fMRI for BPS: A Descriptive Study of Findings and Symptoms
ConditionBladder Pain Syndrome
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorRenJi Hospital
About this trial
The goal of this observational study is to investigate the relationship between functional magnetic resonance imaging (fMRI) findings of the brain and symptom presentation in patients with bladder pain syndrome (BPS). The main questions it aims to answer are:
1. To explore the distribution characteristics of fMRI imaging and possible target lesions in the patient population. 2. To provide appropriate clues and evidence for etiological exploration and therapeutic targeting of BPS.
Participants will undergo fMRI as well as other routine laboratory tests and queries.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Be 18 years of age or older and female;
Be diagnosed with BPS (persistent or recurrent pain in the bladder area accompanied by at least one other symptom, such as increased pain when the bladder is full, and frequent urination during the day and/or at night, according to the current diagnostic criteria and clinical guidelines, without any of the conditions listed in the "
Disqualifiers
Persistence of symptoms for more than 6 months;
Visual analogue scale (VAS) of pain ≥ 4;
O'Leary-Sant Interstitial Cystitis questionnaire (IC-Q) score of 12 or more, with pain and nocturia domain scores >2;
Pelvic Pain and Urgency/Frequency Patient Symptom Scale (PUF) >13;
Trial population
The groups or cohorts will be selected from Urology clinic of Renji Hospital, Shanghai Jiao Tong University School of Medicine
Trial design
Design model
Case-control
Time perspective
Other
Treatments tested in this trial
fMRI
Diagnostic testThe fMRI is acquired using a Siemens 3.0T MRI scanner. BOLD functional images are scanned using an echo planar imaging (EPI) sequence. The scanning parameters are: TR=2s, matrix size of 64\*64, number of layers=30, layer thickness=3.75\*3.75\*4.5mm, and bottom-up interval scanning. A total of 540 whole brain functional images are acquired.
Treatment groups
120 Participants
are divided into 2 treatment groupsGroup A: BPS group1 intervention
Group B: Control group1 intervention
Trial outcomes
Primary outcomes
1
fMRI findings
The fMRI is acquired using a Siemens 3.0T MRI scanner. BOLD functional images are scanned using an echo planar imaging (EPI) sequence. The scanning parameters are: TR=2s, matrix size of 64\*64, number of layers=30, layer thickness=3.75\*3.75\*4.5mm, and bottom-up interval scanning. A total of 540 whole brain functional images are acquired. The relevant data acquired from fMRI should undergo the following pre-processing before generating findings: (1) data format conversion; (2) temporal layer correction; (3) head movement correction; (4) normalization; (5) smoothing
Time frame
1 day (fMRI is performed once upon the recruitment of the study subject.)Sponsors and contacts
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Source ClinicalTrials.gov