Fecal Incontinence
Conditions
Keywords
Fecal incontinence, Loperamide, anal exercises, biofeedback
Brief summary
The study is a multi-center, randomized, placebo controlled trial with participants randomized into one of four groups: 1. placebo/usual care (educational pamphlet) 2. loperamide/usual care (educational pamphlet) 3. placebo/anal exercises with biofeedback 4. loperamide/anal exercises with biofeedback The primary outcome, change from baseline in St. Marks (Vaizey) Score at 24 weeks, will be compared between treatment groups using linear regression.
Detailed description
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: 1. there is no difference in outcomes between women randomized to loperamide and women randomized to oral placebo for treatment of FI; 2. there is no difference in outcomes between women randomized to anal sphincter exercises with biofeedback and women randomized to usual care (educational pamphlet) for FI treatment; 3. there is no difference between women randomized to both treatments together and women randomized to either FI treatment alone; and 4. there is no correlation between anal manometry measurements and digital anal squeeze strength or measures of FI severity and bother. 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.
Interventions
DRUGLoperamide
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.
DRUGPlacebo
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.
BEHAVIORALAnal exercises with biofeedback
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).
BEHAVIORALUsual Care
Usual care consists of patients receiving an educational pamphlet on fecal incontinence created by the National Institute of Diabetes and Digestive and Kidney Diseases.
Sponsors
The Cleveland Clinic
University of Alabama at Birmingham
University of California, San Diego
Duke University
National Institutes of Health (NIH)
University of New Mexico
Women and Infants Hospital of Rhode Island
RTI International
University of Pennsylvania
University of Pittsburgh
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NICHD Pelvic Floor Disorders Network
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥18 years * Fecal incontinence defined as any uncontrolled loss of liquid or solid fecal material that occurs at least monthly over the last 3 months that is bothersome enough to desire treatment
Exclusion criteria
* Stool consistency over the last 3 months that includes items 1 or 7 based on the Bristol Stool form scale * Current or past diagnosis of colorectal or anal malignancy * Diagnosis of inflammatory bowel disease * Current or history of rectovaginal fistula or cloacal defect * Rectal prolapse (mucosal or full thickness) * Prior removal or diversion of any portion of colon or rectum * Prior pelvic floor or abdominal radiation * Refusal or inability to provide written consent * Inability to conduct telephone interviews conducted in English or Spanish * Fecal impaction by exam * Untreated pelvic organ prolapse beyond the hymen; Patients with prolapse beyond the hymen who are currently using a pessary are eligible * Incontinence only to flatus * Has taken any loperamide (Imodium®) or diphenoxylate plus atropine (Lomotil®) in the last 30 days * Previously received and failed treatment of fecal incontinence using loperamide (Imodium®) or diphenoxylate plus atropine (Lomotil®) over the last 3 months * Current supervised anal sphincter exercise/pelvic floor muscle training with biofeedback * Previously received and failed treatment of fecal incontinence using supervised anal sphincter exercise/pelvic floor muscle training with biofeedback * Previous allergy or intolerance to loperamide * Pregnant, nursing, or planning to become pregnant before the end of the study follow-up period. * Childbirth within the last 3 months * Currently taking anti-retroviral drugs * Neurological disorders known to affect continence, including spinal cord injury, advanced multiple sclerosis or Parkinson's disease and debilitating stroke * Known diagnosis of hepatic impairment * Chronic abdominal pain in the absence of diarrhea
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline St. Mark's (Vaizey) Score | 12 and 24 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Colorectal-Anal Subscale of the Pelvic Floor Impact Questionnaire Short Form (CRAIQ) Score | 12 and 24 weeks | 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. |
| Change From Baseline Accident-free Days at 12 and 24 Weeks | 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). |
| Change From Baseline Pad-change Leaks Per Day at 12 and 24 Weeks | 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). |
| Change From Baseline Pad-change Leaks Per Week at 12 and 24 Weeks | 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). |
