Ignite Creation Date:
2025-12-24 @ 6:44 PM
Ignite Modification Date:
2026-01-22 @ 5:25 AM
Study NCT ID:
NCT00127257
Status:
COMPLETED
Last Update Posted:
2010-01-13
First Post:
2005-08-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Biofeedback for Dyssynergic Constipation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003248', 'term': 'Constipation'}, {'id': 'D001259', 'term': 'Ataxia'}], 'ancestors': [{'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D020820', 'term': 'Dyskinesias'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001676', 'term': 'Biofeedback, Psychology'}, {'id': 'D003975', 'term': 'Diazepam'}], 'ancestors': [{'id': 'D026441', 'term': 'Mind-Body Therapies'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D030141', 'term': 'Feedback, Psychological'}, {'id': 'D001570', 'term': 'Benzodiazepinones'}, {'id': 'D001569', 'term': 'Benzodiazepines'}, {'id': 'D001552', 'term': 'Benzazepines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 117}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1999-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-01', 'completionDateStruct': {'date': '2006-06'}, 'lastUpdateSubmitDate': '2010-01-12', 'studyFirstSubmitDate': '2005-08-04', 'studyFirstSubmitQcDate': '2005-08-04', 'lastUpdatePostDateStruct': {'date': '2010-01-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-08-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of subjects reporting adequate relief per treatment group'}], 'secondaryOutcomes': [{'measure': 'Demonstrate association of improvement in quality of life with treatment outcome'}, {'measure': 'Identify predictors of successful treatment outcome'}, {'measure': 'Describe physiological mechanism of treatment effects'}]}, 'conditionsModule': {'keywords': ['Constipation', 'Biofeedback', 'Dyssynergia', 'Pelvic floor dyssynergia', 'Outlet dysfunction'], 'conditions': ['Constipation']}, 'referencesModule': {'references': [{'pmid': '15497616', 'type': 'BACKGROUND', 'citation': 'Palsson OS, Heymen S, Whitehead WE. Biofeedback treatment for functional anorectal disorders: a comprehensive efficacy review. Appl Psychophysiol Biofeedback. 2004 Sep;29(3):153-74. doi: 10.1023/b:apbi.0000039055.18609.64.'}, {'pmid': '12972965', 'type': 'BACKGROUND', 'citation': 'Heymen S, Jones KR, Scarlett Y, Whitehead WE. Biofeedback treatment of constipation: a critical review. Dis Colon Rectum. 2003 Sep;46(9):1208-17. doi: 10.1007/s10350-004-6717-8.'}, {'type': 'BACKGROUND', 'citation': 'Whitehead WE, Heymen S, Schuster MM. Motility as a therapeutic modality: biofeedback treatment of gastrointestinal disorders. Chapter 27. In MM Schuster, MD Crowell, KL Koch (Eds.), Schuster Atlas of Gastrointestinal Motility in Health and Disease. London, BC Decker Inc. 2002; 381-397.'}, {'type': 'BACKGROUND', 'citation': 'Heymen S, Jones KR, Ringel Y, Scarlett Y, Drossman D, Whitehead WE (abstract). Biofeedback for fecal incontinence and constipation: the role of medical management and education. Gastro 2001 (suppl 1):120, A397.'}, {'type': 'RESULT', 'citation': 'Heymen S, Scarlett Y, Whitehead WE. Constipated subjects reporting physical abuse are more likely to fail an education/medical management intervention. Am J Gastroenterol Suppl 2004;99:T1364'}, {'type': 'RESULT', 'citation': 'Heymen S, Scarlett Y, Whitehead WE. Severity of constipation and anxiety predict failure to improve with conservative medical treatment for constipation. Am J Gastroenterol Suppl 2004;99:T1370'}, {'type': 'RESULT', 'citation': 'Heymen S, Scarlett Y, and Whitehead WE. Elevated Beck Depression Inventory (BDI) Scores Predict Biofeedback Treatment Failure for Fecal Incontinence and Constipation (abstract). Gastroenterology 2003,124:4(suppl 1)A-685.'}]}, 'descriptionModule': {'briefSummary': 'Constipation affects 4% of adults in the United States (U.S.). An estimated half of constipated patients are unable to relax pelvic floor muscles during defecation, a type of constipation called pelvic floor dyssynergia (PFD). Biofeedback has been recommended for the treatment of constipation because uncontrolled studies over the past 10 years suggest that these treatments are as effective as medical or surgical management and involve no risk. However, placebo-controlled trials are still lacking. The aims of this study are:\n\n* to compare biofeedback to alternative therapies for which patients have a similar expectation of benefit;\n* to identify which patients are most likely to benefit; and\n* to assess the impact of treatment on quality of life.', 'detailedDescription': 'This study is a long-term prospective, single-blind study comparing biofeedback for pelvic floor dyssynergia to a skeletal muscle relaxant drug (diazepam 5 mg two hours before attempted defecation) and to placebo medication. Prior to randomization, patients will first receive medical therapy (laxatives and education) for 4 weeks and only those remaining constipated will be randomized. Physiological tests of anal canal pressure during straining to defecate and ability to pass a 50-ml air filled balloon will be tested before and after treatment. Patients will keep a diary throughout baseline and treatment, and they will be reassessed at 3, 6, and 12 months follow-up. Treatment will consist of 6 clinic visits at 2-week intervals. The investigators will develop a detailed treatment manual for this disorder which would permit other investigators to replicate their study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males or females ages 16 or above who have symptoms of constipation due to pelvic floor dyssynergia\n\nExclusion Criteria:\n\n* Pregnancy (because of the possibility of randomization into the diazepam group)\n* Prior history of biofeedback treatment for pelvic floor disorders'}, 'identificationModule': {'nctId': 'NCT00127257', 'briefTitle': 'Biofeedback for Dyssynergic Constipation', 'organization': {'class': 'NIH', 'fullName': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)'}, 'officialTitle': 'Biofeedback for Fecal Incontinence and Constipation', 'orgStudyIdInfo': {'id': 'RO1 DK57048b (completed)'}, 'secondaryIdInfos': [{'id': 'R01DK057048', 'link': 'https://reporter.nih.gov/quickSearch/R01DK057048', 'type': 'NIH'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Biofeedback', 'type': 'BEHAVIORAL'}, {'name': 'Diazepam', 'type': 'DRUG'}, {'name': 'Pelvic floor retraining', 'type': 'BEHAVIORAL'}]}, 'contactsLocationsModule': {'locations': [{'zip': '27599', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'University of North Carolina Department of Medicine', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}], 'overallOfficials': [{'name': 'William E Whitehead, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of North Carolina, Chapel Hill'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)', 'class': 'NIH'}}}}