Fecal IncontinenceFIXNCT01717456
Educational-Medical-Behavioral Treatment of Fecal Incontinence
A study testing Education, Fiber supplements and Laxatives or anti-diarrheals in people with Fecal Incontinence, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
In previous studies at a university referral center the investigators demonstrated that a multicomponent conservative treatment for fecal incontinence was effective. The treatment combines patient education with medical management of diarrhea and constipation plus behavioral training. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fecal Incontinence
- What is being tested?
- Education, Fiber supplements and Laxatives or anti-diarrheals
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2013to Mar 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Self-reported fecal incontinence at least once a month
- Family caregiver available and willing to participate in treatment sessions and willing to assist patient with study procedures
- Patients and caregivers willing to be interviewed by a research assistant in their home on three occasions
- Onset of fecal incontinence more than 3 months previously (i.e., not transient fecal incontinence)
Who cannot join
- Has a stoma or fecal incontinence status is unknown
- Has fecal incontinence less than monthly
- Severe cognitive impairment (response of 4 on OASIS question M1700)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599-7080
About this study
Official title: Conservative Treatment of Fecal Incontinence: Community-Based Effectiveness Trial
In previous studies at a university referral center the investigators demonstrated that a multicomponent conservative treatment for fecal incontinence was effective. The treatment combines patient education with medical management of diarrhea and constipation plus behavioral training. The purpose of this study is to determine whether this treatment is effective when delivered by home health care nurses to frail elderly patients.
Read the detailed description
Fecal incontinence (FI) affects 9% of U.S. adults and occurs weekly or more often in 2.7%. Prevalence increases with age reaching 15% by 70 years. FI has a devastating impact on quality of life and substantially increases caregiver burden when patients have comorbid conditions requiring caregiver assistance. The investigators propose an effectiveness trial whose overall goal is to determine whether a conservative intervention which has been shown to be effective in single-site studies will sustain its efficacy when disseminated to a home bound population by home health care nurses. The treatment includes patient education about the physiology of how continence is maintained, pelvic floor exercises, behavioral strategies for preventing FI, and use of fiber or nonprescription medication to treat diarrhea or constipation. To minimize drift when the treatment is disseminated to a large group of providers, patient education and other basic components of treatment are included in a printed training manual and are available to nurse providers on a website; however, nurse supervision to individualize treatment remains important. The study will be carried out in 8 counties in central North Carolina which are served by the University of North Carolina Home Health Care and Rex Home Health Care agencies (partners in this study). Nurses in these agencies will be randomly assigned to two groups. For the first two years all patients of the nurses in one group will receive the active intervention while all patients of nurses in the other group will receive usual care plus a training manual and symptom monitoring to control for expectancy. After two years, all patients in these home health care agencies will receive the active intervention. After excluding patients with severe cognitive impairment and those with stomas, the investigators estimate 252 - 340 patients with FI who are over age 50 will receive treatment (at least 189 in active treatment and 63 controls). Specific aims are (1) to show that the active treatment is more effective than the control treatment for improving FI severity, patient quality of life, and caregiver burden, and that improvements are maintained for at least 6 months; (2) to identify moderators of treatment effectiveness (candidate variables are cognitive status, mobility impairment, willingness of family caregiver to assist with treatment, anxiety, depression, age, and race); and (3) to explore whether successful treatment of FI reduces the risk of nursing home referral.
- Conditions
- Fecal Incontinence
- Being tested
- Education, Fiber supplements, Laxatives or anti-diarrheals, Pelvic floor muscle exercises, Tips on how to prevent fecal incontinence
- Keywords
- Fecal incontinence, Frail elders, Home health care, Nurse, Patient education
- Medical subject headings
- Fecal Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EducationOther
Patient and caregiver will be taught which muscles are used in continence and defecation through the use of a training manual and anatomical drawings.
Fiber supplementsDietary supplement
Patients and caregivers will be taught to use fiber supplements to normalize stool consistency if patient reports diarrhea or constipation. Fiber supplements will be in the form of Metamucil beginning with 3.4 grams per day and increasing up to 13.6 grams per day if needed to control stool consistency.
