Bowel Biofeedback Training to Improve Bowel Function in Individuals With SCI
Phase: NA
Conditions: Spinal Cord Injury, Constipation, Fecal Incontinence, Neurogenic Bowel
Sponsor: VA Office of Research and Development

 
Utility of an Animated Bowel Biofeedback Training Routine to Improve Bowel 
Function in Individuals With SCI 
 
NCT02406859 
 
October 10, 2016 

STUDY TITLE: Utility of an Animated Bowel Biofeedback Training Routine to Improve 
Bowel Function in Individuals with SCI 
A. SPECIFIC AIMS
Biofeedback techniques are known to decrease the frequency of fecal incontinence (FI) in able-
bodied (AB) populations and improve reflex defection in persons who experience constipation.
We hypothesize that bowel biofeedback training in spinal cord injured (SCI) patients will result
in the following:
In subjects with decreased external sphincter strength and control (FI subjects): Improved 
objective bowel function parameters as measured by anorectal manometry, a decrease of FI 
episodes, a decrease in Wexner’s incontinency score and a decrease in the SCI Bowel Surveys 
Score. 
In subjects with tonic, constricted external sphincter and missing/decreased recto-anal inhibitory 
reflex (RAIR) (constipation subjects): An increase in sensitivity and strength of the RAIR and 
decreased symptoms of constipation (Bowel and Bladder Survey).  
Specific Aims: 
1. To assess baseline motility characteristics (resting pressure, squeezing pressure, high pressure
zone, and RAIR) in persons with chronic SCI.
We hypothesize that individuals with SCI will have abnormal resting pressures (either
increased or decreased, decreased squeezing pressures and an impaired RAIR reflex.
2. To determine the characteristics of SCI (level, completeness, baseline manometric parameters)
which best predict the outcome of the biofeedback training. Additionally, we aim to assess the
efficacy of bowel biofeedback therapy in SCI patients in improving:
a) Changes in maximum rectal and sphincter pressures generated during “squeeze” and
“bear down” maneuvers performed during anorectal manometric studies pre-post
treatment.
We hypothesize that due to the learning and conditioning effects of the biofeedback
training, we will observe increases in generated sphincter pressures.
b) Changes to the sensitivity and strength of response of the RAIR reflex in response to
rectal distension.
We hypothesize that the RAIR response will may be partially restored or strengthened by
biofeedback training.
c) FI and constipation as assessed by the Bowel Surveys and Wexner’s Incontinence Scale.
We hypothesize that biofeedback will improve subjective symptoms of FI, constipation, or
both.
B. BRIEF REVIEW OF RESULTS OF OTHERS AND CURRENT STAGE OF
KNOWLEDGE
SCI results in a multiplicity of secondary medical complications, including neurogenic 
bowel. Neurogenic bowel as a sequela of SCI, is characterized by difficulty with evacuation 
(DWE), chronic abdominal pain and fecal incontinence (FI). There are approximately 300,000 
individuals with SCI in the United States. SCI affects 12,700 new patients every year in the USA 
Utility of an Animated Bowel Biofeedback Training Routine to improve Bowel Function in Individuals With 
SCI -NCT02406859, October 10, 2016 

and this number is projected to increase to 17,560 in 2050 [1]. The incidence of SCI is lower 
(10,000 new patients per year) in the European Union. Studies have shown variable incidence of 
FI in SCI patients; the incidence of FI in these studies ranged from 15% to 85% depending on 
completeness of the spinal lesion. Valles et al. conducted a study in 54 patients with motor 
complete SCI and reported the following; constipation in 67% of patients and FI in 85% of 
patients [2]. In a self report survey study of 424 SCI individuals, Krogh et al. reported fecal 
incontinence in 75% of SCI patients at least once per year, 20% at least once per month and 5% 
once per day [3]. It is clear that bowel dysfunction is a common and distressing problem in these 
individuals, and it significantly affects the quality of life of SCI patients [4]. Studies assessing 
the influence of bowel function on quality of life have showed, that up to 65% patients with SCI 
had quality of life issues compared to 8% of AB patients [5].  
Neurogenic bowel characteristics differ among 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 the conus medullaris (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 [3, 6].  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 [2]. 
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 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. Various techniques, such 
as the measurement of pressure profiles facilitate assessment of GI motor function. Anorectal 
manometry can provide valuable information about sphincter strength, defecation dynamics and 
reflex mechanisms. In the past few decades, motility studies have been conducted using water-
perfused systems. These systems consist of a multilumen catheter which is connected to an array 
of pressure tranducers, a pnuemohydraulic pump to provide the continuous flow of water, and a 
display system. The pnuemohydraulic pump drives water through very narrow channels of the 
catheter at a constant low rate, but under very high pressure. Each channel of the catheter is 
connected to a separate pressure tranducer. Any interference with the flow of water from any of 
the various channels by lumen occluding contractions in the channel raises pressures in that 
channel. Pressure transducers continuously monitor pressures in the channels. This information 
is transmitted to a computer and displayed as line tracings. While useful, such systems are 
limited by the number of channels each catheter can accommodate as catheter size is limited. 
This greatly reduces the amount of information that can be captured, especially in small, activity-
laden areas such as sphincteric regions. New high-resolution anorectal manometric systems 
(Given Imaging, Duluth, GA), simultaneously captures pressure data from the rectum, IAS, EAS 
and atmosphere. These systems allow for tight spacing of many pressure sensors, which allow 
visualization of short as well as long segment retrograde and anterograde contractions. Short 
segment retrograde contractions cannot be normally visualized using traditional manometry due 
Utility of an Animated Bowel Biofeedback Training Routine to improve Bowel Function in Individuals With 
SCI -NCT02406859, October 10, 2016 

