HealthyNCT04846387
Mapping of the Human Brainstem During Continence and Micturition: Noninvasive 7-T fMRI Study
An observational study of Healthy, run by The Methodist Hospital Research Institute at 1 site in United States.
Trial summary
The lower urinary tract (bladder, bladder neck, urethra and urethral sphincter) has two functions: Storage (Continence) and voiding (micturition). Lower urinary tract dysfunction (LUTD) includes symptoms in the storage phase (such as urinary frequency, urgency, incontinence) or micturition phase (such as voiding… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Magnetic Resonance Imaging (MRI), Post-Void Residual and Uroflowmetry
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jan 2021to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: We will recruit healthy male and female volunteers > 18 years of age with no neurological disease and urinary issues at Houston Methodist Hospital. We anticipate an equal gender distribution (10 men and 10 women) among study participants. Once screened for inclusion and exclusion criteria, volunteers will be approached and asked if they would like to participate in this study. They will then be given study material and allowed sufficient time to make an informed decision regarding participation.
Who may be able to join
- Healthy adult male and female volunteers ≥18 years of age with no neurological disease and genitourinary abnormalities will be screened:
- Post-Void Residual (PVR) < 20% of their bladder capacity OR
- Above 10 percentile of Liverpool nomogram
- AND
- AUASS score < 7 will be eligible to participate in the study.
Who cannot join
- history of clinically relevant genitourinary malignancy or surgery such as:
- anti-incontinence procedures
- urethral strictures
- advanced pelvic organ prolapse
- any neurological disorders
- history of seizures,
Show all 9Show fewer
- pregnancy or planning to become pregnant,
- and contraindications to MRI will be excluded.
- Research team members who are involved with the data collection and the data analysis for this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: High-resolution Mapping of the Human Brainstem During Continence and Micturition: in Vivo Noninvasive 7 Tesla fMRI Study
The lower urinary tract (bladder, bladder neck, urethra and urethral sphincter) has two functions: Storage (Continence) and voiding (micturition). Lower urinary tract dysfunction (LUTD) includes symptoms in the storage phase (such as urinary frequency, urgency, incontinence) or micturition phase (such as voiding dysfunction, hesitancy and urinary retention), or both. Proper urinary tract function is controlled by a complex network of peripheral and central nervous system. A delicate and complex switch exists between storage of urine and elimination of urine and in humans, the control over this switch is located in brain stem. Although significant research efforts have been utilized to understand supraspinal neural control of LUTs in humans, our understanding of the brainstem in humans is very limited, mainly due to the small size of nuclei.
The extensive involvement of the brainstem in LUTS control has urged us to look into a better way to investigate and identify the brainstem nuclei involved throughout the entire bladder cycle, especially in neurogenic patients. To our knowledge, there has been no published study using high-resolution MRI (7 Tesla) to study the role of brainstem specifically in LUT. Brainstem evaluation in regards to LUT function in a thorough and accurate manner using high-resolution techniques is of high priority for benign urology and National Institute of Health. The findings from this proposal will lay the foundation to study of brainstem control in the bladder cycle in neurogenic patients with high-resolution neuroimaging, and will be seminal research in the field.
The investigators hypothesize that Grey matter (blood-oxygen-level-dependent BOLD) signals and functional connectivity (FC) evaluation of the brainstem regions involved in continence and micturition are superior in 7T when compared to 3T in humans allowing assessment of the variations between men and women. Brainstem Regions of Interest (ROIs) include Pontine Storage Center (PSC) ("L region of the pons) and PAG are expected to be activated during the storage (continence) phase and Pontine Micturition Center (PMC) ("M" region of the pons) are expected to be activated during the voiding (micturition) phase.
Read the detailed description
The current proposal will be the first 7-Tesla study evaluating brain and specifically brainstem control over LUT. The study will utilize a noninvasive functional MRI (fMRI) protocol that allows for evaluation of brainstem activity during continence and micturition in real-time, using high-resolution neuroimaging techniques (7T fMRI) in both men and women. The study will recruit 20 healthy subjects (10 male and 10 female) for participation in this study. The participants for this study will undergo a few tests including a uroflow, PVR and a protocol training session during screening at visit 1, and a fMRI at visit 2.
During screening, subject will be asked to come to their appointment with a full bladder. For the uroflow, they will urinate into a special funnel connected to a measuring instrument in a private bathroom followed by measuring Post void residual volume through PVR scanner. This is to ensure that they do not have any urological issue which can disqualify them from the study. At this visit, we will also instruct them about the urine voiding-holding task, our noninvasive fMRI paradigm which will involve having the participant drink 500-750 mL of water approximately 20 minutes prior to the start of their scan, which the subjects will be performing during the fMRI portion of the study at visit 2.
The subsequent Grey matter (BOLD) signals and functional connectivity (FC) analysis will allow investigators to further the current understanding of brainstem control of the LUT and bladder cycle.
- Conditions
- Healthy
- Being tested
- Magnetic Resonance Imaging (MRI), Post-Void Residual, Uroflowmetry, Questionaire - AUA Symptom Score
- Keywords
- Pontine Storage Center (PSC), Functional Magnetic Resonance Imaging (fMRI), Lower Urinary Tract Symptoms (LUTS), Pontine Micturition Center (PMC), Neuroimaging, Periaqueductal Gray (PAG), Micturition, Bladder, Incontinence, Overactive Bladder
- Medical subject headings
- Lower Urinary Tract Symptoms, Urinary Bladder, Overactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic Resonance Imaging (MRI)Diagnostic test
A T1-weighted Anatomical Image, Diffusion Weighted Image, and functional MRI (fMRI) of "empty bladder" image will be obtained.
Additionally, fMRI image during "full bladder" state and voiding/holding tasks will be obtained.
Post-Void ResidualDiagnostic test
Also called PVR
The patient's post-void residual is determined using a portable ultrasound machine after emptying the bladder just prior to entering the MRI scanner and immediately after the MRI scan.
UroflowmetryDiagnostic test
Patients will urinate into a funnel connected to an electric flow meter to record urine flow rates in mililters per second. This is used as part of the screening process.
Questionaire - AUA Symptom ScoreBehavioural
Also called AUASS
Subjects will fill out questionnaire asking about urinary symptoms. The range is 0-35.
| Study group | Role | What they receive |
|---|---|---|
| Females with Normal Bladder Function | Diagnostic Tests: functional MRI and urodynamic studies.
During screening, subject will be asked to come to their appointment with a full bladder. For the uroflow, they will urinate into a special funnel connected to a measuring instrument in a private bathroom followed by measuring Post void residual volume through PVR scanner. This is to ensure that they do not have any urological issue which can disqualify them from the study. At this visit, we will also instruct them about the urine voiding-holding task, our noninvasive fMRI paradigm, which the subjects will be performing during the fMRI portion of the study at visit 2. A 7-Tesla Siemens MAGNETOM scanner will be used. A urinary pouch will be used to collect the participant's urine while in the scanner. Receives: Diagnostic Test: Magnetic Resonance Imaging (MRI); Diagnostic Test: Post-Void Residual; Diagnostic Test: Uroflowmetry; Behavioral: Questionaire - AUA Symptom Score | |
| Males with Normal Bladder Function | Diagnostic Tests: functional MRI and urodynamic studies.
During screening, subject will be asked to come to their appointment with a full bladder. For the uroflow, they will urinate into a special funnel connected to a measuring instrument in a private bathroom followed by measuring Post void residual volume through PVR scanner. This is to ensure that they do not have any urological issue which can disqualify them from the study. At this visit, we will also instruct them about the urine voiding-holding task, our noninvasive fMRI paradigm, which the subjects will be performing during the fMRI portion of the study at visit 2. A 7-Tesla Siemens MAGNETOM scanner will be used. A condom catheter will be used to collect the participant's urine while in the scanner. Receives: Diagnostic Test: Magnetic Resonance Imaging (MRI); Diagnostic Test: Post-Void Residual; Diagnostic Test: Uroflowmetry; Behavioral: Questionaire - AUA Symptom Score |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Oxygen Level Dependent (BOLD) signals intensity
BOLD signal intensity in the regions of interest during empty bladder, full bladder, and micturition in healthy males and females
Measured: 2 years
Secondary outcomes (6)
Blood Oxygen Level Dependent (BOLD) signals
Differences in BOLD signal intensity in brainstem ROIs during micturition between genders
Measured: 2 years
Uroflow measure
Maximum Qmax of urine (ml/sec): The range is between 0-40 mL/sec.
Measured: 2 years
Postvoid Residual
Postvoid Residual (PVR) of urine in mL: The range is between 0-900 mL.
Measured: 2 years
Urinary symptoms scores
Urinary symptom scores (no unit): The range is between 0-35. A higher score is associated with a worse outcome.
Measured: 2 years
Mean Diffusivity (MD)
MD is a scalar value that describes the degree of diffusivity. MD of white matter tracts that are implicated in brain control of bladder are of interest.
