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NCT05109208 Clinical Trial

The Use of Ultrasound in Assessing Post-prostatectomy Erectile Dysfunction

Prostate Adenocarcinoma Clinical Trial

Official title:
Ultrasound Vibroelastography in Post-Prostatectomy Erectile Dysfunction

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05109208
Other study ID # 21-001713
Secondary ID NCI-2024-00502
Status Recruiting
Phase N/A
First received
Last updated
Start date October 2, 2023
Est. completion date October 2025

Study information
Verified date March 2024
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Researchers are trying to determine whether there is additional utility to using vibroelastography, a noninvasive ultrasound technique to evaluate for the presence of tissue fibrosis, in conjunction with standard penile duplex Doppler ultrasound to assess erectile function (recovery) after prostate cancer surgery.

Recruitment information / eligibility
Status Recruiting
Enrollment 10
Est. completion date October 2025
Est. primary completion date October 2025
Accepts healthy volunteers No
Gender Male
Age group 40 Years and older
Eligibility Inclusion criteria include: - Age > 40 years - Clinically localized prostate cancer (American Urological Association Grade Groups 1-2; cT1c or cT2a-b; PSA < 10) without clinic or imaging evidence of localized extra-prostatic or metastatic disease (i.e. AUA low and favorable intermediate risk prostate cancer) - International Index of Erectile Function (IIEF) of = 21 points at baseline (no or mild erectile dysfunction) - Patient-expressed interest in consultation for sexual function (erectile function) preservation/ optimization - Planned bilateral nerves-paring prostatectomy Exclusion criteria include: - Moderate or severe ED based in IIEF criteria (score < 21) - History of prior pelvic or penile surgery - Current or prior androgen deprivation therapy - Planned non-nerve sparing prostatectomy

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Ulrasound Vibroelastography (UVE)
Ultrasound technique to quantitatively assess tissue stiffness (elasticity and viscosity) by applying vibration through a specialized probe (indenter).

Locations
Country Name City State
United States Mayo Clinic in Rochester Rochester Minnesota

Sponsors (1)
Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in Viscoelasticity As measured by Ultrasound Vibroelastography (UVE) Baseline, 3 months, 6 months and 9 months post-prostatectomy
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