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| ID | Type | Description | Link |
|---|---|---|---|
| 2U10HD041261 | U.S. NIH Grant/Contract | View source | |
| 2U10HD054215 | U.S. NIH Grant/Contract | View source | |
| 2U10HD041267 | U.S. NIH Grant/Contract | View source | |
| 1U10HD069006 | U.S. NIH Grant/Contract | View source | |
| 2U10HD054214 | U.S. NIH Grant/Contract | View source | |
| 1U10HD069013 | U.S. NIH Grant/Contract | View source | |
| 1U10HD069025 | U.S. NIH Grant/Contract | View source | |
| 1U10HD069010 | U.S. NIH Grant/Contract | View source | |
| 1U01HD069031 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| The Cleveland Clinic | OTHER |
| University of Alabama at Birmingham | OTHER |
| University of California, San Diego | OTHER |
| Duke University |
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The study is a multi-center, randomized, placebo controlled trial with participants randomized into one of four groups:
The primary outcome, change from baseline in St. Marks (Vaizey) Score at 24 weeks, will be compared between treatment groups using linear regression.
The goals of this trial are to compare the use of loperamide to oral placebo and to compare the use of anal sphincter exercise training with biofeedback to usual care (educational pamphlet) in the treatment of women suffering from fecal incontinence (FI). We will test the following null hypotheses:
A supplemental study, Stool Metabolome and Microbiome in Women with Fecal Incontinence in CAPABLe, will evaluate the stool metabolome and microbiome in women with fecal incontinence and unaffected age matched controls.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo - Exercise plus Biofeedback | Placebo Comparator | Placebo and biofeedback intervention. Placebo doses range from 2mg every other day to 8mg per day. Capsules are taken by mouth once a day for 24 weeks. Anal exercises with biofeedback intervention is a total of six sessions with trained personnel occurring every 2 weeks over a 12-week period. Sessions are held at the following study visits: baseline, 2, 4, 6, 9, and 12 week visits. |
|
| Loperamide - Exercise plus Biofeedback | Experimental | Loperamide and biofeedback intervention. Loperamide doses range from 2mg every other day to 8mg per day. Capsules are taken by mouth once a day for 24 weeks. Anal exercises with biofeedback intervention is a total of six sessions with trained personnel occurring every 2 weeks over a 12-week period. Sessions are held at the following study visits: baseline, 2, 4, 6, 9, and 12 week visits. |
|
| Placebo - Education Only | Placebo Comparator | Placebo and education (usual care). Placebo doses range from 2mg every other day to 8mg per day. Capsules are taken by mouth once a day for 24 weeks. Participants receive education and a NIDDK Bowel Control Educational pamphlet. |
|
| Loperamide - Education Only | Experimental | Loperamide and education (usual care). Loperamide doses range from 2mg every other day to 8mg per day. Capsules are taken by mouth once a day for 24 weeks. Participants receive education and a NIDDK Bowel Control Educational pamphlet. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Loperamide | Drug | Participants randomized to the loperamide group will begin with 2mg of loperamide/day. The participant will be administered the Patient Global Symptom Control rating scale (PGSC) to determine dose escalation. Participants who report inadequate control of stool leakage on the PGSC will be instructed to increase the daily dose of loperamide by 2 mg up to a maximum of 8 mg per day (1-4 capsules). Bothersome adverse events and resulting dose reduction will be based exclusively on the result of the Patient Global Tolerability Scale (PGTS). The daily dose will be decreased by 2mg to a minimum of 2mg every other day. If a PGSC score indicates inadequate control of stool leakage combined with a PGTS score indicating bothersome side effects, the participant will discontinue the study medication. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline St. Mark's (Vaizey) Score | The primary outcome measure for all study arms is the change from baseline in St. Mark's (Vaizey) Score 24 weeks after treatment initiation to compare the marginal outcomes of anal exercise with biofeedback to usual care and loperamide to placebo. The St. Mark's (Vaizey) score, published in 1999, is commonly used in clinical studies and reports and was based on the Jorge-Wexner score but added two further items for assessment: the use of constipating medication and the presence of fecal urgency. Minimum score is 0 = perfect continence; maximum score is 24 = totally incontinent. | 12 and 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Quality of Life on Colorectal-Anal Distress Inventory (CRADI) | The Pelvic Floor Distress Inventory is a 20-question, validated, self-reported instrument used to evaluate pelvic floor symptoms. It consists of an overall scale (range: 0-300) comprised of 3 sub-scales: 1) Pelvic Organ Prolapse Distress Inventory (range: 0-100), 2) Colorectal Anal Distress Inventory (range: 0-100), and 3) Urinary Distress Inventory (range: 0-100). The range of responses on the CRADI is 1-4 with (1) Not at all, (2) Somewhat, (3) Moderately, and (4), Quite a bit. Scores are calculated by multiplying the mean value of all questions answered by 25 for the scale. The range of responses is: 0-100 with 0 (least distress) to 100 (most distress). Change = (Week [12, 24] Score - Baseline Score). Lower scores indicate better function / fewer symptoms. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| J E Jelovsek | The Cleveland Clinic | Study Chair |
| Matthew Barber | The Cleveland Clinic | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35233 | United States | ||
| University of California at San Diego |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31320277 | Derived | Jelovsek JE, Markland AD, Whitehead WE, Barber MD, Newman DK, Rogers RG, Dyer K, Visco AG, Sutkin G, Zyczynski HM, Carper B, Meikle SF, Sung VW, Gantz MG; National Institute of Child Health and Human Development Pelvic Floor Disorders Network. Controlling faecal incontinence in women by performing anal exercises with biofeedback or loperamide: a randomised clinical trial. Lancet Gastroenterol Hepatol. 2019 Sep;4(9):698-710. doi: 10.1016/S2468-1253(19)30193-1. Epub 2019 Jul 15. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Loperamide - Exercise Plus Biofeedback | Participants receive loperamide drug and anal exercise with biofeedback intervention. |
| FG001 | Placebo - Exercise Plus Biofeedback | Participants receive placebo drug and anal exercise with biofeedback intervention. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| OTHER |
| National Institutes of Health (NIH) | NIH |
| University of New Mexico | OTHER |
| Women and Infants Hospital of Rhode Island | OTHER |
| RTI International | OTHER |
| University of Pennsylvania | OTHER |
| University of Pittsburgh | OTHER |
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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|
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| Placebo | Drug | Participants randomized to the placebo arm will begin the a dose of one capsule per day and will be dose increased or dose decreased using the same algorithm described for the loperamide arm. |
|
|
| Anal exercises with biofeedback | Behavioral | Participants will receive a formal anal exercises training program that can be easily applied in an office setting with minimal participant burden. Participants will attend six anal exercises with biofeedback sessions with trained personnel over a 12-week period for the 24-week study. Sessions will include introduction, standard patient education, and exercises using anal manometry-assisted biofeedback introducing concepts such as shaping, generalization and termination. The protocol uses strength and sensory training including urge resistance training. During the final twelve weeks, participants will perform anal exercises on their own. The sessions with interventionists will occur every other week for 12 weeks (total 6 supervised sessions). |
|
| Usual Care | Behavioral | Usual care consists of patients receiving an educational pamphlet on fecal incontinence created by the National Institute of Diabetes and Digestive and Kidney Diseases. |
|
| 12 and 24 weeks |
| Change in Colorectal-Anal Subscale of the Pelvic Floor Impact Questionnaire Short Form (CRAIQ) Score | The Pelvic Floor Impact Questionnaire short form (PFIQ-7) measuring the impact of bladder, bowel, and vaginal symptoms on a woman's daily activities, relationships and emotions is composed of 3 scales of 7 questions each: the Urinary Impact Questionnaire (UIQ; range 0-100), the Pelvic Organ Prolapse Impact Questionnaire (POPIQ; range 0-100), and the Colorectal-Anal Impact Questionnaire (CRAIQ; range 0-100). The range of responses on the CRAIQ is 0-3 with (0) Not at all, (1) Somewhat, (2) Moderately, and (3), Quite a bit. Scores are calculated by multiplying the mean value of all answered questions for a scale by 100 divided by 3. The range of responses is: 0-100 with 0 (least negative impact) to 100 (most negative impact). Change = (Week [12, 24] Score - Baseline Score). Lower scores indicate better function / fewer symptoms. | 12 and 24 weeks |
| Change From Baseline Accident-free Days at 12 and 24 Weeks | Based on data collected from participant-completed diaries at baseline and 12 and 24 weeks, the outcome variable is computed as the difference in number of accident-free days at 12 and 24 weeks and the number of accident-free days at baseline. Only valid diaries were included in the analyses (e.g. completion of all 7 days for baseline and at least 3 complete days, not necessarily consecutive, for follow-up diaries). | 12 and 24 weeks |
| Change From Baseline Pad-change Leaks Per Day at 12 and 24 Weeks | Based on data collected from participant-completed diaries at baseline and 12 and 24 weeks, the outcome variable is computed as the difference in number of fecal incontinence episodes per day resulting in a change in pad, clothes or underwear at 12 and 24 weeks and the number of fecal incontinence episodes resulting in a change in pad, clothes or underwear at baseline. Only valid diaries were included in the analyses (e.g. completion of all 7 days for baseline and at least 3 complete days, not necessarily consecutive, for follow-up diaries). | 12 and 24 weeks |
| Change From Baseline Pad-change Leaks Per Week at 12 and 24 Weeks | Based on data collected from participant-completed diaries at baseline and 12 and 24 weeks, the outcome variable is computed as the difference in number of fecal incontinence episodes per week resulting in a change in pad, clothes or underwear at 12 and 24 weeks and the number of fecal incontinence episodes resulting in a change in pad, clothes or underwear at baseline. Only valid diaries were included in the analyses (e.g. completion of all 7 days for baseline and at least 3 complete days, not necessarily consecutive, for follow-up diaries). | 12 and 24 weeks |
| Change From Baseline Total Number of Leaks Per Day at 12 and 24 Weeks | Based on data collected from participant-completed diaries at baseline and 12 and 24 weeks, the outcome variable is computed as the difference in daily average FI episodes at 12 and 24 weeks and the daily average FI episodes at baseline. Only valid diaries were included in the analyses (e.g. completion of all 7 days for baseline and at 3 complete days, not necessarily consecutive, for follow-up diaries). | 12 and 24 weeks |
| Change in Fecal Incontinence Severity Index (FISI) Score | The Modified Manchester Health Questionnaire (MMHQ) includes the 4-item Fecal Incontinence Severity Index (FISI), which measures the severity of liquid, solid, mucus, or gas incontinence that occurs from "2 or more times per day," "once per day," "2 or more times per week," "once a week," to "1-3 times per month." Patient-weighted scores were used to determine severity and scores ranged from 0-61, with higher scores indicating worse fecal incontinence (FI) severity. An FISI score of 0 indicated continence. | 12 and 24 weeks |
| Participants With Improvement in Patient Global Impression of Improvement (PGI-I) Score | The Patient Global Impression of Improvement (PGI-I) is a patient-reported measure of perceived improvement with treatment, as assessed on a scale of 1 (very much better) to 7 (very much worse). Included here are participants who had improvement as indicated by a rating of 1 (very much better), 2 (much better), or 3 (a little better). | 12 and 24 Weeks |
| Change From Baseline Resting Anal Canal Pressures (mm of Hg) at 2 cm, 1 cm, and 0 cm Insertion at 12 and 24 Weeks | Based on data collected from the manometry form, the outcome variable is computed as the difference in resting anal canal pressures (mm Hg) at 2 cm, 1 cm, and 0 cm insertion at 12 and 24 weeks and resting anal canal pressures (mm Hg) at 2 cm, 1 cm, and 0 cm insertion at baseline | 12 and 24 weeks |