| Change From Baseline Total Number of Leaks Per Day at 12 and 24 Weeks | 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). |
| Change in Quality of Life on Colorectal-Anal Distress Inventory (CRADI) | 12 and 24 weeks | 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. |
| Participants With Improvement in Patient Global Impression of Improvement (PGI-I) Score | 12 and 24 Weeks | 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). |
| Change From Baseline Resting Anal Canal Pressures (mm of Hg) at 2 cm, 1 cm, and 0 cm Insertion at 12 and 24 Weeks | 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 |
| Change From Baseline Volume of Air (mL) at First Sensation for Perception of Rectal Distention at 12 and 24 Weeks | 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. |
| Change From Baseline Volume of Air (mL) at Urge to Defecate at 12 and 24 Weeks | 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. |
| Change From Baseline Maximum Anal Pressures During Squeeze With the Catheter at the HPZ at 12 and 24 Weeks | 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. |
| Change in Fecal Incontinence Severity Index (FISI) Score | 12 and 24 weeks | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Loperamide - Exercise Plus Biofeedback Participants receive loperamide drug and anal exercises with biofeedback intervention. | 85 |
| Placebo - Exercise Plus Biofeedback Participants receive placebo drug and anal exercises with biofeedback intervention. | 83 |
| Loperamide - Education Only Participants receive loperamide drug and educational pamphlet (usual care). | 86 |
| Placebo - Education Only Participants receive placebo drug and educational pamphlet (usual care). | 42 |
| Total | 296 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Protocol Violation | 1 | 1 | 2 | 0 |
Baseline characteristics
| Characteristic | Loperamide - Exercise Plus Biofeedback | Placebo - Exercise Plus Biofeedback | Total | Placebo - Education Only | Loperamide - Education Only |
|---|---|---|---|---|---|
| Age, Continuous | 65.2 years STANDARD_DEVIATION 10.9 | 63.2 years STANDARD_DEVIATION 12.2 | 63.6 years STANDARD_DEVIATION 11.1 | 62.6 years STANDARD_DEVIATION 10.6 | 63.4 years STANDARD_DEVIATION 10.6 |
| BMI, mean (SD) | 30.1 kg/m^2 STANDARD_DEVIATION 7.4 | 28.5 kg/m^2 STANDARD_DEVIATION 6.7 | 30.0 kg/m^2 STANDARD_DEVIATION 7.8 | 30.5 kg/m^2 STANDARD_DEVIATION 10.4 | 30.9 kg/m^2 STANDARD_DEVIATION 6.6 |
| Bristol Stool Index, No. (%) Type 2 (Sausage shaped but lumpy) | 18 Participants | 9 Participants | 45 Participants | 11 Participants | 7 Participants |
| Bristol Stool Index, No. (%) Type 3 (Like a sausage or snake but with cracks on | 12 Participants | 11 Participants | 43 Participants | 3 Participants | 17 Participants |
| Bristol Stool Index, No. (%) Type 4 (Like a sausage or snake, smooth and soft) | 21 Participants | 28 Participants | 93 Participants | 15 Participants | 29 Participants |
| Bristol Stool Index, No. (%) Type 5 (Soft blobs with clear cut edges) | 17 Participants | 17 Participants | 53 Participants | 5 Participants | 14 Participants |
| Bristol Stool Index, No. (%) Type 6 (Fluffy pieces with ragged edges, a mushy s | 17 Participants | 18 Participants | 62 Participants | 8 Participants | 19 Participants |
| Cesarean deliveries, median [min, max] | 0.0 Cesarean deliveries | 0.0 Cesarean deliveries | 0.0 Cesarean deliveries | 0.0 Cesarean deliveries | 0.0 Cesarean deliveries |
| Connective tissue disease, No. (%) Connective tissue disease | 3 Participants | 5 Participants | 12 Participants | 1 Participants | 3 Participants |
| Connective tissue disease, No. (%) Does not have connective tissue disease | 82 Participants | 78 Participants | 284 Participants | 41 Participants | 83 Participants |
| Currently using estrogen therapy, No. (%) Not currently using estrogen therapy | 54 Participants | 53 Participants | 193 Participants | 29 Participants | 57 Participants |
| Currently using estrogen therapy, No. (%) Oral/Patch | 7 Participants | 8 Participants | 28 Participants | 3 Participants | 10 Participants |
| Currently using estrogen therapy, No. (%) Vaginal | 24 Participants | 22 Participants | 75 Participants | 10 Participants | 19 Participants |
| Current smoker, No. (%) Current smoker | 3 Participants | 8 Participants | 21 Participants | 2 Participants | 8 Participants |
| Current smoker, No. (%) Not current smoker | 82 Participants | 75 Participants | 275 Participants | 40 Participants | 78 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 8 Participants | 8 Participants | 26 Participants | 3 Participants | 7 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 76 Participants | 73 Participants | 265 Participants | 38 Participants | 78 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 2 Participants | 5 Participants | 1 Participants | 1 Participants |
| Menstrual status, No. (%) Not Sure | 2 Participants | 7 Participants | 16 Participants | 2 Participants | 5 Participants |
| Menstrual status, No. (%) Post-menopausal | 74 Participants | 69 Participants | 251 Participants | 34 Participants | 74 Participants |
| Menstrual status, No. (%) Pre-menopausal | 9 Participants | 7 Participants | 29 Participants | 6 Participants | 7 Participants |
| Prior accidental bowel leakage surgery, No. (%) No prior accidental bowel leakage surgery | 82 Participants | 77 Participants | 283 Participants | 42 Participants | 82 Participants |
| Prior accidental bowel leakage surgery, No. (%) Prior accidental bowel leakage surgery | 3 Participants | 6 Participants | 13 Participants | 0 Participants | 4 Participants |
| Prior hysterectomy, No. (%) No prior hysterectomy | 40 Participants | 43 Participants | 148 Participants | 24 Participants | 41 Participants |
| Prior hysterectomy, No. (%) Prior hysterectomy | 45 Participants | 40 Participants | 148 Participants | 18 Participants | 45 Participants |
| Prior pelvic organ prolapse surgery, No. (%) No prior pelvic organ prolapse surgery | 63 Participants | 61 Participants | 226 Participants | 34 Participants | 68 Participants |
| Prior pelvic organ prolapse surgery, No. (%) Prior pelvic organ prolapse surgery | 22 Participants | 22 Participants | 70 Participants | 8 Participants | 18 Participants |
| Prior rectal or anal surgery, No. (%) No prior rectal or anal surgery | 72 Participants | 72 Participants | 256 Participants | 35 Participants | 77 Participants |
| Prior rectal or anal surgery, No. (%) Prior rectal or anal surgery | 13 Participants | 11 Participants | 40 Participants | 7 Participants | 9 Participants |
| Prior urinary incontinence surgery, No. (%) No prior urinary incontinence surgery | 61 Participants | 61 Participants | 219 Participants | 31 Participants | 66 Participants |
| Prior urinary incontinence surgery, No. (%) Prior urinary incontinence surgery | 24 Participants | 22 Participants | 77 Participants | 11 Participants | 20 Participants |
| Race/Ethnicity, Customized American Indian/Alaskan Native | 1 Participants | 0 Participants | 3 Participants | 2 Participants | 0 Participants |
| Race/Ethnicity, Customized Black/African American | 13 Participants | 13 Participants | 46 Participants | 7 Participants | 13 Participants |
| Race/Ethnicity, Customized More than one race | 4 Participants | 1 Participants | 5 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Other | 2 Participants | 2 Participants | 8 Participants | 2 Participants | 2 Participants |
| Race/Ethnicity, Customized White | 65 Participants | 67 Participants | 234 Participants | 31 Participants | 71 Participants |
| Sex: Female, Male Female | 85 Participants | 83 Participants | 296 Participants | 42 Participants | 86 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Vaginal deliveries, median [min, max] | 2.0 Vaginal deliveries | 2.0 Vaginal deliveries | 2.0 Vaginal deliveries | 2.0 Vaginal deliveries | 2.0 Vaginal deliveries |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 86 | 1 / 84 | 0 / 88 | 0 / 42 |
| other Total, other adverse events | 71 / 86 | 60 / 84 | 60 / 88 | 26 / 42 |
| serious Total, serious adverse events | 6 / 86 | 5 / 84 | 10 / 88 | 3 / 42 |
Outcome results
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.
Time frame: 12 and 24 weeks
Population: 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.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Loperamide - Exercise Plus Biofeedback | Change From Baseline St. Mark's (Vaizey) Score | 12 Week St. Mark's Score | -5.5 units on a scale |
| Loperamide - Exercise Plus Biofeedback | Change From Baseline St. Mark's (Vaizey) Score | 24 Week St. Mark's Score | -9.7 units on a scale |
| Placebo - Exercise Plus Biofeedback | Change From Baseline St. Mark's (Vaizey) Score | 24 Week St. Mark's Score | -5.9 units on a scale |
| Placebo - Exercise Plus Biofeedback | Change From Baseline St. Mark's (Vaizey) Score | 12 Week St. Mark's Score | -4.4 units on a scale |
| Loperamide - Education Only | Change From Baseline St. Mark's (Vaizey) Score | 24 Week St. Mark's Score | -6.2 units on a scale |
| Loperamide - Education Only | Change From Baseline St. Mark's (Vaizey) Score | 12 Week St. Mark's Score | -4.5 units on a scale |
| Placebo - Education Only | Change From Baseline St. Mark's (Vaizey) Score | 24 Week St. Mark's Score | -4.5 units on a scale |
| Placebo - Education Only | Change From Baseline St. Mark's (Vaizey) Score | 12 Week St. Mark's Score | -3.4 units on a scale |
p-value: 0.092Mixed Models Analysis
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).
Time frame: 12 and 24 weeks
Population: 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.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Loperamide - Exercise Plus Biofeedback | Change From Baseline Accident-free Days at 12 and 24 Weeks | 12 Weeks | 1.8 accident-free days |
| Loperamide - Exercise Plus Biofeedback | Change From Baseline Accident-free Days at 12 and 24 Weeks | 24 Weeks | 2.5 accident-free days |
| Placebo - Exercise Plus Biofeedback | Change From Baseline Accident-free Days at 12 and 24 Weeks | 24 Weeks | 1.9 accident-free days |
| Placebo - Exercise Plus Biofeedback | Change From Baseline Accident-free Days at 12 and 24 Weeks | 12 Weeks | 1.9 accident-free days |
| Loperamide - Education Only | Change From Baseline Accident-free Days at 12 and 24 Weeks | 12 Weeks | 1.7 accident-free days |
| Loperamide - Education Only | Change From Baseline Accident-free Days at 12 and 24 Weeks | 24 Weeks | 1.7 accident-free days |
| Placebo - Education Only | Change From Baseline Accident-free Days at 12 and 24 Weeks | 12 Weeks | 1.4 accident-free days |
| Placebo - Education Only | Change From Baseline Accident-free Days at 12 and 24 Weeks | 24 Weeks | 2.1 accident-free days |
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.
Time frame: 12 and 24 weeks
Population: 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.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Loperamide - Exercise Plus Biofeedback | Change From Baseline Maximum Anal Pressures During Squeeze With the Catheter at the HPZ at 12 and 24 Weeks | 12 Week Maximum Anal Canal Pressure (Squeeze) | 83.0 max. anal canal pressure squeeze (mmHg) |
| Loperamide - Exercise Plus Biofeedback | Change From Baseline Maximum Anal Pressures During Squeeze With the Catheter at the HPZ at 12 and 24 Weeks | 24 Week Maximum Anal Canal Pressure (Squeeze) | 83.0 max. anal canal pressure squeeze (mmHg) |
| Placebo - Exercise Plus Biofeedback | Change From Baseline Maximum Anal Pressures During Squeeze With the Catheter at the HPZ at 12 and 24 Weeks | 24 Week Maximum Anal Canal Pressure (Squeeze) | 74.6 max. anal canal pressure squeeze (mmHg) |
| Placebo - Exercise Plus Biofeedback | Change From Baseline Maximum Anal Pressures During Squeeze With the Catheter at the HPZ at 12 and 24 Weeks | 12 Week Maximum Anal Canal Pressure (Squeeze) | 76.3 max. anal canal pressure squeeze (mmHg) |
| Loperamide - Education Only | Change From Baseline Maximum Anal Pressures During Squeeze With the Catheter at the HPZ at 12 and 24 Weeks | 12 Week Maximum Anal Canal Pressure (Squeeze) | 73.6 max. anal canal pressure squeeze (mmHg) |
| Loperamide - Education Only | Change From Baseline Maximum Anal Pressures During Squeeze With the Catheter at the HPZ at 12 and 24 Weeks | 24 Week Maximum Anal Canal Pressure (Squeeze) | 67.1 max. anal canal pressure squeeze (mmHg) |
| Placebo - Education Only | Change From Baseline Maximum Anal Pressures During Squeeze With the Catheter at the HPZ at 12 and 24 Weeks | 12 Week Maximum Anal Canal Pressure (Squeeze) | 73.1 max. anal canal pressure squeeze (mmHg) |
| Placebo - Education Only | Change From Baseline Maximum Anal Pressures During Squeeze With the Catheter at the HPZ at 12 and 24 Weeks | 24 Week Maximum Anal Canal Pressure (Squeeze) | 72.7 max. anal canal pressure squeeze (mmHg) |
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).
Time frame: 12 and 24 weeks
Population: 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.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Loperamide - Exercise Plus Biofeedback | Change From Baseline Pad-change Leaks Per Day at 12 and 24 Weeks | 12 Weeks | -0.4 pad-change leaks per day |
| Loperamide - Exercise Plus Biofeedback | Change From Baseline Pad-change Leaks Per Day at 12 and 24 Weeks | 24 Weeks | -0.5 pad-change leaks per day |
| Placebo - Exercise Plus Biofeedback | Change From Baseline Pad-change Leaks Per Day at 12 and 24 Weeks | 24 Weeks | -0.1 pad-change leaks per day |
| Placebo - Exercise Plus Biofeedback | Change From Baseline Pad-change Leaks Per Day at 12 and 24 Weeks | 12 Weeks | -0.2 pad-change leaks per day |
| Loperamide - Education Only | Change From Baseline Pad-change Leaks Per Day at 12 and 24 Weeks | 12 Weeks | -0.3 pad-change leaks per day |
| Loperamide - Education Only | Change From Baseline Pad-change Leaks Per Day at 12 and 24 Weeks | 24 Weeks | -0.4 pad-change leaks per day |
| Placebo - Education Only | Change From Baseline Pad-change Leaks Per Day at 12 and 24 Weeks | 12 Weeks | -0.2 pad-change leaks per day |
| Placebo - Education Only | Change From Baseline Pad-change Leaks Per Day at 12 and 24 Weeks | 24 Weeks | -0.4 pad-change leaks per day |
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).
