Image quality of female pelvic organs
Conditions
Interventions
Group 1: Filling condition of the bladder
- filled normally
- empty bladder
- heavily filled bladder
Group 2: Fasting - meal - after meal
Group 3: Influence of the menstrual cycle with hormone intak
Sponsors
Kantonsspital Baden Institut für Radiologie
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Common inclusion criteria: • full age • if possible without claustrophobia • agreement to participate as a proband in study Study arm (procedure) related criteria: Filling state of bladder (A): - Existing bladder - Present incontinence with capability to lie motionless on the back for 10 min with a moderately or completely filled bladder Food abstention (B): - No known health related issues that don’t allow for a 4h food abstention or that would cause hypoglycaemia (e.g., drugs that need to be taken in periods less than 4 hours, or diabetes with the risk of hypoglaecemia with concurrent intake of an antidiabetic drug) - No gut relaxing medication, e.g., Buscopan, on the day of the examination Timepoint within menstruation cycle (C): - Proband in pre-menopausal state with existing cycle - Willingness to state if hormon intake or contraception used, and if so, which drug
Exclusion criteria
Exclusion criteria: Common exclusion criteria: • Known contraindications related to MRT (pacemaker, MRI unsuitable foreign material, please refer to MRT brochure) • Pregnant women • Intent to become pregnant during study period • In case of high probability of unplanned pregnancy • Women with hysterectomy • Known or assumed non-compliance to study protocol • Incapability of proband to understand study procedures, e.g., due to language problems, psycologic diseases, dementia, etc. • No written consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoint by procedure: • Procedure: filling state of the bladder: Endpoint: identifiability of the separating fat streak • Procedure: food abstention: Endpoint: image quality in relation to motion artefacts • Procedure: timepoint within menstruation cycle: Endpoint: change in image quality in relation to anatomy of female pelvic organs, by hormonal status | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary exploratory endpoints by procedure: • Procedure: filling state of the bladder: Endpoints: - Motion artefacts - Volume measurement of the filling state of the bladder -> correlation with subjective assessment of the filling state by the patient - Location/position of uterus - Identifiability of the ovaries - Dislocation of ovaries in relation to their normal position • Procedure: food abstention: - Influence of saturation band in the fasting state • Procedure: timepoint within menstruation cycle: Endpoints: - ROI measurement (ratio between signal intensity junctional zone / myometrium -Thickness of endometrium by hormonal status | — |
Countries
Switzerland
Contacts
Public ContactMahshid Sheikh-Sarraf
Ärztezentrum LimmatfeldInstitut für Radiologie
Outcome results
None listed