NCT01882101

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2014

Shorter than P25 for phase_3

Geographic Reach
1 country

6 active sites

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 17, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 20, 2013

Completed
7 months until next milestone

Study Start

First participant enrolled

January 1, 2014

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

April 27, 2017

Status Verified

April 1, 2017

Enrollment Period

5 months

First QC Date

June 17, 2013

Last Update Submit

April 25, 2017

Conditions

Fecal Incontinence

Keywords

Fecal incontinenceposterior tibial nerve stimulationbiofeedbackquality of life

Outcome Measures

Primary Outcomes (1)

  • Weekly episodes of fecal incontinence

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

    1 week

Secondary Outcomes (4)

  • Weekly episodes of fecal incontinence

    6 months

  • Severity of fecal incontinence

    6 months

  • Quality of life associated with fecal incontinence

    6 months

  • Anal function

    6 months

Study Arms (2)

Posterior tibial nerve stimulation

EXPERIMENTAL
Procedure: Posterior tibial nerve stimulation

Biofeedback

EXPERIMENTAL
Procedure: Biofeedback

Interventions

Posterior tibial nerve stimulationPROCEDURE

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.

Also known as: PTNS
Posterior tibial nerve stimulation
BiofeedbackPROCEDURE

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.

Also known as: Pelvic floor muscle exercise
Biofeedback

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient with 2 or more weekly episodes of fecal incontinence
  • Patient who understands and accepts to sign the informed consent form

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Hallym University College of Medicine

Anyang-si, Gyeonggi-do, 431-070, South Korea

Location

National Cancer Center

Goyang-si, Gyeonggi-do, 410-769, South Korea

Location

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 463-707, South Korea

Location

Seoul National University Hospital

Seoul, Jongno-gu, 110-744, South Korea

Location

Daehang Hospital

Seoul, 137-063, South Korea

Location

Seoul Metropolitan Government Seoul National University Boramae Medical Center

Seoul, 156-707, South Korea

Location

MeSH Terms

Conditions

Fecal Incontinence

Interventions

Biofeedback, Psychology

Condition Hierarchy (Ancestors)

Rectal DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsBehavior TherapyPsychotherapyBehavioral Disciplines and ActivitiesFeedback, Psychological

Study Officials

  • Sung-Bum Kang, Ph.D.

    Seoul National University Bundang Hospital

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 17, 2013

First Posted

June 20, 2013

Study Start

January 1, 2014

Primary Completion

June 1, 2014

Study Completion

December 1, 2014

Last Updated

April 27, 2017

Record last verified: 2017-04

Locations

KR(6)