Trial Outcomes & Findings for Phenotyping Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS) by Intravesical Contrast Enhanced - Magnetic Resonance Imaging (ICE-MRI) Bladder Permeability Assay (NCT NCT05811377)
NCT ID: NCT05811377
Last Updated: 2026-07-10
Results Overview
Changes in bladder permeability were demonstrated by increased or decreased absorption of the contrast- Gadobutrol. This was measured in artificial units through signal intensity. Increased absorption was shown with brighter color in the bladder wall (associated with higher artificial unit values), while less absorption was demonstrated with darker color (associated with lower artificial unit values). Elevated absorption of instilled Gadobutrol into bladder wall was assessed with the darker appearance of the bladder center.
COMPLETED
7 participants
12 min image post-contrast
2026-07-10
Participant Flow
The study team was unable to recruit any asymptomatic control participants.
Participant milestones
| Measure |
Non-Hunner IC
Participants who did not show Hunner lesion on cystoscopy performed prior to MRI
|
Hunner IC
Participants who showed Hunner lesions on cystoscopy before MRI
|
|---|---|---|
|
Overall Study
STARTED
|
5
|
2
|
|
Overall Study
COMPLETED
|
5
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Phenotyping Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS) by Intravesical Contrast Enhanced - Magnetic Resonance Imaging (ICE-MRI) Bladder Permeability Assay
Baseline characteristics by cohort
| Measure |
Non Hunner IC
n=5 Participants
Participants Without Hunner Lesion on cystoscopy performed prior to ICE-MRI
|
Participants With Hunner Lesion
n=2 Participants
Participants with Hunner Lesion on cystoscopy performed prior to ICE-MRI
|
Total
n=7 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
51.2 years
STANDARD_DEVIATION 20.75 • n=9 Participants
|
59.5 years
STANDARD_DEVIATION 13.43 • n=27 Participants
|
56.75 years
STANDARD_DEVIATION 16.61 • n=267 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=9 Participants
|
2 Participants
n=27 Participants
|
7 Participants
n=267 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=9 Participants
|
2 Participants
n=27 Participants
|
7 Participants
n=267 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=9 Participants
|
2 Participants
n=27 Participants
|
7 Participants
n=267 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=9 Participants
|
2 participants
n=27 Participants
|
7 participants
n=267 Participants
|
PRIMARY outcome
Timeframe: 12 min image post-contrastChanges in bladder permeability were demonstrated by increased or decreased absorption of the contrast- Gadobutrol. This was measured in artificial units through signal intensity. Increased absorption was shown with brighter color in the bladder wall (associated with higher artificial unit values), while less absorption was demonstrated with darker color (associated with lower artificial unit values). Elevated absorption of instilled Gadobutrol into bladder wall was assessed with the darker appearance of the bladder center.
Outcome measures
| Measure |
Hunner IC
n=2 Participants
Participants with Hunner Lesion on cystoscopy performed prior to ICE-MRI
|
Non-Hunner IC
n=5 Participants
Participants Without Hunner Lesion on cystoscopy performed prior to ICE-MRI
|
|---|---|---|
|
Bladder Permeability
|
144.25 artificial units
Standard Deviation 7.40
|
202.28 artificial units
Standard Deviation 11.958
|
Adverse Events
Non-Hunner IC
Hunner IC
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Vickie Polanco-garcia
Department of Urology, University of Pittsburgh School of Medicine
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place