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Fecal Incontinence Treatment (FIT) Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03811821
Recruitment Status : Recruiting
First Posted : January 21, 2019
Last Update Posted : June 18, 2019
Sponsor:
Collaborators:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Mayo Clinic
Colon and Rectal Surgery Associates, Ltd.
Augusta University
RTI International
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

Brief Summary:
Patients with severe fecal incontinence (FI), defined as two or more episodes of staining, solid or liquid FI per week, and who meet the inclusion criteria for sacral nerve electrical stimulation (SNS), Injection of Solesta (INJ; an inert bulking agent), or Biofeedback (BIO) will be enrolled. The baseline rate of FI will be assessed using a 2-week daily stool diary. All participants will initially be enrolled into a 4-week trial of Enhanced Medical Management (EMM; education, pelvic floor exercises, and use of non-prescription drugs to normalize stool consistency). Those who demonstrate at least a 75% reduction in FI frequency will not be randomized to one of the three treatment groups but will be followed-up for two years. Those not showing a 75% reduction in FI frequency will be randomized to BIO, SNS, or INJ and will be evaluated three months later with respect to efficacy for reducing the frequency of fecal incontinence, safety of the interventions, and cost of providing care. All participants who experience a 75% decrease in FI after three months of treatment, compared to baseline, will be followed-up for a further 21 months, for a total of 24 months from the time of treatment initiation. To assess the long-term response to treatment, those who improve less than 75% in FI episodes will be offered an additional treatment with one of the two treatments to which they were not randomized. Anorectal manometry and Magnetic Evoked Potentials will be used to subtype the physiological basis for FI. Quality of life and psychological factors will be used to assess outcomes.

Condition or disease Intervention/treatment Phase
Fecal Incontinence Bowel Incontinence Behavioral: Biofeedback Procedure: Sacral Nerve Stimulation Device: Injection Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 569 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Participants who do not demonstrate at least a 75% reduction in FI following a 4-week trial of EMM will be randomized to one of three treatments (SNS, INJ, or BIO) and assessed after three months. All participants who experience a 75% decrease in FI after three months of treatment, compared to baseline, will then be followed-up for two years. To assess the long-term response to treatment, those who demonstrate an improvement of less than 75% in FI episodes will be offered an additional treatment with one of the two treatments to which they were not initially randomized.

An anticipated 569 participants will be enrolled in the EMM to ensure a sample size of 129 in each of the three treatments arms.

Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparative Effectiveness of Biofeedback, Sacral Nerve Stimulation, and Injectable Bulking Agents for Treatment of Fecal Incontinence: The Fecal Incontinence Treatment (FIT) Study
Actual Study Start Date : February 1, 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : March 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bowel Movement

Arm Intervention/treatment
Active Comparator: Biofeedback (BIO)
Participants will receive biofeedback intervention during five (5) required weekly 1-hour sessions. A 6th treatment session will be made available for participants if it is shown through anorectal manometry that they are having trouble understanding directions given during the first five sessions.
Behavioral: Biofeedback
The participant will learn how to improve strength and rectal sensation during five (5) - six (6) visits each lasting 60 minutes.

Active Comparator: Sacral Nerve Stimulation (SNS)
Wire electrode inserted to S3 or S4, connected to stimulator. This involves two surgical procedures and a clinic visit of 45 minutes duration at weeks 0, 2 and 6 weeks respectively.
Procedure: Sacral Nerve Stimulation
The participant will have a wire electrode inserted to S3 or S4, connected to stimulator. This involves two surgical procedures and a clinic visit of 45 minutes duration at weeks 0, 2 and 6 weeks respectively.

Active Comparator: Injection (INJ)
Bulking agent injected into rectal wall to narrow opening. Two visits each lasting 45 minutes at weeks 0 and 6 respectively.
Device: Injection
The participant will have a bulking agent injected into rectal wall to narrow opening. Two visits each lasting 45 minutes at weeks 0 and 6 respectively.




Primary Outcome Measures :
  1. Treatment response defined as a 75% or greater change in number of average weekly FI episodes at 3-month follow-up compared to baseline [ Time Frame: 3-month follow-up ]
    FI episodes will be assessed using a validated symptom diary at Baseline and at three months follow-up.

