Voiding DisordersNCT03991429
Brain Imaging in Men With Lower Urinary Tract Symptoms
An observational study of Voiding Disorders, run by The Methodist Hospital Research Institute at 1 site in United States.
Trial summary
Benign Prostatic Hyperplasia (BPH) affects the storage and voiding phases of the micturition cycle. Lower urinary tract symptoms (LUTS) refers to storage symptoms such as urinary frequency, urgency, urge urinary incontinence and nocturia. Read more about this study
- Who is it for?
- Ages 45 to 90 years, men only
- Conditions the study is for
- Voiding Disorders
- What is being tested?
- Simultaneous functional MRI and urodynamic studies, Questionnaires and Post Void Residual (PVR), Uroflow and Bladder Diary
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Jun 2019to 31 Jul 2022
- 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 45 to 90 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Houston Methodist Hospital has four fulltime fellowship-trained Urologists in the field of functional Urology and voiding dysfunction who perform over 300 Bladder Outlet Obstruction procedures per year. Patients for our study will be recruited from our clinics
Who may be able to join
- Controls (n=13) Men older than 45 years undergoing radical prostatectomy without LUTS
- IPSS (International prostate symptom score lower than 12)
- Nocturia equal or less than 2 on a two day bladder diary
- Group 1 (n=18) Men older than 45 with improved LUTS after 6 months of a BOO procedure and IPSS less than 12
- Improvement in IPSS in at least 3 points for storage symptoms
- Nocturia equal or less than 2 on a two day bladder diary
Show all 10Show fewer
- Group 2 (n=9) Men older than 45 with persistent LUTS at six months post BOO procedure
- IPSS higher than 8
- Nocturia more than 2
- Delta change in IPSS score less than negative 3 points
Who cannot join
- Men with
- Neurogenic bladder
- Urethral stricture
- Prior BOO procedures
- History of urinary retention with indwelling foley catheter or intermittent catheterization Additional exclusion criteria for Group 1 and 2 (Subjects with BPH and LUTS)
- History of bladder cancer within 5 years
- History of treatment for prostate cancer other than active surveillance
- Intradetrusor injection of BTX-A within 9 months prior to screening for any urological condition
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Higher Neural Contribution Underlying Lower Urinary Tract Symptoms in Men With Benign Prostatic Hyperplasia Undergoing Bladder Outlet Procedures.
Benign Prostatic Hyperplasia (BPH) affects the storage and voiding phases of the micturition cycle. Lower urinary tract symptoms (LUTS) refers to storage symptoms such as urinary frequency, urgency, urge urinary incontinence and nocturia. Surgical options for bladder outlet obstruction (BOO), including prostate ablation and transurethral resection, are currently offered for symptomatic improvement. However, 30% of patients report persistent LUTS after BOO procedures. Neuroplasticity induced by BPH and BOO can be contributory of persistent LUTS in these men, having different brain activation patterns during the micturition cycle. The investigators proposed unique multimodal functional Magnetic Resonance Imaging (fMRI) study that will identify for the first time, structural and functional brain contributions to LUTS in men with BPH and BOO at baseline and following BOO procedures. The investigators hypothesize that men with symptomatic BPH who have persistent LUTS following BOO procedures have a distinct brain activation pattern in Regions of Interest (RoI) that regulate the micturition cycle.
Read the detailed description
The investigators propose a unique, multimodal prospective study that will allow investigators to identify for the first time the structural and functional brain contributions to LUTS in men with BPH and BOO at baseline and post procedure. For this, The investigators will recruit three different groups of patients:
Group 1: Patients with BPH and significant improvement in the storage symptoms following BOO procedures.
Group 2: Patients with BPH who have persistent storage symptoms following BOO procedures.
Group 3 (CONTROL GROUP): Men without LUTS who are planning to undergo radical prostatectomy.
Each participant will provide a detailed history, undergo a complete physical examination and will have the following assessments: IPSS, IPSS Quality of life, Incontinence Severity Index (ISI), Patient Global impression of severity (PGI-S) and improvement (PGI-I)19, 20, International Index of Erectile Function (IIEF-5), MRI Safety Screening Questionnaire. A post void residual volume will be measured and a urine sample will be obtained for urinalysis (patients and controls). A two-day bladder diary will also be obtained from the participants. Participants in group 1 and 2 will undergo a clinical urodynamic study within a year prior to the neuroimaging scan. All participants will be followed up at one, three and six months after the BOO procedures (Transurethral resection/ablation of prostate and simple prostatectomy) and radical prostatectomy in the control group. On each visit, the investigators will gather the following data: Uroflow and PVR assessment, bladder diary, and all questionnaires will be repeated in all patients at one, three, and six months. Participants with persistent storage LUTS at six months will have a repeat UDS to ensure BOO is resolved. Group 1 and 2 will undergo simultaneous fMRI/UDS scanning twice during this study: First before BOO procedures and at the second one at six months. The control group will undergo baseline fMRI/UDS.
Investigators' established platform for simultaneous urodynamic study and functional MRI scanning will allow investigators to detect structural changes during the micturition cycle. Providing 3D structural images and functional images to have a better understanding of the brain effect on LUTS. By correlating the bold signal changes, structural markers and participant's clinical data, investigators will provide scientific rationale for subsequent studies in the field of neurourology.
- Conditions
- Voiding Disorders
- Being tested
- Simultaneous functional MRI and urodynamic studies, Questionnaires, Post Void Residual (PVR), Uroflow and Bladder Diary, Urinalysis
- Keywords
- Voiding dysfunction, Benign Prostatic Hyperplasia (BPH), Lower urinary tract symptoms (LUTS), Functional Magnetic Resonance Imaging, Urodynamic studies
- Medical subject headings
- Prostatic Hyperplasia, Lower Urinary Tract Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simultaneous functional MRI and urodynamic studiesDiagnostic test
Double lumen 7 Fr MRI-compatible catheters will be placed in the bladder and rectum. A Phillips Ingenia 3.0T full body MRI scanner with standard 12 channel head coil will be used. Instructions to communicate using right hand signals representing "full urge" and "voiding or attempt of voiding" will be given. Signs will be shown to the patient when filling of the bladder is begun and when filling is stopped. Also, in order to keep our noise-to-signal ratio low, all stimulators including any extra visual stimuli and the UDS machine will be removed from the MRI scanner room. The filling and voiding cycle will be repeated up to 4 times in each patient. Bladder will be aspirated after each voiding. This algorithm will be performed before, and, 3 and 6 months following BOO procedure.
QuestionnairesBehavioural
Each patient will provide a detailed history and undergo a complete physical examination. Each patient will have the following assessments: IPSS and Incontinence Severity Index (ISI), Patient Global impression of severity (PGI-S) and improvement (PGI-I), International Index of Erectile Function (IIEF-5), MRI Safety Screening Questionnaire.
Post Void Residual (PVR), Uroflow and Bladder DiaryOther
Follow-up assessments: Uroflow and PVR assessment, bladder diary, and all questionnaires will be repeated in all patients at one, three, and six months.
UrinalysisDiagnostic test
Urine sample
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Patients with BPH and significant improvement in storage symptoms after BOO procedures Receives: Diagnostic Test: Simultaneous functional MRI and urodynamic studies; Behavioral: Questionnaires; Other: Post Void Residual (PVR), Uroflow and Bladder Diary; Diagnostic Test: Urinalysis | |
| Group 2 | Patients with BPH who have persistent storage symptoms after BOO procedures Receives: Diagnostic Test: Simultaneous functional MRI and urodynamic studies; Behavioral: Questionnaires; Other: Post Void Residual (PVR), Uroflow and Bladder Diary; Diagnostic Test: Urinalysis | |
| Group 3 (Control group) | Men without LUTS who are planning to undergo radical prostatectomy Receives: Diagnostic Test: Simultaneous functional MRI and urodynamic studies; Behavioral: Questionnaires; Other: Post Void Residual (PVR), Uroflow and Bladder Diary; Diagnostic Test: Urinalysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Oxygen Level Dependent (BOLD) signals
BOLD signal intensity in the Regions of Interest at the point of "full urge" at baseline and following Bladder Outlet Obstruction (BOO) procedures in groups 1, 2, and controls.
Measured: 1 year
Secondary outcomes (5)
Fractional Anisotropy (FA)
FA; Fractional anisotropy (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, i.e. it is unrestricted (or equally restricted) in all directions. No units.
Measured: 1 year
Mean Diffusivity (MD)
Mean diffusivity of Anterior Thalamic Radiation (ATR) and Superior Longitudinal Fasciculus (SLF) white matter tracts in groups 1,2, and controls. MD is a scalar value between zero and one that describes the degree of diffusivity. No units.
