Comparison of PTNS and Biofeedback for Fecal Incontinence

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified November 2013 by Seoul National University Hospital
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
ClinicalTrials.gov Identifier:
NCT01882101
First received: June 17, 2013
Last updated: November 10, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention Phase
Fecal Incontinence
Procedure: Posterior tibial nerve stimulation
Procedure: Biofeedback
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparison of Posterior Tibial Nerve Stimulation and Biofeedback for Fecal Incontinence: Prospective Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • Weekly episodes of fecal incontinence [ Time Frame: 1 week ] [ Designated as safety issue: No ]
    Measured by bowel diary at pre-treatment(baseline) and post-treatment(1 week)


Secondary Outcome Measures:
  • Weekly episodes of fecal incontinence [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Measured by bowel diary at post-treatment(2, 4, 6 months)

  • Severity of fecal incontinence [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Measured by FIQL questionnaire at pre-treatment(baseline) and post-treatment(1 week, 2, 4, 6 months)

  • Anal function [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Measured by manometry at pre-treatment(baseline) and post-treatment(1 week, 2, 4, 6 months)


Estimated Enrollment: 50
Study Start Date: January 2014
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Posterior tibial nerve stimulation 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
Experimental: Biofeedback 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

Detailed 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.

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01882101

Contacts
Contact: Sung-Bum Kang, Ph.D. +82-31-787-7093 kangsb@snubh.org
Contact: Heung-Kwon Oh, M.D. +82-31-787-6907 crsohk@gmail.com

Locations
Korea, Republic of
Hallym University College of Medicine Not yet recruiting
Anyang, Gyeong-gi, Korea, Republic of, 431-070
Contact: Bong Hwa Lee, Ph.D.    +82-31-380-3041    bshlee@hallym.or.kr   
Contact: Hyoung-Chul Park, Ph.D.    +82-31-380-3041    greatpa1@hallym.or.kr   
Principal Investigator: Bong Hwa Lee, Ph.D.         
Sub-Investigator: Hyoung-Chul Park, Ph.D.         
National Cancer Center Not yet recruiting
Goyang-si, Gyeonggi-do, Korea, Republic of, 410-769
Contact: Jae-Hwan Oh, Ph.D.       jayoh@ncc.re.kr   
Contact: Sung-Chan Park, Ph.D.       sungchan486@medimail.co.kr   
Principal Investigator: Jae-Hwan Oh, Ph.D.         
Sub-Investigator: Sung-Chan Park, Ph.D.         
Seoul National University Bundang Hospital Not yet recruiting
SeongNam, GyeongGi, Korea, Republic of, 463-707
Contact: Sung-Bum Kang, Ph.D.    +82-31-787-7093    kangsb@snubh.org   
Contact: Heung-Kwon Oh, M.D.    +82-31-787-6907    crsohk@gmail.com   
Principal Investigator: Sung-Bum Kang, Ph.D.         
Sub-Investigator: Na Young Kim, Ph.D.         
Sub-Investigator: Eun Joo Yang, Ph.D.         
Sub-Investigator: Heung-Kwon Oh, M.D.         
Sub-Investigator: Soo Young Lee, M.D.         
Sub-Investigator: Myong Hun Ihn, M.D.         
Sub-Investigator: Soyeon Ahn, Ph.D.         
Seoul National University Hospital Not yet recruiting
Seoul, Jongno-gu, Korea, Republic of, 110-744
Contact: Kyu Joo Park, Ph.D.       kjparkmd@plaza.snu.ac.kr   
Contact: Seung-Yong Jeong, Ph.D.       syjeong@snu.ac.kr   
Principal Investigator: Kyu Joo Park, Ph.D.         
Sub-Investigator: Seung-Yong Jeong, Ph.D.         
Sub-Investigator: Min Jeong Kim, M.D.         
Seoul Metropolitan Government Seoul National University Boramae Medical Center Not yet recruiting
Seoul, Korea, Republic of, 156-707
Contact: Seung Chul Heo, Ph.D.    +82-2-870-2273    heosc3@brm.co.kr   
Contact: Rumi Shin, M.D.    82-2-2072-0612    roomie79@gmail.com   
Principal Investigator: Seung Chul Heo, Ph.D.         
Sub-Investigator: Rumi Shin, M.D.         
Daehang Hospital Not yet recruiting
Seoul, Korea, Republic of, 137-063
Contact: Eui Gon Youk, Ph.D.       youkgon@hanmail.net   
Principal Investigator: Eui Gon Youk, Ph.D.         
Sponsors and Collaborators
Seoul National University Hospital
Seoul National University Bundang Hospital
National Cancer Center, Korea
Seoul National University Boramae Hospital
Hallym University Medical Center
Daehang Hospital
Investigators
Principal Investigator: Sung-Bum Kang, Ph.D. Seoul National University Bundang Hospital
  More Information

No publications provided

Responsible Party: Sung-Bum Kang, Principal Investigator, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier: NCT01882101     History of Changes
Other Study ID Numbers: PTNS trial
Study First Received: June 17, 2013
Last Updated: November 10, 2013
Health Authority: Korea: Food and Drug Administration
Korea: Institutional Review Board
Korea: Ministry for Health, Welfare and Family Affairs

Keywords provided by Seoul National University Hospital:
Fecal incontinence
posterior tibial nerve stimulation
biofeedback
quality of life

Additional relevant MeSH terms:
Fecal Incontinence
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on July 26, 2014