| Change From Baseline Volume of Air (mL) at First Sensation for Perception of Rectal Distention at 12 and 24 Weeks | Based on data collected from the manometry form, the outcome variable is computed as the difference in volume of air (mL) at first sensation for perception of rectal distention at 12 and 24 weeks and volume of air (mL) at first sensation for perception of rectal distention at baseline. | 12 and 24 weeks |
| Change From Baseline Volume of Air (mL) at Urge to Defecate at 12 and 24 Weeks | Based on data collected from the manometry form, the outcome variable is computed as the difference in maximum tolerable rectal volume of air (mL) at 12 and 24 weeks and maximum tolerable rectal volume of air (mL) at baseline. | 12 and 24 weeks |
| Change From Baseline Maximum Anal Pressures During Squeeze With the Catheter at the HPZ at 12 and 24 Weeks | Based on data collected from the manometry form, the outcome variable will be computed as the difference in maximum anal pressures during squeeze with the catheter at the high pressure zone (HPZ) at 12 and 24 weeks and maximum anal pressures during squeeze with the catheter at the HPZ at baseline. | 12 and 24 weeks |
| La Jolla |
| California |
| 92037-0974 |
| United States |
| Kaiser San Diego | San Diego | California | 92110 | United States |
| University of New Mexico | Albuquerque | New Mexico | 87131 | United States |
| Duke University | Durham | North Carolina | 27707 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19118 | United States |
| University of Pittsburgh | Pittsburgh | Pennsylvania | 15213 | United States |
| Brown/Women and Infants Hospital of Rhode Island | Providence | Rhode Island | 02903 | United States |
| FG002 | Loperamide - Education Only | Participants receive loperamide drug and educational pamphlet (usual care). |
| FG003 | Placebo - Education Only | Participants receive placebo drug and educational pamphlet (usual care). |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Loperamide - Exercise Plus Biofeedback | Participants receive loperamide drug and anal exercises with biofeedback intervention. |
| BG001 | Placebo - Exercise Plus Biofeedback | Participants receive placebo drug and anal exercises with biofeedback intervention. |
| BG002 | Loperamide - Education Only | Participants receive loperamide drug and educational pamphlet (usual care). |
| BG003 | Placebo - Education Only | Participants receive placebo drug and educational pamphlet (usual care). |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Vaginal deliveries, median [min, max] | Median | Full Range | Vaginal deliveries |
| |||||||||||||||
| Cesarean deliveries, median [min, max] | Median | Full Range | Cesarean deliveries |
| |||||||||||||||
| Menstrual status, No. (%) | Count of Participants | Participants |
| ||||||||||||||||
| Currently using estrogen therapy, No. (%) | Count of Participants | Participants |
| ||||||||||||||||
| Current smoker, No. (%) | Count of Participants | Participants |
| ||||||||||||||||
| Connective tissue disease, No. (%) | Count of Participants | Participants |
| ||||||||||||||||
| Prior accidental bowel leakage surgery, No. (%) | Count of Participants | Participants |
| ||||||||||||||||
| Prior rectal or anal surgery, No. (%) | Count of Participants | Participants |
| ||||||||||||||||
| Prior hysterectomy, No. (%) | Count of Participants | Participants |
| ||||||||||||||||
| Prior urinary incontinence surgery, No. (%) | Count of Participants | Participants |
| ||||||||||||||||
| Prior pelvic organ prolapse surgery, No. (%) | Count of Participants | Participants |
| ||||||||||||||||
| BMI, mean (SD) | Mean | Standard Deviation | kg/m^2 |
| |||||||||||||||
| Bristol Stool Index, No. (%) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline St. Mark's (Vaizey) Score | The primary outcome measure for all study arms is the change from baseline in St. Mark's (Vaizey) Score 24 weeks after treatment initiation to compare the marginal outcomes of anal exercise with biofeedback to usual care and loperamide to placebo. The St. Mark's (Vaizey) score, published in 1999, is commonly used in clinical studies and reports and was based on the Jorge-Wexner score but added two further items for assessment: the use of constipating medication and the presence of fecal urgency. Minimum score is 0 = perfect continence; maximum score is 24 = totally incontinent. | An intent-to-treat (ITT) analysis was performed for primary analyses. ITT analysis included all eligible participants who were randomized. The primary analyses included randomized patients who provided outcome data at 12 or 24 weeks. | Posted | Mean | 95% Confidence Interval | units on a scale | 12 and 24 weeks |
