An interventional study of Brain functional MRI with simplified urodynamics in Urgency Urinary Incontinence, sponsored by University of Pittsburgh. Completed at 1 site in United States. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-05.
Sponsored by University of Pittsburgh · Not applicable, Interventional, and Other
Urge urinary incontinence (UUI) is a common problem in older people which vastly reduces quality of life, yet the cause and mechanism of disease are not well understood. This study will characterize brain control of the bladder in young and old continent individuals and age-matched incontinent counterparts. This will expand the investigators current knowledge of how the brain controls the bladder, how that control changes with age and disease, and suggest new targets to guide development of better treatment.
Current data suggest that bladder control comprises 3 cerebral circuits that maintain continence by suppressing the voiding reflex in the midbrain. In the UUI phenotype that responded to BFB (Biofeedback assisted pelvic floor muscle therapy), the mechanism involved enhancing deactivation of the first brain circuit (medial prefrontal cortex, mPFC) which resulted in less activation of the second circuit (which includes the midcingulate cortex). In the phenotype that was resistant to BFB, no brain changes were seen. Although the investigators have an emerging picture of the brain's role in UUI, the investigators have only rudimentary understanding of what is 'normal', i.e. how the brain normally controls the bladder. Moreover, the investigators do not know whether this control mechanism is the same across the lifespan, or whether it changes owing to the impact of aging. Thus, the investigators aims are to characterize the brain's normal role in bladder control in both young and old people, to determine the changes in brain structure and function that lead to bladder control failure (UUI), and to examine how such changes differ between young and old individuals. To address the aims, the investigators will utilize detailed neuroimaging to evaluate 80 asymptomatic women and 80 women with UUI, each group divided into young (18-45) and old (65+ years) individuals. The study will enable the investigators to define the brain's key structures, functional activity, and mechanisms involved in normal bladder control, and to identify the differences in these elements among those with UUI, both young and old.
By elucidating the mechanisms that mediate the brain's control (and loss of control) of bladder function, the proposed study should enhance the investigators working model, deepen the understanding of the impact of aging, and identify better targets for the treatment of UUI. It may thereby enable scientists to develop novel and more effective new therapies based on the revolution in neuroscience-and more hope for UUI sufferers.
1,363 studies on the registry are indexed under Urinary Incontinence; 228 are open to participants now.
This study's enrollment of 217 is above the median of 66 across 1,011 interventional studies indexed under Urinary Incontinence.
Browse Urinary Incontinence studies →University of Pittsburgh is the lead sponsor of 1,385 studies on the registry; 167 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 4 (50%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Dry Groups
All Groups: 'Wet' or 'Dry'; 'Young' or 'Old'
Cognitive impairment:
Impaired mobility
o Timed up and go test ≥ 12 secs
Medical instability:
MRI incompatibility:
Medication incompatibility:
Neurological conditions:
Lower urinary tract comorbidities/treatment:
Other comorbidities:
Females with urgency urinary incontinence
Other: Brain functional MRI with simplified urodynamics
Structural: MPRAGE provides a structural image, which is used for coregistration of subjects. Structural scans are then performed including Diffusion Spectrum Imaging (DSI; microstructural), and Fluid-attenuated inversion recovery (FLAIR; white matter specific) scans. Functional: With about 50 ml in the bladder, resting state functional BOLD measurements are made, followed by functional whole-brain images while a small amount of saline is infused and withdrawn from the bladder, in 2 blocks of 4 repetitions each. Each repetition starts with a 12-scan pause, followed by infusion (6 scans = 12 s), pause (6 scans), and withdrawal (6 scans). Each block of 4 repetitions is completed by a 6 scan pause during which scanning continues. 24 ml is infused at 120 ml/min, and slightly less is withdrawn to avoid accommodation.This is repeated on an empty and full bladder along with a resting state image.
BOLD (Blood Oxygen Level Dependent) fMRI Signal Contrast - mPFC
BOLD signal contrast - voxel-wise subtraction of normalized brain activity signal measure (BOLD response) during bladder fluid withdrawal from that during bladder infusion in the a priori defined mPFC (medial prefrontal cortex) region. Since BOLD signal represents the normalized contrast in fMRI signal between two states as a proxy for cerebral blood flow, it does not have a unit. The beta value represents the amplitude of the BOLD signal difference between the two conditions. A larger beta value represents a larger difference in activity. Negative values represent greater activity in the 'withdrawal' condition.
Time frame: Baseline
BOLD (Blood Oxygen Level Dependent) fMRI Signal Contrast - Left Insula
BOLD signal contrast - voxel-wise subtraction of normalized brain activity signal measure (BOLD response) during bladder fluid withdrawal from that during bladder infusion in the a priori defined insula region. Since BOLD signal represents the normalized contrast in fMRI signal between two states as a proxy for cerebral blood flow, it does not have a unit. The beta value represents the amplitude of the BOLD signal difference between the two conditions. A larger beta value represents a larger difference in activity. Negative values represent greater activity in the 'withdrawal' condition.
Time frame: Baseline
BOLD (Blood Oxygen Level Dependent) fMRI Signal Contrast - dACC
BOLD signal contrast - voxel-wise subtraction of normalized brain activity signal measure (BOLD response) during bladder fluid withdrawal from that during bladder infusion in the a priori defined dACC (dorsal anterior cingulate cortex) region. Since BOLD signal represents the normalized contrast in fMRI signal between two states as a proxy for cerebral blood flow, it does not have a unit. The beta value represents the amplitude of the BOLD signal difference between the two conditions. A larger beta value represents a larger difference in activity. Negative values represent greater activity in the 'withdrawal' condition.
Time frame: Baseline
Participants recruited to single University of Pittsburgh site using online research registries and local geriatrics and urology clinics.
| Milestone | Young Dry | Young Wet | Old Dry | Old Wet |
|---|---|---|---|---|
| Started | 52 | 67 | 47 | 51 |
| Completed | 41 | 40 | 40 | 42 |
| Not completed | 11 | 27 | 7 | 9 |
BOLD signal contrast - voxel-wise subtraction of normalized brain activity signal measure (BOLD response) during bladder fluid withdrawal from that during bladder infusion in the a priori defined mPFC (medial prefrontal cortex) region. Since BOLD signal represents the normalized contrast in fMRI signal between two states as a proxy for cerebral blood flow, it does not have a unit. The beta value represents the amplitude of the BOLD signal difference between the two conditions. A larger beta value represents a larger difference in activity. Negative values represent greater activity in the 'withdrawal' condition.
| beta value (no units) | Young Dry | Young Wet | Old Dry | Old Wet |
|---|---|---|---|---|
| BOLD (Blood Oxygen Level Dependent) fMRI Signal Contrast - mPFC | -0.1960800 ± 0.3793670 | -0.1141890 ± 0.5451350 | -0.1688894 ± 0.3134661 | -0.1224623 ± 0.3120977 |
BOLD signal contrast - voxel-wise subtraction of normalized brain activity signal measure (BOLD response) during bladder fluid withdrawal from that during bladder infusion in the a priori defined insula region. Since BOLD signal represents the normalized contrast in fMRI signal between two states as a proxy for cerebral blood flow, it does not have a unit. The beta value represents the amplitude of the BOLD signal difference between the two conditions. A larger beta value represents a larger difference in activity. Negative values represent greater activity in the 'withdrawal' condition.
| beta value (no units) | Young Dry | Young Wet | Old Dry | Old Wet |
|---|---|---|---|---|
| BOLD (Blood Oxygen Level Dependent) fMRI Signal Contrast - Left Insula | 0.14190175 ± 0.2700647 | 0.14075584 ± 0.3971482 | 0.02884665 ± 0.2219877 | 0.11903335 ± 0.2174073 |
BOLD signal contrast - voxel-wise subtraction of normalized brain activity signal measure (BOLD response) during bladder fluid withdrawal from that during bladder infusion in the a priori defined dACC (dorsal anterior cingulate cortex) region. Since BOLD signal represents the normalized contrast in fMRI signal between two states as a proxy for cerebral blood flow, it does not have a unit. The beta value represents the amplitude of the BOLD signal difference between the two conditions. A larger beta value represents a larger difference in activity. Negative values represent greater activity in the 'withdrawal' condition.
| beta value (no units) | Young Dry | Young Wet | Old Dry | Old Wet |
|---|---|---|---|---|
| BOLD (Blood Oxygen Level Dependent) fMRI Signal Contrast - dACC | 0.06615236 ± 0.2986924 | 0.15198950 ± 0.4791248 | -0.08932060 ± 0.2751053 | 0.05305285 ± 0.2561589 |
Collected over Adverse event data was collected during study visit with intervention (MRI), i.e., the 3-4 hour visit that included catheterization and an MRI, and up to 3 days later.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Young Dry | 0/41 (0%) | 2/41 (4.9%) | 4/41 (9.8%) |
| Young Wet | 0/40 (0%) | 0/40 (0%) | 2/40 (5%) |
| Old Dry | 0/40 (0%) | 0/40 (0%) | 1/40 (2.5%) |
| Old Wet | 0/42 (0%) | 1/42 (2.4%) | 0/42 (0%) |
| Event | Young Dry | Young Wet | Old Dry | Old Wet |
|---|---|---|---|---|
| 10028050Nervous system disorders | 2/41 | 0/40 | 0/40 | 1/42 |
| Event | Young Dry | Young Wet | Old Dry | Old Wet |
|---|---|---|---|---|
| 10037175Nervous system disorders | 4/41 | 2/40 | 1/40 | 0/42 |
| Age, Categorical(Participants) | Young Dry | Young Wet | Old Dry | Old Wet | Total |
|---|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 41 | 40 | 0 | 0 | 81 |
| >=65 years | 0 | 0 | 40 | 42 | 82 |
| Age, Continuous(years) | Young Dry | Young Wet | Old Dry | Old Wet | Total |
|---|---|---|---|---|---|
| Mean | 32.6 ± 7.5 | 36.4 ± 6.7 | 69.4 ± 3.5 | 72.1 ± 5.4 | 52.7 ± 10.2 |
| Sex: Female, Male(Participants) | Young Dry | Young Wet | Old Dry | Old Wet | Total |
|---|---|---|---|---|---|
| Female | 41 | 40 | 40 | 42 | 163 |
| Male | 0 | 0 | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | Young Dry | Young Wet | Old Dry | Old Wet | Total |
|---|---|---|---|---|---|
| Hispanic or Latino | 1 | 2 | 0 | 0 | 3 |
| Not Hispanic or Latino | 40 | 38 | 39 | 41 | 158 |
| Unknown or Not Reported | 0 | 0 | 1 | 1 | 2 |
| Race (NIH/OMB)(Participants) | Young Dry | Young Wet | Old Dry | Old Wet | Total |
|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 |
| Asian | 3 | 1 | 0 | 0 | 4 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 4 | 9 | 2 | 5 | 20 |
| White | 30 | 26 | 38 | 36 | 130 |
| More than one race | 3 | 3 | 0 | 1 | 7 |
| Unknown or Not Reported | 1 | 1 | 0 | 0 | 2 |
| Region of Enrollment(participants) | Young Dry | Young Wet | Old Dry | Old Wet | Total |
|---|---|---|---|---|---|
| United States | 41 | 40 | 40 | 42 | 163 |
| No of leaks/24h(leaks /24hours on 3 day bladder diary) | Young Dry | Young Wet | Old Dry | Old Wet | Total |
|---|---|---|---|---|---|
| Mean | 0 ± 0 | 3.79 ± 2.26 | 0 ± 0 | 3.97 ± 2.13 | 1.95 ± 2.48 |
| BMI(kg/m^2) | Young Dry | Young Wet | Old Dry | Old Wet | Total |
|---|---|---|---|---|---|
| Mean | 27.5 ± 7.8 | 33.2 ± 7.9 | 25.4 ± 5.2 | 33.1 ± 13.4 | 29.8 ± 9.7 |
1 further baseline measures are reported on the registry.
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — All of the individual participant data collected during the trial, after de-identification may be shared with other researchers.
Supporting information: Study protocol, Sap, Icf, Csr
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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