Measured: 1 year
Uroflow measure
Maximum Qmax of urine (ml/sec): The range is between 0-40 ml/ sec.
Measured: 1 year
Postvoid Residual
Postvoid Residual (PVR) of urine in mL: The range is between 0-900 ml.
Measured: 1 year
Urinary symptoms scores
Urinary symptoms scores (no unit): The range is between 0-35
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2019
- Study start4 Jun 2019
- Primary completion30 Jul 2022
- Study completion31 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Voiding DisordersStudies of the same condition, open and under way.
- 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
- 11 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
- NCT03991429
- Sponsor's protocol ID
- Pro00020695
- Status last verified
- Jan 2023
- First submitted
- 2 Jan 2019
- Last updated
- 5 Jan 2023
- 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 5 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Higher Neural Contribution Underlying Lower Urinary Tract Symptoms in Men With Benign Prostatic Hyperplasia Undergoing Bladder Outlet Procedures.
- ClinicalTrials.gov ID
- NCT03991429
- Acronym / sponsor ID
- Pro00020695
- Conditions
- Voiding Disorders
- Keywords
- Voiding dysfunction, Benign Prostatic Hyperplasia (BPH), Lower urinary tract symptoms (LUTS), Functional Magnetic Resonance Imaging, Urodynamic studies
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- The Methodist Hospital Research InstituteUniversity, hospital or other
- Study start
- 4 Jun 2019 (actual)
- Primary completion
- 30 Jul 2022 (actual)
- Study completion
- 31 Jul 2022 (actual)
- First posted
- 19 Jun 2019 (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.
Benign Prostatic Hyperplasia (BPH) affects the storage and voiding phases of the micturition cycle. Lower urinary tract symptoms (LUTS) refers to storage symptoms such as urinary frequency, urgency, urge urinary incontinence and nocturia. Surgical options for bladder outlet obstruction (BOO), including prostate ablation and transurethral resection, are currently offered for symptomatic improvement. However, 30% of patients report persistent LUTS after BOO procedures. Neuroplasticity induced by BPH and BOO can be contributory of persistent LUTS in these men, having different brain activation patterns during the micturition cycle. The investigators proposed unique multimodal functional Magnetic Resonance Imaging (fMRI) study that will identify for the first time, structural and functional brain contributions to LUTS in men with BPH and BOO at baseline and following BOO procedures. The investigators hypothesize that men with symptomatic BPH who have persistent LUTS following BOO procedures have a distinct brain activation pattern in Regions of Interest (RoI) that regulate the micturition cycle.
Detailed description
The investigators propose a unique, multimodal prospective study that will allow investigators to identify for the first time the structural and functional brain contributions to LUTS in men with BPH and BOO at baseline and post procedure. For this, The investigators will recruit three different groups of patients:
Group 1: Patients with BPH and significant improvement in the storage symptoms following BOO procedures.
Group 2: Patients with BPH who have persistent storage symptoms following BOO procedures.
Group 3 (CONTROL GROUP): Men without LUTS who are planning to undergo radical prostatectomy.
Each participant will provide a detailed history, undergo a complete physical examination and will have the following assessments: IPSS, IPSS Quality of life, Incontinence Severity Index (ISI), Patient Global impression of severity (PGI-S) and improvement (PGI-I)19, 20, International Index of Erectile Function (IIEF-5), MRI Safety Screening Questionnaire. A post void residual volume will be measured and a urine sample will be obtained for urinalysis (patients and controls). A two-day bladder diary will also be obtained from the participants. Participants in group 1 and 2 will undergo a clinical urodynamic study within a year prior to the neuroimaging scan. All participants will be followed up at one, three and six months after the BOO procedures (Transurethral resection/ablation of prostate and simple prostatectomy) and radical prostatectomy in the control group. On each visit, the investigators will gather the following data: Uroflow and PVR assessment, bladder diary, and all questionnaires will be repeated in all patients at one, three, and six months. Participants with persistent storage LUTS at six months will have a repeat UDS to ensure BOO is resolved. Group 1 and 2 will undergo simultaneous fMRI/UDS scanning twice during this study: First before BOO procedures and at the second one at six months. The control group will undergo baseline fMRI/UDS.
