MRI in Evaluation of Fecal IncontinenceNCT07898748
Fecal Incontinence (FI) is a Debilitating Physical and Psychological Disorder Characterizedbytheinvoluntary Loss of Flatus or Liquid/Solid Stool.
An observational study of MRI in Evaluation of Fecal Incontinence, run by Assiut University.
Trial 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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- MRI in Evaluation of Fecal Incontinence
- What is being tested?
- 3DendoanalultrasoundversusexternalphasedarrayMRI inevaluationoffecal Incontinence
- Type of treatment
- Medical device
- How many people
- 22 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2026to 30 Jan 2029
- How long will I take part?
- 6 Weeks
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients presenting to the Outpatient Clinics of General/Colorectal Surgery and referred to the Radiology Department with clinical symptoms of fecal incontinence.
Who may be able to join
- 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.
Who cannot join
- Patients with absolute contraindications 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 malignancies: Patients with active pelvic, colorectal, or gynecological malignancies
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
SamiAbdel-AzizSayedKhalil Khalil prof SamiAbdel-AzizSayedKhalil, Professor of radiology contact
About this study
Official title: 3D Endoanal Ultrasound Versus External Phased Array MRI in Evaluation of Fecal Incontinence
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.
- Conditions
- MRI in Evaluation of Fecal Incontinence
- Being tested
- 3DendoanalultrasoundversusexternalphasedarrayMRI inevaluationoffecal Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3DendoanalultrasoundversusexternalphasedarrayMRI inevaluationoffecal IncontinenceDevice
) 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.
| Study group | Role | What they receive |
|---|---|---|
| 3DendoanalultrasoundversusexternalphasedarrayMRI inevaluationoffecal Incontinence | Not described Receives: Device: 3DendoanalultrasoundversusexternalphasedarrayMRI inevaluationoffecal Incontinence |
What is being measured
The primary outcome is the main question the study is designed to answer.
Toevaluate the diagnostic agreement and correlation between 3D endoanal ultrasound (3D-EAUS) and external phased array MRI
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2026
- Study start1 Dec 2026 (estimated)
- Primary completion1 Dec 2028 (estimated)
- Study completion30 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for MRI in Evaluation of Fecal IncontinenceStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 22 participants (estimated)
- Target duration
- 6 Weeks
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatma Elzahraa Mohamed Hassan, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07898748
- Sponsor's protocol ID
- fecal Incontinence
- Status last verified
- Oct 2026
- First submitted
- 21 Oct 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
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 2021846Rociu 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 10429703Stoker J, Halligan S, Bartram CI. Pelvic floor imaging. Radiology. 2001 Mar;218(3):621-41. doi: 10.1148/radiology.218.3.r01mr26621.
PubMed 11230632
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 3D Endoanal Ultrasound Versus External Phased Array MRI in Evaluation of Fecal Incontinence
- ClinicalTrials.gov ID
- NCT07898748
- Acronym / sponsor ID
- fecal Incontinence
- Conditions
- MRI in Evaluation of Fecal Incontinence
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 1 Dec 2028 (estimated)
- Study completion
- 30 Jan 2029 (estimated)
- First posted
- 27 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Weeks
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 3DendoanalultrasoundversusexternalphasedarrayMRI inevaluationoffecal Incontinence | – | Device: 3DendoanalultrasoundversusexternalphasedarrayMRI inevaluationoffecal Incontinence |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients presenting to the Outpatient Clinics of General/Colorectal Surgery and referred to the Radiology Department with clinical symptoms of fecal incontinence.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (4 listed)
- Patients with absolute contraindications 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 malignancies: Patients with active pelvic, colorectal, or gynecological malignancies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3DendoanalultrasoundversusexternalphasedarrayMRI 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. | Device | 3DendoanalultrasoundversusexternalphasedarrayMRI inevaluationoffecal Incontinence |
Primary outcome
Toevaluate the diagnostic agreement and correlation between 3D endoanal ultrasound (3D-EAUS) and external phased array MRI
Time frame: one year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Results publication: PubMed 2021846Law 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.
- Results publication: PubMed 10429703Rociu 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.
- Results publication: PubMed 11230632Stoker J, Halligan S, Bartram CI. Pelvic floor imaging. Radiology. 2001 Mar;218(3):621-41. doi: 10.1148/radiology.218.3.r01mr26621.
- Individual participant dataSharing planned: Yes
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
SamiAbdel-AzizSayedKhalil Khalil prof SamiAbdel-AzizSayedKhalil, Professor of radiology contact
Questions about this trial
What is this clinical trial studying?
An observational study of MRI in Evaluation of Fecal Incontinence, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact SamiAbdel-AzizSayedKhalil Khalil prof SamiAbdel-AzizSayedKhalil, Professor of radiology (01006788053, Samyabdelziz@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Toevaluate the diagnostic agreement and correlation between 3D endoanal ultrasound (3D-EAUS) and external phased array MRI (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07898748, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.