Evaluation of pelvic organ prolapse using upright magnetic resonance imaging

Evaluation of pelvic organ prolapse using upright magnetic resonance imaging - POP UP MRI - Pelvic Organ Prolapse UPright MRI

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON45910

Enrollment

Registered

2017-12-12

Start date

2016-12-07

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 floor dysfunction - Prolapse

Interventions

Pelvic organ prolapse

Reference lines

Surgery

Weight bearing MRI

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: For patients: Signed informed consent Symptomatic grade 2 pelvic organ prolapse Planned for surgery (anterior and/or posterior wall repair, Manchester, sacrocolpopexie);For volunteers without pelvic floor disorders: Signed informed consent In same age and BMI category as the patient population At least one vaginal delivery

Exclusion criteria

Exclusion criteria: Previous prolapse surgery Hip waist >47 cm Not eligible for MRI, in response to the MRI safety checklist Inability to stand for 15 minutes, without assistance;Additionally for healthy volunteers: No prior history of pelvic organ complaints

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 in both volunteers without pelvic floor disorders and patients.	—

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 post- operative. *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 post- operative. *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

—

Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)