New MRI test spots leaky bladders in chronic pain condition
NCT ID NCT05811377
First seen Jul 10, 2026 ยท Last updated Jul 10, 2026
Summary
This study tests a new MRI method to see if the bladder lining is leaky in people with Interstitial Cystitis (IC), a chronic bladder pain condition. Participants receive a single MRI after contrast dyes are placed into the bladder through a catheter. The goal is to distinguish between different types of IC, which could guide more personalized treatment.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Ferumoxytol and Gadobutrol (contrast dyes)
- What this could lead to
- If successful, this MRI test could help doctors identify different types of Interstitial Cystitis more accurately, leading to better-targeted treatments.
- What could go wrong
- This is a very small, early-stage study with only 7 participants. The test may not reliably distinguish between types of IC, and results may not apply to all patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
-
7 people
The number who actually took part.
- Started
-
Mar 2023
- Finished
-
May 2025
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
18-80 years old subjects from both genders and an IC/BPS diagnosis with a cystoscopic finding of Hunner lesions or absence
- Ages
-
18 to 80 years
- Sex
-
Anyone
- Healthy volunteers
-
Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 18-80 years old subjects from both genders and an IC/BPS diagnosis with a cystoscopic finding of Hunner lesions or absence and also have the following: 1. Pain (suprapubic, pelvic, urethral, vaginal or perineal) associated with bladder storage symptoms and pain on bladder filling that is relieved upon emptying 2. Urgency or nocturia (average of \>1 nocturnal void over 3 consecutive days on bladder diary). The O'Leary-Sant Interstitial cystitis symptom index (ICSI) and Interstitial cystitis problem index (ICPI) are valid and reliable measures of IC/BPS symptoms, and only IC/BPS patients with scores of ICSI of \> 9 and an ICPI \> 8 will be recruited. Age matched controls with no abnormal cystoscopic findings and with no bladder storage symptoms will be recruited. Exclusion Criteria: 1. Patients with urinary incontinence, suspicion for UTI on urine dipstick, history of recurrent UTIs, or history of spinal cord injury. Notwithstanding the fact that chronic bladder inflammation of IC/BPS patients evokes higher bladder permeability to instilled radiolabeled sodium chloride than acute inflammation of UTI patients, the investigators plan to exclude patients with UTIs as a confounding factor to rigorously establish the link between Hunner lesion and bladder permeability. 2. Patients with current diagnosis or previous history of urologic malignancy, prior bladder augmentation surgery, pelvic radiation, serum creatinine \>1.5mg/dl, diabetes mellitus, untreated hypertension, and proteinuria. 3. Participants in whom magnetic resonance imaging (MRI) is contraindicated including, but not limited to, those with a pacemaker, presence of metallic fragments near the eyes or spinal cord, or cochlear implant, any other implanted MRI non-compatible device of any type (cardiac pacemaker, sacral neuromodulation device, and shunt) 4. Patients who are claustrophobic, cannot sign informed consent, or have a past allergic reaction to either Gadobutrol or Ferumoxytol and any history of allergic reaction to any intravenous iron product. 5. Women of child-bearing age who are pregnant or plan to become pregnant (urine pregnancy test will be performed for premenopausal women with no history of prior hysterectomy) 6. Patients who cannot safely refrain from taking any analgesics or steroidal/non-steroidal anti-inflammatory or immunosuppressive drugs for one week preceding the MRI to avoid any confounding effect of anti-inflammatory drugs on bladder permeability. 7. Any patient with a history of allergic reaction to any intravenous iron product.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Ic - interstitial cystitis are added.
By submitting, you agree to our Terms of use
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
UPMC Magee Women's Hospital
Pittsburgh, Pennsylvania, 15213, United States