Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
36 participants
INTERVENTIONAL
2021-03-01
2024-04-01
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Pelvipower chair
High Resolution Anorectal Manometry
A test used to measure the strength of the muscles in the anal canal
Endoanal Ultrasound
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 diary
A daily diary to assess episodes of faecal incontinence
MYMOP2
Questionnaire to assess individual symptoms, general wellbeing and activity in faecal incontinence
FIQOL
Questionnaire to assess the quality of life with faecal incontinence
FISI
Questionnaire to assess the severity of faecal incontinence
Follow up call
At 28 days and 3 months post final pelvipower or sham session to assess faecal incontience after study period
St Mark's incontinence score
A score of incontinence
Sham stimulation
High Resolution Anorectal Manometry
A test used to measure the strength of the muscles in the anal canal
Endoanal Ultrasound
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 diary
A daily diary to assess episodes of faecal incontinence
MYMOP2
Questionnaire to assess individual symptoms, general wellbeing and activity in faecal incontinence
FIQOL
Questionnaire to assess the quality of life with faecal incontinence
FISI
Questionnaire to assess the severity of faecal incontinence
Follow up call
At 28 days and 3 months post final pelvipower or sham session to assess faecal incontience after study period
St Mark's incontinence score
A score of incontinence
Interventions
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High Resolution Anorectal Manometry
A test used to measure the strength of the muscles in the anal canal
Endoanal Ultrasound
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 diary
A daily diary to assess episodes of faecal incontinence
MYMOP2
Questionnaire to assess individual symptoms, general wellbeing and activity in faecal incontinence
FIQOL
Questionnaire to assess the quality of life with faecal incontinence
FISI
Questionnaire to assess the severity of faecal incontinence
Follow up call
At 28 days and 3 months post final pelvipower or sham session to assess faecal incontience after study period
St Mark's incontinence score
A score of incontinence
Eligibility Criteria
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Inclusion Criteria
2. Female
3. Have suffered from faecal incontinence, for \>6 months, sufficiently severe enough to warrant intervention . Previous exposure to treatment is not a contraindication to this.
4. Body Mass Index between 18.9 and 40.0kg/m2 (bounds included)
5. \>6 months post-natal
6. ≥4 FI episodes during 2 week screening period
Exclusion Criteria
2. Thromboses
3. Suffering from or recovering from a serious illness or operation
4. Faecal incontinence secondary to impaction
5. Currently using rectal irrigation
6. Currently undergoing biofeedback therapy
7. Pregnancy
8. Pacemaker in situ
9. Indwelling metal implants
10. Recent skeletomuscular injury or surgery in the last month
11. Congenital anorectal disorders such as cloacal defect
12. Participant has a \> grade 2 rectal prolapse
13. Absence of native rectum due to surgery (anterior resection)
14. Previous anal/rectal surgery in the past 12 months
15. Stoma in situ
16. Chronic bowel diseases with chronic uncontrolled diarrhoea
17. Unable to discontinue Loperamide during washout period
18. Severe cardiac arrhythmia
19. Epilepsy
18 Years
FEMALE
No
Sponsors
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The Functional Gut Clinic
OTHER
Responsible Party
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Dr Anthony Hobson
Clinical Director
Principal Investigators
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Anthony Hobson
Role: PRINCIPAL_INVESTIGATOR
The Functional Gut Clinic
Locations
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The Functional Gut Clinic
London, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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FGC-20-001
Identifier Type: -
Identifier Source: org_study_id
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