In this study we aim to evaluate pelvic floor structures in both POP patients and controls with the use of different anatomical landmarks and reference lines in non-invasive dynamic MRI. Additionally we propose to evaluate the feasibility of DTI in…
ID
Source
Brief title
Condition
- Genitourinary tract disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
Secondary endpoints are the feasibility of DTI in evaluating pelvic floor
musculature and the intra- interobserver variability using reference lines in
dynamic MRI.
Background summary
For the assessment of Pelvic Organ Prolaps (POP) several methods to interpret
dynamic MRI are reported in literature. However until now the reference lines
and anatomical landmarks which should be used to assess and stage pelvic
prolapse are not defined, therefore reliability of the used reference lines
should be determined. Secondly, diffusion tensor imaging (DTI) in combination
with fiber tracking algorithms has been reported as imaging method for the
visualization in human muscle. We hypothesized that DTI can be applied to the
pelvic floor musculature for visualization and the potential in identifying
abnormalities in POP patients.
Study objective
In this study we aim to evaluate pelvic floor structures in both POP patients
and controls with the use of different anatomical landmarks and reference lines
in non-invasive dynamic MRI. Additionally we propose to evaluate the
feasibility of DTI in characterizing pelvic floor musculature.
Study design
Prospective pilot study. The study population comprises POP patients and
controls that are allocated into 3 groups. All three groups (n=30) will
undergo dynamic MRI with additional DTI, of the pelvic floor.
Study burden and risks
Risks for subjects undergoing dynamic MRI examination are minimal, provided
precautions have made to prevent examining individuals with contraindications.
For this purpose, the routine MRI contra indications form of the AMC will be
used. Dynamic MRI is a diagnostic procedure so there are no direct therapeutic
effects. A group-related benefit of this diagnostic study is that with the
demonstration of feasibility of dynamic MRI and DTI, an applicable non-invasive
tool in the detection of disorders of the pelvis could be obtained.
Meibergdreef 9
1105 AZ Amsterdam
Nederland
Meibergdreef 9
1105 AZ Amsterdam
Nederland
Listed location countries
Age
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
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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL27491.018.09 |