Evaluation of the pelvic floor patients with Pelvic Organ Prolaps (POP) and controls, using dynamic MRI and Diffusion Tensor Imaging (DTI).

• Conditions: prolapse; 10018188

• Registration Number: NL-OMON33068
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 30

Inclusion Criteria

Patients: Women in the age of 40 * 75 years, with at least a grade 2 prolaps in conformity with the POP-Q guidelines, as scored by the gynecologist. Women who are willing to undergo dynamic MRI and are willing to give informed consent for the study. Sufficient knowledge of the Dutch language to fill out the study questionnaires.
Controls: Women in the age of 18 - 75 years willing to undergo dynamic MRI scan and who are willing to give informed consent. Sufficient knowledge of the Dutch language to fill out the study questionnaire.

Exclusion Criteria

Patients and Controls:
-pelvic surgery with related changes to the pelvic floor anatomy.
-Inability to follow instructions of straining pelvic muscles, relaxing pelvic muscles and increasing abdominal pressure.
-Other exclusion criteria are (relative) contraindications to undergo MRI; pacemakers, claustrophobia and pregnancy.

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study endpoint is the assessment of pelvic organ prolapse (POP) with<br /><br>the use of different reference lines and anatomical landmarks by comparing<br /><br>diagnostic outcomes with POP-Q findings. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoints are the feasibility of DTI in evaluating pelvic floor<br /><br>musculature and the intra- interobserver variability using reference lines in<br /><br>dynamic MRI. </p><br>