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Search / Trial NCT06294951

fMRI for BPS: A Descriptive Study of Findings and Symptoms

Launched by RENJI HOSPITAL · Mar 5, 2024

Trial Information

Current as of June 27, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying bladder pain syndrome (BPS), a condition that causes persistent or recurrent pain in the bladder area, often accompanied by symptoms like increased pain when the bladder is full and frequent urination. The research aims to understand how brain images taken using a special type of scan called functional magnetic resonance imaging (fMRI) relate to the symptoms that patients experience. By doing this, the researchers hope to gather clues that could lead to better treatment options for BPS in the future.

To participate in the study, women aged 18 and older who have been diagnosed with BPS and have experienced symptoms for at least six months may be eligible. Participants will undergo an fMRI scan along with routine lab tests to help researchers learn more about the condition. It’s important to note that there are specific criteria for joining, such as not having had certain treatments for BPS in the past two years. Overall, this study is focused on gaining a deeper understanding of BPS and how it affects women, with the hope of improving care for those who suffer from this painful condition.

Gender

FEMALE

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.

About Renji Hospital

Renji Hospital, a prestigious medical institution affiliated with Shanghai Jiao Tong University School of Medicine, is dedicated to advancing healthcare through innovative clinical research. With a strong emphasis on patient-centered care, Renji Hospital conducts a wide range of clinical trials across various therapeutic areas, harnessing cutting-edge technology and evidence-based practices. The hospital's multidisciplinary team of experienced researchers and medical professionals collaborates closely to ensure rigorous study design and execution, aiming to contribute significantly to medical knowledge and improve treatment outcomes for patients worldwide.

Locations

Shanghai, Shanghai, China

Patients applied

0 patients applied

Trial Officials

Zhebin Du, Dr.

Principal Investigator

RenJi Hospital

Yinghui Fan, Dr.

Principal Investigator

RenJi Hospital

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported