Investigating the effects of sacral neuromodulation on fecal incontinence and the external anal sphincter
SFINX - Sacral Neuromodulation and Faecal Incontinence and Its Unknown Effect on the External Anal Sphincter
This study is trying to see how a treatment called sacral neuromodulation can help people with fecal incontinence by looking at changes in the muscles around the anus.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 15 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Umeå University Academic / other |
| Locations | 1 site (Umeå, Västerbotten County) |
| Trial ID | NCT06763861 on ClinicalTrials.gov |
What this trial studies
This observational project aims to explore the morphology and biochemistry of the external anal sphincter (EAS) in patients with fecal incontinence (FI) and the impact of sacral neuromodulation (SNM) on these factors. SNM is an established treatment for FI that involves electrical stimulation of sacral nerve roots to enhance continence. The study will consist of three phases, starting with biopsies from the EAS of patients diagnosed with rectal cancer who have no history of FI, followed by assessments in patients receiving SNM for FI. The goal is to deepen the understanding of SNM's effects on the anal sphincter complex to improve treatment methods for FI.
Who should consider this trial
Good fit: Ideal candidates include adults diagnosed with fecal incontinence who are scheduled to receive sacral neuromodulation treatment.
Not a fit: Patients with a previous diagnosis of fecal incontinence or those unable to communicate in Swedish may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment strategies for patients suffering from fecal incontinence.
How similar studies have performed: While sacral neuromodulation has been established as a treatment for fecal incontinence, the specific investigation of its effects on the external anal sphincter is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Phase 1 Inclusion Criteria: * ≥ 18 years of age * Male or female * Diagnosed with rectal cancer and receive treatment with abdominoperineal resection * Signed an informed consent Exclusion Criteria: * Previous diagnosis of FI * Unable to speak and/or read Swedish to ensure informed consent * Tumour involving the sphincter complex or is in close connection Phase 2 and 3 Inclusion Criteria: * Diagnosed with FI and will receive treatment with sacral neuromodulation * Male or female * Signed an informed consent Exclusion Criteria: * Unable to speak and/or read Swedish to ensure informed consent
Where this trial is running
Umeå, Västerbotten County
- Umeå University Hospital — Umeå, Västerbotten County, Sweden (Recruiting)
Study contacts
- Study coordinator: Strigård, Prof., Senior consultant
- Email: karin.strigard@umu.se
- Phone: +46(0)90 785 00 00
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.