to wide spacing between channels. 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.  
The aim of most treatment strategies for neurogenic bowel in this population is to 
regularize bowel movements and preempt constipation. Most often, multifaceted programs 
(using non- pharmacological and pharmacological methods) are required for the management of 
neurogenic bowel. The non-pharmacological options include dietary fiber and fluid intake, 
digital rectal stimulation, and abdominal massage.  The pharmacological treatment include use of 
irritant suppositories and prokinetics. Additional approaches include use of assistive devices like 
standing tables and modified toilet seats, irrigation techniques and implantation of electrical 
stimulation devices. Colostomy and implanted irrigation catheters are tried as a last resort. 
However, these programs are successful in only approximately 67% of patients [3]. There still 
remain a significant proportion of patients in whom the multifaceted programs are not effective. 
These patients are burdened by cumbersome and time consuming bowel care programs, recurrent 
episodes of FI and other secondary complications such as chronic pain and autonomic 
dysreflexia. Additionally, most standard treatment protocols address the problem of difficulty 
with evacuation/constipation. While this may be partially effective in preventing overflow 
incontinence, it does not address the issue of FI that occurs as a result of atonic musculature, or 
from urgency caused by hypersensitive rectum. Furthermore, these typed of treatment methods 
are aimed to promote bowel movement without voluntary input from the patient and are not 
aimed at improving bowel function.  
Modalities in which the patient can be trained to control the IAS and EAS are promising 
solutions to FI, and have been shown to be useful in AB populations [7-9]. 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 [10-13] 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.    
It may be appreciated that using biofeedback therapy to control the bowel would require 
presence of some sensation in SCI patients; i.e., motor incomplete SCI patients with partially 
preserved motor and sensory function. Individuals with SCI are categorized as motor complete or 
incomplete using the American Spinal Injury Association (ASIA) criteria. Motor complete SCI 
patients have a higher incidence of FI, attributed to complete loss of motor and sensory feedback 
to the CNS from the peripheral organs/muscles [4].  However, some patients with motor 
complete SCI as defined by ASIA criteria, occasionally reported diffuse visceral sensations 
preceding involuntary colonic mass movement and defecation [14].   Enck et al. evaluated fifteen 
patients with complete SCI using anorectal manometry, and five out of fifteen patients reported 
some sensation and three out of fifteen reported pain during rectal distension [14].  Therefore, it 
is reasonable to postulate that some individuals with complete SCI may still benefit from such 
therapy, arguing for the widespread utility of biofeedback training.  
Utility of an Animated Bowel Biofeedback Training Routine to improve Bowel Function in Individuals 
With SCI -NCT02406859, October 10, 2016 

