Biofeedback for Fecal Incontinence

05:22 EDT 23rd October 2014 | BioPortfolio

Summary

Fecal incontinence affects 2% of adults in the United States. Biofeedback has been recommended for the treatment of fecal incontinence because uncontrolled studies over the past 25 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: (1) to compare biofeedback to alternative therapies for which patients have a similar expectation of benefit; (2) to identify which patients are most likely to benefit; and (3) to assess the impact of treatment on quality of life.

Description

Study I is a long-term, prospective, single-blind study comparing biofeedback for fecal incontinence to a standard therapy (Kegel exercises) that is associated with a similar expectation of improvement (i.e., comparable placebo effect). Prior to randomization, patients will receive medical therapy (antidiarrheal medications as appropriate) and education for 4 weeks, and only patients who remain incontinent will be randomized. Anal canal squeeze pressures and rectal sensory thresholds will be tested before and after treatment. Patients will keep a diary throughout baseline and treatment, and they will be re-assessed at 3, 6, and 12 months. Treatment will consist of 6 clinic visits at 2-week intervals. The primary outcome is the patient's response to the question, "Have you had satisfactory relief of fecal incontinence (yes/no)?" This question is asked at 3 months following the end of treatment and at each follow-up visit. The investigators will develop a detailed treatment manual for fecal incontinence which would permit other investigators to replicate our study.

Study Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Conditions

Fecal Incontinence

Intervention

Biofeedback, Kegel exercises

Location

University of North Carolina Department of Medicine
Chapel Hill
North Carolina
United States
27599

Status

Completed

Source

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

Results (where available)

View Results

Links

Clinical Trials [173 Associated Clinical Trials listed on BioPortfolio]

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PubMed Articles [782 Associated PubMed Articles listed on BioPortfolio]

Effect of home-based Kegel exercises on quality of life in women with stress and mixed urinary incontinence.

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The effects of cervical stabilization exercises on the electromyographic activity of shoulder stabilizers.

[Purpose] The purpose of the present study was to examine the effects of cervical stabilization exercises on the electromyographic activity of the shoulder stabilizers in normal adults. [Subjects] In ...

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To compare the outcomes of the open-ended six to ten sessions of biofeedback against a novel regime of four sessions of biofeedback to treat children with dysfunctional voiding.

Abstracts of Scientific Papers Presented at the 17th Annual Meeting of the Biofeedback Federation of Europe.

Medical and Biotech [MESH] Definitions

Abnormal descent of a pelvic organ resulting in the protrusion of the organ beyond its normal anatomical confines. Symptoms often include vaginal discomfort, DYSPAREUNIA; URINARY STRESS INCONTINENCE; and FECAL INCONTINENCE.

Circumscribed collections of suppurative material occurring in the spinal or intracranial EPIDURAL SPACE. The majority of epidural abscesses occur in the spinal canal and are associated with OSTEOMYELITIS of a vertebral body; ANALGESIA, EPIDURAL; and other conditions. Clinical manifestations include local and radicular pain, weakness, sensory loss, URINARY INCONTINENCE, and FECAL INCONTINENCE. Cranial epidural abscesses are usually associated with OSTEOMYELITIS of a cranial bone, SINUSITIS, or OTITIS MEDIA. (From Adams et al., Principles of Neurology, 6th ed, p710 and pp1240-1; J Neurol Neurosurg Psychiatry 1998 Aug;65(2):209-12)

Therapeutic exercises aimed to deepen inspiration or expiration or even to alter the rate and rhythm of respiration.

Exercises that stretch the muscle fibers with the aim to increase muscle-tendon FLEXIBILITY, improve RANGE OF MOTION or musculoskeletal function, and prevent injuries. There are various types of stretching techniques including active, passive (relaxed), static, dynamic (gentle), ballistic (forced), isometric, and others.

Involuntary loss of URINE, such as leaking of urine. It is a symptom of various underlying pathological processes. Major types of incontinence include URINARY URGE INCONTINENCE and URINARY STRESS INCONTINENCE.

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