Faecal IncontinenceNCT05900726
Pelvipower for Faecal Incontinence
A study testing High Resolution Anorectal Manometry, Endoanal Ultrasound and Bowel diary in people with Faecal Incontinence, run by The Functional Gut Clinic at 1 site in United Kingdom.
Trial summary
Faecal incontinence (FI) is a common condition which drastically reduces patient's quality of life and for which there are few effective treatments. The causes of FI are multiple and include disturbances in neuromuscular function (and structure) of the anal canal, rectum and pelvic floor. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Faecal Incontinence
- What is being tested?
- High Resolution Anorectal Manometry, Endoanal Ultrasound and Bowel diary
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Mar 2021to 1 Apr 2024
- Phase
- Interventional
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- >18 years of age
- Female
- Have suffered from faecal incontinence, for >6 months, sufficiently severe enough to warrant intervention . Previous exposure to treatment is not a contraindication to this.
- Body Mass Index between 18.9 and 40.0kg/m2 (bounds included)
- >6 months post-natal
- ≥4 FI episodes during 2 week screening period
Who cannot join
- Neurological disease which may affect continence (i.e. diabetic neuropathy, multiple sclerosis, Parkinson's disease etc)
- Thromboses
- Suffering from or recovering from a serious illness or operation
- Faecal incontinence secondary to impaction
- Currently using rectal irrigation
- Currently undergoing biofeedback therapy
Show all 19Show fewer
- Pregnancy
- Pacemaker in situ
- Indwelling metal implants
- Recent skeletomuscular injury or surgery in the last month
- Congenital anorectal disorders such as cloacal defect
- Participant has a > grade 2 rectal prolapse
- Absence of native rectum due to surgery (anterior resection)
- Previous anal/rectal surgery in the past 12 months
- Stoma in situ
- Chronic bowel diseases with chronic uncontrolled diarrhoea
- Unable to discontinue Loperamide during washout period
- Severe cardiac arrhythmia
- Epilepsy
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
The Functional Gut Clinic
London, NW1 6PU
Sam Treadway, 01613027777, sam.treadway@thefunctionalgutclinic.com
About this study
Official title: Pilot Study to Determine Clinical Efficacy of Extracorporeal Pelvic Floor Magnetic Neuromuscular Stimulation in Patients With Faecal Incontinence.
Faecal incontinence (FI) is a common condition which drastically reduces patient's quality of life and for which there are few effective treatments. The causes of FI are multiple and include disturbances in neuromuscular function (and structure) of the anal canal, rectum and pelvic floor. Treatment options include antidiarrheals, laxatives, biofeedback, surgery, SNS and PTNS. This study will test the Pelvipower extracorporeal magnetic stimulation device as a treatment for faecal incontinence.
Read the detailed description
First line treatment with antidiarrheal or laxative therapy can fail, and then it is common practice to employ biofeedback and physiotherapy techniques as second line conservative management strategies with the aim of improving muscle strength, sensory awareness and effective toileting technique, which in turn helps to reduce FI episodes . Whilst these techniques can be effective, a significant proportion of patients remain symptomatic and are then considered for potential surgical treatment.
Surgical treatment of FI can involve improving the structural integrity of the anal sphincter with a repair procedure, or via implantation of an electrical neurostimulator (sacral nerve stimulation - SNS). SNS has been shown to be effective in treating FI, but the procedure is invasive and expensive.
Percutaneous tibial stimulation (PTNS) is an intermediate treatment which involves stimulating the nerves on the top of the foot which project to the same spinal regions as those influenced through SNS. This requires patients to attend an outpatient clinic for up to 12 sessions, each lasting around 30-45 minutes. Stimulation is delivered via needle electrodes which connect to a stimulation device. A course of treatment costs approximately £2000 per patient for 1-year of treatment.
Whilst SNS and PTNS utilise electric neural stimulation, an alternative approach is through the use of magnetic stimulation as a way of activating neural pathways and inducing neuromuscular recovery. The technique is thought to work on the nerves and muscular structures in the anal canal. This technique has been employed in a broad range of disorders. Magnetic stimulation has some advantages as it can be delivered completely non-invasively using different sized magnetic coils placed over the region of interest.