Investigators' established platform for simultaneous urodynamic study and functional MRI scanning will allow investigators to detect structural changes during the micturition cycle. Providing 3D structural images and functional images to have a better understanding of the brain effect on LUTS. By correlating the bold signal changes, structural markers and participant's clinical data, investigators will provide scientific rationale for subsequent studies in the field of neurourology.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Diagnostic Test: Simultaneous functional MRI and urodynamic studies, Behavioral: Questionnaires, Other: Post Void Residual (PVR), Uroflow and Bladder Diary, Diagnostic Test: UrinalysisPatients with BPH and significant improvement in storage symptoms after BOO procedures |
| Group 2 | – | Diagnostic Test: Simultaneous functional MRI and urodynamic studies, Behavioral: Questionnaires, Other: Post Void Residual (PVR), Uroflow and Bladder Diary, Diagnostic Test: UrinalysisPatients with BPH who have persistent storage symptoms after BOO procedures |
| Group 3 (Control group) | – | Diagnostic Test: Simultaneous functional MRI and urodynamic studies, Behavioral: Questionnaires, Other: Post Void Residual (PVR), Uroflow and Bladder Diary, Diagnostic Test: UrinalysisMen without LUTS who are planning to undergo radical prostatectomy |
Who may qualify
- Ages
- 45 to 90 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Houston Methodist Hospital has four fulltime fellowship-trained Urologists in the field of functional Urology and voiding dysfunction who perform over 300 Bladder Outlet Obstruction procedures per year. Patients for our study will be recruited from our clinics
Key inclusion criteria (10 listed)
- Controls (n=13) Men older than 45 years undergoing radical prostatectomy without LUTS
- IPSS (International prostate symptom score lower than 12)
- Nocturia equal or less than 2 on a two day bladder diary
- Group 1 (n=18) Men older than 45 with improved LUTS after 6 months of a BOO procedure and IPSS less than 12
- Improvement in IPSS in at least 3 points for storage symptoms
Key exclusion criteria (8 listed)
- Men with
- Neurogenic bladder
- Urethral stricture
- Prior BOO procedures
- History of urinary retention with indwelling foley catheter or intermittent catheterization Additional exclusion criteria for Group 1 and 2 (Subjects with BPH and LUTS)
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 |
|---|---|---|
| Simultaneous functional MRI and urodynamic studiesDouble lumen 7 Fr MRI-compatible catheters will be placed in the bladder and rectum. A Phillips Ingenia 3.0T full body MRI scanner with standard 12 channel head coil will be used. Instructions to communicate using right hand signals representing "full urge" and "voiding or attempt of voiding" will be given. Signs will be shown to the patient when filling of the bladder is begun and when filling is stopped. Also, in order to keep our noise-to-signal ratio low, all stimulators including any extra visual stimuli and the UDS machine will be removed from the MRI scanner room. The filling and voiding cycle will be repeated up to 4 times in each patient. Bladder will be aspirated after each voiding. This algorithm will be performed before, and, 3 and 6 months following BOO procedure. | Diagnostic test | Group 1, Group 2, Group 3 (Control group) |
| QuestionnairesEach patient will provide a detailed history and undergo a complete physical examination. Each patient will have the following assessments: IPSS and Incontinence Severity Index (ISI), Patient Global impression of severity (PGI-S) and improvement (PGI-I), International Index of Erectile Function (IIEF-5), MRI Safety Screening Questionnaire. | Behavioural | Group 1, Group 2, Group 3 (Control group) |
| Post Void Residual (PVR), Uroflow and Bladder DiaryFollow-up assessments: Uroflow and PVR assessment, bladder diary, and all questionnaires will be repeated in all patients at one, three, and six months. | Other | Group 1, Group 2, Group 3 (Control group) |
| UrinalysisUrine sample | Diagnostic test | Group 1, Group 2, Group 3 (Control group) |
Primary outcome
Blood Oxygen Level Dependent (BOLD) signals
Time frame: 1 year
BOLD signal intensity in the Regions of Interest at the point of "full urge" at baseline and following Bladder Outlet Obstruction (BOO) procedures in groups 1, 2, and controls.
5 secondary outcomes
Fractional Anisotropy (FA)
Time frame: 1 year
Mean Diffusivity (MD)
Time frame: 1 year
Uroflow measure
Time frame: 1 year
Postvoid Residual
Time frame: 1 year
Urinary symptoms scores
Time frame: 1 year
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 5 Jan 2023.
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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 Voiding Disorders, 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 10 inclusion and 8 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 5 Jan 2023. 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 (time frame: 1 year). 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 5 Jan 2023; AzTrials last refreshed its copy on 30 Oct 2026.