Time frame: 12 and 24 weeks
Population: 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.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Loperamide - Exercise Plus Biofeedback | Change From Baseline Pad-change Leaks Per Week at 12 and 24 Weeks | 12 Weeks | -2.7 pad-change leaks per week |
| Loperamide - Exercise Plus Biofeedback | Change From Baseline Pad-change Leaks Per Week at 12 and 24 Weeks | 24 Weeks | -3.3 pad-change leaks per week |
| Placebo - Exercise Plus Biofeedback | Change From Baseline Pad-change Leaks Per Week at 12 and 24 Weeks | 24 Weeks | -0.7 pad-change leaks per week |
| Placebo - Exercise Plus Biofeedback | Change From Baseline Pad-change Leaks Per Week at 12 and 24 Weeks | 12 Weeks | -1.1 pad-change leaks per week |
| Loperamide - Education Only | Change From Baseline Pad-change Leaks Per Week at 12 and 24 Weeks | 12 Weeks | -1.3 pad-change leaks per week |
| Loperamide - Education Only | Change From Baseline Pad-change Leaks Per Week at 12 and 24 Weeks | 24 Weeks | -2.2 pad-change leaks per week |
| Placebo - Education Only | Change From Baseline Pad-change Leaks Per Week at 12 and 24 Weeks | 12 Weeks | -1.7 pad-change leaks per week |
| Placebo - Education Only | Change From Baseline Pad-change Leaks Per Week at 12 and 24 Weeks | 24 Weeks | -2.5 pad-change leaks per week |
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
Time frame: 12 and 24 weeks
Population: 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.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Loperamide - Exercise Plus Biofeedback | Change From Baseline Resting Anal Canal Pressures (mm of Hg) at 2 cm, 1 cm, and 0 cm Insertion at 12 and 24 Weeks | 12 Week Maximum Anal Canal Pressure (Rest) | 52.6 resting anal canal pressure (mm Hg) |
| Loperamide - Exercise Plus Biofeedback | Change From Baseline Resting Anal Canal Pressures (mm of Hg) at 2 cm, 1 cm, and 0 cm Insertion at 12 and 24 Weeks | 24 Week Maximum Anal Canal Pressure (Rest) | 47.7 resting anal canal pressure (mm Hg) |
| Loperamide - Exercise Plus Biofeedback | Change From Baseline Resting Anal Canal Pressures (mm of Hg) at 2 cm, 1 cm, and 0 cm Insertion at 12 and 24 Weeks | 12 Week Maximum Anal Canal Pressure (Squeeze) | 83.0 resting anal canal pressure (mm Hg) |
| Loperamide - Exercise Plus Biofeedback | Change From Baseline Resting Anal Canal Pressures (mm of Hg) at 2 cm, 1 cm, and 0 cm Insertion at 12 and 24 Weeks | 24 Week Maximum Anal Canal Pressure (Squeeze) | 83.0 resting anal canal pressure (mm Hg) |
| Placebo - Exercise Plus Biofeedback | Change From Baseline Resting Anal Canal Pressures (mm of Hg) at 2 cm, 1 cm, and 0 cm Insertion at 12 and 24 Weeks | 24 Week Maximum Anal Canal Pressure (Rest) | 47.8 resting anal canal pressure (mm Hg) |
| Placebo - Exercise Plus Biofeedback | Change From Baseline Resting Anal Canal Pressures (mm of Hg) at 2 cm, 1 cm, and 0 cm Insertion at 12 and 24 Weeks | 12 Week Maximum Anal Canal Pressure (Squeeze) | 76.3 resting anal canal pressure (mm Hg) |
| Placebo - Exercise Plus Biofeedback | Change From Baseline Resting Anal Canal Pressures (mm of Hg) at 2 cm, 1 cm, and 0 cm Insertion at 12 and 24 Weeks | 24 Week Maximum Anal Canal Pressure (Squeeze) | 74.6 resting anal canal pressure (mm Hg) |
| Placebo - Exercise Plus Biofeedback | Change From Baseline Resting Anal Canal Pressures (mm of Hg) at 2 cm, 1 cm, and 0 cm Insertion at 12 and 24 Weeks | 12 Week Maximum Anal Canal Pressure (Rest) | 49.4 resting anal canal pressure (mm Hg) |
