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Diagnostic Test
Ultrasound for Erectile Dysfunction
N/A
Recruiting
Led By Matthew Ziegelmann, MD
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 3 months, 6 months and 9 months post-prostatectomy
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to investigate if adding vibroelastography, a noninvasive ultrasound technique, to the standard penile duplex Doppler ultrasound can help evaluate tissue fibrosis and erectile function recovery after
Who is the study for?
Men over 40 with early-stage prostate cancer (low to intermediate risk) and mild or no erectile dysfunction, as measured by a score of ≥21 on the IIEF. They must be interested in preserving sexual function and planning to undergo nerve-sparing prostatectomy surgery.
What is being tested?
The trial is testing Ultrasound Vibroelastography (UVE), a noninvasive technique, alongside standard penile duplex Doppler ultrasound to see if it better assesses erectile function recovery after prostate cancer surgery.
What are the potential side effects?
Since UVE is a diagnostic procedure using ultrasound, side effects are minimal but may include discomfort during the procedure or minor skin irritation.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 3 months, 6 months and 9 months post-prostatectomy
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 3 months, 6 months and 9 months post-prostatectomy
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in Viscoelasticity
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Ultrasound viscoelastography (UVE) in radical proctectomy recoveryExperimental Treatment1 Intervention
Subjects undergoing radical prostatectomy for prostate cancer disease as standard of care will have a ultrasound vibroelastography performed before surgery, 3 months, 6 months and 9 months post-prostatectomy.
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Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,339 Previous Clinical Trials
3,062,135 Total Patients Enrolled
Matthew Ziegelmann, MDPrincipal InvestigatorMayo Clinic
2 Previous Clinical Trials
192 Total Patients Enrolled
Matthew J. Ziegelmann, M.D.Principal InvestigatorMayo Clinic
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