For our pilot study, we are proposing the use of a 12 week biofeedback training to 
improve anorectal motility and voluntary control of the IAS, EAS and rectal musculature. It is 
unknown as to what level and completeness of SCI patients can expect to benefit from such 
treatment. As such, we are planning on enrolling all non-ambulatory SCI subjects with complete 
or incomplete injuries (ASIA A, B, C or D). Subjects will be enrolled only if they currently 
report problems with either constipation or FI on a based on survey responses (Ten Item SCI 
Bowel Survey (10 SCIB) and Wexner’s Incontinency Scale (WIS). Anorectal motility pre to post 
biofeedback training will be performed. We aim to describe the anorectal pressure profile in 
persons with SCI and to identify responders to biofeedback training. We believe anorectal 
function will differ according to the level and completeness of injury. Additionally, we seek to 
define the levels and completeness of injury, and baseline manometric parameters which are 
predictors of treatment success.   
C. PROCEDURES, METHODS AND EXPERIMENTAL DESIGN
This is a prospective, non-randomized, single center clinical trial. SCI patients will be stratified
to 4 different arms according to the level of SCI:
•
Upper motor neuron (UMN) incomplete (C5-T12)
•
Lower motor neuron incomplete (LMN) (L2-S5)
•
UMN complete (C5-T12)
•
LMN motor neuron complete (L2-S5)
The Inclusion/Exclusion criteria are as follows: 
Inclusion Criteria: 
•
Chronic SCI (duration over 1 year),
•
Able-bodied (non-SCI)
•
Between the ages of 18-75.
Exclusion Criteria: 
•
Contraindication to bowel biofeedback,
•
Currently pregnant or trying to become pregnant,
•
Inability to provide informed consent.
Study Population  
Veterans from the JJPVAMC with chronic SCI, who are seen routinely in outpatient clinic and 
who complain of fecal incontinence or constipation (Screening Questionnaire: Appendix 1). 
Additional healthy AB veterans and/or non-veterans will be included in the study population as 
controls.   
Recruitment and Enrollment: 
We propose to recruit and enroll patients with SCI who suffer from FI. Patients with SCI who are 
followed by an SCI primary care physician at the James J Peters Veterans Affairs Medical 
Center (JJP VAMC) are from a large geographical area (New York, New Jersey, Connecticut, 
and Pennsylvania) and are referred to this Center for treatment and management of their chronic 
SCI.  Veterans are evaluated in the SCI Clinic where a primary care physician, a registered nurse 
and a medical assistant evaluate, assess and treat the patients for routine medical care, preventive 
medicine and urgent care.  In FY 2005-2006, 165 unique SCI patients had a total of 295 inpatient 
stays at the JJP VAMC.  In fiscal year 2007, 900 patient encounters were recorded from the SCI 
Utility of an Animated Bowel Biofeedback Training Routine to improve Bowel Function in Individuals With 
SCI -NCT02406859, October 10, 2016 

outpatient clinic (stop code 210), of which 200 were unique patients and 182 annual physical 
exams (mean=15 per month). On average, the SCI Clinic has been successful at recruiting 10 
subjects per month for other studies, suggesting our goal of recruiting 50 patients during the 12-
month study period is feasible. Patients who visit the SCI clinic for a routine examination will be 
provided information regarding study participation by their primary care physician. If the patient 
is interested in study participation, a research coordinator will review the study procedures with 
the subject, and informed consent will be signed and a medical history questionnaire will be 
administered. Additionally, both SCI and AB subjects will be recruited if they indicated interest 
in being contacted for other studies during participation in a previous center research study.  
Utility of an Animated Bowel Biofeedback Training Routine to improve Bowel Function in Individuals 
With SCI -NCT02406859, October 10, 2016 

Part 1: Anorectal Manometry: 
For Part 1 of the study (Anorectal Manometry), 50 SCI subjects will be stratified into the 
following groups:  
•
Group 1: UMN complete,
•
Group 2: UMN incomplete,
•
Group 3: LMN complete and
•
Group 4: LMN incomplete injury.
Fifty subjects will first undergo an SCI ASIA Impairment examination performed by a trained 
SCI research staff member. Upon completion of the ASIA exam to determine 
completeness/incompleteness of the injury, all subjects will undergo an anorectal manometry and 
a baseline assessment of level of constipation or frequency of FI. Approximately 15 AB subjects 
will also undergo anorectal manometry and serve as a comparison group for baseline measures. 
The 10 Question Bowel Survey, and Wexner’s Incontinence Scale (Appendix 2) will be 
administered to both groups. All SCI subjects will also complete 3 additional surveys: SCI 
Bowel Management QOL, SCI Bladder Complication, and SCI Bladder Management. These 
surveys will test the sensitivity of the SCI-QOL measures within the context of existing 
interventional studies by comparing it with the legacy tool(s) being used. All manometry studies 
for AB and SCI subjects will be scheduled for bowel care days (post bowel care routine) to 
decrease the incidence of incidental bowel movement. After informed consent has been obtained, 
all subjects will be asked to arrive on the morning of the scheduled visit to the SCI Research Unit 
(Suite 7A-13). Subjects will be transferred onto a commode bed and asked to lie on their left 
side. A sheathed and lubricated probe with an inflatable balloon attached to the distal end, will be 
inserted into the rectum. The probe will be outfitted with an EMG sensor in order to monitor 
pelvic floor muscle activity. The manometric study will last for approximately 45 minutes and 
will consist of the following tests, during which muscle activity and pressure will be monitored. 
1. Baseline assessment- after a period of acclimation, subjects will be asked to relax for a 30
second period, in which they will be asked to refrain from performing any squeezing or
bearing down maneuvers.
2. Squeezing maneuvers- subjects will be asked to squeeze their sphincter muscles as if they
were retaining stool. Squeezing maneuvers will be performed until 3 consistent attempts
are made.
3. Bearing down maneuvers- subjects will be asked to bear down as though they were
attempting to move their bowels. Bearing down maneuvers will be performed until 3
consistent attempts are made.
4. Assessment of the rectoanal inhibitory reflex (RAIR)- a balloon distension test will be
performed. The rectal balloon attached to the pressure probe will be gradually filled with
air starting at 30ccs and in 10cc increments until a RAIR reflex is identified. Balloon
distension increases pressure registered by intrarectal sensors. The volume of air injected
is displayed along with the pressure change it induced. Balloon distension normally
produces a graded relaxation of the anal canal musculature. The RAIR reflex should
appear as a relaxation of the IAS which starts on the rectal side of the anal canal which
spreads caudally.
Manometric Parameters
RESTING 
Maximum sphincter pressure 
SQUEEZE 
Maximum sphincter pressure 
Utility of an Animated Bowel Biofeedback Training Routine to improve Bowel Function in Individuals With 
SCI -NCT02406859, October 10, 2016 

Figure 1: Biofeedback Visual
Mean sphincter pressure 
Length of IAS and EAS 
Length of anal verge to centre of anal canal 
Duration of sustained squeeze 
BEAR DOWN 
Residual anal pressure 
Percentage anal relaxation 
Intrarectal pressure 
Rectoanal pressure differential 
BALLOON INFLATION ( cc) 
Presence of rectoanal inhibitory reflex 
(RAIR) 
First sensation  
Urge to defecate 
Discomfort 
Minimum rectal compliance 
Maximum rectal compliance 
The 10 Question Bowel Survey, SCI Bowel Management QOL, SCI Bladder Complication, SCI 
Bladder Management, and Wexner’s Incontinence Scale will be administered. A subgroup of 20 
subjects who report either constipation or FI and who have an incomplete injury as defined by 
the ASIA Impairment Scale will be identified, and will have the option of enrolling in part 2 of 
the study; standard bowel biofeedback training.  
Part 2: Biofeedback Training: 
Once a subject has been identified as a candidate for biofeedback based on the ASIA 
examination (SCI incomplete ASIA B, C, D) and expressed interest in participation, an informed 
consent interview will be scheduled. Once written consent is obtained, a training schedule of 
twice weekly sessions will be scheduled. Twenty subjects will be recruited for this arm of the 
study. Each training session will last for approximately 60 minutes.  
All training session will take 
place at the SCI Research Unit (Suite 
7A-13). Subjects will be transferred onto 
a commode bed and asked to lie on their 
left side. A small disposable 
electromyography (EMG) plug electrode 
will be inserted into the rectal cavity, 
which will permit the subject to watch 
the trace of pelvic floor muscle activity 
(Figure 1) at rest, during voluntary 
contraction (squeeze) and during 
relaxation (bearing down). The subject 
will be asked to try to follow the visual 
prompts for approximately 30 minutes; 
for example, in the visual provided in 
Figure 1, the subject will be asked to try 
to guide the fish through the stream by 
voluntarily contracting and relaxing their 
pelvic floor muscles. These tracings will increase in levels of difficulty and complexity, as the 
subject is able accurately (< 10 percent error) reproduce the tracing in the level, within set times. 
Response to balloon distension will be performed following the tracing exercises. The EMG 
Decreased 
EMG Activity 
Utility of an Animated Bowel Biofeedback Training Routine to improve Bowel Function in Individuals With 
SCI -NCT02406859, October 10, 2016 

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Part 1 Able-bodied 
Manometry and Survey 
Study 
N=15 (1visit) 
Able-bodied 
To compare baseline anorectal pressure 
with SCI  
Part 1 SCI 
Manometry and 
Survey Study 
N=50 (1 visit)  
All levels of completeness 
of SCI 
To determine baseline anorectal 
pressure and EMG activity profiles 
Part 2 Biofeeback 
Training 
N=20 (14 visits) 
Incomplete SCI (Asia B, C or D)  
All subjects must have completed 
part 1 
To identify “responders” to 
biofeedback and quantify 
strength of response  

