NCT05900726

Pelvipower for Faecal Incontinence

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: The Functional Gut Clinic · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Faecal Incontinence

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	High Resolution Anorectal Manometry	A test used to measure the strength of the muscles in the anal canal
DIAGNOSTIC_TEST	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.
OTHER	Bowel diary	A daily diary to assess episodes of faecal incontinence
OTHER	MYMOP2	Questionnaire to assess individual symptoms, general wellbeing and activity in faecal incontinence
OTHER	FIQOL	Questionnaire to assess the quality of life with faecal incontinence
OTHER	FISI	Questionnaire to assess the severity of faecal incontinence
OTHER	Follow up call	At 28 days and 3 months post final pelvipower or sham session to assess faecal incontience after study period
OTHER	St Mark's incontinence score	A score of incontinence

Timeline

• Start date: 2021-03-01
• Primary completion: 2023-12-01
• Completion: 2024-04-01
• First posted: 2023-06-13
• Last updated: 2023-06-13

Locations

1 site across 1 country: United Kingdom