RecruitingNCT06323109

US Imaging for the Assessment of LUTS

Ultrasound Imaging for the Assessment of Lower Urinary Tract Symptoms


Sponsor

University of Wisconsin, Madison

Enrollment

80 participants

Start Date

Nov 28, 2023

Study Type

OBSERVATIONAL

Conditions

Summary

The purpose of this research is to develop an ultrasound (US) based urodynamics (UDS) evaluation of voiding based on successful magnetic resonance imaging (MRI)-UDS evaluation. Both US and MRI are non-invasive imaging techniques, but US is a more cost-effective and widely available technology. 80 participants will be enrolled and will be on study for up to 2.5 hours (1.5 hour MRI and 1 hour US).


Eligibility

Sex: MALEMin Age: 18 YearsMax Age: 80 Years

Inclusion Criteria3

  • Age 18-80 years old
  • Diagnosed with BPH/LUTS with or without obstruction
  • \- Age 18-80 years old not experiencing any symptoms consistent with LUTS

Exclusion Criteria4

  • Patients with contraindication to MRI and/or GBCA contrast agent. Diabetic subjects will not receive contrast.
  • 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.

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Interventions

DEVICEMRI-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.


Locations(1)

University of Wisconsin

Madison, Wisconsin, United States

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NCT06323109


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