Clinical trial NCT05900726: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Faecal Incontinence
Lead sponsor: The Functional Gut Clinic
Sponsor class: OTHER
First posted: 2023-06-13
Enrollment: 36
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. \>18 years of age
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:

1. Neurological disease which may affect continence (i.e. diabetic neuropathy, multiple sclerosis, Parkinson's disease etc)
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

Primary outcomes:
measure: Bowel diary - total FI episodes
timeFrame: up to 10 weeks
Secondary outcomes:
measure: Bowel diary - passive FI episodes
timeFrame: up to 10 weeks
measure: Bowel diary - urgency FI Episodes
timeFrame: up to 10 weeks
measure: St Mark's incontinence score
timeFrame: up to 5 months
measure: Loperamide use
timeFrame: up to 10 weeks
measure: Measure Yourself Medical Outcome Profile 2 (MYMOP2)
timeFrame: up to 5 months
measure: Faecal incontinence quality of life questionnaire (FIQL)
timeFrame: up to 5 months
measure: Faecal incontinence symptom index (FISI)
timeFrame: up to 5 months
Other outcomes:
measure: Assessment of anal canal resting tone
timeFrame: up to 10 weeks
measure: Assessment of voluntary anal squeeze pressures
timeFrame: up to 10 weeks
measure: Assessment of rectal sensation
timeFrame: up to 10 weeks
measure: Assessment of anal sensation
timeFrame: up to 10 weeks
Locations:
city: London
country: United Kingdom
facility: The Functional Gut Clinic
Study officials:
affiliation: The Functional Gut Clinic
name: Anthony Hobson
role: PRINCIPAL_INVESTIGATOR
References: