Using magnetic stimulation to treat faecal incontinence
Pilot Study to Determine Clinical Efficacy of Extracorporeal Pelvic Floor Magnetic Neuromuscular Stimulation in Patients With Faecal Incontinence.
NA · The Functional Gut Clinic · NCT05900726
This study is testing a new magnetic device to see if it can help women with severe faecal incontinence feel better and improve their quality of life.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 36 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | The Functional Gut Clinic (other) |
| Locations | 1 site (London) |
| Trial ID | NCT05900726 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of the Pelvipower extracorporeal magnetic stimulation device as a treatment for faecal incontinence, a condition that significantly impacts quality of life. It aims to provide an alternative to existing treatments, such as surgical options and percutaneous tibial nerve stimulation, which can be invasive and costly. The study will involve various assessments, including high-resolution anorectal manometry and endoanal ultrasound, to monitor patient progress and outcomes. Participants will be women over 18 who have experienced severe faecal incontinence for more than six months.
Who should consider this trial
Good fit: Ideal candidates for this study are women over 18 who have experienced severe faecal incontinence for more than six months.
Not a fit: Patients with neurological diseases affecting continence or those with certain medical conditions, such as thromboses or recent surgeries, may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could offer a non-invasive and effective solution for women suffering from faecal incontinence.
How similar studies have performed: While sacral nerve stimulation has shown effectiveness, the use of magnetic stimulation for this condition is a novel approach that has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
London
- The Functional Gut Clinic — London, United Kingdom (RECRUITING)
Study contacts
- Principal investigator: Anthony Hobson — The Functional Gut Clinic
- Study coordinator: Sam Treadway
- Email: sam.treadway@thefunctionalgutclinic.com
- Phone: 0161 302 7777
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Faecal Incontinence