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| Secondary | Change in Quality of Life on Colorectal-Anal Distress Inventory (CRADI) | The Pelvic Floor Distress Inventory is a 20-question, validated, self-reported instrument used to evaluate pelvic floor symptoms. It consists of an overall scale (range: 0-300) comprised of 3 sub-scales: 1) Pelvic Organ Prolapse Distress Inventory (range: 0-100), 2) Colorectal Anal Distress Inventory (range: 0-100), and 3) Urinary Distress Inventory (range: 0-100). The range of responses on the CRADI is 1-4 with (1) Not at all, (2) Somewhat, (3) Moderately, and (4), Quite a bit. Scores are calculated by multiplying the mean value of all questions answered by 25 for the scale. The range of responses is: 0-100 with 0 (least distress) to 100 (most distress). Change = (Week [12, 24] Score - Baseline Score). Lower scores indicate better function / fewer symptoms. | An intent-to-treat (ITT) analysis was performed for primary analyses. ITT analysis included all eligible participants who were randomized. The primary analyses included randomized patients who provided outcome data at 12 or 24 weeks. | Posted | Mean | 95% Confidence Interval | units on a scale | 12 and 24 weeks |
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| Secondary | Change in Colorectal-Anal Subscale of the Pelvic Floor Impact Questionnaire Short Form (CRAIQ) Score | The Pelvic Floor Impact Questionnaire short form (PFIQ-7) measuring the impact of bladder, bowel, and vaginal symptoms on a woman's daily activities, relationships and emotions is composed of 3 scales of 7 questions each: the Urinary Impact Questionnaire (UIQ; range 0-100), the Pelvic Organ Prolapse Impact Questionnaire (POPIQ; range 0-100), and the Colorectal-Anal Impact Questionnaire (CRAIQ; range 0-100). The range of responses on the CRAIQ is 0-3 with (0) Not at all, (1) Somewhat, (2) Moderately, and (3), Quite a bit. Scores are calculated by multiplying the mean value of all answered questions for a scale by 100 divided by 3. The range of responses is: 0-100 with 0 (least negative impact) to 100 (most negative impact). Change = (Week [12, 24] Score - Baseline Score). Lower scores indicate better function / fewer symptoms. | An intent-to-treat (ITT) analysis was performed for primary analyses. ITT analysis included all eligible participants who were randomized. The primary analyses included randomized patients who provided outcome data at 12 or 24 weeks. | Posted | Mean | 95% Confidence Interval | units on a scale | 12 and 24 weeks |
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| Secondary | Change From Baseline Accident-free Days at 12 and 24 Weeks | Based on data collected from participant-completed diaries at baseline and 12 and 24 weeks, the outcome variable is computed as the difference in number of accident-free days at 12 and 24 weeks and the number of accident-free days at baseline. Only valid diaries were included in the analyses (e.g. completion of all 7 days for baseline and at least 3 complete days, not necessarily consecutive, for follow-up diaries). | An intent-to-treat (ITT) analysis was performed for primary analyses. ITT analysis included all eligible participants who were randomized. The primary analyses included randomized patients who provided outcome data at 12 or 24 weeks. | Posted | Mean | 95% Confidence Interval | accident-free days | 12 and 24 weeks |
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| Secondary | Change From Baseline Pad-change Leaks Per Day at 12 and 24 Weeks | Based on data collected from participant-completed diaries at baseline and 12 and 24 weeks, the outcome variable is computed as the difference in number of fecal incontinence episodes per day resulting in a change in pad, clothes or underwear at 12 and 24 weeks and the number of fecal incontinence episodes resulting in a change in pad, clothes or underwear at baseline. Only valid diaries were included in the analyses (e.g. completion of all 7 days for baseline and at least 3 complete days, not necessarily consecutive, for follow-up diaries). | An intent-to-treat (ITT) analysis was performed for primary analyses. ITT analysis included all eligible participants who were randomized. The primary analyses included randomized patients who provided outcome data at 12 or 24 weeks. | Posted | Mean | 95% Confidence Interval | pad-change leaks per day | 12 and 24 weeks |
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| Secondary | Change From Baseline Pad-change Leaks Per Week at 12 and 24 Weeks | Based on data collected from participant-completed diaries at baseline and 12 and 24 weeks, the outcome variable is computed as the difference in number of fecal incontinence episodes per week resulting in a change in pad, clothes or underwear at 12 and 24 weeks and the number of fecal incontinence episodes resulting in a change in pad, clothes or underwear at baseline. Only valid diaries were included in the analyses (e.g. completion of all 7 days for baseline and at least 3 complete days, not necessarily consecutive, for follow-up diaries). | An intent-to-treat (ITT) analysis was performed for primary analyses. ITT analysis included all eligible participants who were randomized. The primary analyses included randomized patients who provided outcome data at 12 or 24 weeks. | Posted | Mean | 95% Confidence Interval | pad-change leaks per week | 12 and 24 weeks |
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| Secondary | Change From Baseline Total Number of Leaks Per Day at 12 and 24 Weeks | Based on data collected from participant-completed diaries at baseline and 12 and 24 weeks, the outcome variable is computed as the difference in daily average FI episodes at 12 and 24 weeks and the daily average FI episodes at baseline. Only valid diaries were included in the analyses (e.g. completion of all 7 days for baseline and at 3 complete days, not necessarily consecutive, for follow-up diaries). | An intent-to-treat (ITT) analysis was performed for primary analyses. ITT analysis included all eligible participants who were randomized. The primary analyses included randomized patients who provided outcome data at 12 or 24 weeks. | Posted | Mean | 95% Confidence Interval | leaks per day | 12 and 24 weeks |
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| Secondary | Change in Fecal Incontinence Severity Index (FISI) Score | The Modified Manchester Health Questionnaire (MMHQ) includes the 4-item Fecal Incontinence Severity Index (FISI), which measures the severity of liquid, solid, mucus, or gas incontinence that occurs from "2 or more times per day," "once per day," "2 or more times per week," "once a week," to "1-3 times per month." Patient-weighted scores were used to determine severity and scores ranged from 0-61, with higher scores indicating worse fecal incontinence (FI) severity. An FISI score of 0 indicated continence. | An intent-to-treat (ITT) analysis was performed for primary analyses. ITT analysis included all eligible participants who were randomized. The primary analyses included randomized patients who provided outcome data at 12 or 24 weeks. | Posted | Mean | 95% Confidence Interval | units on a scale | 12 and 24 weeks |
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| Secondary | Participants With Improvement in Patient Global Impression of Improvement (PGI-I) Score | The Patient Global Impression of Improvement (PGI-I) is a patient-reported measure of perceived improvement with treatment, as assessed on a scale of 1 (very much better) to 7 (very much worse). Included here are participants who had improvement as indicated by a rating of 1 (very much better), 2 (much better), or 3 (a little better). | An intent-to-treat (ITT) analysis was performed for primary analyses. ITT analysis included all eligible participants who were randomized. The primary analyses included randomized patients who provided outcome data at 12 or 24 weeks. | Posted | Count of Participants | Participants | 12 and 24 Weeks |
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| Secondary | Change From Baseline Resting Anal Canal Pressures (mm of Hg) at 2 cm, 1 cm, and 0 cm Insertion at 12 and 24 Weeks | Based on data collected from the manometry form, the outcome variable is computed as the difference in resting anal canal pressures (mm Hg) at 2 cm, 1 cm, and 0 cm insertion at 12 and 24 weeks and resting anal canal pressures (mm Hg) at 2 cm, 1 cm, and 0 cm insertion at baseline | An intent-to-treat (ITT) analysis was performed for primary analyses. ITT analysis included all eligible participants who were randomized. The primary analyses included randomized patients who provided outcome data at 12 or 24 weeks. | Posted | Mean | 95% Confidence Interval | resting anal canal pressure (mm Hg) | 12 and 24 weeks |
