The Use of Ultrasound in Assessing Post-prostatectomy Erectile Dysfunction

NCT05109208 | Recruiting

• 1 other identifier: 21-001713
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Prostate Adenocarcinoma

Keywords

Radical Prostatectomy

Outcome Measures

Primary Outcomes (1)

• Change in Viscoelasticity

  As measured by Ultrasound Vibroelastography (UVE)

  Baseline, 3 months, 6 months and 9 months post-prostatectomy

Study Arms (1)

Ultrasound viscoelastography (UVE) in radical proctectomy recovery

EXPERIMENTAL

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.

Diagnostic Test: Ulrasound Vibroelastography (UVE)

Interventions

Ulrasound Vibroelastography (UVE) DIAGNOSTIC_TEST

Ultrasound technique to quantitatively assess tissue stiffness (elasticity and viscosity) by applying vibration through a specialized probe (indenter).

Ultrasound viscoelastography (UVE) in radical proctectomy recovery

Eligibility Criteria

• Age: 40 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

RECRUITING

Related Links

• Mayo Clinic Clinical Trials

Study Officials

• Matthew J. Ziegelmann, M.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2021
• First Posted: November 5, 2021
• Study Start: October 2, 2023
• Primary Completion (Estimated): October 31, 2028
• Study Completion (Estimated): October 31, 2028
• Last Updated: June 9, 2026

Record last verified: 2026-06

Locations

US (1)