The Use of Ultrasound in Assessing Post-prostatectomy Erectile Dysfunction

Mayo Clinic

Status: Enrolling

Conditions: Prostate Adenocarcinoma

Treatments: Diagnostic Test: Ulrasound Vibroelastography (UVE)

Study type: Interventional

Funder types: Other

Identifiers

NCT05109208

21-001713

NCI-2024-00502 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment: 10 estimated patients

Sex: Male

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Health Services Research

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Ultrasound viscoelastography (UVE) in radical proctectomy recovery

Experimental group

Description:

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.

Treatment:

Diagnostic Test: Ulrasound Vibroelastography (UVE)