Laxatives or anti-diarrhealsDrug
Also called Miralax (polyethylene glycol), Imodium (loperamide)
Miralax at a dose of one packet (17 grams) daily may be used for constipation if unresponsive to fiber. Dose may be titrated up to two packets (34 grams) daily if needed.
Imodium at a starting dose of 2 mg/day may be used for diarrhea if unresponsive to fiber. Dose of Imodium may be titrated down to 1 mg or up to 4 mg if needed.
Pelvic floor muscle exercisesBehavioural
Patients will be taught how to perform pelvic floor muscle contractions during digital rectal examination by a nurse. They will be asked to squeeze 100 times daily.
Tips on how to prevent fecal incontinenceBehavioural
Examples of behavioral tips are "Walk, don't run to the toilet" and "Squeeze before you lift objects or sneeze".
Daily diaryBehavioural
Both groups will keep a daily diary, but amount of detail differs: Active comparator group records bowel accidents, bowel movements, Bristol Stool ratings of stool consistency, number of times they do pelvic floor exercises, study medications, and comments for the nurse to read. Placebo comparator group records only bowel accidents, bowel movements, and Bristol Stool scores.
Protective pads or garmentsOther
Also called Continence pads
In both groups, patients will be permitted to use pads or protective garments to avoid embarrassment. They will be told that fecal leakage that is stopped by a pad or protective garment should still be recorded as fecal incontinence.
| Study group | Role | What they receive |
|---|---|---|
| Educational-Medical-Behavioral | Active comparator | Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives or anti-diarrheals [Miralax 1-2 packets (17-34 g)/day or Imodium 0.5-2 tablets (1-4 mg)/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, daily diary, and protective pads or garments [as needed]. Receives: Other: Education; Dietary Supplement: Fiber supplements; Drug: Laxatives or anti-diarrheals; Behavioral: Pelvic floor muscle exercises; Behavioral: Tips on how to prevent fecal incontinence; Behavioral: Daily diary; Other: Protective pads or garments |
| Standard Care | Placebo comparator | Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed]. Receives: Dietary Supplement: Fiber supplements; Behavioral: Daily diary; Other: Protective pads or garments |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fecal Incontinence Severity Index (FISI) at End of Treatment
At the end of treatment, the FISI requires the patient to report the frequency of occurrence of 4 types of fecal incontinence (solid, liquid, mucus, and gas incontinence) in the past month. These four responses are multiplied by empirically derived patient weights and the values are added together. Range of scores is 0-61. Higher scores show more severe fecal incontinence.
Measured: End of Treatment (Week 6)
Fecal Incontinence Severity Index (FISI) at Follow-Up (FU)
At follow up 6 months after the end of treatment, the subject reports the frequency of occurrence of 4 types of fecal incontinence (solid, liquid, mucus, and gas incontinence) in the past month. These four responses are multiplied by empirically derived patient weights and the values are added together. Range is 0-61. No data is available to interpret the scale as mild, moderate, or severe fecal incontinence.
Measured: 6 months after (6-Week) treatment ends
Secondary outcomes (23)
Adequate Relief of Fecal Incontinence at End of Treatment
At the end of treatment, the subject is asked, "Compared to before you started home health care, have you experienced adequate relief of your fecal incontinence symptoms? [Responses: yes or no]". A responder is anyone answering yes. A treatment would be judged successful if there was at least 10% more responders in the active compared to the control groups.
Measured: End of Treatment (Week 6)
Adequate Relief of Fecal Incontinence at Follow Up
At follow up 6 months after the end of treatment, the subject is asked, "Compared to before you started home health care, have you experienced adequate relief of your fecal incontinence symptoms? [Responses: yes or no]". A responder to treatment is a subject who answers "yes". When applied to group analysis, a treatment is regarded as effective if the responder rate is at least 10% greater in the active treatment arm compared to the control arm. This measure is not recorded at baseline because it is undefined until treatment has been provided.