Measured: 2 years
Fractional Anisotropy (FA)
FA is a scalar value between zero and one that describes the degree of anisotropy of a diffusion process. A value of zero means that diffusion is isotropic (equally restricted) in all direction. No units. FA of white matter tracts that are implicated in brain control of bladder are of interest.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2021
- Study start18 Jan 2021
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by The Methodist Hospital Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Methodist Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rose Khavari, M.D., The Methodist Hospital Research Institute
- Investigators
- Rose Khavari, MD, Principal investigator, The Methodist Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04846387
- Sponsor's protocol ID
- PRO00026967
- Status last verified
- Apr 2025
- First submitted
- 12 Apr 2021
- Last updated
- 10 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High-resolution Mapping of the Human Brainstem During Continence and Micturition: in Vivo Noninvasive 7 Tesla fMRI Study
- ClinicalTrials.gov ID
- NCT04846387
- Acronym / sponsor ID
- PRO00026967
- Conditions
- Healthy
- Keywords
- Pontine Storage Center (PSC), Functional Magnetic Resonance Imaging (fMRI), Lower Urinary Tract Symptoms (LUTS), Pontine Micturition Center (PMC), Neuroimaging, Periaqueductal Gray (PAG), Micturition, Bladder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- The Methodist Hospital Research InstituteUniversity, hospital or other
- Study start
- 18 Jan 2021 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 15 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The lower urinary tract (bladder, bladder neck, urethra and urethral sphincter) has two functions: Storage (Continence) and voiding (micturition). Lower urinary tract dysfunction (LUTD) includes symptoms in the storage phase (such as urinary frequency, urgency, incontinence) or micturition phase (such as voiding dysfunction, hesitancy and urinary retention), or both. Proper urinary tract function is controlled by a complex network of peripheral and central nervous system. A delicate and complex switch exists between storage of urine and elimination of urine and in humans, the control over this switch is located in brain stem. Although significant research efforts have been utilized to understand supraspinal neural control of LUTs in humans, our understanding of the brainstem in humans is very limited, mainly due to the small size of nuclei.
The extensive involvement of the brainstem in LUTS control has urged us to look into a better way to investigate and identify the brainstem nuclei involved throughout the entire bladder cycle, especially in neurogenic patients. To our knowledge, there has been no published study using high-resolution MRI (7 Tesla) to study the role of brainstem specifically in LUT. Brainstem evaluation in regards to LUT function in a thorough and accurate manner using high-resolution techniques is of high priority for benign urology and National Institute of Health. The findings from this proposal will lay the foundation to study of brainstem control in the bladder cycle in neurogenic patients with high-resolution neuroimaging, and will be seminal research in the field.
The investigators hypothesize that Grey matter (blood-oxygen-level-dependent BOLD) signals and functional connectivity (FC) evaluation of the brainstem regions involved in continence and micturition are superior in 7T when compared to 3T in humans allowing assessment of the variations between men and women. Brainstem Regions of Interest (ROIs) include Pontine Storage Center (PSC) ("L region of the pons) and PAG are expected to be activated during the storage (continence) phase and Pontine Micturition Center (PMC) ("M" region of the pons) are expected to be activated during the voiding (micturition) phase.
Detailed description
The current proposal will be the first 7-Tesla study evaluating brain and specifically brainstem control over LUT. The study will utilize a noninvasive functional MRI (fMRI) protocol that allows for evaluation of brainstem activity during continence and micturition in real-time, using high-resolution neuroimaging techniques (7T fMRI) in both men and women. The study will recruit 20 healthy subjects (10 male and 10 female) for participation in this study. The participants for this study will undergo a few tests including a uroflow, PVR and a protocol training session during screening at visit 1, and a fMRI at visit 2.
During screening, subject will be asked to come to their appointment with a full bladder. For the uroflow, they will urinate into a special funnel connected to a measuring instrument in a private bathroom followed by measuring Post void residual volume through PVR scanner. This is to ensure that they do not have any urological issue which can disqualify them from the study. At this visit, we will also instruct them about the urine voiding-holding task, our noninvasive fMRI paradigm which will involve having the participant drink 500-750 mL of water approximately 20 minutes prior to the start of their scan, which the subjects will be performing during the fMRI portion of the study at visit 2.
The subsequent Grey matter (BOLD) signals and functional connectivity (FC) analysis will allow investigators to further the current understanding of brainstem control of the LUT and bladder cycle.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Females with Normal Bladder Function | – | Diagnostic Test: Magnetic Resonance Imaging (MRI), Diagnostic Test: Post-Void Residual, Diagnostic Test: Uroflowmetry, Behavioral: Questionaire - AUA Symptom ScoreDiagnostic Tests: functional MRI and urodynamic studies. During screening, subject will be asked to come to their appointment with a full bladder. For the uroflow, they will urinate into a special funnel connected to a measuring instrument in a private bathroom followed by measuring Post void residual volume through PVR scanner. This is to ensure that they do not have any urological issue which can disqualify them from the study. At this visit, we will also instruct them about the urine voiding-holding task, our noninvasive fMRI paradigm, which the subjects will be performing during the fMRI portion of the study at visit 2. A 7-Tesla Siemens MAGNETOM scanner will be used. A urinary pouch will be used to collect the participant's urine while in the scanner. |
| Males with Normal Bladder Function | – | Diagnostic Test: Magnetic Resonance Imaging (MRI), Diagnostic Test: Post-Void Residual, Diagnostic Test: Uroflowmetry, Behavioral: Questionaire - AUA Symptom ScoreDiagnostic Tests: functional MRI and urodynamic studies. During screening, subject will be asked to come to their appointment with a full bladder. For the uroflow, they will urinate into a special funnel connected to a measuring instrument in a private bathroom followed by measuring Post void residual volume through PVR scanner. This is to ensure that they do not have any urological issue which can disqualify them from the study. At this visit, we will also instruct them about the urine voiding-holding task, our noninvasive fMRI paradigm, which the subjects will be performing during the fMRI portion of the study at visit 2. A 7-Tesla Siemens MAGNETOM scanner will be used. A condom catheter will be used to collect the participant's urine while in the scanner. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- We will recruit healthy male and female volunteers > 18 years of age with no neurological disease and urinary issues at Houston Methodist Hospital. We anticipate an equal gender distribution (10 men and 10 women) among study participants. Once screened for inclusion and exclusion criteria, volunteers will be approached and asked if they would like to participate in this study. They will then be given study material and allowed sufficient time to make an informed decision regarding participation.
Key inclusion criteria (5 listed)
- Healthy adult male and female volunteers ≥18 years of age with no neurological disease and genitourinary abnormalities will be screened:
- Post-Void Residual (PVR) < 20% of their bladder capacity OR
- Above 10 percentile of Liverpool nomogram
- AND
- AUASS score < 7 will be eligible to participate in the study.
Key exclusion criteria (9 listed)
- history of clinically relevant genitourinary malignancy or surgery such as:
- any neurological disorders
- history of seizures,
- pregnancy or planning to become pregnant,
- and contraindications to MRI will be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnetic Resonance Imaging (MRI)A T1-weighted Anatomical Image, Diffusion Weighted Image, and functional MRI (fMRI) of "empty bladder" image will be obtained. Additionally, fMRI image during "full bladder" state and voiding/holding tasks will be obtained. | Diagnostic test | Females with Normal Bladder Function, Males with Normal Bladder Function |
| Post-Void ResidualAlso: PVRThe patient's post-void residual is determined using a portable ultrasound machine after emptying the bladder just prior to entering the MRI scanner and immediately after the MRI scan. | Diagnostic test | Females with Normal Bladder Function, Males with Normal Bladder Function |
| UroflowmetryPatients will urinate into a funnel connected to an electric flow meter to record urine flow rates in mililters per second. This is used as part of the screening process. | Diagnostic test | Females with Normal Bladder Function, Males with Normal Bladder Function |
| Questionaire - AUA Symptom ScoreAlso: AUASSSubjects will fill out questionnaire asking about urinary symptoms. The range is 0-35. | Behavioural | Females with Normal Bladder Function, Males with Normal Bladder Function |
Primary outcome
Blood Oxygen Level Dependent (BOLD) signals intensity
Time frame: 2 years
BOLD signal intensity in the regions of interest during empty bladder, full bladder, and micturition in healthy males and females
6 secondary outcomes
Blood Oxygen Level Dependent (BOLD) signals
Time frame: 2 years
Uroflow measure
Time frame: 2 years
Postvoid Residual
Time frame: 2 years
Urinary symptoms scores
Time frame: 2 years
Mean Diffusivity (MD)
Time frame: 2 years
Fractional Anisotropy (FA)
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rose Khavari, MD principal investigator
The Methodist Hospital Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by The Methodist Hospital Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood Oxygen Level Dependent (BOLD) signals intensity (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2025.