The Use of Ultrasound in Assessing Post-prostatectomy Erectile Dysfunction

Overview

About this study

This is a single-center, prospective, single-cohort unblinded pilot study that will enroll 10 patients undergoing radical prostatectomy for prostate adenocarcinoma. The studies will be carried out through collaboration between the primary investigator teams in the departments of urology and radiology. The goal is 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. Potential study participants will be identified during consultation for prostate cancer in the urology clinic at Mayo Clinic in Rochester, MN. Given that we perform approximately 300-500 prostatectomies at Mayo Clinic annually, we anticipate a large pool of potential participants to recruit for the current study protocol.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

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:

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.

Eligibility last updated 4/14/23. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location	Status	Contact
Rochester, Minn. Mayo Clinic principal investigator Matthew Ziegelmann, M.D.	Open for enrollment	Contact information: Wyatt Anians CCRP (507) 538-6151 Anians.Wyatt@mayo.edu

Mayo Clinic Location

Status

Contact

Rochester, Minn.

Mayo Clinic principal investigator

Matthew Ziegelmann, M.D.

Open for enrollment

Contact information:

Wyatt Anians CCRP

(507) 538-6151

Anians.Wyatt@mayo.edu

More information

Publications

Publications are currently not available

Clinical Trials