Functional MRI for Urinary Incontinence

Overseen By Helmet Karim, PhD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of Pittsburgh

Must not be taking: Prophylactic antibiotics

Disqualifiers: Cognitive impairment, Impaired mobility, Neurological conditions, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand how the brain controls the bladder, focusing on urge urinary incontinence (UUI), a condition causing sudden, strong urges to urinate that are hard to control. Researchers will use functional MRI brain scans to study women with and without UUI, both young and older. The goal is to discover new ways to improve treatments for this condition. Women who have experienced urinary leakage from sudden urges more than five times a week for at least three months might be suitable candidates for this study. As an unphased study, this trial offers participants the chance to contribute to groundbreaking research that could lead to better treatments for UUI.

Will I have to stop taking my current medications?

If you are currently using anticholinergic or beta-3 agonist medications, you will need to stop taking them for at least 4 weeks before participating in the study. For other medications, the protocol does not specify, but any expected changes in medication during the study may affect eligibility.

What prior data suggests that this method is safe for studying urinary incontinence?

Research has shown that using functional MRI with simplified urodynamics is generally safe. This method aids in understanding brain function during bladder control. For example, one study examined brain activity in healthy women to gain insights into urination. Another study involved 23 women with multiple sclerosis and found no serious safety issues related to brain activity monitoring.

Although these studies focus on brain activity, participants have generally tolerated the technique well. No major reports of negative effects have been specifically linked to this method. This suggests it is likely safe for studying urge urinary incontinence. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using brain functional MRI with simplified urodynamics to study urinary incontinence because it offers a fresh perspective on understanding this condition. Unlike traditional treatments like medications or pelvic floor exercises, which focus on managing symptoms, this approach aims to uncover how the brain's activity correlates with bladder function. By mapping brain activity, researchers hope to gain insights into the neurological aspects of urinary urgency, potentially leading to more targeted and effective treatments in the future. This technique could pave the way for a deeper understanding of the condition and novel therapeutic strategies.

What evidence suggests that this brain fMRI with simplified urodynamics is effective for urge urinary incontinence?

This trial will use brain scans (functional MRI) along with simple bladder tests to understand how the brain controls the bladder in females with urgency urinary incontinence. Research has shown that these methods can identify specific brain regions active in managing bladder function. For instance, one study examined brain activity in 65 people with urge urinary incontinence, while another study used this method on six people and successfully identified brain areas involved in bladder control. This research identifies new treatment targets by revealing how the brain's control changes with age and urinary issues. While this primarily enhances understanding of the condition, it also lays the groundwork for developing better treatments. ^{1 3 6 7 8}

Who Is on the Research Team?

Becky Clarkson, PhD

Principal Investigator

University of Pittsburgh

Are You a Good Fit for This Trial?

This trial is for women aged 18-45 or 65+ with urge urinary incontinence (UUI) more than five times a week, despite treatment. It's also for continent women without UUI. Participants must be able to differentiate between UUI and stress incontinence, have no major health issues affecting mobility or requiring upcoming surgery, and be MRI compatible.

Inclusion Criteria

I am willing to stop my anticholinergic/beta-3 agonist medications for 4 weeks.

I am a woman over 65 or between 18-45, mentally and physically able.

I can tell the difference between leakage when I cough or move and when I suddenly need to urinate.

Exclusion Criteria

I do not have severe depression.

You have metal implants that are not safe for MRI, or you are claustrophobic and cannot be in a small, closed space for the MRI.

You have trouble with memory and thinking, have difficulty keeping track of medication, or are unable to follow instructions for certain tests.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Neuroimaging Evaluation

Participants undergo detailed neuroimaging to evaluate brain structures and functions related to bladder control

1 hour per session

1 visit (in-person)

Data Analysis

Analysis of neuroimaging data to compare brain structure and function across different groups

4-8 weeks

Follow-up

Participants are monitored for any changes in brain function or urinary continence

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Brain functional MRI with simplified urodynamics

Trial Overview The study uses brain functional MRI alongside simplified urodynamics to understand how the brain controls the bladder in young vs old individuals and those with vs without urinary incontinence. The goal is to identify changes due to aging or disease.

How Is the Trial Designed?

Group I: Brain functional MRI with simplified urodynamics Experimental Treatment 1 Intervention

Females with urgency urinary incontinence

Who Is Running the Clinical Trial?

University of Pittsburgh

Lead Sponsor

Trials

1,820

Recruited

16,360,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Published Research Related to This Trial

In a preliminary study involving nine healthy volunteers and nine women with genuine stress incontinence, dynamic MRI was used to analyze bladder voiding patterns after physiological filling.

The study did not find any specific differences in voiding patterns between the healthy volunteers and those with genuine stress incontinence, suggesting that further research is needed to explore this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The clinical value of dynamic magnetic resonance imaging in normal and incontinent women--a preliminary study on micturition. Hedlund, H., Bø, K., Lilleås, F., et al.[2019]

In a study involving 20 healthy adults, fMRI revealed that brain activity in the salience network, default mode network, and central executive network significantly increased when the bladder was full compared to when it was empty, indicating these networks play a role in bladder control.

