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

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

Study Overview

• Status: Completed
• Conditions: Endometrial Bladder Disease
• Intervention / Treatment: Other: Magnetic resonance imaging (MRI)

Detailed 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).

• Study Type: Observational
• Enrollment (Actual): 39

Contacts and Locations

Study Locations

• France
  • Pierre-Bénite, France, 69310
    • Hospices Civils de Lyon - Centre Hospitalier Lyon Sud -Service de Radiologie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Patients treated in the gynecological surgery departments of the University Hospital Center of the Civil Hospitals of Lyon: Lyon Sud.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 1, 2017
• Primary Completion (ACTUAL): September 15, 2017
• Study Completion (ACTUAL): September 1, 2018

Study Registration Dates

• First Submitted: November 15, 2018
• First Submitted That Met QC Criteria: April 5, 2019
• First Posted (ACTUAL): April 8, 2019

Study Record Updates

• Last Update Posted (ACTUAL): April 8, 2019
• Last Update Submitted That Met QC Criteria: April 5, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Endometriosis; Urinary Bladder Diseases
• Other Study ID Numbers: 17-171

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No