| Loperamide - Education Only | Change From Baseline Resting Anal Canal Pressures (mm of Hg) at 2 cm, 1 cm, and 0 cm Insertion at 12 and 24 Weeks | 12 Week Maximum Anal Canal Pressure (Squeeze) | 73.6 resting anal canal pressure (mm Hg) |
| Loperamide - Education Only | Change From Baseline Resting Anal Canal Pressures (mm of Hg) at 2 cm, 1 cm, and 0 cm Insertion at 12 and 24 Weeks | 24 Week Maximum Anal Canal Pressure (Rest) | 45.7 resting anal canal pressure (mm Hg) |
| Loperamide - Education Only | Change From Baseline Resting Anal Canal Pressures (mm of Hg) at 2 cm, 1 cm, and 0 cm Insertion at 12 and 24 Weeks | 24 Week Maximum Anal Canal Pressure (Squeeze) | 67.1 resting anal canal pressure (mm Hg) |
| Loperamide - Education Only | Change From Baseline Resting Anal Canal Pressures (mm of Hg) at 2 cm, 1 cm, and 0 cm Insertion at 12 and 24 Weeks | 12 Week Maximum Anal Canal Pressure (Rest) | 51.1 resting anal canal pressure (mm Hg) |
| Placebo - Education Only | Change From Baseline Resting Anal Canal Pressures (mm of Hg) at 2 cm, 1 cm, and 0 cm Insertion at 12 and 24 Weeks | 24 Week Maximum Anal Canal Pressure (Squeeze) | 72.7 resting anal canal pressure (mm Hg) |
| Placebo - Education Only | Change From Baseline Resting Anal Canal Pressures (mm of Hg) at 2 cm, 1 cm, and 0 cm Insertion at 12 and 24 Weeks | 24 Week Maximum Anal Canal Pressure (Rest) | 46.5 resting anal canal pressure (mm Hg) |
| Placebo - Education Only | Change From Baseline Resting Anal Canal Pressures (mm of Hg) at 2 cm, 1 cm, and 0 cm Insertion at 12 and 24 Weeks | 12 Week Maximum Anal Canal Pressure (Rest) | 46.3 resting anal canal pressure (mm Hg) |
| Placebo - Education Only | Change From Baseline Resting Anal Canal Pressures (mm of Hg) at 2 cm, 1 cm, and 0 cm Insertion at 12 and 24 Weeks | 12 Week Maximum Anal Canal Pressure (Squeeze) | 73.1 resting anal canal pressure (mm Hg) |
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).
Time frame: 12 and 24 weeks
Population: 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.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Loperamide - Exercise Plus Biofeedback | Change From Baseline Total Number of Leaks Per Day at 12 and 24 Weeks | 12 Weeks | -1.1 leaks per day |
| Loperamide - Exercise Plus Biofeedback | Change From Baseline Total Number of Leaks Per Day at 12 and 24 Weeks | 24 Weeks | -1.3 leaks per day |
| Placebo - Exercise Plus Biofeedback | Change From Baseline Total Number of Leaks Per Day at 12 and 24 Weeks | 12 Weeks | -0.7 leaks per day |
| Placebo - Exercise Plus Biofeedback | Change From Baseline Total Number of Leaks Per Day at 12 and 24 Weeks | 24 Weeks | -0.7 leaks per day |
| Loperamide - Education Only | Change From Baseline Total Number of Leaks Per Day at 12 and 24 Weeks | 12 Weeks | -0.9 leaks per day |
| Loperamide - Education Only | Change From Baseline Total Number of Leaks Per Day at 12 and 24 Weeks | 24 Weeks | -1.0 leaks per day |
| Placebo - Education Only | Change From Baseline Total Number of Leaks Per Day at 12 and 24 Weeks | 24 Weeks | -1.3 leaks per day |
| Placebo - Education Only | Change From Baseline Total Number of Leaks Per Day at 12 and 24 Weeks | 12 Weeks | -1.0 leaks per day |
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.
