Bladder Endometriosis: Evaluation in MRI of the Involvement of the Posterior Inferior Wall

Endometrial Bladder Disease Clinical Trial

Official title:

Bladder Endometriosis: Evaluation in MRI of the Involvement of the Posterior Inferior Wall

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03906760
• Other study ID #: 17-171
• Status: Completed
• Start date: September 1, 2017
• Est. completion date: September 1, 2018

Study information

• Verified date: April 2019
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Evaluate MRI criteria for involvement of the posterior inferior wall of the bladder in patients with endometrial bladder disease.

Description:

PURPOSE: to retrospectively evaluate on MRI the local staging with assessment of ureteral orifices extension in bladder endometriosis./ MATERIALS AND METHODS: Institutional review board approval for this study was obtained and waived written informed consent. The MR images of 39 patients operated for bladder endometriosis over a 6 years period in 3 university Lyon hospitals were reviewed. Two experienced readers reported the vesical repletion volume, the largest lesion size, the location and extension of the lesion within the bladder wall, the distance between the ureteral orifices and the lesion when the vesicovaginal wall was involved, the presence of muco-sub mucosal complex edema and the association with external adenomyosis. MR images were compared with surgical and pathological findings. Efficacy parameters were calculated with 95% confidence interval (CI).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: September 1, 2018
• Est. primary completion date: September 15, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient operated for pelvic endometriosis with bladder resection.

• Performing a preoperative pelvic MRI with at least 2 perpendicular T2 planes

Exclusion Criteria:

• Refusal to use clinical data and exploration acquired

• Absence of interpretable preoperative pelvic MRI

Related Conditions & MeSH terms

• Endometrial Bladder Disease
• Endometriosis
• Urinary Bladder Diseases

Intervention

Other:
• Magnetic resonance imaging (MRI)
MRI protocol associating sagittal and axial (+/- coronal) sequences in T2 + / - turbo spin T1 weighting with fat saturation.

Locations

Country	Name	City	State
France	Hospices Civils de Lyon - Centre Hospitalier Lyon Sud -Service de Radiologie	Pierre-Bénite

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of MRI data with intraoperative data and anatomopathology.	A bladder lesion will be retained when a signal abnormality is present on at least two different sectional planes or weights. The topography of the lesion will be related to the vesico-uterine cul-de-sac, its lateralization, its distance from the bladder neck and meatus, its size and its signal.	Through bladder endometriosis surgery