Measured: 6 months after (6-Week) treatment ends
MHQ Severity Scale at End of Treatment
Quality of life scale specific to fecal incontinence. Severity is one of 8 MHQ subscales. This subscale has a range of 0 to 100. Higher scores indicate greater severity of QOL impact.
Measured: End of Treatment (Week 6)
MHQ Severity Scale at Follow Up
Quality of life scale specific to fecal incontinence. This is one of 8 subscales. This subscale has a range of 0 to 100. Higher scores indicate greater impact on quality of life.
Measured: 6 months after (6-Week) treatment ends
Zarit Caregiver Burden Scale at End of Treatment
Validated questionnaire developed to assess the psychosocial and health burden experienced by a family caregiver of the identified patient. The 22-items ask about behaviors and feelings of caregivers on a 6-step ordinal scale (never to almost always). The scale is valid for caregivers of individuals with diverse chronic disabilities (dementia, advanced cancer, acquired brain injury). The scale has good internal consistency. Total scores range 0-66, and 21 or greater is interpreted as high burden (J Clin Epidemiol 2010;63:535-42). Subscales (role and personal strain) have been described but are unreliable so total scores were used.
Measured: End of Treatment (Week 6)
Zarit Caregiver Burden Scale at Follow Up
Validated questionnaire developed to assess the psychosocial and health burden experienced by a family caregiver of the identified patient. The total score range is from 0 to 66. Higher scores indicate greater severity of burden on the family.
Measured: 6 months after (6-Week) treatment ends
Fecal Incontinence Frequency at End of Treatment
OASIS question M1620: Bowel incontinence frequency. Response options are:
0 - Very rarely or never has bowel incontinence
- - Less than once weekly
- - One to three times weekly
- - Four to six times weekly
- - On a daily basis
- - More often than once daily
Measured: End of Treatment (Week 6)
Urinary Incontinence Status Change From Baseline to End of Treatment
OASIS question M1610: Urinary incontinence or urinary catheter presence. Response options are:
0 - No incontinence or catheter (includes anuria or ostomy for urinary drainage)
- - Patient is incontinent
- - Patient requires a urinary catheter (i.e., external, indwelling, intermittent, suprapubic)
Measured: Baseline, end of treatment (week 6)
Admission to Nursing Home at End of Treatment
Was patient admitted to a nursing home for one or more days at any time between enrollment and follow-up 7-8 months after treatment onset.
Measured: End of Treatment (Week 6)
MHQ Incontinence Impact at End of Treatment
Quality of life scale specific to fecal incontinence. This is one of 8 subscales. This subscale has a range of 0-100, with higher scores signifying greater impairment in quality of life.
Measured: End of Treatment (Week 6)
MHQ Incontinence Impact at Follow Up
Quality of life scale specific to fecal incontinence. This is one of 8 subscales. This subscale has a range of 0-100, with higher scores signifying greater impairment in quality of life.
Measured: 6 months after (6-Week) treatment ends
MHQ Role Limitations at End of Treatment
Quality of life scale specific to fecal incontinence. This is one of 8 subscales. This subscale has a range of 0-100, with higher scores signifying greater impairment in quality of life.
Measured: End of Treatment (Week 6)
MHQ Role Limitations at Follow Up
Quality of life scale specific to fecal incontinence. This is one of 8 subscales. This subscale has a range of 0-100, with higher scores signifying greater impairment in quality of life.
Measured: 6 months after (6-Week) treatment ends
MHQ Physical Limitations at End of Treatment
Quality of life scale specific to fecal incontinence. This is one of 8 subscales. This subscale has a range of 0-100, with higher scores signifying greater impairment in quality of life.
Measured: End of Treatment (Week 6)
MHQ Physical Limitations at Follow Up
Quality of life scale specific to fecal incontinence. This is one of 8 subscales. This subscale has a range of 0-100, with higher scores signifying greater impairment in quality of life.
Measured: 6 months after (6-Week) treatment ends
MHQ Social Limitations at End of Treatment
Quality of life scale specific to fecal incontinence. This is one of 8 subscales. This subscale has a range of 0-100, with higher scores signifying greater impairment in quality of life.
Measured: End of Treatment (Week 6)
MHQ Social Limitations at Follow Up
Quality of life scale specific to fecal incontinence. This is one of 8 subscales. This subscale has a range of 0-100, with higher scores signifying greater impairment in quality of life.
Measured: 6 months after (6-Week) treatment ends
MHQ Personal Relationships at End of Treatment
Quality of life scale specific to fecal incontinence. This is one of 8 subscales. This subscale has a range of 0-100, with higher scores signifying greater impairment in quality of life.
Measured: End of Treatment (Week 6)
MHQ Personal Relationships at Follow Up
Quality of life scale specific to fecal incontinence. This is one of 8 subscales. This subscale has a range of 0-100, with higher scores signifying greater impairment in quality of life.
Measured: 6 months after (6-Week) treatment ends
MHQ Emotions at End of Treatment
Quality of life scale specific to fecal incontinence. This is one of 8 subscales. This subscale has a range of 0-100, with higher scores signifying greater impairment in quality of life.
Measured: End of Treatment (Week 6)
MHQ Emotions at Follow Up
Quality of life scale specific to fecal incontinence. This is one of 8 subscales. This subscale has a range of 0-100, with higher scores signifying greater impairment in quality of life.
Measured: 6 months after (6-Week) treatment ends
MHQ Sleep Energy at End of Treatment
Quality of life scale specific to fecal incontinence. This is one of 8 subscales. This subscale has a range of 0-100, with higher scores signifying greater impairment in quality of life.
Measured: End of Treatment (Week 6)
MHQ Sleep Energy at Follow Up
Quality of life scale specific to fecal incontinence. This is one of 8 subscales. This subscale has a range of 0-100, with higher scores signifying greater impairment in quality of life.
Measured: 6 months after (6-Week) treatment ends
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2012 (estimated)
- Study startJan 2013
- Primary completionMar 2015
- Study completionMar 2015
Why it stopped: Low enrollment led sponsor to terminate study early.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Fecal IncontinenceStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Responsible party
- Principal investigator, William (Bill) Whitehead, PhD, University of North Carolina, Chapel Hill
- Investigators
- William E Whitehead, PhD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01717456
- Sponsor's protocol ID
- 11-1569
- Other IDs
- R01HS018695
- Acronym
- FIX
- Status last verified
- Feb 2017
- First submitted
- 15 Sep 2012
- Last updated
- 17 Feb 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No: Insufficient data to be analyzed by an outside investigator.
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Conservative Treatment of Fecal Incontinence: Community-Based Effectiveness Trial
- ClinicalTrials.gov ID
- NCT01717456
- Acronym / sponsor ID
- FIX / 11-1569
- Conditions
- Fecal Incontinence
- Keywords
- Fecal incontinence, Frail elders, Home health care, Nurse, Patient education
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low enrollment led sponsor to terminate study early.
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Study start
- Jan 2013
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 30 Oct 2012 (estimated)
- Results
- Posted 17 Feb 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In previous studies at a university referral center the investigators demonstrated that a multicomponent conservative treatment for fecal incontinence was effective. The treatment combines patient education with medical management of diarrhea and constipation plus behavioral training. The purpose of this study is to determine whether this treatment is effective when delivered by home health care nurses to frail elderly patients.
