RecruitingNCT06294951

fMRI for BPS: A Descriptive Study of Findings and Symptoms

Functional Magnetic Resonance Imaging Findings and Symptoms in Bladder Pain Syndrome: A Descriptive Study

Sponsor

RenJi Hospital

Enrollment

120 participants

Start Date

Mar 1, 2024

Study Type

OBSERVATIONAL

Conditions

Bladder Pain Syndrome

Summary

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

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria7

Be 18 years of age or older and female;
Be 18 years of age or older and female;
With symptoms of bladder pain (defined as 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 current diagnostic criteria and clinical guidelines;
Have a pain visual analogue scale (VAS) ≥ 4;
Evidence of a current urinary tract infection;
Pelvic Pain and Urgency/Frequency Patient Symptom Scale (PUF) >13;
No history of cystoscopy within 2 years.

Exclusion Criteria26

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;
No history of cystoscopy within 2 years.
With proliferative cystoplasty or previous surgery or any pharmacological and non-pharmacological treatment for BPS;
Pregnant or lactating women;
Contraindications to MRI;
Average urine output less than 40 ml or more than 400 ml;
Haematuria (more than 1+ in urine dipstick test);
Evidence of current urinary tract infection at the time of recruitment;
Tuberculosis of the genitourinary system or cancer of the bladder or uroepithelial cancer;
Recurrent urinary tract infection;
History of hysterectomy, mid-urethral sling, pelvic organ prolapse repair, vaginal delivery or caesarean section, prostate surgery or treatment within 6 months;
History of neurological disease such as cerebral infarction, multiple sclerosis, or Parkinson's disease;
Reliance on catheterisation; including clean intermittent catheterisation or indwelling catheterisation;
Planned rehabilitation therapy affecting bladder function.
With proliferative cystoplasty or previous surgery or any pharmacological and non-pharmacological treatment for BPS;
Pregnant or lactating women;
Contraindications to MRI;
Average urine output less than 40 ml or more than 400 ml;
Tuberculosis of the genitourinary system or cancer of the bladder or uroepithelial cancer;
History of hysterectomy, mid-urethral sling, pelvic organ prolapse repair, vaginal delivery or caesarean section, prostate surgery or treatment within 6 months;
History of neurological disease such as cerebral infarction, multiple sclerosis, or Parkinson's disease;
Dependence on catheterisation; including clean intermittent catheterisation or indwelling catheterisation;
Planned rehabilitation that affects bladder function.

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Interventions

DIAGNOSTIC_TESTfMRI

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.