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Randomized, controlled trial of biofeedback with anal manometry, transanal ultrasound, or pelvic floor retraining with digital guidance alone in the treatment of mild to moderate fecal incontinence.
Dis Colon Rectum. 2003 Jun; 46(6):703-10.DC

Abstract

BACKGROUND

A prospective, three-armed, randomized, controlled trial was performed to assess whether pelvic floor exercises with biofeedback using anal manometry or transanal ultrasound are superior to pelvic floor exercises with feedback from digital examination alone in terms of continence, quality of life, physiologic sphincter strength, and compliance. Its secondary objectives were to assess whether there are any differences in these outcomes between biofeedback with transanal ultrasound vs. anal manometry and to correlate the physiologic measures with clinical outcome.

METHODS

One hundred twenty patients with mild to moderate fecal incontinence were randomized into one of three treatment groups: biofeedback with anal manometry, biofeedback with transanal ultrasound, or pelvic floor exercises with feedback from digital examination alone. Commencing one week after an initial 45-minute assessment session, patients attended monthly treatments for a total of five sessions. Each session lasted 30 minutes and involved sphincter exercises with biofeedback that involved instrumentation or digital examination alone, and patients were encouraged to perform identical exercises twice per day between outpatient visits.

RESULTS

One hundred two patients (85 percent) completed the four-month treatment program. Across all treatment allocations, patients experienced modest but highly significant improvements in all nine outcome measures during treatment, with 70 percent of all patients perceiving improvement in symptom severity and 69 percent of patients reporting improved quality of life. With the possible exception of isotonic fatigue time, there were no significant differences between the three treatment groups in compliance, physiologic sphincter strength, and clinical or quality-of-life measures. Correlations between physiologic measures and clinical outcomes were much stronger with ultrasound-based measures than with manometry.

CONCLUSIONS

Although patients in this study who completed pelvic floor exercises with feedback from digital examination achieved no additional benefit from biofeedback and measurement with transanal ultrasound or manometry, it may be that the guidance received through digital examination alone offered patients in the pelvic floor exercise group an effective biofeedback mechanism. Contrary to our hypothesis, the use of transanal ultrasound offered no benefit over manometry, but the use of ultrasound for isotonic fatigue time and isometric fatigue contractions provided potentially important physiologic measures that require further study. This study has confirmed, through a large sample of patients, that pelvic floor retraining programs are an effective treatment for improving physiologic, clinical, and quality-of-life parameters in the short term.

Authors+Show Affiliations

Central Sydney Area Department of Colorectal Surgery at Royal Prince Alfred Hospital, Australia.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Comparative Study
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

12794569

Citation

Solomon, Michael J., et al. "Randomized, Controlled Trial of Biofeedback With Anal Manometry, Transanal Ultrasound, or Pelvic Floor Retraining With Digital Guidance Alone in the Treatment of Mild to Moderate Fecal Incontinence." Diseases of the Colon and Rectum, vol. 46, no. 6, 2003, pp. 703-10.
Solomon MJ, Pager CK, Rex J, et al. Randomized, controlled trial of biofeedback with anal manometry, transanal ultrasound, or pelvic floor retraining with digital guidance alone in the treatment of mild to moderate fecal incontinence. Dis Colon Rectum. 2003;46(6):703-10.
Solomon, M. J., Pager, C. K., Rex, J., Roberts, R., & Manning, J. (2003). Randomized, controlled trial of biofeedback with anal manometry, transanal ultrasound, or pelvic floor retraining with digital guidance alone in the treatment of mild to moderate fecal incontinence. Diseases of the Colon and Rectum, 46(6), 703-10.
Solomon MJ, et al. Randomized, Controlled Trial of Biofeedback With Anal Manometry, Transanal Ultrasound, or Pelvic Floor Retraining With Digital Guidance Alone in the Treatment of Mild to Moderate Fecal Incontinence. Dis Colon Rectum. 2003;46(6):703-10. PubMed PMID: 12794569.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Randomized, controlled trial of biofeedback with anal manometry, transanal ultrasound, or pelvic floor retraining with digital guidance alone in the treatment of mild to moderate fecal incontinence. AU - Solomon,Michael J, AU - Pager,Chet K, AU - Rex,Jenny, AU - Roberts,Rachael, AU - Manning,Jane, PY - 2003/6/10/pubmed PY - 2003/7/12/medline PY - 2003/6/10/entrez SP - 703 EP - 10 JF - Diseases of the colon and rectum JO - Dis. Colon Rectum VL - 46 IS - 6 N2 - BACKGROUND: A prospective, three-armed, randomized, controlled trial was performed to assess whether pelvic floor exercises with biofeedback using anal manometry or transanal ultrasound are superior to pelvic floor exercises with feedback from digital examination alone in terms of continence, quality of life, physiologic sphincter strength, and compliance. Its secondary objectives were to assess whether there are any differences in these outcomes between biofeedback with transanal ultrasound vs. anal manometry and to correlate the physiologic measures with clinical outcome. METHODS: One hundred twenty patients with mild to moderate fecal incontinence were randomized into one of three treatment groups: biofeedback with anal manometry, biofeedback with transanal ultrasound, or pelvic floor exercises with feedback from digital examination alone. Commencing one week after an initial 45-minute assessment session, patients attended monthly treatments for a total of five sessions. Each session lasted 30 minutes and involved sphincter exercises with biofeedback that involved instrumentation or digital examination alone, and patients were encouraged to perform identical exercises twice per day between outpatient visits. RESULTS: One hundred two patients (85 percent) completed the four-month treatment program. Across all treatment allocations, patients experienced modest but highly significant improvements in all nine outcome measures during treatment, with 70 percent of all patients perceiving improvement in symptom severity and 69 percent of patients reporting improved quality of life. With the possible exception of isotonic fatigue time, there were no significant differences between the three treatment groups in compliance, physiologic sphincter strength, and clinical or quality-of-life measures. Correlations between physiologic measures and clinical outcomes were much stronger with ultrasound-based measures than with manometry. CONCLUSIONS: Although patients in this study who completed pelvic floor exercises with feedback from digital examination achieved no additional benefit from biofeedback and measurement with transanal ultrasound or manometry, it may be that the guidance received through digital examination alone offered patients in the pelvic floor exercise group an effective biofeedback mechanism. Contrary to our hypothesis, the use of transanal ultrasound offered no benefit over manometry, but the use of ultrasound for isotonic fatigue time and isometric fatigue contractions provided potentially important physiologic measures that require further study. This study has confirmed, through a large sample of patients, that pelvic floor retraining programs are an effective treatment for improving physiologic, clinical, and quality-of-life parameters in the short term. SN - 0012-3706 UR - https://www.unboundmedicine.com/medline/citation/12794569/Randomized_controlled_trial_of_biofeedback_with_anal_manometry_transanal_ultrasound_or_pelvic_floor_retraining_with_digital_guidance_alone_in_the_treatment_of_mild_to_moderate_fecal_incontinence_ L2 - http://link.springer.com/article/10.1007/s10350-004-6643-9 DB - PRIME DP - Unbound Medicine ER -