Gastroenterology

Gastroenterology

Volume 125, Issue 5, November 2003, Pages 1320-1329
Gastroenterology

Clinical-alimentary tract
Randomized controlled trial of biofeedback for fecal incontinence

https://doi.org/10.1016/j.gastro.2003.09.039Get rights and content

Abstract

Background & Aims:

Behavioral treatment (biofeedback) has been reported to improve fecal incontinence but has not been compared with standard care.

Methods:

A total of 171 patients with fecal incontinence were randomized to 1 of 4 groups: (1) standard care (advice); (2) advice plus instruction on sphincter exercises; (3) hospital-based computer-assisted sphincter pressure biofeedback; and (4) hospital biofeedback plus the use of a home electromyelogram biofeedback device. Outcome measures included diary, symptom questionnaire, continence score, patient’s rating of change, quality of life (short-form 36 and disease specific), psychologic status (Hospital Anxiety and Depression scale), and anal manometry.

Results:

Biofeedback yielded no greater benefit than standard care with advice (53% improved in group 3 vs. 54% in group 1). There was no difference between the groups on any of the following measures: episodes of incontinence decreased from a median of 2 to 0 per week (P < 0.001). Continence score (worst = 20) decreased from a median of 11 to 8 (P < 0.001). Disease-specific quality of life, short-form 36 (vitality, social functioning, and mental health), and Hospital Anxiety and Depression scale all significantly improved. Patients improved resting, squeeze, and sustained squeeze pressures (all P < 0.002). These improvements were largely maintained 1 year after finishing treatment.

Conclusions:

Conservative therapy for fecal incontinence improves continence, quality of life, psychologic well-being, and anal sphincter function. Benefit is maintained in the medium term. Neither pelvic floor exercises nor biofeedback was superior to standard care supplemented by advice and education.

Section snippets

Materials and methods

The study was set in a specialist colorectal hospital that acts as a secondary and tertiary referral center. Biofeedback is the therapy of first choice for patients who do not have major anal sphincter and perineal body disruption (these patients are offered the option of surgery). The biofeedback service is nurse-led, in the context of a multidisciplinary unit. Patients normally have been examined previously by anorectal physiologic studies and anal ultrasonography before referral for

Patient demographics

Figure 1 gives a flow chart of recruitment. A total of 103 eligible patients were not recruited because they refused randomization (59), could not commit to regular attendance (27), or were unwilling to complete the documentation (17 patients).

A total of 171 patients were recruited into the study (Table 2). There were 12 men and 159 women, with a mean age of 56 years (range, 26–85 years). They had experienced fecal incontinence for a median of 4 years (range, 2 months to 59 years). Of the 159

Discussion

This was an evaluation of different elements of conservative bowel care. Unexpectedly, the hypothesis that biofeedback would enhance the therapeutic effect compared with standard care with advice was not upheld. Sixty percent of patients with fecal incontinence entering the study reported that undergoing this treatment had improved their symptoms. However, unexpectedly, group 4, who had the most intensive input, rated the least degree of improvement and there was little difference between the

Acknowledgements

The authors thank Paul Bassett for assistance with the statistical analysis.

References (31)

  • C. Norton et al.

    Methodology of biofeedback for adults with fecal incontinence—a program of care

    J Wound Ostomy Continence Nursing

    (2001)
  • C. Norton et al.

    A nursing assessment tool for adults with fecal incontinence

    J Wound Ostomy Continence Nursing

    (2000)
  • D.M. Chaput de Saintonge et al.

    Harnessing placebo effects in health care

    Lancet

    (1994)
  • S. Perry et al.

    The prevalence of faecal incontinence in adults aged 40 years or more living in the community

    Gut

    (2002)
  • C. Norton et al.

    Anal incontinence

  • C. Norton et al.

    Anal sphincter biofeedback and pelvic floor exercises for faecal incontinence in adults—a systematic review

    Aliment Pharmacol Ther

    (2001)
  • C. Norton et al.

    Effectiveness of biofeedback and/or sphincter exercises for the treatment of faecal incontinence in adults

    Cochrane Electronic Library

    (2003)
  • C.J. Vaizey et al.

    Prospective comparison of faecal incontinence grading systems

    Gut

    (1999)
  • J.E. Ware et al.

    SF-36 health survey manual and interpretation guide

    (1993)
  • A.S. Zigmond et al.

    The hospital anxiety and depression scale

    Acta Psychiatr Scand

    (1983)
  • C. Norton et al.

    Outcome of biofeedback for faecal incontinence

    Br J Surg

    (1999)
  • W.E. Whitehead et al.

    Functional disorders of the anus and rectum

    Gut

    (1999)
  • P.J. Law et al.

    Anal endosonography in the investigation of faecal incontinence

    Br J Surg

    (1991)
  • S. Heymen et al.

    Biofeedback treatment of fecal incontinencea critical review

    Dis Colon Rectum

    (2001)
  • K.W. Heaton et al.

    How bad are the symptoms and bowel dysfunction of patients with the irritable bowel syndrome? A prospective, controlled study with emphasis on stool form

    Gut

    (1991)
  • Cited by (320)

    • The Mexican consensus on fecal incontinence

      2023, Revista de Gastroenterologia de Mexico
    • Accidental Bowel Leakage/Fecal Incontinence: Evidence-Based Management

      2021, Obstetrics and Gynecology Clinics of North America
    • Fecal Incontinence in the Elderly

      2021, Clinics in Geriatric Medicine
      Citation Excerpt :

      Table 1 lists etiologies of common bowel disturbances, the diagnostic workup, and first-line treatments. The current anorectum-specific treatments with the best evidence to date are sacral nerve stimulation, a type of neuromodulation involving outpatient surgical implantation of electrodes adjacent to the sacral nerves,74 and biofeedback, which is performed with the assistance of a therapist to retrain a patient’s neuromuscular coordination and improve rectal sensation.75,76 These treatment modalities have been reviewed in depth,77 and typically require subspecialty guidance.

    View all citing articles on Scopus

    Supported by Action Research for 3 years of the study (to S.C.). Action Research was not involved in the study design or the decision to publish.

    1

    C.N., J.W.-B., S.R., and M.A.K. designed the study; C.N. and S.C. recruited and treated all the patients and input the data; all authors contributed to the analysis of the study and writing the article.

    View full text