The findings suggest that the salience network helps with bladder sensation, the default mode network is involved in decision-making about whether to void, and the central executive network supports memory processes related to bladder control, providing insights into how the brain processes bladder function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Responses of functional brain networks to bladder control in healthy adults: a study using regional homogeneity combined with independent component analysis methods. Pang, D., Gao, Y., Liao, L.[2021]

This study mapped brain activity during urination in 12 healthy women using functional MRI, identifying key brain regions like the parahippocampal gyrus and anterior cingulate gyrus that are active during micturition.

The research revealed that brain activation patterns differ between individuals who can urinate and those who cannot, suggesting that understanding these differences could lead to better treatments for urinary issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A preliminary report on the use of functional magnetic resonance imaging with simultaneous urodynamics to record brain activity during micturition. Krhut, J., Tintera, J., Holý, P., et al.[2012]

This study assessed the reliability of fMRI measurements related to lower urinary tract (LUT) control in 20 healthy participants, showing that the right insula and right ventrolateral prefrontal cortex (VLPFC) are the most reliable brain regions for detecting task-specific responses during bladder filling.

The results indicated significant BOLD signal changes during bladder filling compared to the starting condition, with high reliability in the activation patterns across two separate fMRI sessions, suggesting that fMRI could be a useful tool for evaluating LUT treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reliability of supraspinal correlates to lower urinary tract stimulation in healthy participants - A fMRI study. Walter, M., Leitner, L., Michels, L., et al.[2019]

The study assessed the repeatability of an fMRI protocol in 59 older women with urgency incontinence, finding no significant differences in brain activity between two scans taken 5-10 minutes apart.

The intra-class correlation values indicated limited repeatability of brain responses related to bladder control, suggesting that while fMRI can provide insights at a group level, it may not be reliable for individual assessments of brain function in continence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Test-retest repeatability of patterns of brain activation provoked by bladder filling. Clarkson, BD., Tyagi, S., Griffiths, DJ., et al.[2020]

This study identified five key brain regions involved in the initiation of voiding, specifically within the periaqueductal gray (PAG) and pontine micturition center (PMC), using advanced 7 Tesla MRI technology with 20 healthy adult volunteers.

The research revealed that females exhibited lower brain activation levels compared to males during the voiding process, except in the caudate lobe, highlighting potential gender differences in brainstem function related to urinary control.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is the Brainstem Activation Different Between Healthy Young Male and Female Volunteers at Initiation of Voiding? A High Definition 7-Tesla Magnetic Resonance Imaging Study. Schott, B., Choksi, D., Tran, K., et al.[2023]

This study involved 23 healthy female volunteers and used advanced functional magnetic resonance imaging (fMRI) to map brain activity during bladder filling and pelvic floor muscle contractions, revealing specific brain regions involved in these processes.

Key areas of brain activation were identified, including the primary motor area and supplementary motor area during pelvic floor contractions, and regions such as the inferior frontal lobe and insula during bladder filling, supporting the understanding of neural control over the lower urinary tract.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brain activity during bladder filling and pelvic floor muscle contractions: a study using functional magnetic resonance imaging and synchronous urodynamics. Krhut, J., Holy, P., Tintera, J., et al.[2014]

This study successfully used 7-tesla functional magnetic resonance imaging (7T-fMRI) to visualize specific brain areas involved in controlling pelvic floor muscle contractions (PFMC) in 17 healthy male volunteers, highlighting the method's efficacy in mapping neural representations.

Distinct activation patterns were observed for PFMC compared to tongue movements, indicating that different neural networks are engaged for these tasks, which could enhance our understanding of pelvic floor control mechanisms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Whole brain 7T-fMRI during pelvic floor muscle contraction in male subjects. Groenendijk, IM., Luijten, SPR., de Zeeuw, CI., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5485249/

Functional Magnetic Resonance Imaging during Urodynamic ... Krhut et al reported preliminary results in 6 subjects with successful micturition using simultaneous urodynamics and fMRI. Results revealed upper pontine ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0022534712034258

A Preliminary Report on the Use of Functional Magnetic ... We mapped brain activity during micturition using functional magnetic resonance imaging with simultaneous recording of urodynamic properties during slow ...

3. withpower.com withpower.com/trial/phase-urinary-incontinence-11-2020-fc329

Functional MRI for Urinary Incontinence Trial Overview The study uses brain functional MRI alongside simplified urodynamics to understand how the brain controls the bladder in young vs old individuals ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4865681/

Brain Mechanisms Underlying Urge Incontinence and its ... Functional magnetic resonance imaging was done to determine the brain reaction to rapid bladder filling with urgency. Results. Of 65 subjects with urge urinary ...

5. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1002/nau.25333

Functional neuroimaging related to lower urinary tract ... Neuroimaging studies have advanced our understanding of the intricate central nervous system control network governing lower urinary tract (LUT) function.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5497828/

Functional Magnetic Resonance Imaging with Concurrent ... We report brain activity on functional magnetic resonance imaging and simultaneous urodynamic testing in 23 ambulatory female patients with multiple sclerosis.

7. einj.org einj.org/m/journal/view.php?number=1069

Is the Brainstem Activation Different Between Healthy ... Functional magnetic resonance imaging during urodynamic testing identifies brain structures initiating micturition. J Urol 2014;192:1149-54 ...

8. mdpi.com mdpi.com/2227-9059/11/2/403

Assessment of Brainstem Functional Organization in ... We aimed to assess consistency of PAG functional organization across different bladder sensory states in OAB patients.