Detailed description
Fecal incontinence (FI) affects 9% of U.S. adults and occurs weekly or more often in 2.7%. Prevalence increases with age reaching 15% by 70 years. FI has a devastating impact on quality of life and substantially increases caregiver burden when patients have comorbid conditions requiring caregiver assistance. The investigators propose an effectiveness trial whose overall goal is to determine whether a conservative intervention which has been shown to be effective in single-site studies will sustain its efficacy when disseminated to a home bound population by home health care nurses. The treatment includes patient education about the physiology of how continence is maintained, pelvic floor exercises, behavioral strategies for preventing FI, and use of fiber or nonprescription medication to treat diarrhea or constipation. To minimize drift when the treatment is disseminated to a large group of providers, patient education and other basic components of treatment are included in a printed training manual and are available to nurse providers on a website; however, nurse supervision to individualize treatment remains important. The study will be carried out in 8 counties in central North Carolina which are served by the University of North Carolina Home Health Care and Rex Home Health Care agencies (partners in this study). Nurses in these agencies will be randomly assigned to two groups. For the first two years all patients of the nurses in one group will receive the active intervention while all patients of nurses in the other group will receive usual care plus a training manual and symptom monitoring to control for expectancy. After two years, all patients in these home health care agencies will receive the active intervention. After excluding patients with severe cognitive impairment and those with stomas, the investigators estimate 252 - 340 patients with FI who are over age 50 will receive treatment (at least 189 in active treatment and 63 controls). Specific aims are (1) to show that the active treatment is more effective than the control treatment for improving FI severity, patient quality of life, and caregiver burden, and that improvements are maintained for at least 6 months; (2) to identify moderators of treatment effectiveness (candidate variables are cognitive status, mobility impairment, willingness of family caregiver to assist with treatment, anxiety, depression, age, and race); and (3) to explore whether successful treatment of FI reduces the risk of nursing home referral.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Educational-Medical-Behavioral | Active comparator | Other: Education, Dietary Supplement: Fiber supplements, Drug: Laxatives or anti-diarrheals, Behavioral: Pelvic floor muscle exercises, Behavioral: Tips on how to prevent fecal incontinence, Behavioral: Daily diary, Other: Protective pads or garmentsEducational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives or anti-diarrheals [Miralax 1-2 packets (17-34 g)/day or Imodium 0.5-2 tablets (1-4 mg)/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, daily diary, and protective pads or garments [as needed]. |
| Standard Care | Placebo comparator | Dietary Supplement: Fiber supplements, Behavioral: Daily diary, Other: Protective pads or garmentsStandard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed]. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Self-reported fecal incontinence at least once a month
- Family caregiver available and willing to participate in treatment sessions and willing to assist patient with study procedures
- Patients and caregivers willing to be interviewed by a research assistant in their home on three occasions
- Onset of fecal incontinence more than 3 months previously (i.e., not transient fecal incontinence)
Key exclusion criteria (3 listed)
- Has a stoma or fecal incontinence status is unknown
- Has fecal incontinence less than monthly
- Severe cognitive impairment (response of 4 on OASIS question M1700)
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 |
|---|---|---|
| EducationPatient and caregiver will be taught which muscles are used in continence and defecation through the use of a training manual and anatomical drawings. | Other | Educational-Medical-Behavioral |
| Fiber supplementsPatients and caregivers will be taught to use fiber supplements to normalize stool consistency if patient reports diarrhea or constipation. Fiber supplements will be in the form of Metamucil beginning with 3.4 grams per day and increasing up to 13.6 grams per day if needed to control stool consistency. | Dietary supplement | Educational-Medical-Behavioral, Standard Care |
| Laxatives or anti-diarrhealsAlso: Miralax (polyethylene glycol), Imodium (loperamide)Miralax at a dose of one packet (17 grams) daily may be used for constipation if unresponsive to fiber. Dose may be titrated up to two packets (34 grams) daily if needed. Imodium at a starting dose of 2 mg/day may be used for diarrhea if unresponsive to fiber. Dose of Imodium may be titrated down to 1 mg or up to 4 mg if needed. | Drug | Educational-Medical-Behavioral |
| Pelvic floor muscle exercisesPatients will be taught how to perform pelvic floor muscle contractions during digital rectal examination by a nurse. They will be asked to squeeze 100 times daily. | Behavioural | Educational-Medical-Behavioral |
| Tips on how to prevent fecal incontinenceExamples of behavioral tips are "Walk, don't run to the toilet" and "Squeeze before you lift objects or sneeze". | Behavioural | Educational-Medical-Behavioral |
| Daily diaryBoth groups will keep a daily diary, but amount of detail differs: Active comparator group records bowel accidents, bowel movements, Bristol Stool ratings of stool consistency, number of times they do pelvic floor exercises, study medications, and comments for the nurse to read. Placebo comparator group records only bowel accidents, bowel movements, and Bristol Stool scores. | Behavioural | Educational-Medical-Behavioral, Standard Care |
| Protective pads or garmentsAlso: Continence padsIn both groups, patients will be permitted to use pads or protective garments to avoid embarrassment. They will be told that fecal leakage that is stopped by a pad or protective garment should still be recorded as fecal incontinence. | Other | Educational-Medical-Behavioral, Standard Care |
Primary outcome
Fecal Incontinence Severity Index (FISI) at End of Treatment
Time frame: End of Treatment (Week 6)
At the end of treatment, the FISI requires the patient to report the frequency of occurrence of 4 types of fecal incontinence (solid, liquid, mucus, and gas incontinence) in the past month. These four responses are multiplied by empirically derived patient weights and the values are added together. Range of scores is 0-61. Higher scores show more severe fecal incontinence.