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| Secondary | Change From Baseline Volume of Air (mL) at First Sensation for Perception of Rectal Distention at 12 and 24 Weeks | Based on data collected from the manometry form, the outcome variable is computed as the difference in volume of air (mL) at first sensation for perception of rectal distention at 12 and 24 weeks and volume of air (mL) at first sensation for perception of rectal distention at baseline. | An intent-to-treat (ITT) analysis was performed for primary analyses. ITT analysis included all eligible participants who were randomized. The primary analyses included randomized patients who provided outcome data at 12 or 24 weeks. | Posted | Mean | 95% Confidence Interval | volume of air (mL) | 12 and 24 weeks |
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| Secondary | Change From Baseline Volume of Air (mL) at Urge to Defecate at 12 and 24 Weeks | Based on data collected from the manometry form, the outcome variable is computed as the difference in maximum tolerable rectal volume of air (mL) at 12 and 24 weeks and maximum tolerable rectal volume of air (mL) at baseline. | An intent-to-treat (ITT) analysis was performed for primary analyses. ITT analysis included all eligible participants who were randomized. The primary analyses included randomized patients who provided outcome data at 12 or 24 weeks. | Posted | Mean | 95% Confidence Interval | volume of air (mL) | 12 and 24 weeks |
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| Secondary | Change From Baseline Maximum Anal Pressures During Squeeze With the Catheter at the HPZ at 12 and 24 Weeks | Based on data collected from the manometry form, the outcome variable will be computed as the difference in maximum anal pressures during squeeze with the catheter at the high pressure zone (HPZ) at 12 and 24 weeks and maximum anal pressures during squeeze with the catheter at the HPZ at baseline. | An intent-to-treat (ITT) analysis was performed for primary analyses. ITT analysis included all eligible participants who were randomized. The primary analyses included randomized patients who provided outcome data at 12 or 24 weeks. | Posted | Mean | 95% Confidence Interval | max. anal canal pressure squeeze (mmHg) | 12 and 24 weeks |
|
24 weeks
All events reported by the participants at study visits and EMR review from randomization until 24 weeks
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Loperamide - Exercise Plus Biofeedback | Participants receive loperamide drug and anal exercise with biofeedback intervention. | 0 | 86 | 6 | 86 | 71 | 86 |
| EG001 | Placebo - Exercise Plus Biofeedback | Participants receive placebo drug and anal exercise with biofeedback intervention. | 1 | 84 | 5 | 84 | 60 | 84 |
| EG002 | Loperamide - Education Only | Participants receive loperamide drug and educational pamphlet (usual care). | 0 | 88 | 10 | 88 | 60 | 88 |
| EG003 | Placebo - Education Only | Participants receive placebo drug and educational pamphlet (usual care). | 0 | 42 | 3 | 42 | 26 | 42 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 17.1 | Non-systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA 17.1 | Non-systematic Assessment |
| |
| Sinus node dysfunction | Cardiac disorders | MedDRA 17.1 | Non-systematic Assessment |
| |
| Ventricular tachycardia | Cardiac disorders | MedDRA 17.1 | Non-systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 17.1 | Non-systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA 17.1 | Non-systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 17.1 | Non-systematic Assessment |
| |
| Death | General disorders | MedDRA 17.1 | Non-systematic Assessment |
| |
| Animal bite | Injury, poisoning and procedural complications | MedDRA 17.1 | Non-systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA 17.1 | Non-systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA 17.1 | Non-systematic Assessment |
| |
| Suture related complication | Injury, poisoning and procedural complications | MedDRA 17.1 | Non-systematic Assessment |
| |
| Vascular pseudoaneurysm | Injury, poisoning and procedural complications | MedDRA 17.1 | Non-systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 17.1 | Non-systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Non-systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.1 | Non-systematic Assessment |
