NCT06294951 fMRI for BPS: A Descriptive Study of Findings and Symptoms
| NCT ID | NCT06294951 |
| Status | Recruiting |
| Phase | — |
| Sponsor | RenJi Hospital |
| Condition | Bladder Pain Syndrome |
| Study Type | OBSERVATIONAL |
| Enrollment | 120 participants |
| Start Date | 2024-03-01 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 120 participants in total. It began in 2024-03-01 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Zhebin Du, Dr.
PRINCIPAL INVESTIGATOR
RenJi Hospital
Frequently Asked Questions
Who can join the NCT06294951 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Bladder Pain Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06294951 currently recruiting?
Yes, NCT06294951 is actively recruiting participants. Contact the research team at Dzbdzb1989@163.com for enrollment information.
Where is the NCT06294951 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT06294951 clinical trial?
NCT06294951 is sponsored by RenJi Hospital. The principal investigator is Zhebin Du, Dr. at RenJi Hospital. The trial plans to enroll 120 participants.