Recruiting

Ultrasound Urodynamics

Sponsor:

University of Wisconsin, Madison

Code:

NCT06323109

Conditions

Lower Urinary Tract Symptoms

BPH

Eligibility Criteria

Sex: Male

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

MRI-UDS; US-UDS; MCUD

Study Details

Brief 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).

Conditions

Lower Urinary Tract Symptoms

BPH

Study ID

NCT06323109

Start date

Nov 28, 2023

Status verified date

Dec, 2025

Completion date

Jan, 2027

Anticipated

Primary completion date

Jan, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria: Patients with BPH/LUTS

  • Age 18-80 years old
  • Diagnosed with BPH/LUTS with or without obstruction

Exclusion Criteria:

  • 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).

Inclusion Criteria: Healthy Volunteers

\- Age 18-80 years old not experiencing any symptoms consistent with LUTS

Exclusion Criteria:

  • 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.

Study Design

Enrollment

80 participants

Anticipated

Interventions and Outcome Measures

Arms

Healthy Controls

Age-matched healthy men with no lower urinary tract symptoms

Known BPH/LUTS

Adult men diagnosed with BPH/LUTS

Interventions

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.

Primary outcome measure

  • MRI Urodynamics - Change in Bladder Volume [ Time Frame: Research visit 1 day ]
  • MRI Urodynamics - Change in Urine Velocity [ Time Frame: Research visit 1 day ]
  • MRI Urodynamics - Change in Pressure [ Time Frame: Research visit 1 day ]
  • Bladder outlet obstruction index (BOOI) [ Time Frame: Research visit 1 day ]
  • Bladder contractility index (BOI) [ Time Frame: Research visit 1 day ]
  • International Prostate Symptom Score (IPSS) [ Time Frame: Research visit 1 day ]

Central Contacts and Locations

Central contacts

Radiology Studies

608-282-8349Radstudy@uwhealth.org

Suzanne Hanson, BS

608.262.7269shanson@uwhealth.org

Locations

University of Wisconsin

Recruiting

Madison, Wisconsin, United States, 53705

Principal Investigator:

Alejandro Roldan-Alzate, PhD

More Information

Sponsor

University of Wisconsin, Madison

Last update posted

Dec 22, 2025

Last verified

Dec, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-10. This information was provided to ClinicalTrials.gov by University of Wisconsin, Madison on 2025-12-22. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.