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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON33068

Enrollment

Registered

2009-09-16

Start date

2009-04-01

Completion date

Unknown

Last updated

2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

prolapse

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
The main study endpoint is the assessment of pelvic organ prolapse (POP) with the use of different reference lines and anatomical landmarks by comparing diagnostic outcomes with POP-Q findings.	—

Secondary

Measure	Time frame
Secondary endpoints are the feasibility of DTI in evaluating pelvic floor musculature and the intra- interobserver variability using reference lines in dynamic MRI.	—

Countries

Netherlands

Outcome results