Biofeedback for Dyssynergic Constipation

NCT ID: NCT00127257

Last Updated: 2010-01-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 117 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1999-09-30
• Study Completion Date: 2006-06-30

Brief Summary

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:

• to compare biofeedback to alternative therapies for which patients have a similar expectation of benefit;
• to identify which patients are most likely to benefit; and
• to assess the impact of treatment on quality of life.

Detailed Description

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.

Conditions

Constipation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Interventions

Biofeedback

Intervention Type: BEHAVIORAL

Diazepam

Intervention Type: DRUG

Pelvic floor retraining

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Males or females ages 16 or above who have symptoms of constipation due to pelvic floor dyssynergia

Exclusion Criteria

• Pregnancy (because of the possibility of randomization into the diazepam group)
• Prior history of biofeedback treatment for pelvic floor disorders

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: lead

Principal Investigators

William E Whitehead, PhD

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Locations

University of North Carolina Department of Medicine

Chapel Hill, North Carolina, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 15497616 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 12972965 (View on PubMed)

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.

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

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

Reference Type: RESULT

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

Reference Type: RESULT

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.

Reference Type: RESULT

Other Identifiers

R01DK057048

Identifier Type: NIH

Identifier Source: secondary_id

View Link

RO1 DK57048b (completed)

Identifier Type: -

Identifier Source: org_study_id