Pilot study to determine clinical efficacy of extracorporeal pelvic floor magnetic neuromuscular stimulation in patients with faecal incontinence.
Study status – Recruiting
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. Treatments include medical therapy and muscular training techniques; however, these are not always effective. Surgical options can be invasive and expensive.
Pelvipower (PonteMed AG, Switzerland) is a magnetic stimulation device built into a patient friendly chair. The chair 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.
To participate you must meet the following criteria:
- 18 years of age
- Have suffered from faecal incontinence, more than 6 months.
- BMI – 18.9 – 40.0kg/m2.
Other medical conditions, pregnancy or treatments may exclude you from taking part in the study. This will be assessed in more detail before enrolment in the study.
The Functional Gut Clinic, 262 Deansgate, Manchester, M3 4BG
The study involves 12 visits to the clinic over the space of 9 weeks. Participants will be required to complete follow up questions at 1, 3 and 6 months after their final visit. The participant information sheet details what happens at each of the study visits.
You will be re-imbursed travel expenses for your visits to the clinic. Those completing the study will also receive £300, to compensate their time. All participants who are randomly assigned to the ‘sham’ stimulation will be offered a full complementary course of the genuine Pelvipower stimulation once they have finished participating in the study.
Sam Treadway – Sam.email@example.com