Pelvipower (PonteMed AG, Switzerland) extracorporeal magnetic stimulation device built into a patient friendly chair, incorporating a rapid rate magnetic stimulation system through a stimulation coil. The coil can be used to non-invasively stimulate the nerves and muscles in the pelvic floor that contribute to continence, and it has several potential advantages over existing techniques in terms of cost and convenience, with 6-12 weekly 15 minute sessions currently normal practice. Pelvipower has been used successfully in patients with urinary incontinence, but thus far little research exists in terms of its effect in treating faecal incontinence. However, one study of extracorporeal magnetic stimulation applied via a similar chair apparatus demonstrated increased muscle function in the anal canal, as well as a significant decrease in faecal incontinence. Although faecal incontinence was shown to improve in participants, the study did not include a sham treatment comparison group. The aim of this study is to evaluate the effect of the extracorporeal magnetic stimulation on faecal incontinence, using the Pelvipower© chair compared to a sham treatment.
- Conditions
- Faecal Incontinence
- Being tested
- High Resolution Anorectal Manometry, Endoanal Ultrasound, Bowel diary, MYMOP2, FIQOL
- Medical subject headings
- Encopresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Resolution Anorectal ManometryDiagnostic test
A test used to measure the strength of the muscles in the anal canal
Endoanal UltrasoundDiagnostic test
An examination of the anal canal (back passage) that allows us to see the muscles involved in passing stool and the tissues that surround these.
Bowel diaryOther
A daily diary to assess episodes of faecal incontinence
MYMOP2Other
Questionnaire to assess individual symptoms, general wellbeing and activity in faecal incontinence
FIQOLOther
Questionnaire to assess the quality of life with faecal incontinence
FISIOther
Questionnaire to assess the severity of faecal incontinence
Follow up callOther
At 28 days and 3 months post final pelvipower or sham session to assess faecal incontience after study period
St Mark's incontinence scoreOther
A score of incontinence
| Study group | Role | What they receive |
|---|---|---|
| Pelvipower chair | Experimental | Not described Receives: Diagnostic Test: High Resolution Anorectal Manometry; Diagnostic Test: Endoanal Ultrasound; Other: Bowel diary; Other: MYMOP2; Other: FIQOL; Other: FISI; Other: Follow up call; Other: St Mark's incontinence score |
| Sham stimulation | Sham comparator | Not described Receives: Diagnostic Test: High Resolution Anorectal Manometry; Diagnostic Test: Endoanal Ultrasound; Other: Bowel diary; Other: MYMOP2; Other: FIQOL; Other: FISI; Other: Follow up call; Other: St Mark's incontinence score |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bowel diary - total FI episodes
Assessment of change in total faecal incontinence episodes as measured as a reduction by >= 50%
Measured: up to 10 weeks
Secondary outcomes (7)
Bowel diary - passive FI episodes
Assessment of change in passive faecal incontinence episodes as measured as a reduction by >= 50%
Measured: up to 10 weeks
Bowel diary - urgency FI Episodes
Assessment of change in urge faecal incontinence episodes as measured as a reduction by >= 50%
Measured: up to 10 weeks
St Mark's incontinence score
Effect of extracorporeal magnetic stimulation using the Pelvipower chair on FI, assessed using mean change from randomisation visit to post treatment visit FI scores (as measured by St Marks incontinence score) between treatment and sham groups.
Measured: up to 5 months
Loperamide use
Mean change in loperamide use from randomisation to post- treatment visit between treatment and sham groups, measured using pre-treatment and post-treatment bowel diaries.
Measured: up to 10 weeks
Measure Yourself Medical Outcome Profile 2 (MYMOP2)
Mean change from randomisation visit to post-treatment visit in questionnaire total score between treatment and sham groups.
Measured: up to 5 months
Faecal incontinence quality of life questionnaire (FIQL)
Mean change from randomisation visit to post treatment visit in FIQOL score between treatment and sham groups.
