Faecal IncontinencePhase 3CONFIDeNTNCT02349334
UK Trial of Percutaneous Tibial Nerve Stimulation in Patients With Faecal Incontinence
A Phase 3 study testing Percutaneous Tibial Nerve Stimulation in people with Faecal Incontinence and Bowel Incontinence, run by Queen Mary University of London.
Trial summary
Faecal incontinence occurs when a person passes faeces (stools) without the usual control. It is a distressing condition that is actually very common although under-reported because of embarrassment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Faecal Incontinence, Bowel Incontinence
- What is being tested?
- Percutaneous Tibial Nerve Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 227 participants
- Where
- No sites listed yet
- Study dates
- Jan 2012to Sep 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Faecal incontinence sufficiently severe enough to warrant intervention
- Failure of appropriate conservative therapies
- Age ≥ 18 years
Who cannot join
- Inability to provide informed consent for the research study
- Inability to fill in the detailed bowel diaries required for outcome assessments (this will exclude participants who do not speak / read English)*
- Neurological diseases, such as diabetic neuropathy, multiple sclerosis and Parkinson's disease (any participant with painful peripheral neuropathy)
- Anatomical limitations that would prevent successful placement of needle electrode
- Other medical conditions precluding stimulation: e.g. bleeding disorders, certain cardiac pacemakers, peripheral vascular disease or ulcer, lower leg cellulitis
- Congenital anorectal anomalies or absence of native rectum due to surgery
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- A cloacal defect
- Present evidence of external full thickness rectal prolapse
- Previous rectal surgery (rectopexy / resection) done < 12 months ago (24 months for cancer),
- Stoma in situ
- Chronic bowel diseases such as inflammatory bowel disease leading to chronic uncontrolled diarrhoea
- Pregnancy or intention to become pregnant
- Previous experience of SNS or PTNS
About this study
Official title: CONtrol of Faecal Incontinence Using Distal NeuromodulaTion (CONFIDeNT)
Faecal incontinence occurs when a person passes faeces (stools) without the usual control. It is a distressing condition that is actually very common although under-reported because of embarrassment. Milder symptoms may be managed by treatments such as dietary change, drugs and bowel retraining, but many patients still resort to surgery to improve symptoms. Although several operations exist to treat incontinence e.g. those aiming to repair damaged anal sphincter muscles, it is now clear that these often have poor results.
Two relatively new treatments called sacral nerve stimulation (SNS) and percutaneous tibial nerve stimulation (PTNS) involve sending pulses of electricity to the nerves controlling the bowel and muscles of the anus (anal sphincter).
Read more
SNS does this by inserting electrodes in the lower back just above the tailbone and connecting them to an implanted electrical stimulator which is buried in the buttock and acts a bit like a heart pacemaker. SNS is a relatively well-established treatment in specialist centres, which has been used for over 10 years. It has been shown in studies to be successful for faecal incontinence achieving some improvement in at least three quarters of patients. In Europe, this procedure is fast becoming first treatment offered when non-surgical treatments fail. Nevertheless, SNS is not a miracle cure for all, requiring 2 operations, with potential complications and expensive equipment (> £10,000 approx).
PTNS is a newer treatment, which involves electrically stimulating a nerve at the ankle, using a very small needle, as an outpatient (a bit like acupuncture). This sends signals back to the spine region to try and improve symptoms of faecal incontinence. Since this is a newer treatment, fewer studies have been performed to quantify how successful it is, but early results of PTNS suggest that it may be as good as SNS. If this is true, this is very important because it is much less invasive and considerably cheaper than SNS (equipment £500 per patient).
This project will for the first time determine how effective PTNS is in the treatment of patients with faecal incontinence, by comparing it to sham (fake stimulation). This study is a properly designed clinical trial of 212 patients in at least 14 UK Specialist Centres.. The results of this trial will lead to direct benefits for patients and the NHS.
- Conditions
- Faecal Incontinence, Bowel Incontinence
- Being tested
- Percutaneous Tibial Nerve Stimulation
- Medical subject headings
- Encopresis, Fecal Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous Tibial Nerve StimulationDevice
| Study group | Role | What they receive |
|---|---|---|
| Sham electrical stimulation | Sham comparator | Sham electrical stimulation to forefoot by TENS Receives: Device: Percutaneous Tibial Nerve Stimulation |
| Percutaneous tibial nerve stimulation | Active comparator | Active PTNS via Urgent PC Neuromodulation device, Uroplasty Receives: Device: Percutaneous Tibial Nerve Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary outcome: Binary - success or failure based on % patients achieving > or = 50% reduction in faecal incontinence episodes
From 2 weekly bowel diaries before and after treatment
Measured: 3 months
Secondary outcomes (3)
Reduction in faecal incontinence episodes
Measured: 3 months
Proportion of patients achieving >25%, >75% and 100% reduction in faecal incotinence episodes
Measured: 3 months
Reduction in Cleveland Clinic Constipation Score
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2015 (estimated)
- Study startJan 2012
- Primary completionFeb 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Faecal IncontinenceStudies of the same condition, open and under way.
