ConstipationNCT04159350
Point-of-care Anorectal Testing to Predict Outcomes With Biofeedback Therapy: Clinical Trial
A study testing Rectal Expulsion Device (RED) - Feasibility and Rectal Expulsion Device (RED) - Validation in people with Constipation, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
Trial summary
To prospectively evaluate the clinical utility of baseline anorectal function testing using a point-of-care device in predicting response of chronically constipated patients to physical therapy biofeedback training. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Constipation
- What is being tested?
- Rectal Expulsion Device (RED) - Feasibility and Rectal Expulsion Device (RED) - Validation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jun 2020to 13 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- individuals aged 18-80 with a body mass index of 18 to 40 kg/m2 and a primary ICD-10 diagnosis for constipation (K59*) or referral for constipation.
- Does the patient meet Rome IV criteria for functional constipation (FC)?
- Does the patient report that fiber or laxative therapy has been ineffective to treat constipation in a documented treatment trial for at least two weeks prior to screening?
- Patient is already scheduled for anorectal manometry and physical therapy as part of routine care.
- The patient must agree to maintain their current dietary fiber intake and osmotic or bulk-forming laxative regimen (if any) throughout the trial
- The patient must agree to use stimulant laxatives (such as magnesium citrate [Milk of Magnesia], senna or bisacodyl [Dulcolax]) NO MORE THAN two days per week during the trial
- Patient must be able to participate in physical therapy for biofeedback
- Individuals must have health insurance coverage to undergo anorectal function testing and biofeedback therapy as part of their non-study routine clinical care
Who cannot join
- adults unable to consent, individuals who are not yet adults, pregnant women, and prisoners, as they would be unable to reasonably comply with physical therapy within the duration of the study and would thus undergo unnecessary testing.
- Patient must NOT have tried biofeedback therapy or undergone anorectal manometry previously
- Patient must NOT report prior SURGERY involving the colon or rectum (including surgery for anal fissure, rectal prolapse)
- Patient must NOT recent opioid use within 30 days of enrollment
- Patient must NOT report a neurodegenerative condition (i.e. Parkinson's disease, dementia, multiple sclerosis, spinal cord injury) or uncontrolled inflammatory bowel disease
- Patient must NOT have used linaclotide (Linzess), lubiprostone (Amitiza), plecanatide (Trulance), tegaserod (Zelnorm) or prucalopride (Motegrity) within 30 days prior to enrollment. Patients MUST agree not to use these agents during the trial
Trial locations and contacts
1 site in 1 country.
United States1 site
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
About this study
To prospectively evaluate the clinical utility of baseline anorectal function testing using a point-of-care device in predicting response of chronically constipated patients to physical therapy biofeedback training.
Read the detailed description
Chronic constipation affects 10-20% of the US population and can impact quality-of-life to a similar degree as congestive heart failure or rheumatoid arthritis. Notably, 700,000 individuals present to the emergency department for constipation each year in the US and $10 billion is spent annually on laxative therapy. For symptomatic chronic constipation refractory to fiber or laxative therapy, clinical practice guidelines recommend physiological testing to identify abnormalities in anorectal function as the next step5. Abnormal anorectal function testing (including anorectal manometry and balloon expulsion testing) suggests an evacuation disorder, the most common of which is dyssynergic defecation or dyssynergia. Identification of patients with an evacuation disorder as a primary driver of constipation is important since therapy can then be targeted.
To enable standardized, accessible chronic constipation testing for general gastroenterologists, the investigators invented an office-based, point-of-care Rectal Expulsion Device (RED). By incorporating RED into a general gastroenterologist's outpatient visit, chronically constipated individuals with abnormal anorectal function can be identified quickly and directly triaged to biofeedback therapy. Thus, RED offers the possibility of disrupting the current treatment paradigm by enabling an initial biomarker based strategy for patients with chronic constipation. Before such a process of care can be realized, there is a critical need for prospective data to determine the best setting for anorectal function testing in the clinical care pathway. The investigators aim to prospectively evaluate the clinical utility of baseline anorectal function testing using RED in identifying chronically constipated patients with evacuation disorders who would benefit from biofeedback therapy.
The investigators will conduct a 12-week clinical trial enrolling individuals with laxative-refractory chronic constipation. All study participants will undergo RED and traditional lab-based testing at baseline, followed by a standardized three-session biofeedback protocol for dyssynergia.