Measured: up to 5 months
Faecal incontinence symptom index (FISI)
Mean change from randomisation visit to post treatment visit in FISI score between treatment and sham groups.
Measured: up to 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2023
- Study start1 Mar 2021
- Primary completion1 Dec 2023 (estimated)
- Study completion1 Apr 2024 (estimated)
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.
- 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
- Model description
- This protocol describes a single blinded, two-armed, parallel-group, randomised exploratory study with control arm, assessing the effect of pelvic floor magnetic neuromuscular stimulation (Pelvipower) versus sham stimulation, in patients with faecal incontinence.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Functional Gut Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Anthony Hobson, The Functional Gut Clinic
- Investigators
- Anthony Hobson, Principal investigator, The Functional Gut Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05900726
- Sponsor's protocol ID
- FGC-20-001
- Status last verified
- Jun 2023
- First submitted
- 31 Jan 2023
- Last updated
- 13 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study to Determine Clinical Efficacy of Extracorporeal Pelvic Floor Magnetic Neuromuscular Stimulation in Patients With Faecal Incontinence.
- ClinicalTrials.gov ID
- NCT05900726
- Acronym / sponsor ID
- FGC-20-001
- Conditions
- Faecal Incontinence
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- The Functional Gut ClinicUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 1 Apr 2024 (estimated)
- First posted
- 13 Jun 2023 (actual)
- 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 (FI) is a common condition which drastically reduces patient's quality of life and for which there are few effective treatments. The causes of FI are multiple and include disturbances in neuromuscular function (and structure) of the anal canal, rectum and pelvic floor. Treatment options include antidiarrheals, laxatives, biofeedback, surgery, SNS and PTNS. This study will test the Pelvipower extracorporeal magnetic stimulation device as a treatment for faecal incontinence.
Detailed description
First line treatment with antidiarrheal or laxative therapy can fail, and then it is common practice to employ biofeedback and physiotherapy techniques as second line conservative management strategies with the aim of improving muscle strength, sensory awareness and effective toileting technique, which in turn helps to reduce FI episodes . Whilst these techniques can be effective, a significant proportion of patients remain symptomatic and are then considered for potential surgical treatment.
Surgical treatment of FI can involve improving the structural integrity of the anal sphincter with a repair procedure, or via implantation of an electrical neurostimulator (sacral nerve stimulation - SNS). SNS has been shown to be effective in treating FI, but the procedure is invasive and expensive.
Percutaneous tibial stimulation (PTNS) is an intermediate treatment which involves stimulating the nerves on the top of the foot which project to the same spinal regions as those influenced through SNS. This requires patients to attend an outpatient clinic for up to 12 sessions, each lasting around 30-45 minutes. Stimulation is delivered via needle electrodes which connect to a stimulation device. A course of treatment costs approximately £2000 per patient for 1-year of treatment.
Whilst SNS and PTNS utilise electric neural stimulation, an alternative approach is through the use of magnetic stimulation as a way of activating neural pathways and inducing neuromuscular recovery. The technique is thought to work on the nerves and muscular structures in the anal canal. This technique has been employed in a broad range of disorders. Magnetic stimulation has some advantages as it can be delivered completely non-invasively using different sized magnetic coils placed over the region of interest.
Pelvipower (PonteMed AG, Switzerland) extracorporeal magnetic stimulation device built into a patient friendly chair, incorporating a rapid rate magnetic stimulation system through a stimulation coil. The coil can be used to non-invasively stimulate the nerves and muscles in the pelvic floor that contribute to continence, and it has several potential advantages over existing techniques in terms of cost and convenience, with 6-12 weekly 15 minute sessions currently normal practice. Pelvipower has been used successfully in patients with urinary incontinence, but thus far little research exists in terms of its effect in treating faecal incontinence. However, one study of extracorporeal magnetic stimulation applied via a similar chair apparatus demonstrated increased muscle function in the anal canal, as well as a significant decrease in faecal incontinence. Although faecal incontinence was shown to improve in participants, the study did not include a sham treatment comparison group. The aim of this study is to evaluate the effect of the extracorporeal magnetic stimulation on faecal incontinence, using the Pelvipower© chair compared to a sham treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This protocol describes a single blinded, two-armed, parallel-group, randomised exploratory study with control arm, assessing the effect of pelvic floor magnetic neuromuscular stimulation (Pelvipower) versus sham stimulation, in patients with faecal incontinence.
| Arm | Type | Receives |
|---|---|---|
| Pelvipower chair | Experimental | Diagnostic Test: High Resolution Anorectal Manometry, Diagnostic Test: Endoanal Ultrasound, Other: Bowel diary, Other: MYMOP2, Other: FIQOL, Other: FISI, Other: Follow up call, Other: St Mark's incontinence score |
| Sham stimulation | Sham comparator | Diagnostic Test: High Resolution Anorectal Manometry, Diagnostic Test: Endoanal Ultrasound, Other: Bowel diary, Other: MYMOP2, Other: FIQOL, Other: FISI, Other: Follow up call, Other: St Mark's incontinence score |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- >18 years of age
- Female
- Have suffered from faecal incontinence, for >6 months, sufficiently severe enough to warrant intervention . Previous exposure to treatment is not a contraindication to this.
- Body Mass Index between 18.9 and 40.0kg/m2 (bounds included)
- >6 months post-natal
Key exclusion criteria (19 listed)
- Neurological disease which may affect continence (i.e. diabetic neuropathy, multiple sclerosis, Parkinson's disease etc)
- Thromboses
- Suffering from or recovering from a serious illness or operation
- Faecal incontinence secondary to impaction
- Currently using rectal irrigation
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 |
|---|---|---|
| High Resolution Anorectal ManometryA test used to measure the strength of the muscles in the anal canal | Diagnostic test | Pelvipower chair, Sham stimulation |
| Endoanal UltrasoundAn examination of the anal canal (back passage) that allows us to see the muscles involved in passing stool and the tissues that surround these. | Diagnostic test | Pelvipower chair, Sham stimulation |
| Bowel diaryA daily diary to assess episodes of faecal incontinence | Other | Pelvipower chair, Sham stimulation |
| MYMOP2Questionnaire to assess individual symptoms, general wellbeing and activity in faecal incontinence | Other | Pelvipower chair, Sham stimulation |
| FIQOLQuestionnaire to assess the quality of life with faecal incontinence | Other | Pelvipower chair, Sham stimulation |
| FISIQuestionnaire to assess the severity of faecal incontinence | Other | Pelvipower chair, Sham stimulation |
| Follow up callAt 28 days and 3 months post final pelvipower or sham session to assess faecal incontience after study period | Other | Pelvipower chair, Sham stimulation |
| St Mark's incontinence scoreA score of incontinence | Other | Pelvipower chair, Sham stimulation |
Primary outcome
Bowel diary - total FI episodes
Time frame: up to 10 weeks
Assessment of change in total faecal incontinence episodes as measured as a reduction by >= 50%
7 secondary outcomes
Bowel diary - passive FI episodes
Time frame: up to 10 weeks
Bowel diary - urgency FI Episodes
Time frame: up to 10 weeks
St Mark's incontinence score
Time frame: up to 5 months
Loperamide use
Time frame: up to 10 weeks
Measure Yourself Medical Outcome Profile 2 (MYMOP2)
Time frame: up to 5 months
Faecal incontinence quality of life questionnaire (FIQL)
Time frame: up to 5 months
Faecal incontinence symptom index (FISI)
Time frame: up to 5 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2023.
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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.
Anthony Hobson principal investigator
The Functional Gut Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Resolution Anorectal Manometry, Endoanal Ultrasound and Bowel diary in people with Faecal Incontinence, run by The Functional Gut Clinic at 1 site in United Kingdom.
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 6 inclusion and 19 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: status not confirmed, as of the sponsor's last update on 13 Jun 2023. 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 Kingdom. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sam Treadway (0161 302 7777, sam.treadway@thefunctionalgutclinic.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bowel diary - total FI episodes (time frame: up to 10 weeks). 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 13 Jun 2023.