Sacral Neuromodulation and Faecal Incontinence and Its Unknown Effect on the External Anal Sphincter

Launched by UMEÅ UNIVERSITY · Jan 7, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called sacral neuromodulation (SNM) for people experiencing fecal incontinence, which is the inability to control bowel movements. SNM involves using electrical impulses to stimulate nerves in the lower back, helping to improve bowel control. The trial aims to understand how SNM affects the external anal sphincter (EAS), a muscle critical for keeping bowel movements in check. Researchers will look at the structure and function of the EAS before and after the SNM treatment to learn more about how it works and how to make it even better for patients.

To participate in this study, individuals must be at least 18 years old, and if they are part of Phase 1, they should have rectal cancer and be undergoing specific surgery. For Phases 2 and 3, participants need to have diagnosed fecal incontinence and be scheduled for SNM treatment. Throughout the trial, participants can expect to undergo various tests, including ultrasound and biopsies, to gather important information about their condition and the effects of the treatment. This research will help doctors and scientists find new ways to improve care for people with fecal incontinence.

Gender

ALL

Eligibility 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