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Pelvipower for Faecal Incontinence

Primary Purpose

Faecal Incontinence

Status
Recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
High Resolution Anorectal Manometry
Endoanal Ultrasound
Bowel diary
MYMOP2
FIQOL
FISI
Follow up call
St Mark's incontinence score
Sponsored by
The Functional Gut Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Faecal Incontinence

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • The Functional Gut ClinicRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Pelvipower chair

Sham stimulation

Arm Description

Outcomes

Primary Outcome Measures

Bowel diary - total FI episodes
Assessment of change in total faecal incontinence episodes as measured as a reduction by >= 50%

Secondary Outcome Measures

Bowel diary - passive FI episodes
Assessment of change in passive faecal incontinence episodes as measured as a reduction by >= 50%
Bowel diary - urgency FI Episodes
Assessment of change in urge faecal incontinence episodes as measured as a reduction by >= 50%
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.
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.
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.
Faecal incontinence quality of life questionnaire (FIQL)
Mean change from randomisation visit to post treatment visit in FIQOL score between treatment and sham groups.
Faecal incontinence symptom index (FISI)
Mean change from randomisation visit to post treatment visit in FISI score between treatment and sham groups.

Full Information

First Posted
January 31, 2023
Last Updated
June 1, 2023
Sponsor
The Functional Gut Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT05900726
Brief Title
Pelvipower for Faecal Incontinence
Official Title
Pilot Study to Determine Clinical Efficacy of Extracorporeal Pelvic Floor Magnetic Neuromuscular Stimulation in Patients With Faecal Incontinence.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2021 (Actual)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
April 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Functional Gut Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Faecal Incontinence

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Participant
Masking Description
Randomised allocation to treatment or sham arm will be performed using sealedenvelope.com, the software will only be available to the study team. Participant ID's will be entered 001 - 036 randomisation tool on sealedenvelope.com where they will be assigned to group A (treatment) or group B (sham). A randomisation log will be kept in the site file. Participants will be blinded to which group they have been assigned too.
Allocation
Randomized
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pelvipower chair
Arm Type
Experimental
Arm Title
Sham stimulation
Arm Type
Sham Comparator
Intervention Type
Diagnostic Test
Intervention Name(s)
High Resolution Anorectal Manometry
Intervention Description
A test used to measure the strength of the muscles in the anal canal
Intervention Type
Diagnostic Test
Intervention Name(s)
Endoanal Ultrasound
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Bowel diary
Intervention Description
A daily diary to assess episodes of faecal incontinence
Intervention Type
Other
Intervention Name(s)
MYMOP2
Intervention Description
Questionnaire to assess individual symptoms, general wellbeing and activity in faecal incontinence
Intervention Type
Other
Intervention Name(s)
FIQOL
Intervention Description
Questionnaire to assess the quality of life with faecal incontinence
Intervention Type
Other
Intervention Name(s)
FISI
Intervention Description
Questionnaire to assess the severity of faecal incontinence
Intervention Type
Other
Intervention Name(s)
Follow up call
Intervention Description
At 28 days and 3 months post final pelvipower or sham session to assess faecal incontience after study period
Intervention Type
Other
Intervention Name(s)
St Mark's incontinence score
Intervention Description
A score of incontinence
Primary Outcome Measure Information:
Title
Bowel diary - total FI episodes
Description
Assessment of change in total faecal incontinence episodes as measured as a reduction by >= 50%
Time Frame
up to 10 weeks
Secondary Outcome Measure Information:
Title
Bowel diary - passive FI episodes
Description
Assessment of change in passive faecal incontinence episodes as measured as a reduction by >= 50%
Time Frame
up to 10 weeks
Title
Bowel diary - urgency FI Episodes
Description
Assessment of change in urge faecal incontinence episodes as measured as a reduction by >= 50%
Time Frame
up to 10 weeks
Title
St Mark's incontinence score
Description
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.
Time Frame
up to 5 months
Title
Loperamide use
Description
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.
Time Frame
up to 10 weeks
Title
Measure Yourself Medical Outcome Profile 2 (MYMOP2)
Description
Mean change from randomisation visit to post-treatment visit in questionnaire total score between treatment and sham groups.
Time Frame
up to 5 months
Title
Faecal incontinence quality of life questionnaire (FIQL)
Description
Mean change from randomisation visit to post treatment visit in FIQOL score between treatment and sham groups.
Time Frame
up to 5 months
Title
Faecal incontinence symptom index (FISI)
Description
Mean change from randomisation visit to post treatment visit in FISI score between treatment and sham groups.
Time Frame
up to 5 months
Other Pre-specified Outcome Measures:
Title
Assessment of anal canal resting tone
Description
A) Mean change from randomisation visit to post treatment in mean anal resting pressure between treatment and sham groups. Measured using high resolution anorectal manometry, measured in mmHg.
Time Frame
up to 10 weeks
Title
Assessment of voluntary anal squeeze pressures
Description
Mean change from randomisation visit to post treatment in mean voluntary squeeze pressure between treatment and sham groups - using high resolution anorectal manometry, measured in mmHg.
Time Frame
up to 10 weeks
Title
Assessment of rectal sensation
Description
C) Mean change from randomisation visit to post treatment in rectal sensation thresholds (first constant sensation volume, urge to defecate volume and maximum tolerable volume) between treatment and sham groups, using balloon sensation testing as part of anorectal manometry. Thresholds measures of vol of air in balloon (ML) when sensations are noted by the participant.
Time Frame
up to 10 weeks
Title
Assessment of anal sensation
Description
Mean change from randomisation visit to post treatment in anal sensitivity between treatment and sham groups. Measured using anorectal manometry and specialised anal sensitivity probes.
Time Frame
up to 10 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sam Treadway
Phone
0161 302 7777
Email
sam.treadway@thefunctionalgutclinic.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anthony Hobson
Organizational Affiliation
The Functional Gut Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Functional Gut Clinic
City
London
ZIP/Postal Code
NW1 6PU
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sam Treadway
Phone
01613027777
Email
sam.treadway@thefunctionalgutclinic.com

12. IPD Sharing Statement

Learn more about this trial

Pelvipower for Faecal Incontinence

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