  2. Proportion of participants with specified adverse events at 3-month follow-up [ Time Frame: 3-month follow-up ]
    Adverse events of pelvic pain of grade II or higher based on Common Terminology Criteria for AE (CTCAE) criteria, treatment site infection, or SAEs requiring hospitalization.

  3. Treatment costs at 3-month follow-up [ Time Frame: 3-month follow-up ]
    Costs will be measured from three sources: (a) Number of treatment visits multiplied by the Medicare reimbursement rates. (b) An Out-of-Pocket Treatment Cost Questionnaire. (c) A Work Productivity and Impairment Questionnaire for direct and indirect costs. These costs will be combined to establish overall costs.


Secondary Outcome Measures :
  1. Change in the severity of FI as assessed using the Fecal Incontinence Severity Scale at 3-month follow-up compared to baseline [ Time Frame: Baseline; 3-month follow-up ]
    Treatment effect on the severity of FI at 3-month follow-up, compared to baseline, will be assessed using the Fecal Incontinence Severity Scale, a validated FI severity scale which incorporates the frequency of different types of stool loss (solid, liquid, staining and a combination), the circumstances surrounding FI (urgency, passive, combined, or neither), and volume of leakage. Higher scores indicate more severe fecal incontinence.

  2. Change in quality of life as assessed using the Fecal Incontinence Quality of Life Scale at 3-month follow-up compared to baseline [ Time Frame: Baseline; 3-month follow-up ]
    Treatment effect on the impact of FI on quality of life will be assessed using the Fecal Incontinence Quality of Life Scale which contains 29 items and is scored for four subscales: Lifestyle, Coping/Behavior, Depression/Self-Perception, and Embarrassment. Scores for each item range from 1 - 4 with 1 indicating a lower functional status of quality of life. Scale scores are the average (mean) response to all items after adjusting for missing and not applicable items.

  3. Change in psychological distress as assessed using the 7-item PROMIS Anxiety Scale at 3-month follow-up compared to baseline [ Time Frame: Baseline; 3-month follow-up ]
    One of the measures of psychological distress is the 7-item PROMIS Anxiety Scale for which higher scores indicate higher levels of anxiety. The Anxiety Scale (SF 7a) has a score range of 5 - 35.

  4. Change in psychological distress as assessed using the 8-item PROMIS Depression Scale at 3-month follow-up compared to baseline [ Time Frame: Baseline; 3-month follow-up ]
    One of the measures of psychological distress is the 8-item PROMIS Depression Scale for which higher scores indicate higher levels of depression. The Depression Scale (SF 8a) has a score range of 5 - 40.

  5. Change in psychological distress as assessed using the 8-item PROMIS Self-Efficacy Symptom Management Scale at 3-month follow-up compared to baseline [ Time Frame: Baseline; 3-month follow-up ]
    One of the measures of psychological distress is the 8-item PROMIS Self-Efficacy Symptom Management Scale for which higher scores indicate higher levels of self-efficacy. The Self-Efficacy for Managing Symptoms Scale (SF 8a) has a score range of 5 - 40.

  6. Reduction of 50% or more in average weekly FI episodes at 3-month follow-up compared to baseline [ Time Frame: 3-month follow-up ]
  7. Proportion of participants who are continent at 3-month follow-up [ Time Frame: 3-month follow-up ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Physician diagnosis of FI (R15) for the past 6 months or longer.
  • Able to ambulate independently on level surfaces. Patient may use assistive devices other than parallel bars.
  • Average >2 staining, solid or liquid FI episodes per week not including staining by self-report and during the two-week baseline
  • Meets criteria for SNS and dextranomer treatment except an internal anal sphincter defect of 120 degrees or less is acceptable.
  • Less than 75% reduction in the number of FI episodes after 4 weeks of conservative treatment.

Exclusion Criteria:

