Evaluation of Gellhorn pessary on the anatomy of the pelvic floor and the pelvic organs in patients with pelvic organ prolapse using upright MRI

Evaluation of Gellhorn pessary on the anatomy of the pelvic floor and the pelvic organs in patients with pelvic organ prolapse using upright MRI - Gellhorn study

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON57306

Enrollment

Registered

2024-10-16

Start date

2025-12-03

Completion date

Unknown

Last updated

2026-06-01

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

Conditions

Pelvic Organ Prolapse - Organ descent Pelvic organ prolapse

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: The general inclusion criteria are: - Symptomatic POP - POP-Q stage >= 2 - Good knowledge of Dutch language - Signed informed consent - POP in anterior and/or middle compartment - Successful Gellhorn pessary treatment for at least 3 months - Patient is able to remove the pessary herself or willing to visit the ZGT hospital to let her pessary be removed 24 hours before scanning in case the prolapse is not experienced to the maximal extend immediately after pessary removal.

Exclusion criteria

Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: * Inability to stand for 25 minutes without assistance * Not eligible for MRI, in response to the MRI safety checklist * Abdominal circumference >= 143 cm (jeans size >= 52) or weight >= 200 kg

Design outcomes

Primary

Measure	Time frame
The supporting mechanism of the pelvic floor for a Gellhorn pessary	—

Secondary

Measure	Time frame
* Parameters which are associated with (a change of) the position and shape of the pelvic organs due to insertion of a Gellhorn pessary * Position and orientation of the Gellhorn pessary in successful pessary fitting. * Translation of parameters measured using upright MRI to parameters which can be measured in imaging techniques used in clinical practice * Differences in Gellhorn pessary position between the moment after insertion and after one week of pessary wearing * Correlation between the position and orientation of the pessary and anatomical aspects of the levator ani muscle - Correlation between the position and orientation of the pessary and anatomical aspects of the levator ani muscle - Correlation between the position and orientation of the pessary and symptomatic improvement	—

Measure

Time frame

* Parameters which are associated with (a change of) the position and shape of the pelvic organs due to insertion of a Gellhorn pessary * Position and orientation of the Gellhorn pessary in successful pessary fitting. * Translation of parameters measured using upright MRI to parameters which can be measured in imaging techniques used in clinical practice * Differences in Gellhorn pessary position between the moment after insertion and after one week of pessary wearing * Correlation between the position and orientation of the pessary and anatomical aspects of the levator ani muscle - Correlation between the position and orientation of the pessary and anatomical aspects of the levator ani muscle - Correlation between the position and orientation of the pessary and symptomatic improvement

—

Countries

Netherlands

Contacts

Public ContactATM Grob

University of Twente

a.t.m.grob@utwente.nl0534895345

Outcome results