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

NCT06763861 | Recruiting

• 1 other identifier: Dnr 2024-04527-01
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Fecal Incontinence

Keywords

Fecal Incontinence; Sacral neuromodulation; Surgery; Pathology; Proctology; Quality of Life; Health status

Outcome Measures

Primary Outcomes (1)

• The effect of sacral neuromodulation on the external anal sphincter muscle among patients with faecal incontinence

  2 years - The biopsies will be analysed and assessed continuously.

Study Arms (2)

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.

Other: Biopsy

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.

Other: Biopsy

Interventions

Biopsy OTHER

Biopsies from EAS

Patients diagnosed with FI; Patients without diagnosis of FI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Please see Study description.

You may qualify if:

• ≥ 18 years of age
• Male or female
• Diagnosed with rectal cancer and receive treatment with abdominoperineal resection
• Signed an informed consent

You may not qualify if:

• 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
• Diagnosed with FI and will receive treatment with sacral neuromodulation
• Male or female
• Signed an informed consent
• Unable to speak and/or read Swedish to ensure informed consent

Sponsors & Collaborators

• Umeå University: lead

Study Sites (1)

Umeå University Hospital

Umeå, Västerbotten County, Sweden

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Biopsies from the external anal sphincter muscle.

MeSH Terms

Conditions

Fecal Incontinence

Interventions

Biopsy

Condition Hierarchy (Ancestors)

Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Karin Strigård, Prof., Senior consultant

  Department of Diagnostics and Interventions, Umeå University

  STUDY CHAIR

Central Study Contacts

Strigård, Prof., Senior consultant

CONTACT

+46(0)90 785 00 00; karin.strigard@umu.se

Louise Almkvist, MD

CONTACT

+46(0)90 785 00 00; louise.almkvist@umu.se

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2024
• First Posted: January 8, 2025
• Study Start: December 9, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2028
• Last Updated: January 8, 2025

Record last verified: 2024-12

Locations

SE (1)