Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
80 participants
OBSERVATIONAL
2023-11-28
2027-01-31
Brief Summary
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Detailed Description
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Men with BPH/LUTS and age-matched controls will undergo a comprehensive protocol of dynamic MRI, 3D ultrasound and multi-channel urodynamics (MCUD) to evaluate and validate this novel methodology.
Specific aims include:
Aim 1. Develop an ultrasound/CFD based urodynamics (US-UDS) method. A protocol combining 3D US imaging and CFD analysis will be developed. This approach will be validated both in vitro and in vivo, first in an anatomically realistic model and then in control human subjects.
Aim 2. Establish the accuracy of voiding metrics determined with ultrasound urodynamics (US-UDS). MCUD, MRI-UDS and the new US-UDS protocols will all be performed to evaluate voiding in patients with BPH/LUTS and healthy controls. Urodynamic metrics derived from ultrasound will be compared to those obtained from the reference clinical standard MCUD and MRI-UDS.
Aim 3. Develop an optical velocimetry methods that allows the non-invasive quantification of urine velocity while voiding. A setup of high speed cameras will be assembled and utilized to optically image the voiding stream in all subjects recruited for aims 1 and 2.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Healthy Controls
Age-matched healthy men with no lower urinary tract symptoms
MRI-UDS; US-UDS; MCUD
Imaging procedures will include a comprehensive protocol of dynamic MRI, 3D ultrasound and MCUD to evaluate and validate this entirely novel methodology.
Known BPH/LUTS
Adult men diagnosed with BPH/LUTS
MRI-UDS; US-UDS; MCUD
Imaging procedures will include a comprehensive protocol of dynamic MRI, 3D ultrasound and MCUD to evaluate and validate this entirely novel methodology.
Interventions
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MRI-UDS; US-UDS; MCUD
Imaging procedures will include a comprehensive protocol of dynamic MRI, 3D ultrasound and MCUD to evaluate and validate this entirely novel methodology.
Eligibility Criteria
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Inclusion Criteria
* Diagnosed with BPH/LUTS with or without obstruction
\- Age 18-80 years old not experiencing any symptoms consistent with LUTS
Exclusion Criteria
* History of overt neurologic disease other than diabetic neuropathy, urinary tract infection within the last 4 weeks or recent history of urinary retention (within the last 4 weeks).
* Patients with contraindication to MRI and/or GBCA contrast agent.
* Currently taking medications with known effects on the bladder, overt neurologic disease other than diabetic neuropathy, urinary tract infection within the last 4 weeks or urinary retention symptoms.
18 Years
80 Years
MALE
Yes
Sponsors
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Wisconsin Partnership Program
OTHER
University of Wisconsin, Madison
OTHER
Responsible Party
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Principal Investigators
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Alejandro Roldan-Alzate, PhD
Role: PRINCIPAL_INVESTIGATOR
UW Department of Mechanical Engineering and Radiology
Locations
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University of Wisconsin
Madison, Wisconsin, United States
Countries
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Central Contacts
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Other Identifiers
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A196200
Identifier Type: OTHER
Identifier Source: secondary_id
Protocol Version 12/19/24
Identifier Type: OTHER
Identifier Source: secondary_id
2023-1331
Identifier Type: -
Identifier Source: org_study_id