Clinical trial NCT06763861: Sacral Neuromodulation and Faecal Incontinence and Its Unknown Effect on the External Anal Sphincter
Official title: SFINX - Sacral Neuromodulation and Faecal Incontinence and Its Unknown Effect on the External Anal Sphincter
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Fecal Incontinence
Keywords: Fecal Incontinence
Sacral neuromodulation
Surgery
Pathology
Proctology
Quality of Life
Health status
Lead sponsor: Umeå University
Sponsor class: OTHER
First posted: 2025-01-08
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Please see Study description.

Brief summary: 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.


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

Primary outcomes:
measure: The effect of sacral neuromodulation on the external anal sphincter muscle among patients with faecal incontinence
timeFrame: 2 years - The biopsies will be analysed and assessed continuously.
Secondary outcomes:
Other outcomes:
Locations:
city: Umeå
country: Sweden
facility: Umeå University Hospital
state: Västerbotten
Study officials:
affiliation: Department of Diagnostics and Interventions, Umeå University
name: Karin Strigård, Prof., Senior consultant
role: STUDY_CHAIR
References: