Investigating the effects of sacral neuromodulation on fecal incontinence and the external anal sphincter

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.