Imaging Pelvic Organ Prolapse with up-right MRI

Evaluation of pelvic organ prolapse using upright magnetic resonance imaging

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON24051

Enrollment

Registered

2016-07-14

Start date

2016-09-01

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

Pelvic organ Prolapse

Interventions

open low field-MRI (0.25T, Esaote), with a tilting function up to 90 degrees

Eligibility

Inclusion criteria

Inclusion criteria: - Patients with POP >18 yr - Symptomatic prolapse - >Grade 2 POP-Q - Good knowledge of Dutch language - Signed informed consent - Planned for prolapse repair surgery (anterior and/or posterior wall repair, Manchester, sacrocolpopexie)

Exclusion criteria

Exclusion criteria: - Previous prolapse repair surgery - Inability to stand for 15 minutes, without assistance - Hip width < 47 cm - Not allowed to do a maximum Valsalva maneuver because of cardiac or pulmonary disease - Not eligible for MRI, in response to the MRI safety checklist

Design outcomes

Primary

Measure	Time frame
The aim of this explorative study is to evaluate existing clinical parameters that are developed for supine MRI (angles, distances, function/composition of the muscle) in upright scanning and to assess how these parameters change between supine and upright MRI scanning.	—

Secondary

Measure	Time frame
• To evaluate if there is a correlation between the anatomical severity of POP, as measured with POP-Q, and the parameters obtained with MRI. • To evaluate if there is a correlation between the parameters obtained from the MR images pre and postoperative. • To explore if additional parameters can be defined, based on the upright MRI scan, that may be of interest to the surgeon and outcome of surgical treatment, which can be further tested for their clinical merit in a future trial	—

Measure

Time frame

• To evaluate if there is a correlation between the anatomical severity of POP, as measured with POP-Q, and the parameters obtained with MRI. • To evaluate if there is a correlation between the parameters obtained from the MR images pre and postoperative. • To explore if additional parameters can be defined, based on the upright MRI scan, that may be of interest to the surgeon and outcome of surgical treatment, which can be further tested for their clinical merit in a future trial

—

Contacts

Public ContactJudith olde Heuvel

NIM group Twente University

E-mail: j.oldeheuvel@student.utwente.nlPhone: +31 652172679

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)