Home Versus Office Biofeedback Therapy for Fecal Incontinence
| Status: | Recruiting |
|---|---|
| Conditions: | Gastrointestinal |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 6/29/2018 |
| Start Date: | October 2015 |
| End Date: | September 2018 |
| Contact: | Satish Rao, MD, PhD |
| Email: | srao@augusta.edu |
| Phone: | 7067212238 |
Biofeedback therapy is a labor-intensive, multi-disciplinary, team approach for the
management of patients with Fecal Incontinence. It is not easily available to the vast
majority of patients in the community with this problem. It is therefore imperative that a
more pragmatic therapeutic approach that can be administered easily in the community ought to
be developed. However, whether a treatment program that is based on home-training can be just
as useful as office-based training has not been evaluated. The purpose of this study is to
assess whether having patients train their pelvic floor muscles at home is as effective as
in-office biofeedback training.
management of patients with Fecal Incontinence. It is not easily available to the vast
majority of patients in the community with this problem. It is therefore imperative that a
more pragmatic therapeutic approach that can be administered easily in the community ought to
be developed. However, whether a treatment program that is based on home-training can be just
as useful as office-based training has not been evaluated. The purpose of this study is to
assess whether having patients train their pelvic floor muscles at home is as effective as
in-office biofeedback training.
The specific hypotheses that will be tested are:
1. Home training produces a similar degree of improvement as office biofeedback in
1. overall number of episodes of fecal incontinence
2. normalization of anorectal manometric pressures
3. Overall quality of life and symptom perception on previously validated Fecal
Incontinence questionnaires
Thirty patients with fecal incontinence will be recruited for this eight week therapeutic
investigation. Fecal Incontinence will be defined as at least 1 episode of solid or liquid
stool leakage per week. All patients will provide a detailed history and undergo physical
examination, structural (colonoscopy within 10 years) and anorectal manometry. Once eligible
for screening, they will sign a consent form and maintain a 2-week prospective stool diary.
If the diary confirms Fecal Incontinence and the inclusion criteria are met, they will be
enrolled into the study.
After enrollment, patients will be randomized to receive either office-based biofeedback
therapy or home-training.
Office-Training: Patients randomized to receive office-based biofeedback therapy will receive
an outpatient treatment of neuromuscular pelvic-floor conditioning using biofeedback
techniques. In order to improve the pelvic floor muscle coordination and abdominal effort
during defecation, patients will be taught pelvic floor and abdominal muscle coordination
exercise. Here, the patients are taught to perform kegal-type exercises as well as distend
the abdomen by inhaling slowly and then to hold their breath for at least 15 seconds. They
are asked to practice this maneuver for 20 minutes, two or three times a day. Patients will
be asked to attend the motility laboratory, approximately once every week. Biofeedback
therapy will be performed at these clinic office visits by placing a manometry probe that
consists of three pressure sensors and a balloon into the anorectum. The pressure sensors are
located at 1cm and 2.5 cm from the anal verge and the rectal sensor at 9cm. A 4 cm long latex
balloon will be fashioned around the rectal sensor. After probe placement, the patient will
remain clothed and seated on a commode in front of a monitor throughout the study.
Anal and pelvic floor muscle training: The goal is to improve the strength coordination and
isolation of pelvic floor muscles. Firstly, patients are instructed to isolate the anal
sphincter and puborectalis muscles and improve its strength by using modified Kegel exercises
in the sitting or lying position with a probe inserted. Visual and verbal feedback techniques
are used to reinforce the maneuvers, as they are being performed. The anal and rectal
pressure changes displayed on the monitor provides visual feedback to the patient. The verbal
feedback is provided by the therapist and consists of either complimenting the patient for
performing a correct maneuver or rectifying any errors. The patient is instructed to squeeze
and to maintain the squeeze for as long as possible. During the maneuver, the patient
observes the monitor and is educated about the changes in anal pressure/EMG activity. For
comparison, a normal recording is shown. As the sphincter strength improves, the patient is
encouraged to maintain a voluntary contraction for at least 30 seconds. Patients are
instructed not to use their abdominal or gluteal muscles to achieve a voluntary squeeze.
After a few sessions, the patient is encouraged to perform these maneuvers without visual
feedback. The patient is also instructed to perform squeeze exercises at home for at least 20
minutes, two to three times a day, and to perform about 20 squeeze maneuvers per session.
Training may be discontinued when patients demonstrate: A reduction in the number of
incontinence episodes and improvement in anal squeeze pressure and recto-anal coordination
when squeezing. Patients also receive sensory-motor coordination training. The objective here
is to achieve a maximum voluntary squeeze in less than 1 second after inflation of a rectal
balloon and to control the reflex anal relaxation by consciously contracting the sphincter
muscles.
Those randomized to receive home-training will first receive advice regarding standard
treatment for fecal incontinence as described previously. Also, they will be asked to attend
the motility lab every two weeks to check on the training parameter and recheck the
electrical stimulation intensity if it is still appropriate for the training.
During this session, they will be educated regarding the use of the home-trainer device.
After general instructions, the investigators will place a reusable, manometry attached with
electrical transducer probe into their rectum. Patients will be fitted with Velcro straps
that the research team will assist in fitting the patient for. These Velcro straps will allow
the probe to stay in place so that the patient will not be required to hold the probe in
place throughout the entire training session and thus free up their dominant hand. The probe
will be connected to a hand- held pressure sensing device and battery charged monitor with
color illuminations to indicate the patient's response.
This is an FDA approved device for use in fecal incontinence. Next, the patient will be asked
to lay down on the side of their non-dominant hand, and with their dominant hand they will
inflate the manometry probe to a level they consider comfortable, tolerable and "full". If
the patient reports this feeling to be tolerable for sustained daily exercise, this volume
level will be recorded and maintained for their first two weeks of at home training. Patients
will then self-stimulate electrical transducers on the probe to a level they consider
tolerable for sustained at-home exercise. This level will also be used for their electrical
stimulation throughout their first two weeks of in-home training. At this time the patient is
ready to begin their first training session. The device will provide voice-guided
instructions for the patients self-directed biofeedback exercise, as well as visual and audio
feedback during these pelvic floor muscle toning exercises. Thus, by observing the number of
lights that are activated, the patient receives instant feedback about their performance.
Initially, the electrical simulations will be set at the highest initial comfortable level
for most individuals. Thereafter, at subsequent office visits, appropriate adjustments will
be made and suitable targets designed for each patient to achieve the desired goal of pelvic
floor strengthening.
The patient will be instructed by the InTone device's training paradigm, at least twice a day
and practice a minimum of 20 minutes of 10 second sustained squeezing then follow by 5
minutes of rectal electrical stimulation with the device.
After each use, the probe can be rinsed with soap and water and reused. The training device
is battery powered and can be recharged. Once charged the power lasts for at least 30 days
and should facilitate the use of this device between office follow-up sessions.
Patient compliance will be automatically monitored and stored in the device recorder. After
two weeks of home-training, the patients will return for a follow up assessment and exercise
compliance will be reviewed. Based on their progress, newer targets will be set by adjusting
the electrical stimulation levels of the training device. During this visit, any other
problems or issues will also be addressed. Four weeks later they will be asked to return
again and during this visit a repeat anorectal manometry assessment will be performed and
patients will complete post-treatment questionnaires.
1. Home training produces a similar degree of improvement as office biofeedback in
1. overall number of episodes of fecal incontinence
2. normalization of anorectal manometric pressures
3. Overall quality of life and symptom perception on previously validated Fecal
Incontinence questionnaires
Thirty patients with fecal incontinence will be recruited for this eight week therapeutic
investigation. Fecal Incontinence will be defined as at least 1 episode of solid or liquid
stool leakage per week. All patients will provide a detailed history and undergo physical
examination, structural (colonoscopy within 10 years) and anorectal manometry. Once eligible
for screening, they will sign a consent form and maintain a 2-week prospective stool diary.
If the diary confirms Fecal Incontinence and the inclusion criteria are met, they will be
enrolled into the study.
After enrollment, patients will be randomized to receive either office-based biofeedback
therapy or home-training.
Office-Training: Patients randomized to receive office-based biofeedback therapy will receive
an outpatient treatment of neuromuscular pelvic-floor conditioning using biofeedback
techniques. In order to improve the pelvic floor muscle coordination and abdominal effort
during defecation, patients will be taught pelvic floor and abdominal muscle coordination
exercise. Here, the patients are taught to perform kegal-type exercises as well as distend
the abdomen by inhaling slowly and then to hold their breath for at least 15 seconds. They
are asked to practice this maneuver for 20 minutes, two or three times a day. Patients will
be asked to attend the motility laboratory, approximately once every week. Biofeedback
therapy will be performed at these clinic office visits by placing a manometry probe that
consists of three pressure sensors and a balloon into the anorectum. The pressure sensors are
located at 1cm and 2.5 cm from the anal verge and the rectal sensor at 9cm. A 4 cm long latex
balloon will be fashioned around the rectal sensor. After probe placement, the patient will
remain clothed and seated on a commode in front of a monitor throughout the study.
