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Trial record 1 of 1 for:    NCT01882101
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Comparison of PTNS and Biofeedback for Fecal Incontinence

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ClinicalTrials.gov Identifier: NCT01882101
Recruitment Status : Withdrawn (Too small included patients and, not enough cost for PTNS and biofeedback.)
First Posted : June 20, 2013
Last Update Posted : April 27, 2017
Sponsor:
Collaborators:
Seoul National University Bundang Hospital
National Cancer Center, Korea
Seoul National University Boramae Hospital
Hallym University Medical Center
Daehang Hospital
Information provided by (Responsible Party):
Sung-Bum Kang, Seoul National University Bundang Hospital

June 17, 2013
June 20, 2013
April 27, 2017
January 2014
June 2014   (Final data collection date for primary outcome measure)
Weekly episodes of fecal incontinence [ Time Frame: 1 week ]
Measured by bowel diary at pre-treatment(baseline) and post-treatment(1 week)
Same as current
Complete list of historical versions of study NCT01882101 on ClinicalTrials.gov Archive Site
  • Weekly episodes of fecal incontinence [ Time Frame: 6 months ]
    Measured by bowel diary at post-treatment(2, 4, 6 months)
  • Severity of fecal incontinence [ Time Frame: 6 months ]
    Measured by FISI questionnaire at pre-treatment(baseline) and post-treatment(1 week, 2, 4, 6 months)
  • Quality of life associated with fecal incontinence [ Time Frame: 6 months ]
    Measured by FIQL questionnaire at pre-treatment(baseline) and post-treatment(1 week, 2, 4, 6 months)
  • Anal function [ Time Frame: 6 months ]
    Measured by manometry at pre-treatment(baseline) and post-treatment(1 week, 2, 4, 6 months)
Same as current
Not Provided
Not Provided
 
Comparison of PTNS and Biofeedback for Fecal Incontinence
Comparison of Posterior Tibial Nerve Stimulation and Biofeedback for Fecal Incontinence: Prospective Randomized Controlled Trial
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.
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.
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Fecal Incontinence
  • Procedure: Posterior tibial nerve stimulation
    34G needle is introduced percutaneously three finger-breadths superior to the medial malleolus and an electrode is attached to the ipsilateral foot. Electrical stimulation is applied monitoring motor and sensory response. The treatment lasts for 30 minutes, and will be repeated twice a week for 6 weeks.
    Other Name: PTNS
  • Procedure: Biofeedback
    Electrodes are attached to the lower abdomen and acryl plug is inserted into the anal canal. The patients perform pelvic muscle exercise watching EMG activity of themselves. The treatment lasts over 30 minutes, and will be repeated twice a week for 6 weeks.
    Other Name: Pelvic floor muscle exercise
  • Experimental: Posterior tibial nerve stimulation
    Intervention: Procedure: Posterior tibial nerve stimulation
  • Experimental: Biofeedback
    Intervention: Procedure: Biofeedback
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
50
December 2014
June 2014   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
20 Years to 80 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
 
NCT01882101
PTNS trial
No
Not Provided
Not Provided
Sung-Bum Kang, Seoul National University Bundang Hospital
Seoul National University Hospital
  • Seoul National University Bundang Hospital
  • National Cancer Center, Korea
  • Seoul National University Boramae Hospital
  • Hallym University Medical Center
  • Daehang Hospital
Principal Investigator: Sung-Bum Kang, Ph.D. Seoul National University Bundang Hospital
Seoul National University Hospital
April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP