Fecal IncontinencePhase 3NCT01882101
Comparison of PTNS and Biofeedback for Fecal Incontinence
A Phase 3 study testing Posterior tibial nerve stimulation and Biofeedback in people with Fecal Incontinence, run by Seoul National University Hospital at 6 sites in South Korea.
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. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Fecal Incontinence
- What is being tested?
- Posterior tibial nerve stimulation and Biofeedback
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 6 sitesSouth Korea
- Study dates
- Jan 2014to Dec 2014
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient with 2 or more weekly episodes of fecal incontinence
- Patient who understands and accepts to sign the informed consent form
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
South Korea6 sites
Hallym University College of Medicine
Anyang-si, Gyeonggi-do, 431-070
National Cancer Center
Goyang-si, Gyeonggi-do, 410-769
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 463-707
Seoul National University Hospital
Seoul, Jongno-gu, 110-744
Daehang Hospital
Seoul, 137-063
Seoul Metropolitan Government Seoul National University Boramae Medical Center
Seoul, 156-707
About this study
Official title: 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.
Read the 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.
- Conditions
- Fecal Incontinence
- Being tested
- Posterior tibial nerve stimulation, Biofeedback
- Keywords
- Fecal incontinence, posterior tibial nerve stimulation, biofeedback, quality of life
- Medical subject headings
- Fecal Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Posterior tibial nerve stimulationProcedure or surgery
Also called PTNS
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.
BiofeedbackProcedure or surgery
Also called Pelvic floor muscle exercise
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.
| Study group | Role | What they receive |
|---|---|---|
| Posterior tibial nerve stimulation | Experimental | Not described Receives: Procedure: Posterior tibial nerve stimulation |
| Biofeedback | Experimental | Not described Receives: Procedure: Biofeedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weekly episodes of fecal incontinence
Measured by bowel diary at pre-treatment(baseline) and post-treatment(1 week)
Measured: 1 week
Secondary outcomes (4)
Weekly episodes of fecal incontinence
Measured by bowel diary at post-treatment(2, 4, 6 months)
Measured: 6 months
Severity of fecal incontinence
Measured by FISI questionnaire at pre-treatment(baseline) and post-treatment(1 week, 2, 4, 6 months)
Measured: 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)
Measured: 6 months
Anal function
Measured by manometry at pre-treatment(baseline) and post-treatment(1 week, 2, 4, 6 months)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2013 (estimated)
- Study startJan 2014
- Primary completionJun 2014
- Study completionDec 2014
Why it stopped: Too small included patients and, not enough cost for PTNS and biofeedback.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fecal IncontinenceStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Seoul National University Bundang Hospital, National Cancer Center, Korea, Seoul National University Boramae Hospital, Hallym University Medical Center, Daehang Hospital
- Responsible party
- Principal investigator, Sung-Bum Kang, Seoul National University Bundang Hospital
- Investigators
- Sung-Bum Kang, Ph.D., Principal investigator, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01882101
- Sponsor's protocol ID
- PTNS trial
- Status last verified
- Apr 2017
- First submitted
- 17 Jun 2013
- Last updated
- 27 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Posterior Tibial Nerve Stimulation and Biofeedback for Fecal Incontinence: Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01882101
- Acronym / sponsor ID
- PTNS trial
- Conditions
- Fecal Incontinence
- Keywords
- Fecal incontinence, posterior tibial nerve stimulation, biofeedback, quality of life
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Too small included patients and, not enough cost for PTNS and biofeedback.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Seoul National University Bundang Hospital, National Cancer Center, Korea, Seoul National University Boramae Hospital, Hallym University Medical Center, Daehang Hospital
- Study start
- Jan 2014 (actual)
- Primary completion
- Jun 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 20 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Posterior tibial nerve stimulation | Experimental | Procedure: Posterior tibial nerve stimulation |
| Biofeedback | Experimental | Procedure: Biofeedback |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patient with 2 or more weekly episodes of fecal incontinence
- Patient who understands and accepts to sign the informed consent form
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Posterior tibial nerve stimulationAlso: PTNS34G 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. | Procedure or surgery | Posterior tibial nerve stimulation |
| BiofeedbackAlso: Pelvic floor muscle exerciseElectrodes 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. | Procedure or surgery | Biofeedback |
Primary outcome
Weekly episodes of fecal incontinence
Time frame: 1 week
Measured by bowel diary at pre-treatment(baseline) and post-treatment(1 week)
4 secondary outcomes
Weekly episodes of fecal incontinence
Time frame: 6 months
Severity of fecal incontinence
Time frame: 6 months
Quality of life associated with fecal incontinence
Time frame: 6 months
Anal function
Time frame: 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sung-Bum Kang, Ph.D. principal investigator
Seoul National University Bundang Hospital
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Posterior tibial nerve stimulation and Biofeedback in people with Fecal Incontinence, run by Seoul National University Hospital at 6 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 27 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weekly episodes of fecal incontinence (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2017; AzTrials last refreshed its copy on 7 Nov 2026.