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Comparison of PTNS and Biofeedback for Fecal Incontinence

Primary Purpose

Fecal Incontinence

Status
Withdrawn
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Posterior tibial nerve stimulation
Biofeedback
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fecal Incontinence focused on measuring Fecal incontinence, posterior tibial nerve stimulation, biofeedback, quality of life

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hallym University College of Medicine
  • National Cancer Center
  • Seoul National University Bundang Hospital
  • Seoul National University Hospital
  • Daehang Hospital
  • Seoul Metropolitan Government Seoul National University Boramae Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Posterior tibial nerve stimulation

Biofeedback

Arm Description

Outcomes

Primary Outcome Measures

Weekly episodes of fecal incontinence
Measured by bowel diary at pre-treatment(baseline) and post-treatment(1 week)

Secondary Outcome Measures

Weekly episodes of fecal incontinence
Measured by bowel diary at post-treatment(2, 4, 6 months)
Severity of fecal incontinence
Measured by FISI questionnaire at pre-treatment(baseline) and post-treatment(1 week, 2, 4, 6 months)
Quality of life associated with fecal incontinence
Measured by FIQL questionnaire at pre-treatment(baseline) and post-treatment(1 week, 2, 4, 6 months)
Anal function
Measured by manometry at pre-treatment(baseline) and post-treatment(1 week, 2, 4, 6 months)

Full Information

First Posted
June 17, 2013
Last Updated
April 25, 2017
Sponsor
Seoul National University Hospital
Collaborators
Seoul National University Bundang Hospital, National Cancer Center, Korea, Seoul National University Boramae Hospital, Hallym University Medical Center, Daehang Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01882101
Brief Title
Comparison of PTNS and Biofeedback for Fecal Incontinence
Official Title
Comparison of Posterior Tibial Nerve Stimulation and Biofeedback for Fecal Incontinence: Prospective Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Withdrawn
Why Stopped
Too small included patients and, not enough cost for PTNS and biofeedback.
Study Start Date
January 2014 (Actual)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
Collaborators
Seoul National University Bundang Hospital, National Cancer Center, Korea, Seoul National University Boramae Hospital, Hallym University Medical Center, Daehang Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fecal Incontinence
Keywords
Fecal incontinence, posterior tibial nerve stimulation, biofeedback, quality of life

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Posterior tibial nerve stimulation
Arm Type
Experimental
Arm Title
Biofeedback
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Posterior tibial nerve stimulation
Other Intervention Name(s)
PTNS
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Biofeedback
Other Intervention Name(s)
Pelvic floor muscle exercise
Intervention Description
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.
Primary Outcome Measure Information:
Title
Weekly episodes of fecal incontinence
Description
Measured by bowel diary at pre-treatment(baseline) and post-treatment(1 week)
Time Frame
1 week
Secondary Outcome Measure Information:
Title
Weekly episodes of fecal incontinence
Description
Measured by bowel diary at post-treatment(2, 4, 6 months)
Time Frame
6 months
Title
Severity of fecal incontinence
Description
Measured by FISI questionnaire at pre-treatment(baseline) and post-treatment(1 week, 2, 4, 6 months)
Time Frame
6 months
Title
Quality of life associated with fecal incontinence
Description
Measured by FIQL questionnaire at pre-treatment(baseline) and post-treatment(1 week, 2, 4, 6 months)
Time Frame
6 months
Title
Anal function
Description
Measured by manometry at pre-treatment(baseline) and post-treatment(1 week, 2, 4, 6 months)
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sung-Bum Kang, Ph.D.
Organizational Affiliation
Seoul National University Bundang Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hallym University College of Medicine
City
Anyang
State/Province
Gyeong-gi
ZIP/Postal Code
431-070
Country
Korea, Republic of
Facility Name
National Cancer Center
City
Goyang-si
State/Province
Gyeonggi-do
ZIP/Postal Code
410-769
Country
Korea, Republic of
Facility Name
Seoul National University Bundang Hospital
City
SeongNam
State/Province
GyeongGi
ZIP/Postal Code
463-707
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
State/Province
Jongno-gu
ZIP/Postal Code
110-744
Country
Korea, Republic of
Facility Name
Daehang Hospital
City
Seoul
ZIP/Postal Code
137-063
Country
Korea, Republic of
Facility Name
Seoul Metropolitan Government Seoul National University Boramae Medical Center
City
Seoul
ZIP/Postal Code
156-707
Country
Korea, Republic of

12. IPD Sharing Statement

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Comparison of PTNS and Biofeedback for Fecal Incontinence

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