- Conditions
- Constipation
- Being tested
- Rectal Expulsion Device (RED) - Feasibility, Rectal Expulsion Device (RED) - Validation
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rectal Expulsion Device (RED) - FeasibilityDevice
After a complete physical exam at bedside including a digital rectal exam, the patient is turned on their side and RED is gently inserted into the rectum. The patient is then given one minute to expel RED while remaining on their side. If the patient is unable to pass RED, the patient transfers to a commode and attempts to expel the device. If the device is not expelled, the device can be safely removed at bedside and the patient diagnosed with a biofeedback-responsive evacuation disorder.
The RED device is manufactured by Rose Medical (Grand Rapids, MI) under GMP conditions and final assembly is performed by In2Being (Saline, MI). The device contains accepted technologies that are already in use of humans, namely biomedical grade materials.
Rectal Expulsion Device (RED) - ValidationDevice
After a complete physical exam at bedside including a digital rectal exam, the patient is turned on their LEFT side and RED is gently inserted into the rectum. The patient then attempts to expel RED while remaining on their side. If the patient is unable to pass RED, the patient transfers to a commode and attempts to expel the device. If the device is not expelled, the device can be safely removed at bedside and the patient diagnosed with a biofeedback-responsive evacuation disorder.
The RED device is manufactured by Rose Medical (Grand Rapids, MI) under GMP conditions and final assembly is performed by In2Being (Saline, MI). The device contains accepted technologies that are already in use of humans, namely biomedical grade materials.
| Study group | Role | What they receive |
|---|---|---|
| Rectal Expulsion Device (RED) - Feasibility | Experimental | Feasibility Phase. Receives: Device: Rectal Expulsion Device (RED) - Feasibility |
| Rectal Expulsion Device (RED) - Validation | Experimental | Validation Phase. Receives: Device: Rectal Expulsion Device (RED) - Validation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessing Change of Global Constipation Symptoms at completion of physical therapy
The Patient Assessment of Constipation-Symptoms (PAC-SYM) questionnaire is a short, easily-completed instrument for assessing global constipation symptoms. A total PAC-SYM score ranges from 0 to 48.
Measured: Week 0 and 12
Secondary outcomes (7)
Measure Change in Bowel Movement Frequency at completion of physical therapy
Measure 7-day average of bowel movement frequency (number of complete spontaneous bowel movements per week and number of spontaneous bowel movements per week). This information will be gathered at week 0 and week 12 in order to measure the change.
Measured: Week 0 and Week 12
Measure Change in Bowel Movement Form at completion of physical therapy
Using the Bristol Stool Scale at week 0 and week 12 measure the change in bowel movement form. The scale breaks down bowel movements into seven different categories based on the appearance of the stool. Stool type 1 indicates hard, lumpy stool and stool type 7 indicates watery stool.
Measured: Week 0 and Week 12
Measure Change in Severity of Straining for Bowel Movements at completion of physical therapy
Using the 5-point Likert scale at week 0 and week 12 to measure the severity of straining during bowel movements. Lower scores indicate less straining. Higher scores indicate more straining.
Measured: Week 0 and Week 12
Measure Change in Severity of Abdominal Discomfort for Bowel Movements at completion of physical therapy
Using the 5-point Likert scale at week 0 and week 12 to measure the severity of abdominal discomfort during bowel movements. Lower scores indicate less abdominal discomfort. Higher scores indicate more abdominal discomfort.
Measured: Week 0 and Week 12
Measure Change in Severity of Bloating for Bowel Movements at completion of physical therapy
Using the 5-point Likert scale at week 0 and week 12 to measure the severity of bloating. Lower scores indicate less bloating. Higher scores indicate more bloating.
Measured: Week 0 and Week 12
Measure Change in Severity of Constipation Severity for Bowel Movements at completion of physical therapy
Using the 5-point Likert scale at week 0 and week 12 to measure the severity of straining during bowel movements. Lower scores indicate less severity. Higher scores indicate more severity.
Measured: Week 0 and Week 12
Assess the Level of Treatment Satisfaction
Using the 5-point Likert scale at week 12 to measure the level of treatment satisfaction. Lower scores indicate less satisfaction. Higher scores indicate more satisfaction.
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2019
- Study start15 Jun 2020
- Primary completion13 Sep 2021
- Study completion13 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ConstipationStudies of the same condition, open and under way.
- More trials run by Dartmouth-Hitchcock Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- American Gastroenterological Association
- Responsible party
- Principal investigator, Eric.D.Shah, Dartmouth-Hitchcock Medical Center
- Investigators
- Eric D. Shah, MD, Principal investigator, Dartmouth-Hitchcock Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04159350
- Sponsor's protocol ID
- D19162
- Status last verified
- Jan 2022
- First submitted
- 6 Nov 2019
- Last updated
- 19 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Shah ED, Pelletier EA, Greeley C, Sieglinger EE, Sanchez JD, Northam KA, Perrone JA, Curley MA, Navas CM, Ostler TL, Burnett Greeley AR, Martinez-Camblor P, Baker JR, Chey WD. Utility of Anorectal Testing to Predict Outcomes With Pelvic Floor Physical Therapy in Chronic Constipation: Pragmatic Trial. Clin Gastroenterol Hepatol. 2023 Apr;21(4):1070-1081. doi: 10.1016/j.cgh.2022.05.014. Epub 2022 May 29.
PubMed 35640864Shah ED, Pelletier EA, Greeley C, Sieglinger EE, Sanchez JD, Northam KA, Perrone JA, Curley MA, Navas CM, Ostler TL, Burnett Greeley AR, Martinez-Camblor P, Baker JR, Harris A, Siegel CA, Chey WD. An Office-Based, Point-of-Care Test Predicts Treatment Outcomes With Community-Based Pelvic Floor Physical Therapy in Patients With Chronic Constipation. Clin Gastroenterol Hepatol. 2023 Apr;21(4):1082-1090. doi: 10.1016/j.cgh.2022.03.022. Epub 2022 Mar 24.
PubMed 35341952
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Point-of-care Anorectal Testing to Predict Outcomes With Biofeedback Therapy: Clinical Trial
- ClinicalTrials.gov ID
- NCT04159350
- Acronym / sponsor ID
- D19162
- Conditions
- Constipation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Collaborators
- American Gastroenterological Association
- Study start
- 15 Jun 2020 (actual)
- Primary completion
- 13 Sep 2021 (actual)
- Study completion
- 13 Sep 2021 (actual)
- First posted
- 12 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To prospectively evaluate the clinical utility of baseline anorectal function testing using a point-of-care device in predicting response of chronically constipated patients to physical therapy biofeedback training.
Detailed description
Chronic constipation affects 10-20% of the US population and can impact quality-of-life to a similar degree as congestive heart failure or rheumatoid arthritis. Notably, 700,000 individuals present to the emergency department for constipation each year in the US and $10 billion is spent annually on laxative therapy. For symptomatic chronic constipation refractory to fiber or laxative therapy, clinical practice guidelines recommend physiological testing to identify abnormalities in anorectal function as the next step5. Abnormal anorectal function testing (including anorectal manometry and balloon expulsion testing) suggests an evacuation disorder, the most common of which is dyssynergic defecation or dyssynergia. Identification of patients with an evacuation disorder as a primary driver of constipation is important since therapy can then be targeted.
To enable standardized, accessible chronic constipation testing for general gastroenterologists, the investigators invented an office-based, point-of-care Rectal Expulsion Device (RED). By incorporating RED into a general gastroenterologist's outpatient visit, chronically constipated individuals with abnormal anorectal function can be identified quickly and directly triaged to biofeedback therapy. Thus, RED offers the possibility of disrupting the current treatment paradigm by enabling an initial biomarker based strategy for patients with chronic constipation. Before such a process of care can be realized, there is a critical need for prospective data to determine the best setting for anorectal function testing in the clinical care pathway. The investigators aim to prospectively evaluate the clinical utility of baseline anorectal function testing using RED in identifying chronically constipated patients with evacuation disorders who would benefit from biofeedback therapy.
The investigators will conduct a 12-week clinical trial enrolling individuals with laxative-refractory chronic constipation. All study participants will undergo RED and traditional lab-based testing at baseline, followed by a standardized three-session biofeedback protocol for dyssynergia.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rectal Expulsion Device (RED) - Feasibility | Experimental | Device: Rectal Expulsion Device (RED) - FeasibilityFeasibility Phase. |
| Rectal Expulsion Device (RED) - Validation | Experimental | Device: Rectal Expulsion Device (RED) - ValidationValidation Phase. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- individuals aged 18-80 with a body mass index of 18 to 40 kg/m2 and a primary ICD-10 diagnosis for constipation (K59*) or referral for constipation.
Key exclusion criteria (6 listed)
- adults unable to consent, individuals who are not yet adults, pregnant women, and prisoners, as they would be unable to reasonably comply with physical therapy within the duration of the study and would thus undergo unnecessary testing.
- Patient must NOT have tried biofeedback therapy or undergone anorectal manometry previously
- Patient must NOT report prior SURGERY involving the colon or rectum (including surgery for anal fissure, rectal prolapse)
- Patient must NOT recent opioid use within 30 days of enrollment
- Patient must NOT report a neurodegenerative condition (i.e. Parkinson's disease, dementia, multiple sclerosis, spinal cord injury) or uncontrolled inflammatory bowel disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rectal Expulsion Device (RED) - FeasibilityAfter a complete physical exam at bedside including a digital rectal exam, the patient is turned on their side and RED is gently inserted into the rectum. The patient is then given one minute to expel RED while remaining on their side. If the patient is unable to pass RED, the patient transfers to a commode and attempts to expel the device. If the device is not expelled, the device can be safely removed at bedside and the patient diagnosed with a biofeedback-responsive evacuation disorder. The RED device is manufactured by Rose Medical (Grand Rapids, MI) under GMP conditions and final assembly is performed by In2Being (Saline, MI). The device contains accepted technologies that are already in use of humans, namely biomedical grade materials. | Device | Rectal Expulsion Device (RED) - Feasibility |
| Rectal Expulsion Device (RED) - ValidationAfter a complete physical exam at bedside including a digital rectal exam, the patient is turned on their LEFT side and RED is gently inserted into the rectum. The patient then attempts to expel RED while remaining on their side. If the patient is unable to pass RED, the patient transfers to a commode and attempts to expel the device. If the device is not expelled, the device can be safely removed at bedside and the patient diagnosed with a biofeedback-responsive evacuation disorder. The RED device is manufactured by Rose Medical (Grand Rapids, MI) under GMP conditions and final assembly is performed by In2Being (Saline, MI). The device contains accepted technologies that are already in use of humans, namely biomedical grade materials. | Device | Rectal Expulsion Device (RED) - Validation |
Primary outcome
Assessing Change of Global Constipation Symptoms at completion of physical therapy
Time frame: Week 0 and 12
The Patient Assessment of Constipation-Symptoms (PAC-SYM) questionnaire is a short, easily-completed instrument for assessing global constipation symptoms. A total PAC-SYM score ranges from 0 to 48.
7 secondary outcomes
Measure Change in Bowel Movement Frequency at completion of physical therapy
Time frame: Week 0 and Week 12
Measure Change in Bowel Movement Form at completion of physical therapy
Time frame: Week 0 and Week 12
Measure Change in Severity of Straining for Bowel Movements at completion of physical therapy
Time frame: Week 0 and Week 12
Measure Change in Severity of Abdominal Discomfort for Bowel Movements at completion of physical therapy
Time frame: Week 0 and Week 12
Measure Change in Severity of Bloating for Bowel Movements at completion of physical therapy
Time frame: Week 0 and Week 12
Measure Change in Severity of Constipation Severity for Bowel Movements at completion of physical therapy
Time frame: Week 0 and Week 12
Assess the Level of Treatment Satisfaction
Time frame: Week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2022.
- Derived from this study: PubMed 35640864Shah ED, Pelletier EA, Greeley C, Sieglinger EE, Sanchez JD, Northam KA, Perrone JA, Curley MA, Navas CM, Ostler TL, Burnett Greeley AR, Martinez-Camblor P, Baker JR, Chey WD. Utility of Anorectal Testing to Predict Outcomes With Pelvic Floor Physical Therapy in Chronic Constipation: Pragmatic Trial. Clin Gastroenterol Hepatol. 2023 Apr;21(4):1070-1081. doi: 10.1016/j.cgh.2022.05.014. Epub 2022 May 29.
- Derived from this study: PubMed 35341952Shah ED, Pelletier EA, Greeley C, Sieglinger EE, Sanchez JD, Northam KA, Perrone JA, Curley MA, Navas CM, Ostler TL, Burnett Greeley AR, Martinez-Camblor P, Baker JR, Harris A, Siegel CA, Chey WD. An Office-Based, Point-of-Care Test Predicts Treatment Outcomes With Community-Based Pelvic Floor Physical Therapy in Patients With Chronic Constipation. Clin Gastroenterol Hepatol. 2023 Apr;21(4):1082-1090. doi: 10.1016/j.cgh.2022.03.022. Epub 2022 Mar 24.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric D. Shah, MD principal investigator
Dartmouth-Hitchcock Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rectal Expulsion Device (RED) - Feasibility and Rectal Expulsion Device (RED) - Validation in people with Constipation, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessing Change of Global Constipation Symptoms at completion of physical therapy (time frame: Week 0 and 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04159350, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2022.