  • Dementia, assessed using the Six-Item Screener to Identify Cognitive Impairment.
  • Obstetrical injuries including third and fourth degree tears in the anal sphincter within the past 6 months.
  • Pregnant or planning pregnancy in next 2 years
  • Internal anal sphincter separation >120 degrees on ultrasound or magnetic resonance imaging
  • Spinal cord injury or spina bifida
  • Congenital malformation of anus or rectum
  • Complete rectal prolapse or grade III/IV hemorrhoids
  • History of previous anorectal surgery, such as stapled transanal rectal resection (STARR). Stapled hemorrhoidectomy is not an exclusion if performed more than 12 months previously. The FENIX procedure, artificial anal sphincter or transposed gracilis; surgical hemorrhoidectomy (other than stapled), and sphincteroplasty are permitted if performed more than 6 months previously and the patient meets inclusion criteria.
  • Established diagnosis of inflammatory bowel disease
  • Intestinal stoma present
  • History of pelvic radiation
  • FI is secondary to an evacuation disorder
  • Anatomic limitations to placement of SNS or dextranomer injections.
  • Previously failed an adequate (1-2 weeks) trial of SNS or dextranomer injections
  • Presence or history of any medical disorder likely to require follow-up with MRI of the body (not head or neck), diathermy, microwave, or RF energy therapy.
  • Presence of existing implant in the anal or rectal region
  • Allergy to hyaluronic acid-based products
  • Active anal or rectal conditions in the last 6 months including abscess, fissures, sepsis, significant bleeding, proctitis, colovaginal and rectovaginal fistulas, anal or rectal tumors, or other infections.
  • The patient's physician believes it is unsafe for the patient to temporarily stop anticoagulants for any test procedures and treatments associated with the study.
  • Patients who have 4 or more days with 4 or more bowel movements classed as a 6 or 7 on the Bristol Stool Scale per day in either (any) week bowel movements classed as a 6 or 7 during the Baseline will be excluded.
  • Patients with Parkinson's disease, multiple sclerosis, severe diabetic neuropathy documented by EMG, and neurodegenerative disorder.
  • Immunotherapy or chemotherapy in the last 12 months.
  • Significant anal pain in the last 6 months.
  • Unwillingness of participant to stop using over-the-counter medications, herbal supplements, or prescribed medications for the purpose of modifying stool consistency, that are not included in the approved medications list (loperamide, laxatives, fiber supplements, and Questran are approved medications), for the duration of the research study.

Patients with clinically evident diabetic neuropathy, Parkinson's disease, multiple sclerosis, other neurological disorders, and obstetric injuries with or without previous sphincter repair who have less than 1/3 external anal sphincter (EAS) separation, and patients with rectal reconstructions or ileoanal pouches, will be permitted. Medical history will be documented to test for predictors of response.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03811821


Contacts
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Contact: William Whitehead, PhD 919-843-0819 william_whitehead@med.unc.edu
Contact: Jennifer Wu, MD 919-216-0118 Jennifer_wu@med.unc.edu

Locations
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United States, Georgia
Augusta University Medical College of Georgia Recruiting
Augusta, Georgia, United States, 30912
Contact: Satish Rao, MD, PhD    706-721-0207    SRAO@augusta.edu   
Principal Investigator: Satish Rao, MD, PhD         
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Adil Bharucha, MBBS, MD    507-284-2511    bharucha.adil@mayo.edu   
Principal Investigator: Adil Bharucha, MBBS, MD         
Colon and Rectal Surgery Associates, Ltd. Recruiting
Saint Paul, Minnesota, United States, 55114
Contact: Ann Lowry, MD    651-312-1620    ALowry@crsal.org   
Principal Investigator: Ann Lowry, MD         
United States, North Carolina
The University of North Carolina at Chapel Hill Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: William Whitehead, MD    919-843-0819    william_whitehead@med.unc.edu   
Contact: Jennifer Wu    919-216-0118    Jennifer_wu@med.unc.edu   
Sub-Investigator: Jennifer Wu, MD         
Sponsors and Collaborators
University of North Carolina, Chapel Hill
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Mayo Clinic
Colon and Rectal Surgery Associates, Ltd.
Augusta University
RTI International
Investigators
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Principal Investigator: William Whitehead, PhD University of North Carolina, Chapel Hill

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Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT03811821     History of Changes
Other Study ID Numbers: 17-0525
1U01DK115575-01 ( U.S. NIH Grant/Contract )
First Posted: January 21, 2019    Key Record Dates
Last Update Posted: June 18, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
Time Frame: 9 to 36 months following publication
Access Criteria: Following approval from an appropriate review board as described above and execution of a data use/sharing agreement with UNC-Chapel Hill.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by University of North Carolina, Chapel Hill:
Accidental Bowel Leakage
Fecal Incontinence
Biofeedback
Sacral Nerve Stimulation
Injectable Bulking Agents
Enhanced Medical Management
Additional relevant MeSH terms:
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Fecal Incontinence
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases