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Not yet recruitingNCT07898748Updated Oct 27, 2026

Fecal Incontinence (FI) is a Debilitating Physical and Psychological Disorder Characterizedbytheinvoluntary Loss of Flatus or Liquid/Solid Stool.

An observational study in MRI in Evaluation of Fecal Incontinence, sponsored by Assiut University. Not yet recruiting. Per ClinicalTrials.gov, last updated 2026-10-27.

Sponsored by Assiut University · Observational

Updated Oct 27, 2026Newly registeredGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
22
Sex
All
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Study summary

Fecal incontinence (FI) is a debilitating physical and psychological disorder characterizedbytheinvoluntary loss of flatus or liquid/solid stool. It represents a significant clinical challengewithsubstantial impacts on patient quality of life.The severity and clinical impact of fecal incontinenceare standardized using the Jorge-Wexner Incontinence Score, a widely validatedsymptomscoring instrument. The Wexner score assesses five key domains: loss of solid stool, liquidstool, and flatus, as well as the need to wear protective pads and the degree of lifestyle alteration. Eachparameter is graded on a scale from 0 (Never) to 4 (Always), yielding a composite scorerangingfrom 0 (perfect continence) to 20 (complete incontinence). * 1-8: Mild incontinence * 9-14: Moderate incontinence * 15-20: Severeincontinence

Read the detailed description

Establishing an objective clinical baseline via the Wexner score is crucial for stratifyingpatients, correlating structural sphincter defects visualized on imaging with functional clinical impairment,and selecting candidates who will benefit most from anatomical surgical repair[1].Preciseanatomical and functional evaluation of the pelvic floor musculature-specifically theinternal analsphincter (IAS) and external anal sphincter (EAS)-is paramount to selecting appropriatetherapeutic interventions, whether conservative or surgical [2]. Currently, two primary imaging modalities dominate the diagnostic workup of FI: Three-Dimensional Endoanal Ultrasound (3D-EAUS) and External Phased Array Magnetic ResonanceImaging (MRI) [3]. 3D-EAUS has long been regarded as a practical, high-resolutionparadigmforidentifying localized sphincter tears and defects due to its accessibility and superior depictionofthe thin muscular layers. However, its accuracy can be highly operator-dependent, andit provideslimited visualization of complex, deep pelvic floor disorders or external atrophy [4]. Conversely, external phased array MRI offers a wider field of view, exceptional soft-tissuecontrast,and optimal evaluation of sphincter atrophy, scarring, and secondary pelvic organprolapsewithout the discomfort associated with endorectal coils [5]. Despite their integrationintoclinicalpractice, substantial ambiguity persists regarding which modality yields higher precisediagnosticaccuracy for varying severities of structural defects, and how they directly comparewhenoptimizing preoperative strategies [3, 5]. This study aims to establish an optimizeddiagnosticparadigm, helping clinicians select the most efficient imaging modality or integratedapproachtoimprove patient outcomes at Assiut University Hospitals.

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Conditions studied

  • MRI in Evaluation of Fecal Incontinence

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In context

Fecal Incontinence

283 studies on the registry are indexed under Fecal Incontinence; 52 are open to participants now.

This study's planned enrollment of 22 is below the median of 92 across 66 observational studies indexed under Fecal Incontinence.

Browse Fecal Incontinence studies →

Lead sponsor

Assiut University is the lead sponsor of 5,078 studies on the registry; 2,178 are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

Patients presenting to the Outpatient Clinics of General/Colorectal Surgery and referred to the Radiology Department with clinical symptoms of fecal incontinence.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Patients with clinically documented fecal incontinence with a Jorge-Wexner Incontinence Score ≥ 1 (indicative of mild-to-severe clinical symptoms warranting anatomical imaging and potential surgical repair).

Patients referred for anatomical mapping prior to surgical repair.

Exclusion criteria

Exclusion Criteria:

Patients with absolute to MRI (e.g., cardiac pacemakers, metallic implants, severe claustrophobia).

Previous major colorectal or oncological pelvic surgery that drastically alters the local anatomy.

Active perianal sepsis, acute anal fissures, or severe painful perianal conditions preventing probe insertion for EAUS.

Known or suspected pelvic/anorectal : Patients with active pelvic, colorectal, or gynecological malignancies

Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
22 participants (estimated)
Target follow-up
6 Weeks
Patient registry
Yes

Groups and cohorts

  • 3DendoanalultrasoundversusexternalphasedarrayMRI inevaluationoffecal Incontinence

    Device: 3DendoanalultrasoundversusexternalphasedarrayMRI inevaluationoffecal Incontinence

Interventions

  • Device3DendoanalultrasoundversusexternalphasedarrayMRI inevaluationoffecal Incontinence

    ) Toevaluate the diagnostic agreement and correlation between 3D endoanal ultrasound (3D-EAUS) and external phased array MRI in identifying and grading the extent of internal and external anal sphincter defects in patients presenting with fecal incontinence.

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What researchers measure

Primary outcomes

  1. Toevaluate the diagnostic agreement and correlation between 3D endoanal ultrasound (3D-EAUS) and external phased array MRI

    Time frame: one year

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • Law PJ, Kamm MA, Bartram CI. Anal endosonography in the investigation of faecal incontinence. Br J Surg. 1991 Mar;78(3):312-4. doi: 10.1002/bjs.1800780315. PubMed 2021846 ↗
  • Rociu E, Stoker J, Eijkemans MJ, Schouten WR, Lameris JS. Fecal incontinence: endoanal US versus endoanal MR imaging. Radiology. 1999 Aug;212(2):453-8. doi: 10.1148/radiology.212.2.r99au10453. PubMed 10429703 ↗
  • Stoker J, Halligan S, Bartram CI. Pelvic floor imaging. Radiology. 2001 Mar;218(3):621-41. doi: 10.1148/radiology.218.3.r01mr26621. PubMed 11230632 ↗

Individual participant data

Plan to share: Yes

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Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 27, 2026
Show all 1 update
  1. Oct 27, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

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Registry details

Key details

Study ID
NCT07898748
Lead sponsor
Assiut University
Responsible party
Fatma Elzahraa Mohamed Hassan (prinicple investigator, Assiut University) — Principal investigator
First posted
Oct 27, 2026
Start date
Dec 1, 2026 (estimated)
Primary completion
Dec 1, 2028 (estimated)
Completion
Jan 30, 2029 (estimated)
Last update
Oct 27, 2026

Study contacts

SamiAbdel-AzizSayedKhalil Khalil prof SamiAbdel-AzizSayedKhalil, Professor of radiology
Contact
Samyabdelziz@med.aun.edu.eg
01006788053

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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