Pelvipower for Faecal Incontinence

Study Overview
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Brief Summary
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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
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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.

Official Title
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Pilot Study to Determine Clinical Efficacy of Extracorporeal Pelvic Floor Magnetic Neuromuscular Stimulation in Patients With Faecal Incontinence.

Conditions
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Faecal Incontinence

Intervention / Treatment
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* 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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: >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 Exclusion Criteria: 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 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pelvipower chair<br> | Diagnostic Test: High Resolution Anorectal Manometry<br>* A test used to measure the strength of the muscles in the anal canal<br>Diagnostic Test: Endoanal Ultrasound<br>* 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.<br>Other: Bowel diary<br>* A daily diary to assess episodes of faecal incontinence<br>Other: MYMOP2<br>* Questionnaire to assess individual symptoms, general wellbeing and activity in faecal incontinence<br>Other: FIQOL<br>* Questionnaire to assess the quality of life with faecal incontinence<br>Other: FISI<br>* Questionnaire to assess the severity of faecal incontinence<br>Other: Follow up call<br>* At 28 days and 3 months post final pelvipower or sham session to assess faecal incontience after study period<br>Other: St Mark's incontinence score<br>* A score of incontinence<br>|
| Sham Comparator: Sham stimulation<br> | Diagnostic Test: High Resolution Anorectal Manometry<br>* A test used to measure the strength of the muscles in the anal canal<br>Diagnostic Test: Endoanal Ultrasound<br>* 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.<br>Other: Bowel diary<br>* A daily diary to assess episodes of faecal incontinence<br>Other: MYMOP2<br>* Questionnaire to assess individual symptoms, general wellbeing and activity in faecal incontinence<br>Other: FIQOL<br>* Questionnaire to assess the quality of life with faecal incontinence<br>Other: FISI<br>* Questionnaire to assess the severity of faecal incontinence<br>Other: Follow up call<br>* At 28 days and 3 months post final pelvipower or sham session to assess faecal incontience after study period<br>Other: St Mark's incontinence score<br>* A score of incontinence<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bowel diary - total FI episodes | Assessment of change in total faecal incontinence episodes as measured as a reduction by >= 50% | up to 10 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bowel diary - passive FI episodes | Assessment of change in passive faecal incontinence episodes as measured as a reduction by >= 50% | up to 10 weeks | 
| Bowel diary - urgency FI Episodes | Assessment of change in urge faecal incontinence episodes as measured as a reduction by >= 50% | 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. | 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. | 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. | 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. | 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. | up to 5 months |