Investigating brain imaging and symptoms in bladder pain syndrome

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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.
• Email: Dzbdzb1989@163.com
• Phone: +86-13512179027

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Treatment of bladder pain using VNX001

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• Using Botox to treat overactive bladder while preventing urinary tract infections

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.