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.

Study Overview

• Status: Withdrawn
• Conditions: Fecal Incontinence
• Intervention / Treatment: Procedure: Posterior tibial nerve stimulation; Procedure: Biofeedback

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.

• Study Type: Interventional
• Phase: Phase 3

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 156-707
    • Seoul Metropolitan Government Seoul National University Boramae Medical Center
  • Seoul, Korea, Republic of, 137-063
    • DaeHang Hospital
  • Gyeong-gi
    • Anyang, Gyeong-gi, Korea, Republic of, 431-070
      • Hallym University College of Medicine
  • GyeongGi
    • SeongNam, GyeongGi, Korea, Republic of, 463-707
      • Seoul National University Bundang Hospital
  • Gyeonggi-do
    • Goyang-si, Gyeonggi-do, Korea, Republic of, 410-769
      • National Cancer Center
  • Jongno-gu
    • Seoul, Jongno-gu, Korea, Republic of, 110-744
      • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: Pelvic floor muscle exercise
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 Names: PTNS

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weekly episodes of fecal incontinence	Measured by bowel diary at post-treatment(2, 4, 6 months)	6 months
Severity of fecal incontinence	Measured by FISI questionnaire at pre-treatment(baseline) and post-treatment(1 week, 2, 4, 6 months)	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)	6 months
Anal function	Measured by manometry at pre-treatment(baseline) and post-treatment(1 week, 2, 4, 6 months)	6 months

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Collaborators: National Cancer Center, Korea; Seoul National University Bundang Hospital; Seoul National University Boramae Hospital; Hallym University Medical Center; Daehang Hospital
• Investigators: Principal Investigator: Sung-Bum Kang, Ph.D., Seoul National University Bundang Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2014
• Primary Completion (Actual): June 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: June 17, 2013
• First Submitted That Met QC Criteria: June 19, 2013
• First Posted (Estimate): June 20, 2013

Study Record Updates

• Last Update Posted (Actual): April 27, 2017
• Last Update Submitted That Met QC Criteria: April 25, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: biofeedback; quality of life; Fecal incontinence; posterior tibial nerve stimulation
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases; Fecal Incontinence
• Other Study ID Numbers: PTNS trial