| |
| Oesophageal carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.1 | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 17.1 | Non-systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA 17.1 | Non-systematic Assessment |
| |
| Suicidal ideation | Psychiatric disorders | MedDRA 17.1 | Non-systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Non-systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Non-systematic Assessment |
| |
| Medical device removal | Surgical and medical procedures | MedDRA 17.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal distension | Gastrointestinal disorders | MedDRA 17.1 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 17.1 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 17.1 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 17.1 | Non-systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA 17.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 17.1 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 17.1 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 17.1 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 17.1 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 17.1 | Non-systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Marie Gantz | RTI International | 919-597-5110 | mgantz@rti.org |
| ID | Term |
|---|---|
| D005242 | Fecal Incontinence |
| ID | Term |
|---|---|
| D012002 | Rectal Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D008139 | Loperamide |
| D001676 | Biofeedback, Psychology |
| ID | Term |
|---|---|
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
| D030141 | Feedback, Psychological |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Black/African American |
|
| More than one race |
|
| Other |
|
| White |
|
| Post-menopausal |
|
| Pre-menopausal |
|
| Vaginal |
|
| Not currently using estrogen therapy |
|
| Not current smoker |
|
| Does not have connective tissue disease |
|
| No prior accidental bowel leakage surgery |
|
| No prior rectal or anal surgery |
|
| No prior hysterectomy |
|
| No prior urinary incontinence surgery |
|
| No prior pelvic organ prolapse surgery |
|
| Type 3 (Like a sausage or snake but with cracks on |
|
| Type 4 (Like a sausage or snake, smooth and soft) |
|
| Type 5 (Soft blobs with clear cut edges) |
|
| Type 6 (Fluffy pieces with ragged edges, a mushy s |
|
|
| 24 Week St. Mark's Score |
|
|
| OG002 | Loperamide - Education Only | Participants receive loperamide drug and educational pamphlet (usual care). |
| OG003 | Placebo - Education Only | Participants receive placebo drug and educational pamphlet (usual care). |
|
|
| OG002 | Loperamide - Education Only | Participants receive loperamide drug and educational pamphlet (usual care). |
| OG003 | Placebo - Education Only | Participants receive placebo drug and educational pamphlet (usual care). |
|
|
| OG003 | Placebo - Education Only | Participants receive placebo drug and educational pamphlet (usual care). |
|
|
Participants receive loperamide drug and educational pamphlet (usual care).
| OG003 | Placebo - Education Only | Participants receive placebo drug and educational pamphlet (usual care). |
|
|
Participants receive loperamide drug and educational pamphlet (usual care).
| OG003 | Placebo - Education Only | Participants receive placebo drug and educational pamphlet (usual care). |
|
|
| OG003 | Placebo - Education Only | Participants receive placebo drug and educational pamphlet (usual care). |
|
|
Participants receive loperamide drug and educational pamphlet (usual care).
| OG003 | Placebo - Education Only | Participants receive placebo drug and educational pamphlet (usual care). |
|
|
| OG003 |
| Placebo - Education Only |
Participants receive placebo drug and educational pamphlet (usual care). |
|
|
| OG003 |
| Placebo - Education Only |
Participants receive placebo drug and educational pamphlet (usual care). |
|
|
| OG003 |
| Placebo - Education Only |
Participants receive placebo drug and educational pamphlet (usual care). |
|
|
Participants receive placebo drug and educational pamphlet (usual care). |
|
|
| OG003 |
| Placebo - Education Only |
Participants receive placebo drug and educational pamphlet (usual care). |
|
|
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| Title | Measurements |
|---|---|
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