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NCT05811377

Phenotyping Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS) by Intravesical Contrast Enhanced - Magnetic Resonance Imaging (ICE-MRI) Bladder Permeability Assay

Sponsor: Christopher J Chermansky, MD

View on ClinicalTrials.gov

Summary

Each participant will be asked to participate in this research study which distinguishes different types of Interstitial Cystitis/Bladder Pain Syndrome. Research studies include only people who wish to participate. The study team members will explain the study to each participant, and all questions about the study will be answered. Each participant will be given adequate time when deciding to participate in this study. Should the participant consent to participate, then the participant will agree to undergo have a single Magnetic Resonance Imaging (MRI) test that involves the use of radio waves and a powerful magnet which are linked to a computer that looks at the bladder. The MRI test is being performed to see if the bladder is leaky, which would suggest Interstitial Cystitis (IC). The MRI test involves placing Gadobutrol and Ferumoxytol into the bladder using a sterile catheter, a small hollow tube through which fluids pass. Preliminary data suggests that IC patients with Hunners lesions have increased Gadobutrol in the bladder wall lining.

Official title: Phenotyping Interstitial Cystitis/Bladder Pain Syndrome by ICE-MRI Bladder Permeability Assay

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

OBSERVATIONAL

Enrollment

Start Date

2023-03-29

Completion Date

2025-05-20

Last Updated

2026-07-10

Healthy Volunteers

Yes

Conditions

IC - Interstitial Cystitis

Interventions

DIAGNOSTIC_TEST

Ferumoxytol

After fully emptying the bladder with a catheter, 0.1mM Ferumoxytol combined with Gadobutrol 20mM will be instilled into the bladder through the catheter. The catheter will be plugged, and the patient will submit to an MRI scan of the bladder. After the MRI is completed, the Ferumoxytol will be drained through the catheter and the catheter will be removed.

DIAGNOSTIC_TEST

Gadobutrol

After fully emptying the bladder with a catheter, 20mM Gadobutrol (combined with Ferumoxytol) will be instilled into the bladder through the catheter. The catheter will be plugged, and the patient will submit to a MRI scan of the bladder. After the MRI is completed, the Gadobutrol will be drained through the catheter and the catheter will be removed.

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.

Locations (1)

UPMC Magee Women's Hospital

Pittsburgh, Pennsylvania, United States