Biofeeback Schedule

6 week of
2x/week, in house 
training

Second 
Manometry 
6weeks at home 
exercises
Third Manometry
Utility of an Animated Bowel Biofeedback Training Routine to improve Bowel Function in Individuals 
With SCI -NCT02406859, October 10, 2016 

Published Work 
1. Korsten MA, Rosman AS, Ng A, Cavusoglu E, Spungen AM, Radulovic M, Wecht J, Bauman
WA.  Infusion of neostigmine-glycopyrrolate for bowel evacuation in persons with spinal cord
injury.  Am J Gastroenterol 2005;100(7):1560-5.
2. Korsten MA, Fajardo NR, Rosman AS, Creasey GH, Spungen AM, Bauman WA.  Difficulty
evacuation after spinal cord injury: Colonoic motility during sleep and effects of abdominal
wall stimulation.  J Rehabil Res Dev 2004;41(1):95-100.
3. Radulovic M, Spungen AM, Wecht JM, Korsten MA, Schilero GH, Bauman WA, Lesser M.
Effects of neostigmine and glycopyrrolate on pulmonary resistance in spinal cord injury.  J
Rehabil Res Dev 2004;41(1): 53-8.
4. Fajardo NR, Pasiliao RV, Modeste-Duncan R, Creasey G, Bauman WA, Korsten MA.
Decreased colonic motility in persons with chronic spinal cord injury.  Am J Gastroenterol
2003; 98(1):128-34.
5. Amir I, Sharma R, Bauman WA, Korsten MA.  Bowel care for individuals with spinal cord
injury: comparison of four approaches.  J Spinal Cord Med 1998;21(1):21-4.
6. Geders JM, Gaing A, Bauman WA, Korsten MA.  The effect of cisapride on segmental colonic
transit time in patients with spinal cord injury.  Am J Gastroenterol 1995;90(2):285-9.
7. Zhang RL, Chayes Z, Korsten MA, Bauman WA.  Gastric emptying rates to liquid or solid
meals appear to be unaffected by spinal cord injury.  Am J Gastroenterol 1994;89 (10):1856-8.
E. SIGNIFICANCE OF THIS RESEARCH
The VA cares for approximately 40,000 veterans with SCI.   In addition there are over 
200,000 non-veterans with SCI in the US.  Many of these individuals have neurogenic bowel and 
suffer from the embarrassment and social isolation caused by FI.  The life expectancy of SCI 
patients has dramatically increased, with most SCI patients living up to 60 years of age (10 years 
less than non SCI patients). Given that the average age of injury is 37 years and that 25% of SCI 
patients are between 19 to 25 years, these individuals have to live with the ignominy of fecal 
incontinence for many years to come. The current practice of using multifaceted programs for 
bowel care leaves much to be desired, as many SCI patients still suffer from FI and constipation. 
In this respect it has become urgent to develop other treatment options for neurogenic bowel 
complications in order to improve quality of life and to preempt further GI complications/  
Relevance of the proposed work to the VA patient care mission 
The VA system cares for a large number of persons with SCI, and FI and time consuming 
and cumbersome bowel care has been identified as a major QOL issue among the veterans. 
Despite extensive efforts to understand its pathophysiology and numerous clinical guidelines for 
its management, FI and constipation remain tenacious problems that limit the social interactions 
of veterans with SCI. The proposed work will result in the only known data regarding the 
efficacy of bowel biofeedback treatment and the outcome of FI in person with SCI. Furthermore, 
to the extent that biofeedback treatment can improve FI, this research should be cost effective 
because it would prevent physical and psychological comorbidities associated with neurogenic 
bowel as it is far less expensive to provide bio feedback treatment than to treat chronic 
conditions like depression arising from social isolation, and dermatological treatments arising 
from exposure of the skin to FI. Providing veterans with cutting edge preventive care is a key 
component of the VA patient care mission. 
Utility of an Animated Bowel Biofeedback Training Routine to improve Bowel Function in Individuals With 
SCI -NCT02406859, October 10, 2016 

F. LIST OF KEY BIBLIOGRAPHICAL REFERENCES
1.
Devivo, M.J., Epidemiology of traumatic spinal cord injury: trends and future
implications. Spinal Cord. 50(5): p. 365-72.
2.
Valles, M., et al., Bowel dysfunction in patients with motor complete spinal cord injury:
clinical, neurological, and pathophysiological associations. Am J Gastroenterol, 2006.
101(10): p. 2290-9.
3.
Krogh, K., et al., Colorectal function in patients with spinal cord lesions. Dis Colon
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Utility of an Animated Bowel Biofeedback Training Routine to improve Bowel Function in Individuals With SCI 
-NCT02406859, October 10, 2016