Time frame: 12 and 24 weeks
Population: 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.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Loperamide - Exercise Plus Biofeedback | Change From Baseline Volume of Air (mL) at First Sensation for Perception of Rectal Distention at 12 and 24 Weeks | 12 Week Volume of Air at First Sensation | 19.0 volume of air (mL) |
| Loperamide - Exercise Plus Biofeedback | Change From Baseline Volume of Air (mL) at First Sensation for Perception of Rectal Distention at 12 and 24 Weeks | 24 Week Volume of Air at First Sensation | 20.1 volume of air (mL) |
| Placebo - Exercise Plus Biofeedback | Change From Baseline Volume of Air (mL) at First Sensation for Perception of Rectal Distention at 12 and 24 Weeks | 12 Week Volume of Air at First Sensation | 22.7 volume of air (mL) |
| Placebo - Exercise Plus Biofeedback | Change From Baseline Volume of Air (mL) at First Sensation for Perception of Rectal Distention at 12 and 24 Weeks | 24 Week Volume of Air at First Sensation | 24.5 volume of air (mL) |
| Loperamide - Education Only | Change From Baseline Volume of Air (mL) at First Sensation for Perception of Rectal Distention at 12 and 24 Weeks | 24 Week Volume of Air at First Sensation | 21.6 volume of air (mL) |
| Loperamide - Education Only | Change From Baseline Volume of Air (mL) at First Sensation for Perception of Rectal Distention at 12 and 24 Weeks | 12 Week Volume of Air at First Sensation | 21.6 volume of air (mL) |
| Placebo - Education Only | Change From Baseline Volume of Air (mL) at First Sensation for Perception of Rectal Distention at 12 and 24 Weeks | 24 Week Volume of Air at First Sensation | 23.5 volume of air (mL) |
| Placebo - Education Only | Change From Baseline Volume of Air (mL) at First Sensation for Perception of Rectal Distention at 12 and 24 Weeks | 12 Week Volume of Air at First Sensation | 25.1 volume of air (mL) |
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.
Time frame: 12 and 24 weeks
Population: 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.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Loperamide - Exercise Plus Biofeedback | Change From Baseline Volume of Air (mL) at Urge to Defecate at 12 and 24 Weeks | 12 Week Volume of Air at Strong Urge | 69.3 volume of air (mL) |
| Loperamide - Exercise Plus Biofeedback | Change From Baseline Volume of Air (mL) at Urge to Defecate at 12 and 24 Weeks | 24 Week Volume of Air at Strong Urge | 76.0 volume of air (mL) |
| Placebo - Exercise Plus Biofeedback | Change From Baseline Volume of Air (mL) at Urge to Defecate at 12 and 24 Weeks | 24 Week Volume of Air at Strong Urge | 78.4 volume of air (mL) |
| Placebo - Exercise Plus Biofeedback | Change From Baseline Volume of Air (mL) at Urge to Defecate at 12 and 24 Weeks | 12 Week Volume of Air at Strong Urge | 66.9 volume of air (mL) |
| Loperamide - Education Only | Change From Baseline Volume of Air (mL) at Urge to Defecate at 12 and 24 Weeks | 12 Week Volume of Air at Strong Urge | 73.0 volume of air (mL) |
| Loperamide - Education Only | Change From Baseline Volume of Air (mL) at Urge to Defecate at 12 and 24 Weeks | 24 Week Volume of Air at Strong Urge | 77.3 volume of air (mL) |
| Placebo - Education Only | Change From Baseline Volume of Air (mL) at Urge to Defecate at 12 and 24 Weeks | 12 Week Volume of Air at Strong Urge | 71.8 volume of air (mL) |
| Placebo - Education Only | Change From Baseline Volume of Air (mL) at Urge to Defecate at 12 and 24 Weeks | 24 Week Volume of Air at Strong Urge | 73.1 volume of air (mL) |
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.
Time frame: 12 and 24 weeks
Population: 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.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Loperamide - Exercise Plus Biofeedback | Change in Colorectal-Anal Subscale of the Pelvic Floor Impact Questionnaire Short Form (CRAIQ) Score | 12 Weeks | -12.5 units on a scale |
| Loperamide - Exercise Plus Biofeedback | Change in Colorectal-Anal Subscale of the Pelvic Floor Impact Questionnaire Short Form (CRAIQ) Score | 24 Weeks | -41.3 units on a scale |
| Placebo - Exercise Plus Biofeedback | Change in Colorectal-Anal Subscale of the Pelvic Floor Impact Questionnaire Short Form (CRAIQ) Score | 24 Weeks | -32.4 units on a scale |
| Placebo - Exercise Plus Biofeedback | Change in Colorectal-Anal Subscale of the Pelvic Floor Impact Questionnaire Short Form (CRAIQ) Score | 12 Weeks | -10.8 units on a scale |
| Loperamide - Education Only | Change in Colorectal-Anal Subscale of the Pelvic Floor Impact Questionnaire Short Form (CRAIQ) Score | 24 Weeks | -41.6 units on a scale |
| Loperamide - Education Only | Change in Colorectal-Anal Subscale of the Pelvic Floor Impact Questionnaire Short Form (CRAIQ) Score | 12 Weeks | -15.8 units on a scale |
| Placebo - Education Only | Change in Colorectal-Anal Subscale of the Pelvic Floor Impact Questionnaire Short Form (CRAIQ) Score | 24 Weeks | -17.3 units on a scale |
| Placebo - Education Only | Change in Colorectal-Anal Subscale of the Pelvic Floor Impact Questionnaire Short Form (CRAIQ) Score | 12 Weeks | -12.3 units on a scale |
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.
Time frame: 12 and 24 weeks
Population: 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.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Loperamide - Exercise Plus Biofeedback | Change in Fecal Incontinence Severity Index (FISI) Score | 12 Week MMHQ Severity Measures Score | -12.4 units on a scale |
| Loperamide - Exercise Plus Biofeedback | Change in Fecal Incontinence Severity Index (FISI) Score | 24 Week MMHQ Severity Measures Score | -19.1 units on a scale |
| Placebo - Exercise Plus Biofeedback | Change in Fecal Incontinence Severity Index (FISI) Score | 24 Week MMHQ Severity Measures Score | -15.0 units on a scale |
| Placebo - Exercise Plus Biofeedback | Change in Fecal Incontinence Severity Index (FISI) Score | 12 Week MMHQ Severity Measures Score | -10.6 units on a scale |
| Loperamide - Education Only | Change in Fecal Incontinence Severity Index (FISI) Score | 24 Week MMHQ Severity Measures Score | -19.2 units on a scale |
| Loperamide - Education Only | Change in Fecal Incontinence Severity Index (FISI) Score | 12 Week MMHQ Severity Measures Score | -14.4 units on a scale |
| Placebo - Education Only | Change in Fecal Incontinence Severity Index (FISI) Score | 24 Week MMHQ Severity Measures Score | -20.0 units on a scale |
| Placebo - Education Only | Change in Fecal Incontinence Severity Index (FISI) Score | 12 Week MMHQ Severity Measures Score | -7.8 units on a scale |
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.
Time frame: 12 and 24 weeks
Population: 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.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Loperamide - Exercise Plus Biofeedback | Change in Quality of Life on Colorectal-Anal Distress Inventory (CRADI) | 12 Week CRADI Score | -16.3 units on a scale |
| Loperamide - Exercise Plus Biofeedback | Change in Quality of Life on Colorectal-Anal Distress Inventory (CRADI) | 24 Week CRADI Score | -21.5 units on a scale |
| Placebo - Exercise Plus Biofeedback | Change in Quality of Life on Colorectal-Anal Distress Inventory (CRADI) | 12 Week CRADI Score | -13.1 units on a scale |
| Placebo - Exercise Plus Biofeedback | Change in Quality of Life on Colorectal-Anal Distress Inventory (CRADI) | 24 Week CRADI Score | -15.7 units on a scale |
| Loperamide - Education Only | Change in Quality of Life on Colorectal-Anal Distress Inventory (CRADI) | 24 Week CRADI Score | -21.7 units on a scale |
| Loperamide - Education Only | Change in Quality of Life on Colorectal-Anal Distress Inventory (CRADI) | 12 Week CRADI Score | -16.9 units on a scale |
| Placebo - Education Only | Change in Quality of Life on Colorectal-Anal Distress Inventory (CRADI) | 24 Week CRADI Score | -15.7 units on a scale |
| Placebo - Education Only | Change in Quality of Life on Colorectal-Anal Distress Inventory (CRADI) | 12 Week CRADI Score | -4.6 units on a scale |
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).
Time frame: 12 and 24 Weeks
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Loperamide - Exercise Plus Biofeedback | Participants With Improvement in Patient Global Impression of Improvement (PGI-I) Score | 12 Weeks | 68 Participants |
| Loperamide - Exercise Plus Biofeedback | Participants With Improvement in Patient Global Impression of Improvement (PGI-I) Score | 24 Weeks | 67 Participants |
| Placebo - Exercise Plus Biofeedback | Participants With Improvement in Patient Global Impression of Improvement (PGI-I) Score | 24 Weeks | 59 Participants |
| Placebo - Exercise Plus Biofeedback | Participants With Improvement in Patient Global Impression of Improvement (PGI-I) Score | 12 Weeks | 57 Participants |
| Loperamide - Education Only | Participants With Improvement in Patient Global Impression of Improvement (PGI-I) Score | 12 Weeks | 61 Participants |
| Loperamide - Education Only | Participants With Improvement in Patient Global Impression of Improvement (PGI-I) Score | 24 Weeks | 60 Participants |
| Placebo - Education Only | Participants With Improvement in Patient Global Impression of Improvement (PGI-I) Score | 12 Weeks | 26 Participants |
| Placebo - Education Only | Participants With Improvement in Patient Global Impression of Improvement (PGI-I) Score | 24 Weeks | 25 Participants |