Investigating brain imaging and symptoms in bladder pain syndrome

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

This study is testing how brain scans relate to the symptoms of bladder pain syndrome to help understand the condition better for future treatments.

Quick facts

• Study type: Observational
• Enrollment: 120 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: RenJi Hospital (Academic / other)
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT06294951 on ClinicalTrials.gov

What this trial studies

This observational study aims to explore the relationship between functional magnetic resonance imaging (fMRI) findings and symptom presentation in patients diagnosed with bladder pain syndrome (BPS). Participants will undergo fMRI scans along with routine laboratory tests to identify potential target lesions and distribution characteristics of brain activity related to BPS. The study seeks to provide insights that could inform future etiological exploration and therapeutic targeting for this condition. Recruitment occurs at the urology outpatient clinic of Renji Hospital, where informed consent will be obtained from eligible participants.

Who should consider this trial

Good fit: Ideal candidates are adult females aged 18 and older who have been diagnosed with bladder pain syndrome and have experienced symptoms for more than six months.

Not a fit: Patients who have undergone cystoscopy in the past two years or have contraindications to MRI may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance understanding of bladder pain syndrome and lead to improved diagnostic and therapeutic strategies for patients.

How similar studies have performed: While this approach is relatively novel, similar studies using fMRI to investigate chronic pain conditions have shown promising results.

Eligibility criteria

Inclusion Criteria for BPS group:

1. Be 18 years of age or older and female;
2. 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 "Exclusion Criteria" below);
3. Persistence of symptoms for more than 6 months;
4. Visual analogue scale (VAS) of pain ≥ 4;
5. O'Leary-Sant Interstitial Cystitis questionnaire (IC-Q) score of 12 or more, with pain and nocturia domain scores \>2;
6. Pelvic Pain and Urgency/Frequency Patient Symptom Scale (PUF) \>13;
7. No history of cystoscopy within 2 years.

Exclusion Criteria for BPS group:

1. With proliferative cystoplasty or previous surgery or any pharmacological and non-pharmacological treatment for BPS;
2. Pregnant or lactating women;
3. Contraindications to MRI;
4. Average urine output less than 40 ml or more than 400 ml;
5. Haematuria (more than 1+ in urine dipstick test);
6. Evidence of current urinary tract infection at the time of recruitment;
7. Tuberculosis of the genitourinary system or cancer of the bladder or uroepithelial cancer;
8. Recurrent urinary tract infection;
9. History of hysterectomy, mid-urethral sling, pelvic organ prolapse repair, vaginal delivery or caesarean section, prostate surgery or treatment within 6 months;
10. History of neurological disease such as cerebral infarction, multiple sclerosis, or Parkinson's disease;
11. Reliance on catheterisation; including clean intermittent catheterisation or indwelling catheterisation;
12. Planned rehabilitation therapy affecting bladder function.

Inclusion Criteria for Control group:

1. Be 18 years of age or older and female;
2. 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;
3. Have a pain visual analogue scale (VAS) ≥ 4;
4. Evidence of a current urinary tract infection;
5. Pelvic Pain and Urgency/Frequency Patient Symptom Scale (PUF) \>13;
6. No history of cystoscopy within 2 years.

Exclusion Criteria for Control group:

1. With proliferative cystoplasty or previous surgery or any pharmacological and non-pharmacological treatment for BPS;
2. Pregnant or lactating women;
3. Contraindications to MRI;
4. Average urine output less than 40 ml or more than 400 ml;
5. Tuberculosis of the genitourinary system or cancer of the bladder or uroepithelial cancer;
6. History of hysterectomy, mid-urethral sling, pelvic organ prolapse repair, vaginal delivery or caesarean section, prostate surgery or treatment within 6 months;
7. History of neurological disease such as cerebral infarction, multiple sclerosis, or Parkinson's disease;
8. Dependence on catheterisation; including clean intermittent catheterisation or indwelling catheterisation;
9. Planned rehabilitation that affects bladder function.

Where this trial is running

Shanghai, Shanghai Municipality

• Renji Hospital, Shanghai Jiao Tong University School of Medicine — Shanghai, Shanghai Municipality, China (Recruiting)

Study contacts

• Principal investigator: Zhebin Du, Dr. — RenJi Hospital
• Study coordinator: Zhebin Du, Dr.

Conditions Bladder Pain Syndrome