Comparison of PTNS and Biofeedback for Fecal Incontinence

Last updated: April 25, 2017
Sponsor: Seoul National University Hospital
Overall Status: Trial Not Available

Phase

3

Condition

Rectal Disorders

Fecal Incontinence

Bowel Dysfunction

Treatment

N/A

Clinical Study ID

NCT01882101
PTNS trial
  • Ages 20-80
  • All Genders

Study Summary

Until recently, there is no definite treatment for fecal incontinence that is proven to be effective with low morbidity. The efficacy of biofeedback therapy for incontinence has not been proven on the randomized controlled trials. Sacral nerve stimulation is too expensive although some prospective studies showed the therapeutic potential. Recently, posterior tibial nerve stimulation has been reported to be effective with lower cost in comparison with sacral nerve stimulation. This study is designed to show the efficacy of posterior tibial nerve stimulation compared with biofeedback therapy for fecal incontinence.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patient with 2 or more weekly episodes of fecal incontinence

  • Patient who understands and accepts to sign the informed consent form

Exclusion

Exclusion Criteria:

  • Patient with gas incontinence only

  • Major injury in anal sphincter

  • Anorectal operation history within 24 months

  • Previous spinal injury, tumor or surgery

  • Presence of neurological disease

  • Peripheral vascular disease

  • Severe comorbidity

  • Psychiatric disorder

  • Legally prohibited for clinical trial

  • Pregnancy or breast feeding

  • Previous disease or disability expected to influence the assessment of postoperativequality of life

Study Design

Study Start date:
January 01, 2014
Estimated Completion Date:
December 31, 2014

Study Description

This prospective randomized controlled trial is designed to compare the efficacy of biofeedback and posterior tibial nerve stimulation for fecal incontinence. Primary endpoint is weekly episodes of fecal incontinence at 1 week after each treatment. Sample size was calculated as 50 patients. Outcomes include weekly episodes and severity of fecal incontinence, quality of life and anal function. Outcomes will be assessed using bowel diary, FISI questionnaire, FIQL questionnaire and anorectal manometry at 1,8,16 and 24 weeks after each treatment for 6 weeks.

Connect with a study center

  • Hallym University College of Medicine

    Anyang, Gyeong-gi 431-070
    Korea, Republic of

    Site Not Available

  • Seoul National University Bundang Hospital

    SeongNam, GyeongGi 463-707
    Korea, Republic of

    Site Not Available

  • National Cancer Center

    Goyang-si, Gyeonggi-do 410-769
    Korea, Republic of

    Site Not Available

  • Seoul National University Hospital

    Seoul, Jongno-gu 110-744
    Korea, Republic of

    Site Not Available

  • Daehang Hospital

    Seoul, 137-063
    Korea, Republic of

    Site Not Available

  • Seoul Metropolitan Government Seoul National University Boramae Medical Center

    Seoul, 156-707
    Korea, Republic of

    Site Not Available

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