Trial · NCT02008565
Controlling Anal Incontinence by Performing Anal Exercises With Biofeedback or Loperamide (CAPABLe)
NCT02008565, Phase 3, Completed, NICHD Pelvic Floor Disorders Network; results first posted 2018-11-20
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Controlling Anal Incontinence by Performing Anal Exercises With Biofeedback or Loperamide (CAPABLe). Trials, record NCT02008565. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02008565
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Controlling Anal Incontinence by Performing Anal Exercises With Biofeedback or Loperamide (CAPABLe)
- NCT number
- NCT02008565
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 300 participants, actual
- Lead sponsor
- NICHD Pelvic Floor Disorders Network
- Conditions
- Fecal Incontinence
- Interventions
- Loperamide, Placebo, Anal exercises with biofeedback, Usual Care
- First posted
- 2013-12-11
- Last updated
- 2018-11-20
- Results first posted
- 2018-11-20
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | 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. |
| Secondary | 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. |
| Secondary | 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). |
| Secondary | 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). |
| Secondary | 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). |
| Secondary | 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). |
| Secondary | 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. |
| Secondary | 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). |
| 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 | 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 |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline St. Mark's (Vaizey) Score | 12 and 24 weeks | 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. | units on a scale | MEAN |
| SECONDARY | Change in Quality of Life on Colorectal-Anal Distress Inventory (CRADI) | 12 and 24 weeks | 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. | units on a scale | MEAN |
| SECONDARY | Change in Colorectal-Anal Subscale of the Pelvic Floor Impact Questionnaire Short Form (CRAIQ) Score | 12 and 24 weeks | 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. | units on a scale | MEAN |
| SECONDARY | Change From Baseline Accident-free Days at 12 and 24 Weeks | 12 and 24 weeks | 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. | accident-free days | MEAN |
| SECONDARY | Change From Baseline Pad-change Leaks Per Day at 12 and 24 Weeks | 12 and 24 weeks | 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. | pad-change leaks per day | MEAN |
| SECONDARY | Change From Baseline Pad-change Leaks Per Week at 12 and 24 Weeks | 12 and 24 weeks | 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. | pad-change leaks per week | MEAN |
| SECONDARY | Change From Baseline Total Number of Leaks Per Day at 12 and 24 Weeks | 12 and 24 weeks | 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. | leaks per day | MEAN |
| SECONDARY | Change in Fecal Incontinence Severity Index (FISI) Score | 12 and 24 weeks | 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. | units on a scale | MEAN |
| SECONDARY | Participants With Improvement in Patient Global Impression of Improvement (PGI-I) Score | 12 and 24 Weeks | 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. | Participants | COUNT_OF_PARTICIPANTS |
| 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 | 12 and 24 weeks | 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. | resting anal canal pressure (mm Hg) | MEAN |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group112
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline St. Mark's (Vaizey) Score | Loperamide - Exercise Plus Biofeedback | 12 Week St. Mark's Score | -5.5 | 95% Confidence Interval -7.2 to -3.9 | units on a scale |
| Change From Baseline St. Mark's (Vaizey) Score | Placebo - Exercise Plus Biofeedback | 12 Week St. Mark's Score | -4.4 | 95% Confidence Interval -6.0 to -2.8 | units on a scale |
| Change From Baseline St. Mark's (Vaizey) Score | Loperamide - Education Only | 12 Week St. Mark's Score | -4.5 | 95% Confidence Interval -6.1 to -2.9 | units on a scale |
| Change From Baseline St. Mark's (Vaizey) Score | Placebo - Education Only | 12 Week St. Mark's Score | -3.4 | 95% Confidence Interval -6.0 to -0.8 | units on a scale |
| Change From Baseline St. Mark's (Vaizey) Score | Loperamide - Exercise Plus Biofeedback | 24 Week St. Mark's Score | -9.7 | 95% Confidence Interval -11.9 to -7.5 | units on a scale |
| Change From Baseline St. Mark's (Vaizey) Score | Placebo - Exercise Plus Biofeedback | 24 Week St. Mark's Score | -5.9 | 95% Confidence Interval -8.1 to -3.7 | units on a scale |
| Change From Baseline St. Mark's (Vaizey) Score | Loperamide - Education Only | 24 Week St. Mark's Score | -6.2 | 95% Confidence Interval -8.1 to -4.2 | units on a scale |
| Change From Baseline St. Mark's (Vaizey) Score | Placebo - Education Only | 24 Week St. Mark's Score | -4.5 | 95% Confidence Interval -7.1 to -1.9 | units on a scale |
| Change in Quality of Life on Colorectal-Anal Distress Inventory (CRADI) | Loperamide - Exercise Plus Biofeedback | 12 Week CRADI Score | -16.3 | 95% Confidence Interval -22.4 to -10.1 | units on a scale |
| Change in Quality of Life on Colorectal-Anal Distress Inventory (CRADI) | Placebo - Exercise Plus Biofeedback | 12 Week CRADI Score | -13.1 | 95% Confidence Interval -19.2 to -7.1 | units on a scale |
1 to 10 of 112Source ClinicalTrials.gov
See all 112 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Loperamide - Exercise Plus Biofeedback | 86 | |
| Overall Study | STARTED | Placebo - Exercise Plus Biofeedback | 84 | |
| Overall Study | STARTED | Loperamide - Education Only | 88 | |
| Overall Study | STARTED | Placebo - Education Only | 42 | |
| Overall Study | COMPLETED | Loperamide - Exercise Plus Biofeedback | 85 | |
| Overall Study | COMPLETED | Placebo - Exercise Plus Biofeedback | 83 | |
| Overall Study | COMPLETED | Loperamide - Education Only | 86 | |
| Overall Study | COMPLETED | Placebo - Education Only | 42 | |
| Overall Study | NOT COMPLETED | Loperamide - Exercise Plus Biofeedback | 1 | |
| Overall Study | NOT COMPLETED | Placebo - Exercise Plus Biofeedback | 1 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events144
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Abdominal distension | Gastrointestinal disorders | Loperamide - Exercise Plus Biofeedback | 4 | 86 | 5 |
| other | Abdominal distension | Gastrointestinal disorders | Placebo - Exercise Plus Biofeedback | 6 | 84 | 6 |
| other | Abdominal distension | Gastrointestinal disorders | Loperamide - Education Only | 6 | 88 | 7 |
| other | Abdominal distension | Gastrointestinal disorders | Placebo - Education Only | 1 | 42 | 1 |
| other | Abdominal pain | Gastrointestinal disorders | Loperamide - Exercise Plus Biofeedback | 4 | 86 | 4 |
| other | Abdominal pain | Gastrointestinal disorders | Placebo - Exercise Plus Biofeedback | 5 | 84 | 5 |
| other | Abdominal pain | Gastrointestinal disorders | Loperamide - Education Only | 7 | 88 | 9 |
| other | Abdominal pain | Gastrointestinal disorders | Placebo - Education Only | 5 | 42 | 5 |
| other | Constipation | Gastrointestinal disorders | Loperamide - Exercise Plus Biofeedback | 44 | 86 | 61 |
| other | Constipation | Gastrointestinal disorders | Placebo - Exercise Plus Biofeedback | 19 | 84 | 22 |
1 to 10 of 144Source ClinicalTrials.gov
See all 144 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Loperamide - Exercise Plus Biofeedback | 0 | 86 |
| Total, all-cause mortality | Placebo - Exercise Plus Biofeedback | 1 | 84 |
| Total, all-cause mortality | Loperamide - Education Only | 0 | 88 |
| Total, all-cause mortality | Placebo - Education Only | 0 | 42 |
| Total, other adverse events | Loperamide - Exercise Plus Biofeedback | 71 | 86 |
| Total, other adverse events | Placebo - Exercise Plus Biofeedback | 60 | 84 |
| Total, other adverse events | Loperamide - Education Only | 60 | 88 |
| Total, other adverse events | Placebo - Education Only | 26 | 42 |
| Total, serious adverse events | Loperamide - Exercise Plus Biofeedback | 6 | 86 |
| Total, serious adverse events | Placebo - Exercise Plus Biofeedback | 5 | 84 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 31320277 | DERIVED |
Source PubMed
Grants9
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|---|---|---|---|---|---|
| U01HD069031 | Pelvic Floor Disorders Network Data Coordinating Center (U01) | GANTZ, MARIE G | RESEARCH TRIANGLE INSTITUTE | EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT | 2011 to 2015 | NIH RePORTER |
| U10HD041261 | Perioperative Pelvic Floor Rehab: A Rrandomized Trial | RICHTER, HOLLY E | UNIVERSITY OF ALABAMA AT BIRMINGHAM | EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT | 2001 to 2015 | NIH RePORTER |
| U10HD041267 | Pelvic Floor Disorders Network - Duke University Clinical Site | VISCO, ANTHONY G | DUKE UNIVERSITY | EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT | 2001 to 2015 | NIH RePORTER |
| U10HD054214 | Pelvic Floor Disorders Network | LUKACZ, EMILY S. | UNIVERSITY OF CALIFORNIA, SAN DIEGO | EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT | 2006 to 2015 | NIH RePORTER |
| U10HD054215 | Cleveland Clinic Clinical Site | BARBER, MATTHEW D | CLEVELAND CLINIC LERNER COM-CWRU | EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT | 2006 to 2015 | NIH RePORTER |
| U10HD069006 | Pittsburgh Pelvic Floor Research Program | ZYCZYNSKI, HALINA M | MAGEE-WOMEN'S RES INST AND FOUNDATION | EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT | 2011 to 2015 | NIH RePORTER |
| U10HD069010 | Pelvic Floor Disorders Network Clinical Sites (U10) | ARYA, LILY A | UNIVERSITY OF PENNSYLVANIA | EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT | 2011 to 2015 | NIH RePORTER |
| U10HD069013 | Brown/WIH Pelvic Floor Disorders Network Site | SUNG, VIVIAN W | WOMEN AND INFANTS HOSPITAL-RHODE ISLAND | EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT | 2011 to 2015 | NIH RePORTER |
| U10HD069025 | RCT of Hypnotherapy vs Tpolterodine for OAB: Voiding and Brain Activation Changes | ROGERS, REBECCA GLENN | UNIVERSITY OF NEW MEXICO HEALTH SCIS CTR | EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT | 2011 to 2015 | NIH RePORTER |
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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