Anal and pelvic floor muscle training: The goal is to improve the strength coordination and
isolation of pelvic floor muscles. Firstly, patients are instructed to isolate the anal
sphincter and puborectalis muscles and improve its strength by using modified Kegel exercises
in the sitting or lying position with a probe inserted. Visual and verbal feedback techniques
are used to reinforce the maneuvers, as they are being performed. The anal and rectal
pressure changes displayed on the monitor provides visual feedback to the patient. The verbal
feedback is provided by the therapist and consists of either complimenting the patient for
performing a correct maneuver or rectifying any errors. The patient is instructed to squeeze
and to maintain the squeeze for as long as possible. During the maneuver, the patient
observes the monitor and is educated about the changes in anal pressure/EMG activity. For
comparison, a normal recording is shown. As the sphincter strength improves, the patient is
encouraged to maintain a voluntary contraction for at least 30 seconds. Patients are
instructed not to use their abdominal or gluteal muscles to achieve a voluntary squeeze.
After a few sessions, the patient is encouraged to perform these maneuvers without visual
feedback. The patient is also instructed to perform squeeze exercises at home for at least 20
minutes, two to three times a day, and to perform about 20 squeeze maneuvers per session.
Training may be discontinued when patients demonstrate: A reduction in the number of
incontinence episodes and improvement in anal squeeze pressure and recto-anal coordination
when squeezing. Patients also receive sensory-motor coordination training. The objective here
is to achieve a maximum voluntary squeeze in less than 1 second after inflation of a rectal
balloon and to control the reflex anal relaxation by consciously contracting the sphincter
muscles.
Those randomized to receive home-training will first receive advice regarding standard
treatment for fecal incontinence as described previously. Also, they will be asked to attend
the motility lab every two weeks to check on the training parameter and recheck the
electrical stimulation intensity if it is still appropriate for the training.
During this session, they will be educated regarding the use of the home-trainer device.
After general instructions, the investigators will place a reusable, manometry attached with
electrical transducer probe into their rectum. Patients will be fitted with Velcro straps
that the research team will assist in fitting the patient for. These Velcro straps will allow
the probe to stay in place so that the patient will not be required to hold the probe in
place throughout the entire training session and thus free up their dominant hand. The probe
will be connected to a hand- held pressure sensing device and battery charged monitor with
color illuminations to indicate the patient's response.
This is an FDA approved device for use in fecal incontinence. Next, the patient will be asked
to lay down on the side of their non-dominant hand, and with their dominant hand they will
inflate the manometry probe to a level they consider comfortable, tolerable and "full". If
the patient reports this feeling to be tolerable for sustained daily exercise, this volume
level will be recorded and maintained for their first two weeks of at home training. Patients
will then self-stimulate electrical transducers on the probe to a level they consider
tolerable for sustained at-home exercise. This level will also be used for their electrical
stimulation throughout their first two weeks of in-home training. At this time the patient is
ready to begin their first training session. The device will provide voice-guided
instructions for the patients self-directed biofeedback exercise, as well as visual and audio
feedback during these pelvic floor muscle toning exercises. Thus, by observing the number of
lights that are activated, the patient receives instant feedback about their performance.
Initially, the electrical simulations will be set at the highest initial comfortable level
for most individuals. Thereafter, at subsequent office visits, appropriate adjustments will
be made and suitable targets designed for each patient to achieve the desired goal of pelvic
floor strengthening.
The patient will be instructed by the InTone device's training paradigm, at least twice a day
and practice a minimum of 20 minutes of 10 second sustained squeezing then follow by 5
minutes of rectal electrical stimulation with the device.
After each use, the probe can be rinsed with soap and water and reused. The training device
is battery powered and can be recharged. Once charged the power lasts for at least 30 days
and should facilitate the use of this device between office follow-up sessions.
Patient compliance will be automatically monitored and stored in the device recorder. After
two weeks of home-training, the patients will return for a follow up assessment and exercise
compliance will be reviewed. Based on their progress, newer targets will be set by adjusting
the electrical stimulation levels of the training device. During this visit, any other
problems or issues will also be addressed. Four weeks later they will be asked to return
again and during this visit a repeat anorectal manometry assessment will be performed and
patients will complete post-treatment questionnaires.
Inclusion Criteria:
- recurrent episodes of fecal incontinence for six months
- no mucosal disease
- on a two week stool diary patient will report at least one episode of incontinence a
week
Exclusion Criteria:
- severe diarrhea
- on opioids, tricyclics (except on stable doses > 3months)
- active depression
- comorbid illnesses, severe cardiac disease, chronic renal failure or previous
gastrointestinal surgery except cholecystectomy and appendectomy
- neurologic diseases (e.g. head injury, epilepsy, multiple sclerosis, strokes, spinal
cord injury)
- impaired cognizance (mini mental score of < 15) and/or legally blind
- metal implants, pacemakers
- previous pelvic surgery, bladder repair, radical hysterectomy
- ulcerative and Crohn's colitis
- rectal prolapse, anal fissure, anal surgery or inflamed hemorrhoids
- pregnant women or nursing mothers
We found this trial at
1
site
Augusta, Georgia 30912
Principal Investigator: Satish SC Rao, MD, PhD
Phone: 706-721-1968
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