Evaluation of pessary placement on the anatomy of the pelvic organs in patients with pelvic organ prolapse using imaging techniques

Evaluation of pessary placement on the anatomy of the pelvic organs in patients with pelvic organ prolapse using imaging techniques - EPPA: Evaluation of Pessary Placement on the Anatomy of the pelvic organs

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON52584

Enrollment

105

Registered

2020-10-27

Start date

2021-02-18

Completion date

Unknown

Last updated

2024-11-18

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

Conditions

Prolapse - pelvic floor dysfunction

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: General: Signed informed consent Patients: Symptomatic pelvic organ prolapse Pelvic organ prolapse quantification stage 2 or higher Patient underwent a pessary fitting trial by a gynecologist

Exclusion criteria

Exclusion criteria: General: Inability to stand for 20 minutes without assistance Not eligible for MRI, in response to the MRI safety checklist Controls: Symptoms related to POP or incontinence (in history)

Design outcomes

Primary

Measure	Time frame
In general, the main study endpoints are parameters about the position and shape of the pelvic organs that are associated with successful pessary fitting. Both absolute parameter values and changes in these parameters between the scans with and without pessary will be evaluated. For each study specific parameters will be described.	—

Secondary

Measure	Time frame
The secondary study endpoints are: - Parameters which are associated with (a change of) the position and shape of the pelvic organs due to insertion of a pessary in successful pessary fitting, measured using several imaging techniques. - Position and orientation of the pessary in successful pessary fitting. - Influence of the moment of the day on the position of the pelvic organs. - Correlation between the position and orientation of the pessary and anatomical aspects of the levator ani muscle. - Differences in parameters between patients with successful (i.e. continuation of pessary use for >= 3 months) and unsuccessful pessary fitting. These parameters will be investigated in the different studies described in this framework.	—

Measure

Time frame

The secondary study endpoints are: - Parameters which are associated with (a change of) the position and shape of the pelvic organs due to insertion of a pessary in successful pessary fitting, measured using several imaging techniques. - Position and orientation of the pessary in successful pessary fitting. - Influence of the moment of the day on the position of the pelvic organs. - Correlation between the position and orientation of the pessary and anatomical aspects of the levator ani muscle. - Differences in parameters between patients with successful (i.e. continuation of pessary use for >= 3 months) and unsuccessful pessary fitting. These parameters will be investigated in the different studies described in this framework.

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Countries

Netherlands

Outcome results