Clinical trial NCT01882101: 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
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Fecal Incontinence
Keywords: Fecal incontinence
posterior tibial nerve stimulation
biofeedback
quality of life
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Seoul National University Bundang Hospital
name: National Cancer Center, Korea
name: Seoul National University Boramae Hospital
name: Hallym University Medical Center
name: Daehang Hospital
First posted: 2013-06-20
Enrollment: 0
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Weekly episodes of fecal incontinence
timeFrame: 1 week
Secondary outcomes:
measure: Weekly episodes of fecal incontinence
timeFrame: 6 months
measure: Severity of fecal incontinence
timeFrame: 6 months
measure: Quality of life associated with fecal incontinence
timeFrame: 6 months
measure: Anal function
timeFrame: 6 months
Other outcomes:
Locations:
city: Anyang
country: Korea, Republic of
facility: Hallym University College of Medicine
state: Gyeong-gi
city: Goyang-si
country: Korea, Republic of
facility: National Cancer Center
state: Gyeonggi-do
city: SeongNam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: GyeongGi
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
state: Jongno-gu
city: Seoul
country: Korea, Republic of
facility: Daehang Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul Metropolitan Government Seoul National University Boramae Medical Center
Study officials:
affiliation: Seoul National University Bundang Hospital
name: Sung-Bum Kang, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: