cord Injury (ASIA A)
n=13 Participants
Part 1 \[Anorectal Manometry\]: Subjects with complete spinal cord injury will undergo an anorectal manometry to establish baseline pressure characteristics, to compare with the incomplete spinal cord injury group.
|
Incomplete Spinal Cord Injury (ASIA B, C, D)
n=13 Participants
Part 1 \[Anorectal Manometry\]: Subjects with incomplete spinal cord injury 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 occurring due to training.
|
|---|---|---|---|
|
Change in Rectal and Sphincter Pressure Due to Bowel Biofeedback Training in Individuals With Incomplete SCI.
Residual Anal Pressure
|
73.79 mmHg
Standard Deviation 30.38
|
80.09 mmHg
Standard Deviation 34.36
|
84.35 mmHg
Standard Deviation 32.83
|
|
Change in Rectal and Sphincter Pressure Due to Bowel Biofeedback Training in Individuals With Incomplete SCI.
Max Sphincter Pressure
|
71.39 mmHg
Standard Deviation 24.32
|
61.21 mmHg
Standard Deviation 23.36
|
61.41 mmHg
Standard Deviation 20.60
|
|
Change in Rectal and Sphincter Pressure Due to Bowel Biofeedback Training in Individuals With Incomplete SCI.
Mean Sphincter Pressure
|
65.23 mmHg
Standard Deviation 21.49
|
55.58 mmHg
Standard Deviation 21.29
|
56.05 mmHg
Standard Deviation 19.69
|
|
Change in Rectal and Sphincter Pressure Due to Bowel Biofeedback Training in Individuals With Incomplete SCI.
Squeeze Max Pressure
|
109.54 mmHg
Standard Deviation 63.57
|
105.96 mmHg
Standard Deviation 63.20
|
106.69 mmHg
Standard Deviation 52.06
|
|
Change in Rectal and Sphincter Pressure Due to Bowel Biofeedback Training in Individuals With Incomplete SCI.
Intrarectal Pressure
|
29.75 mmHg
Standard Deviation 19.98
|
38.53 mmHg
Standard Deviation 30.17
|
37.48 mmHg
Standard Deviation 37.52
|
SECONDARY outcome
Timeframe: 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.
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)
Outcome measures
| Measure |
Able Bodied Participants
n=17 Participants
Part 1 \[Anorectal Manometry\]: Able bodied subjects will undergo an anorectal manometry to establish baseline pressure characteristics to serve as a comparison group for the SCI complete and incomplete baseline groups.
|
Complete Spinal Cord Injury (ASIA A)
n=13 Participants
Part 1 \[Anorectal Manometry\]: Subjects with complete spinal cord injury will undergo an anorectal manometry to establish baseline pressure characteristics, to compare with the incomplete spinal cord injury group.
|
Incomplete Spinal Cord Injury (ASIA B, C, D)
n=13 Participants
Part 1 \[Anorectal Manometry\]: Subjects with incomplete spinal cord injury 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 occurring due to training.
|
|---|---|---|---|
|
Changes in Recto-anal Inhibitory Reflex (RAIR) Due to Bowel Biofeedback Training in Individuals With Incomplete SCI.
Balloon Volume - First Sensation
|
41.87 cc
Standard Deviation 17.21
|
35.00 cc
Standard Deviation 14.46
|
51.82 cc
Standard Deviation 30.27
|
|
Changes in Recto-anal Inhibitory Reflex (RAIR) Due to Bowel Biofeedback Training in Individuals With Incomplete SCI.
Balloon Volume - Urge to Defecate
|
63.13 cc
Standard Deviation 30.92
|
59.17 cc
Standard Deviation 25.39
|
67.00 cc
Standard Deviation 29.83
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Able Bodied Participants
n=15 Participants
Part 1 \[Anorectal Manometry\]: Able bodied subjects will undergo an anorectal manometry to establish baseline pressure characteristics to serve as a comparison group for the SCI complete and incomplete baseline groups.
|
Complete Spinal Cord Injury (ASIA A)
n=13 Participants
Part 1 \[Anorectal Manometry\]: Subjects with complete spinal cord injury will undergo an anorectal manometry to establish baseline pressure characteristics, to compare with the incomplete spinal cord injury group.
|
Incomplete Spinal Cord Injury (ASIA B, C, D)
n=13 Participants
Part 1 \[Anorectal Manometry\]: Subjects with incomplete spinal cord injury 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 occurring due to training.
|
|---|---|---|---|
|
Change in Subjective Bowel Care Due to Guided and Self-Guided Biofeedback Training in Individuals With Incomplete SCI
Frequency of Bowel Movement Scale:10Question Bowel Survey (QBS) Range:1 (≥7 times/week) to 5(None)
|
2.53 Score on scale
Standard Deviation 1.25
|
2.54 Score on scale
Standard Deviation .97
|
2.38 Score on scale
Standard Deviation 1.33
|
|
Change in Subjective Bowel Care Due to Guided and Self-Guided Biofeedback Training in Individuals With Incomplete SCI
Bowel Evacuation Time: Scale: 10 QBS Range: 1 (5-15min/day) to 5 (≥3hrs/day)
|
2.20 Score on scale
Standard Deviation 1.32
|
1.69 Score on scale
Standard Deviation 1.03
|
2.00 Score on scale
Standard Deviation 1.15
|
|
Change in Subjective Bowel Care Due to Guided and Self-Guided Biofeedback Training in Individuals With Incomplete SCI
Leakage (per week): Range: 1 (leakage 0 times) to 5 (leakage ≥7 times)
|
1.13 Score on scale
Standard Deviation .35
|
1.23 Score on scale
Standard Deviation .44
|
1.31 Score on scale
Standard Deviation .48
|
|
Change in Subjective Bowel Care Due to Guided and Self-Guided Biofeedback Training in Individuals With Incomplete SCI
Enemas (per week): Range: 1 (none used) to 5 (used every time)
|
2.13 Score on scale
Standard Deviation 1.64
|
2.08 Score on scale
Standard Deviation 1.71
|
2.23 Score on scale
Standard Deviation 1.79
|
|
Change in Subjective Bowel Care Due to Guided and Self-Guided Biofeedback Training in Individuals With Incomplete SCI
Oral Medications (per week): Range: 1 (none used) to 5 (used every time)
|
2.33 Score on scale
Standard Deviation 1.84
|
2.00 Score on scale
Standard Deviation 1.73
|
2.54 Score on scale
Standard Deviation 2.03
|
|
Change in Subjective Bowel Care Due to Guided and Self-Guided Biofeedback Training in Individuals With Incomplete SCI
Digital Stimulation (per week): Range: 1 (none) to 5 (every time)
|
1.80 Score on scale
Standard Deviation 1.42
|
1.69 Score on scale
Standard Deviation 1.49
|
2.38 Score on scale
Standard Deviation 1.85
|
Adverse Events
Able Body Participants
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Complete Spinal Cord Injury (ASIA A)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Incomplete Spinal Cord Injury (ASIA B,C,D)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place