NCT06763861 Sacral Neuromodulation and Faecal Incontinence and Its Unknown Effect on the External Anal Sphincter
| NCT ID | NCT06763861 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Umeå University |
| Condition | Fecal Incontinence |
| Study Type | OBSERVATIONAL |
| Enrollment | 15 participants |
| Start Date | 2024-12-09 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 15 participants in total. It began in 2024-12-09 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Contact & Investigator
Karin Strigård, Prof., Senior consultant
STUDY CHAIR
Department of Diagnostics and Interventions, Umeå University
Frequently Asked Questions
Who can join the NCT06763861 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Fecal Incontinence. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06763861 currently recruiting?
Yes, NCT06763861 is actively recruiting participants. Contact the research team at karin.strigard@umu.se for enrollment information.
Where is the NCT06763861 trial being conducted?
This trial is being conducted at Umeå, Sweden.
Who is sponsoring the NCT06763861 clinical trial?
NCT06763861 is sponsored by Umeå University. The principal investigator is Karin Strigård, Prof., Senior consultant at Department of Diagnostics and Interventions, Umeå University. The trial plans to enroll 15 participants.