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Comparison of Posterior Tibial Nerve Stimulation and Biofeedback for Fecal Incontinence: Prospective Randomized Controlled Trial


Phase 3
20 Years
80 Years
Not Enrolling
Both
Fecal Incontinence

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Trial Information

Comparison of Posterior Tibial Nerve Stimulation and Biofeedback for Fecal Incontinence: Prospective Randomized Controlled Trial


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.


Inclusion Criteria:



- Patient with 2 or more weekly episodes of fecal incontinence

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

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 postoperative
quality of life

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Weekly episodes of fecal incontinence

Outcome Description:

Measured by bowel diary at pre-treatment(baseline) and post-treatment(1 week)

Outcome Time Frame:

1 week

Safety Issue:

No

Principal Investigator

Sung-Bum Kang, Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Seoul National University Bundang Hospital

Authority:

Korea: Food and Drug Administration

Study ID:

PTNS trial

NCT ID:

NCT01882101

Start Date:

July 2013

Completion Date:

December 2014

Related Keywords:

  • Fecal Incontinence
  • Fecal incontinence
  • posterior tibial nerve stimulation
  • biofeedback
  • quality of life
  • Fecal Incontinence

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