Fecal Incontinence Treatment (FIT) Study
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|ClinicalTrials.gov Identifier: NCT03811821|
Recruitment Status : Recruiting
First Posted : January 22, 2019
Last Update Posted : May 26, 2021
|Condition or disease||Intervention/treatment||Phase|
|Fecal Incontinence Bowel Incontinence||Behavioral: Biofeedback Device: Injection||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||285 participants|
|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 two treatments (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 either the treatment to which they were not initially randomized or SNS.
An anticipated 285 participants will be enrolled in the EMM to ensure a sample size of 97 in each of the two treatments arms.
|Masking:||None (Open Label)|
|Official Title:||Comparative Effectiveness of Biofeedback 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 2021|
|Estimated Study Completion Date :||December 2023|
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.
The participant will learn how to improve strength and rectal sensation during five (5) - six (6) visits each lasting 60 minutes.
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.
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.
- Treatment Response Defined as a 75% or Greater Change in Number of Average Weekly FI Episodes at Month 3 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.
- Proportion of Participants with Specified Adverse Events at Month 3 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 serious adverse events (SAEs) requiring hospitalization.
- Treatment Costs at Month 3 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.
- Change in the Severity of FI as Assessed Using the Fecal Incontinence Severity Scale [ Time Frame: up to 24 months ]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. Assessed at Baseline, Months 6, 12, and 24.
- Change in Quality of Life as Assessed Using the Fecal Incontinence Quality of Life Scale [ Time Frame: up to 24 months ]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. Assessed at Baseline, Months 6, 12, and 24.
- Change in Psychological Distress as Assessed Using the 7-item Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety Scale [ Time Frame: up to 24 months ]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. Assessed at Baseline, Months 6, 12, and 24.
- Change in Psychological Distress as Assessed Using the 8-item PROMIS Depression Scale [ Time Frame: up to 24 months ]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. Assessed at Baseline, Months 6, 12, and 24.
- Change in Psychological Distress as Assessed Using the 8-item PROMIS Self-Efficacy Symptom Management Scale [ Time Frame: up to 24 months ]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. Assessed at Baseline, Months 6, 12, and 24.
- Number of Participants with Reduction of 50% or More in Average Weekly FI Episodes [ Time Frame: up to 24 months ]Assessed at Baseline, Months 6, 12, and 24.
- Proportion of Participants Who are Continent [ Time Frame: up to 24 months ]Assessed at Baseline, Months 6, 12, and 24.
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
|Contact: William Whitehead, PhDemail@example.com|
|Contact: Jennifer Wu, MD||919-216-0118||Jennifer_wu@med.unc.edu|
|United States, Alabama|
|University of Alabama at Birmingham||Recruiting|
|Birmingham, Alabama, United States, 35801|
|Contact: Isuzu Meyer, MD, MSPH 205-934-1704 firstname.lastname@example.org|
|Principal Investigator: Isuzu Meyer, MD, MSPH|
|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, Michigan|
|University of Michigan||Recruiting|
|Ann Arbor, Michigan, United States, 48109|
|Contact: William Chey, MD 734-763-9337 email@example.com|
|Principal Investigator: William Chey, MD|
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Contact: Adil Bharucha, MBBS, MD 507-284-2511 firstname.lastname@example.org|
|Principal Investigator: Adil Bharucha, MBBS, MD|
|Colon and Rectal Surgery Associates, Ltd.||Terminated|
|Saint Paul, Minnesota, United States, 55114|
|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 email@example.com|
|Contact: Jennifer Wu 919-216-0118 Jennifer_wu@med.unc.edu|
|Sub-Investigator: Jennifer Wu, MD|
|Principal Investigator:||William Whitehead, PhD||University of North Carolina, Chapel Hill|