Comparison of PTNS and Biofeedback for Fecal Incontinence

Fecal Incontinence Clinical Trial

Official title:

Comparison of Posterior Tibial Nerve Stimulation and Biofeedback for Fecal Incontinence: Prospective Randomized Controlled Trial

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01882101
• Other study ID #: PTNS trial
• Status: Withdrawn
• Phase: Phase 3
• First received: June 17, 2013
• Last updated: April 25, 2017
• Start date: January 2014
• Est. completion date: December 2014

Study information

• Verified date: April 2017
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Fecal Incontinence

Intervention

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.
• 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.

Locations

Country	Name	City	State
Korea, Republic of	Hallym University College of Medicine	Anyang	Gyeong-gi
Korea, Republic of	National Cancer Center	Goyang-si	Gyeonggi-do
Korea, Republic of	Seoul National University Bundang Hospital	SeongNam	GyeongGi
Korea, Republic of	Daehang Hospital	Seoul
Korea, Republic of	Seoul Metropolitan Government Seoul National University Boramae Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul	Jongno-gu

Sponsors (6)

Lead Sponsor	Collaborator
Seoul National University Hospital	Daehang Hospital, Hallym University Medical Center, National Cancer Center, Korea, Seoul National University Boramae Hospital, Seoul National University Bundang Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

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