Fecal Incontinence Severity Index (FISI) at Follow-Up (FU)
Time frame: 6 months after (6-Week) treatment ends
At follow up 6 months after the end of treatment, the subject reports the frequency of occurrence of 4 types of fecal incontinence (solid, liquid, mucus, and gas incontinence) in the past month. These four responses are multiplied by empirically derived patient weights and the values are added together. Range is 0-61. No data is available to interpret the scale as mild, moderate, or severe fecal incontinence.
23 secondary outcomes
Adequate Relief of Fecal Incontinence at End of Treatment
Time frame: End of Treatment (Week 6)
Adequate Relief of Fecal Incontinence at Follow Up
Time frame: 6 months after (6-Week) treatment ends
MHQ Severity Scale at End of Treatment
Time frame: End of Treatment (Week 6)
MHQ Severity Scale at Follow Up
Time frame: 6 months after (6-Week) treatment ends
Zarit Caregiver Burden Scale at End of Treatment
Time frame: End of Treatment (Week 6)
Zarit Caregiver Burden Scale at Follow Up
Time frame: 6 months after (6-Week) treatment ends
Fecal Incontinence Frequency at End of Treatment
Time frame: End of Treatment (Week 6)
Urinary Incontinence Status Change From Baseline to End of Treatment
Time frame: Baseline, end of treatment (week 6)
Admission to Nursing Home at End of Treatment
Time frame: End of Treatment (Week 6)
MHQ Incontinence Impact at End of Treatment
Time frame: End of Treatment (Week 6)
MHQ Incontinence Impact at Follow Up
Time frame: 6 months after (6-Week) treatment ends
MHQ Role Limitations at End of Treatment
Time frame: End of Treatment (Week 6)
MHQ Role Limitations at Follow Up
Time frame: 6 months after (6-Week) treatment ends
MHQ Physical Limitations at End of Treatment
Time frame: End of Treatment (Week 6)
MHQ Physical Limitations at Follow Up
Time frame: 6 months after (6-Week) treatment ends
MHQ Social Limitations at End of Treatment
Time frame: End of Treatment (Week 6)
MHQ Social Limitations at Follow Up
Time frame: 6 months after (6-Week) treatment ends
MHQ Personal Relationships at End of Treatment
Time frame: End of Treatment (Week 6)
MHQ Personal Relationships at Follow Up
Time frame: 6 months after (6-Week) treatment ends
MHQ Emotions at End of Treatment
Time frame: End of Treatment (Week 6)
MHQ Emotions at Follow Up
Time frame: 6 months after (6-Week) treatment ends
MHQ Sleep Energy at End of Treatment
Time frame: End of Treatment (Week 6)
MHQ Sleep Energy at Follow Up
Time frame: 6 months after (6-Week) treatment ends
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. Insufficient data to be analyzed by an outside investigator.
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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.
William E Whitehead, PhD principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education, Fiber supplements and Laxatives or anti-diarrheals in people with Fecal Incontinence, run by University of North Carolina, Chapel Hill 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 4 inclusion and 3 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: stopped early, as of the sponsor's last update on 17 Feb 2017. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 17 Feb 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Fecal Incontinence Severity Index (FISI) at End of Treatment (time frame: End of Treatment (Week 6)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Feb 2017.