Sacral Neuromodulation and Faecal Incontinence and Its Unknown Effect on the External Anal Sphincter (SFINX)
SFINX - Sacral Neuromodulation and Faecal Incontinence and Its Unknown Effect on the External Anal Sphincter
This innovative project aims to investigate structures and morphology of the external anal sphincter (EAS) as well as the impact of sacral neuromodulation (SNM) on the EAS morphology and biochemistry among patients with faecal incontinence (FI).
SNM is a well implemented treatment for FI and consist of electrical stimulation of sacral nerve roots to promote continence and may even contribute to total continence. It has shown a positive effects on both short- and long-term. The biologic effect of SNM on EAS is unknown.
The aim is to investigate the effect of SNM on EAS morphology, function, and biochemistry to help physicians and researchers to understand the underlying mechanisms of SNM and the anal sphincter complex to further improve and optimize treatment methods for patients with FI.
The research project consists of three phases. The first phase includes biopsies from the EAS among patients with no previous history of FI. These patients have been diagnosed with rectal cancer and will undergo surgery with abdominoperineal excision.
The second phase includes patients diagnosed with FI and subject for implantation of SNM for treatment of FI. Prior to implantation of SNM all patients will have been examined with 3D endo-anal ultrasound and anorectal manometry as well as answered questionnaires targeting general health, bowel dysfunction and FI. A biopsy of the superficial portion of the EAS is retrieved under local anaesthesia in connection to the test period for implantation of the SNM device.
The last phase, phase three, includes 3D endo-anal ultrasound, anorectal manometry, and a second biopsy of the EAS twelve months after implantation with SNM.
The histopathological analysis in all the three phases will include general morphology, distribution of cell nuclei, satellite cells, muscle fiber type, neural structures and connective tissue.
Study Overview
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Strigård, Prof., Senior consultant
- Phone Number: +46(0)90 785 00 00
- Email: karin.strigard@umu.se
Study Contact Backup
- Name: Louise Almkvist, MD
- Phone Number: +46(0)90 785 00 00
- Email: louise.almkvist@umu.se
Study Locations
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Västerbotten
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Umeå, Västerbotten, Sweden
- Recruiting
- Umeå University Hospital
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Contact:
- Karin Strigård, Prof., Senior consultant
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Patients without diagnosis of FI
Biopsies from EAS among patients diagnosed with rectal cancer and no records of previous diagnosis of FI and now receiving treatment with abdominoperineal resection.
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Biopsies from EAS
|
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Patients diagnosed with FI
Biopsies from EAS among patients diagnosed with FI and recieving treatment with sacral neuromodulation before implantation of the device and 12 months postoperatively.
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Biopsies from EAS
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
The effect of sacral neuromodulation on the external anal sphincter muscle among patients with faecal incontinence
Time Frame: 2 years - The biopsies will be analysed and assessed continuously.
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2 years - The biopsies will be analysed and assessed continuously.
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Karin Strigård, Prof., Senior consultant, Department of Diagnostics and Interventions, Umeå University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Dnr 2024-04527-01
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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