NCT00127257

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
117

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 1999

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 1999

Completed
5.9 years until next milestone

First Submitted

Initial submission to the registry

August 4, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 5, 2005

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2006

Completed
Last Updated

January 13, 2010

Status Verified

January 1, 2010

First QC Date

August 4, 2005

Last Update Submit

January 12, 2010

Conditions

Constipation

Keywords

ConstipationBiofeedbackDyssynergiaPelvic floor dyssynergiaOutlet dysfunction

Outcome Measures

Primary Outcomes (1)

  • Proportion of subjects reporting adequate relief per treatment group

Secondary Outcomes (3)

  • Demonstrate association of improvement in quality of life with treatment outcome

  • Identify predictors of successful treatment outcome

  • Describe physiological mechanism of treatment effects

Interventions

BiofeedbackBEHAVIORAL
DiazepamDRUG
Pelvic floor retrainingBEHAVIORAL

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of North Carolina Department of Medicine

Chapel Hill, North Carolina, 27599, United States

Location

Related Publications (7)

  • 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: 15497616BACKGROUND

  • 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.

    PMID: 12972965BACKGROUND

  • 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.

    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.

    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

    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

    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.

    RESULT

MeSH Terms

Conditions

ConstipationAtaxia

Interventions

Biofeedback, PsychologyDiazepam

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsDyskinesiasNeurologic ManifestationsNervous System Diseases

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsBehavior TherapyPsychotherapyBehavioral Disciplines and ActivitiesFeedback, PsychologicalBenzodiazepinonesBenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • William E Whitehead, PhD

    University of North Carolina, Chapel Hill

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH

Study Record Dates

First Submitted

August 4, 2005

First Posted

August 5, 2005

Study Start

September 1, 1999

Study Completion

June 1, 2006

Last Updated

January 13, 2010

Record last verified: 2010-01

Locations

US(1)