- More trials run by Queen Mary University of LondonThe 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 227 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen Mary University of London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02349334
- Sponsor's protocol ID
- 34825
- Other IDs
- 09/104/16
- Acronym
- CONFIDeNT
- Status last verified
- Jan 2015
- First submitted
- 23 Jan 2015
- Last updated
- 28 Jan 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CONtrol of Faecal Incontinence Using Distal NeuromodulaTion (CONFIDeNT)
- ClinicalTrials.gov ID
- NCT02349334
- Acronym / sponsor ID
- CONFIDeNT / 34825
- Conditions
- Faecal Incontinence, Bowel Incontinence
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 227 participants (actual)
- Lead sponsor
- Queen Mary University of LondonUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Feb 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 28 Jan 2015 (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.
Faecal incontinence occurs when a person passes faeces (stools) without the usual control. It is a distressing condition that is actually very common although under-reported because of embarrassment. Milder symptoms may be managed by treatments such as dietary change, drugs and bowel retraining, but many patients still resort to surgery to improve symptoms. Although several operations exist to treat incontinence e.g. those aiming to repair damaged anal sphincter muscles, it is now clear that these often have poor results.
Two relatively new treatments called sacral nerve stimulation (SNS) and percutaneous tibial nerve stimulation (PTNS) involve sending pulses of electricity to the nerves controlling the bowel and muscles of the anus (anal sphincter).
SNS does this by inserting electrodes in the lower back just above the tailbone and connecting them to an implanted electrical stimulator which is buried in the buttock and acts a bit like a heart pacemaker. SNS is a relatively well-established treatment in specialist centres, which has been used for over 10 years. It has been shown in studies to be successful for faecal incontinence achieving some improvement in at least three quarters of patients. In Europe, this procedure is fast becoming first treatment offered when non-surgical treatments fail. Nevertheless, SNS is not a miracle cure for all, requiring 2 operations, with potential complications and expensive equipment (> £10,000 approx).
PTNS is a newer treatment, which involves electrically stimulating a nerve at the ankle, using a very small needle, as an outpatient (a bit like acupuncture). This sends signals back to the spine region to try and improve symptoms of faecal incontinence. Since this is a newer treatment, fewer studies have been performed to quantify how successful it is, but early results of PTNS suggest that it may be as good as SNS. If this is true, this is very important because it is much less invasive and considerably cheaper than SNS (equipment £500 per patient).
This project will for the first time determine how effective PTNS is in the treatment of patients with faecal incontinence, by comparing it to sham (fake stimulation). This study is a properly designed clinical trial of 212 patients in at least 14 UK Specialist Centres.. The results of this trial will lead to direct benefits for patients and the NHS.
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 |
|---|---|---|
| Sham electrical stimulation | Sham comparator | Device: Percutaneous Tibial Nerve StimulationSham electrical stimulation to forefoot by TENS |
| Percutaneous tibial nerve stimulation | Active comparator | Device: Percutaneous Tibial Nerve StimulationActive PTNS via Urgent PC Neuromodulation device, Uroplasty |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Faecal incontinence sufficiently severe enough to warrant intervention
- Failure of appropriate conservative therapies
- Age ≥ 18 years
Key exclusion criteria (13 listed)
- Inability to provide informed consent for the research study
- Inability to fill in the detailed bowel diaries required for outcome assessments (this will exclude participants who do not speak / read English)*
- Neurological diseases, such as diabetic neuropathy, multiple sclerosis and Parkinson's disease (any participant with painful peripheral neuropathy)
- Anatomical limitations that would prevent successful placement of needle electrode
- Other medical conditions precluding stimulation: e.g. bleeding disorders, certain cardiac pacemakers, peripheral vascular disease or ulcer, lower leg cellulitis
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 |
|---|---|---|
| Percutaneous Tibial Nerve Stimulation | Device | Percutaneous tibial nerve stimulation, Sham electrical stimulation |
Primary outcome
Primary outcome: Binary - success or failure based on % patients achieving > or = 50% reduction in faecal incontinence episodes
Time frame: 3 months
From 2 weekly bowel diaries before and after treatment
3 secondary outcomes
Reduction in faecal incontinence episodes
Time frame: 3 months
Proportion of patients achieving >25%, >75% and 100% reduction in faecal incotinence episodes
Time frame: 3 months
Reduction in Cleveland Clinic Constipation Score
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Percutaneous Tibial Nerve Stimulation in people with Faecal Incontinence and Bowel Incontinence, run by Queen Mary University of London.
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 3 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: finished, as of the sponsor's last update on 28 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
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.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Primary outcome: Binary - success or failure based on % patients achieving > or = 50% reduction in faecal incontinence episodes (time frame: 3 months). 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 28 Jan 2015.