Recruiting

NCT Number: NCT05109208

The Use of Ultrasound in Assessing Post-prostatectomy Erectile Dysfunction

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.

Recruiting

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Key information

Conditions

Prostate Adenocarcinoma

Age range

40 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location status: Recruiting

Location contact

Clinical Trials Referral Office

CONTACT

[email protected]

855-776-0015

Matt J. Ziegelmann, M.D.

PRINCIPAL_INVESTIGATOR

Wyatt Anians

CONTACT

[email protected]

507-538-6151

Xiaoming Zhang, Ph.D.

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ulrasound Vibroelastography (UVE)

Diagnostic Test

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

Primary outcomes

Change in Viscoelasticity

Time frame: Baseline, 3 months, 6 months and 9 months post-prostatectomy

As measured by Ultrasound Vibroelastography (UVE)

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

Ultrasound Vibroelastography in Post-Prostatectomy Erectile Dysfunction

Important dates

Study start: 2023
Primary completion: 2028
Study completion: 2028
First posted: Nov 5, 2021
Registry last updated: Jun 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Recruiting