Fecal IncontinenceNCT01274585
Does Percutaneous Tibial Nerve Stimulation (PTNS) Improve Outcomes in Patients Presenting With Fecal Incontinence
A study testing Posterior tibial nerve stimulation (PTNS) and Posterior tibial nerve stimulation in people with Fecal Incontinence, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
The primary objective of this study is to determine whether Percutaneous Tibial Nerve Stimulation (PTNS), a minimally invasive, simple, cost effective, and outpatient treatment of patients with urinary incontinence, can also be used to treat fecal incontinence. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Fecal Incontinence
- What is being tested?
- Posterior tibial nerve stimulation (PTNS) and Posterior tibial nerve stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2011to Oct 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years or older
- Able to provide informed consent
- Has severe fecal incontinence (defined as weekly episodes of incontinence of mucus, liquid or solid stool)
- Available to present for weekly treatments
- Available for follow-up at 3, 6, and 12 months
Who cannot join
- Severe cardiopulmonary disease
- Lesion of the Tibial Nerve
- Use of a cardiac pacemaker or implantable defibrillator
- History of inflammatory bowel disease
- Active anal fissure, fistula, or abscess
- Active rectal bleeding which has not been evaluated with appropriate testing, such as colonoscopy
Show all 13Show fewer
- Has a sphincter injury that needs sphincteroplasty
- Wants to pursue aggressive surgical therapy with a colostomy or an artificial bowel sphincter
- Severe distal venous insufficiency
- Uncontrolled diabetes with peripheral nerve involvement
- Immunosuppression
- Pregnant or planning on becoming pregnant during treatment
- Patients prone to bleeding
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
The primary objective of this study is to determine whether Percutaneous Tibial Nerve Stimulation (PTNS), a minimally invasive, simple, cost effective, and outpatient treatment of patients with urinary incontinence, can also be used to treat fecal incontinence. Specifically, the primary endpoint of this study is to determine, in a randomized controlled patient blinded study, whether PTNS decrease the episodes of fecal incontinence by 50% in the patients treated with PTNS when compared to placebo as documented by a 2 week patient bowel diary after treatment.
The investigators secondary endpoints will consist of measurements of the impact of PTNS on the severity of incontinence (defined as a decrease in the mean Fecal Incontinence Severity Index (FISI) score ), as well as on the patient quality of life factors related to fecal incontinence (defined as a decrease in the mean Fecal Incontinence Quality of Life (FIQoL) scale).
- Conditions
- Fecal Incontinence
- Being tested
- Posterior tibial nerve stimulation (PTNS), Posterior tibial nerve stimulation
- 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 stimulation (PTNS)Device
Also called Urgent PC
Stimulation using PTNS device for 30 minutes weekly for 12 weeks
Posterior tibial nerve stimulationDevice
Sham needle placement without active PTNS device for 30 minutes weekly for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| No active treatment | Sham comparator | Not described Receives: Device: Posterior tibial nerve stimulation |
| stimulation/treatment | Experimental | Not described Receives: Device: Posterior tibial nerve stimulation (PTNS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of Fecal Incontinence
Patient kept 2 week bowel diary after completion of treatment. Bowel diary were collected to assess frequency of fecal incontinence in the two week span.
Measured: Diary kept for 14 days following treatment
Secondary outcomes (2)
Change in Fecal Incontinence Severity Index (FISI) Score
Fecal Incontinence Severity Index (FISI) is a tool used to stratify severity of fecal incontinence in the subjects. The range of score is from 0 to 61 where the higher score correlates with more severe symptoms of incontinence.
Measured: 12 weeks
Change in Fecal Incontinence Quality of Life (FIQoL) Score
The Fecal incontinence Quality of Life (FIQoL) score evaluates how fecal incontinence impacts the subjects quality of life. The scale ranges from 37 to 159 where the higher the score, the better the quality of life associated with symptoms.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2011 (estimated)
- Study startJan 2011
- Primary completionOct 2013
- Study completionOct 2013
Why it stopped: Study was terminated due to low recruitment rates
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Fecal IncontinenceStudies of the same condition, open and under way.
- More trials run by Massachusetts General 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liliana Bordeianou, Massachusetts General Hospital
- Investigators
- Liliana Bordeianou, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01274585
- Sponsor's protocol ID
- MGH2010-P-000239
- Status last verified
- Dec 2017
- First submitted
- 7 Jan 2011
- Last updated
- 5 Jan 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Percutaneous Tibial Nerve Stimulation (PTNS) Improve Outcomes in Patients Presenting With Fecal Incontinence
- ClinicalTrials.gov ID
- NCT01274585
- Acronym / sponsor ID
- MGH2010-P-000239
- Conditions
- Fecal Incontinence
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study was terminated due to low recruitment rates
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 11 Jan 2011 (estimated)
- Results
- Posted 13 Feb 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to determine whether Percutaneous Tibial Nerve Stimulation (PTNS), a minimally invasive, simple, cost effective, and outpatient treatment of patients with urinary incontinence, can also be used to treat fecal incontinence. Specifically, the primary endpoint of this study is to determine, in a randomized controlled patient blinded study, whether PTNS decrease the episodes of fecal incontinence by 50% in the patients treated with PTNS when compared to placebo as documented by a 2 week patient bowel diary after treatment.
The investigators secondary endpoints will consist of measurements of the impact of PTNS on the severity of incontinence (defined as a decrease in the mean Fecal Incontinence Severity Index (FISI) score ), as well as on the patient quality of life factors related to fecal incontinence (defined as a decrease in the mean Fecal Incontinence Quality of Life (FIQoL) scale).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No active treatment | Sham comparator | Device: Posterior tibial nerve stimulation |
| stimulation/treatment | Experimental | Device: Posterior tibial nerve stimulation (PTNS) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18 years or older
- Able to provide informed consent
- Has severe fecal incontinence (defined as weekly episodes of incontinence of mucus, liquid or solid stool)
- Available to present for weekly treatments
- Available for follow-up at 3, 6, and 12 months
Key exclusion criteria (13 listed)
- Severe cardiopulmonary disease
- Lesion of the Tibial Nerve
- Use of a cardiac pacemaker or implantable defibrillator
- History of inflammatory bowel disease
- Active anal fissure, fistula, or abscess
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 stimulation (PTNS)Also: Urgent PCStimulation using PTNS device for 30 minutes weekly for 12 weeks | Device | stimulation/treatment |
| Posterior tibial nerve stimulationSham needle placement without active PTNS device for 30 minutes weekly for 12 weeks | Device | No active treatment |
Primary outcome
Frequency of Fecal Incontinence
Time frame: Diary kept for 14 days following treatment
Patient kept 2 week bowel diary after completion of treatment. Bowel diary were collected to assess frequency of fecal incontinence in the two week span.
2 secondary outcomes
Change in Fecal Incontinence Severity Index (FISI) Score
Time frame: 12 weeks
Change in Fecal Incontinence Quality of Life (FIQoL) Score
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Liliana Bordeianou, MD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Posterior tibial nerve stimulation (PTNS) and Posterior tibial nerve stimulation in people with Fecal Incontinence, run by Massachusetts General Hospital at 1 site in United States.
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 5 inclusion and 13 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: stopped early, as of the sponsor's last update on 5 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Feb 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Frequency of Fecal Incontinence (time frame: Diary kept for 14 days following treatment). 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 5 Jan 2018.